Alere

COVID-19 NEWS UPDATES

Independent Testing Confirms Human Coronavirus Efficacy

3B Medical announced completion of independent lab testing of Lumin used to decontaminate an N95 respirator. Lumin, a UV sanitizer, has a measured UVC irradiance output of roughly 2,000 mJ/cm2, well in excess of the dose requirement to kill most bacteria and viruses. This latest test study by Microchem utilized an N95 respirator inoculated with Human Coronavirus. In this study, Lumin evidenced greater than a 99.9% kill of Human Coronavirus. Lab results available upon request. Lumin is a high-powered UVC based sanitizing device, initially developed for home use to clean CPAP accessories in a mirrored chamber. It is lab tested to kill bacteria and germs, including human coronavirus and influenza. 3B Medical is a leader in the development; marketing and distribution of medical products for the treatment of sleep disordered breathing and oxygen therapy.

Severe Disease Not Uncommon in Kids Hospitalized With COVID-19

Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest. Jerry Y Chao, MD, from the Department of Anesthesiology, Albert Einstein College of Medicine, Montefiore Medical Center, New York City, and colleagues report their findings in an article published online May 11 in the Journal of Pediatrics. "Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care," senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children's Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release. The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children's hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients. "As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis," the authors write. Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU). Almost one third (14 children; 30.4%) of the admitted patients were obese, and almost one quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission. "We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit," Chao said in the news release. Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. "There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU," the authors write. Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.

Asthma Prolongs Intubation Time in COVID-19 Patients

Asthma may prolong the time a person hospitalized with COVID-19 is on a ventilator, a new study suggests. "Although asthmatics might not be at higher risk to acquire the virus, once they do, asthmatics have a significantly more difficult time with longer intubation and ICU admission," Dr Mahboobeh Mahdavinia of Rush University Medical Center in Chicago said by email. To assess the impact of preexisting asthma on COVID-19 outcomes, the researchers studied 935 patients with confirmed COVID-19, of whom 241 (25.8%) had a diagnosis of asthma. Asthmatic patients with COVID-19 required intubation for about five days more on average than non-asthmatic patients with COVID-19 (P=0.01), the researchers report in The Journal of Allergy and Clinical Immunology: In Practice. The longer intubation time with asthma was seen in people aged 18 to 64 but not in those age 65 and older. This suggests that "younger individuals with asthma may require extra attention as they could develop a sustained pulmonary failure with COVID-19 infection, leading to a prolonged mechanical ventilation," the researchers write. The analysis was adjusted for both obesity and gender, which indicates that asthma is independently linked to intubation duration, they note. There was a trend toward longer hospital stays among patients asthma in those 50 to 64 years old but not in the younger or older age groups. Asthma was not associated with higher rate of death (1.1% vs. 3% in asthmatics vs. non-asthmatics, P=0.22) nor with acute respiratory distress syndrome (8.9% vs. 9.5%; P=0.92).

Antibody Testing Suggests Coronavirus More Widespread Than Expected in LA County

In early April, far more individuals in Los Angeles (LA) County had SARS-CoV-2 antibodies than previously thought, suggesting that confirmed cases don't reveal the true extent of infection in a given community, researchers say. "The findings also suggest that we are far away from herd immunity, and thus we should have a long-term planning horizon in evaluating policies for mitigating this disease," Dr Neeraj Sood of the University of Southern California said. "Public health departments in different counties and cities should conduct their own studies where they test a representative set of households in their communities," Dr Sood said. Such tests can "help target resources to areas with higher burden of disease (and) also identify racial/ethnic or socio-economic disparities in burden of disease." Principal author Dr Jayanta Bhattacharya, also of USC, added in a separate email, "An estimate of the prevalence rate will help clinicians in LA County provide better guidance to their patients about the meaning of a positive or negative antibody test result. Without an estimate of the prevalence rate, it is not possible to calculate either the positive predictive value or negative predictive value of a diagnostic test." Using a proprietary database, the researchers invited close to 2,000 people to be tested, of whom 863 agreed to participate: 55% were ages 35-54; 60%, women; 58%, white; and 43% with yearly household incomes greater than $100,000. Because the sample differed on demographics and income distribution from Los Angeles County overall, results were weighted to match the 2018 census on sex, race/ethnicity, and income. As reported in JAMA, a number of participants were symptomatic: 13% had fever with cough; 9%, fever with shortness of breath; and 6% loss of smell or taste. Thirty-five (4.06%) with varying demographics tested positive, for a weighted proportion of 4.31%. After adjusting for test sensitivity and specificity, the unweighted and weighted prevalence of SARSCoV-2 antibodies was 4.34% and 4.65%, respectively. "The estimate implies that approximately 367,000 adults had SARS-CoV-2 antibodies, which is substantially greater than the 8,430 cumulative number of confirmed infections in the county" at the time, the authors note.

More Severe COVID-19 in Patients With Liver Fibrosis

Patients with non-alcoholic fatty liver disease (NAFLD) and increased liver-fibrosis scores experience more severe illness from COVID-19, according to a study of Chinese patients. One recent study found that patients with severe COVID-19 were more likely than patients with nonsevere COVID-19 to have NAFLD. Among patients with NAFLD, the severity of liver fibrosis determines its prognosis. Dr Giovanni Targher of the University of Verona, in Italy, and colleagues investigated whether increased noninvasive liver-fibrosis score—fibrosis-4 (FIB-4) index and NAFLD fibrosis score (NFS)—are associated with an increased risk for severe illness from COVID-19 in 310 patients from Zheijiang Province in China with laboratory-confirmed COVID-19. Of these patients, 94 had NAFLD, including 44 with low FIB-4, 36 with intermediate FIB-4 and 14 with high FIB-4.

The odds of severe COVID-19 illness were increased 4.32-fold (P<0.001) in patients with intermediate FIB-4 scores and 5.73-fold in patients with high FIB-4 scores (P<0.005), the team reports in Gut.

Intermediate/high NFS was associated with 2.91-fold increased odds of severe COVID-19 illness after controlling for sex, obesity, and diabetes. Similarly, increasing FIB-4 or NFS as continuous variables were significantly associated with greater COVID-19 severity after adjusting for sex, obesity, diabetes and the presence/absence of NAFLD.

Comparing COVID-19, Flu Death Tolls 'Extremely Dangerous'

The number of COVID-19 deaths cannot be directly compared to the number of seasonal influenza deaths because they are calculated differently, researchers say in a report. Whereas COVID-19 death rates are determined from actual counts of people who have died, seasonal influenza death rates are estimated by the Centers for Disease Control and Prevention (CDC) using population modeling algorithms, explains Jeremy Samuel Faust, MD, with Harvard Medical School and Brigham and Women's Hospital, Division of Health Policy and Public Health in Boston, Massachusetts. The CDC estimates that between 24,000 and 62,000 people died from influenza during the 2019–2020 season (through April 4). At the time of the analysis (as of April 28), COVID-19 deaths had reached 65,000 in the United States. Some government officials and others have said the numbers seem similar and have used the comparison as an argument for reopening certain areas. But making that comparison "is extremely dangerous," Faust said. "COVID-19 is far more dangerous and is wreaking far more havoc than seasonal influenza ever has," he said. Faust coauthored the perspective article, with Carlos del Rio, MD, Division of Infectious Diseases at Emory University School of Medicine in Atlanta, Georgia. The message and methodology of Faust's and del Rio's article are on target, according to Jonathan L. Temte, MD, PhD, who has been working in influenza surveillance for almost 25 years. Current flu data draw on limited information from primary care practices and hospitals, said Temte, associate dean for public health and community engagement at the University of Wisconsin School of Medicine and Public Health in Madison. The estimates help bridge the gaps, he said, but the system is inherently vulnerable to error.

"Comparing them ― as so many people in this country have done ― to try to diminish the impact of SARS-CoV2 is not fair," he said. The authors illustrate the difference in the way rates of death from influenza are calculated: "Between 2013–2014 and 2018–2019, the reported yearly estimated influenza deaths ranged from 23,000 to 61,000. Over that same time period, however, the number of counted influenza deaths was between 3448 and 15,620 yearly." "It's apparent [the CDC has] been overestimating," Faust said. "If you publish a number on the higher end of the estimate, people might take your public health messages more seriously, such as, it's important to get your yearly flu shot."

COPD Patients Face Much Higher Risk of Severe COVID-19

Patients with chronic obstructive pulmonary disease (COPD) have more than four times higher odds of developing severe COVID-19 infection, while current smokers may also be more prone to severe disease, according to a new review and meta-analysis. "The results of this study indicate that pre-existing COPD is likely to worsen the progression and prognosis of Covid-19," Dr Qianwen Zhao of West China Hospital, Sichuan University, in Chengdu, and colleagues write in the Journal of Medical Virology. "Strong efforts should be directed to avoid infection in patients with underlying COPD." Early case series suggested that COPD and smoking were more prevalent among patients with severe COVID-19, the authors note, although a recent meta-analysis found no link between smoking and severe disease. Dr Zhao and colleagues reviewed 11 articles, one in Chinese and 10 in English, that included 2,002 patients, 334 of whom had severe COVID-19. Ten studies reported preexisting COPD in participants. Pooled odds ratio (OR) for severe COVID-19 was 4.38 for COPD patients (95% confidence interval, 2.34 to 8.20), with moderate heterogeneity among the studies. Pooled analysis of the seven studies that included information on smoking and COVID-19 severity found active smokers had an OR of 1.98 (95% CI, 1.29 to 3.05) for severe disease. When the authors excluded a study that was a "major source of heterogeneity," the increase was no longer significant (OR, 1.55; 95% CI, 0.83 to 2.87), however. The relationship between smoking and severe COVID-19 is "controversial," the authors note, and the excluded study was the only one to distinguish between current and ex-smokers. Also, not all studies reported smoking duration, they add. "It is well known that cessation of smoking improves pulmonary function, however, this benefit is less among older smokers due to the cumulative injury to lung over a prolonged period of time," the authors write. "These results indicate a complicated relationship between smoking history and the severity of Covid-19."

COVID-19 Panel: Helmet CPAP, Pronation Key Tools for Some Patients

Noninvasive ventilation with helmet continuous positive air pressure (CPAP) deserves to be embraced as an effective strategy in preventing self-induced lung injury, often a key factor in progression from the early milder expression of COVID-19 disease to classic severe acute respiratory distress syndrome, according to European physicians who have been through what they hope are the worst days of the pandemic in the Lombardy region of Northern Italy. Helmet CPAP is a relatively inexpensive, convenient, well-tolerated intervention. It allows patients to remain conscious and responsive to commands such as "Time to roll over," which in turn frees up nursing staff. The purpose of helmet CPAP is to curb the huge inspiratory drive that's a defining feature of this disease and which, unchecked, can lead to self-induced lung injury (SILI), Luciano Gattinoni, MD, explained at a webinar hosted by the European Society of Anaesthesiology. "Paranoid attention to inspiratory effort – checking it and correcting it – is something where we can make the difference between death and life. It's extremely important," said Dr Gattinoni, guest professor of anesthesiology and intensive care at the University of Gottingen (Germany). He and his fellow panelists were in accord regarding the merits of helmet CPAP as the premier method of noninvasive ventilatory assistance. They also addressed the importance of monitoring for hypercoagulation, as well as what they've come to see as the essential role of pronation in what they define as Type H disease, and the need to have detailed respiratory physiotherapy protocols in place.

"COVID-19 doesn't like physiotherapy," explained Paolo Pelosi, MD, professor of anesthesiology and intensive care medicine at the University of Genoa (Italy). Dr Gattinoni is credited for identification of two polar phenotypes of what he considers to be a single COVID-19 disease. Early on, many patients present with an atypical form of acute respiratory distress syndrome (ARDS), distinguished by an often-unexpected degree of hypoxia accompanied by high pulmonary compliance and surprisingly little shortness of breath. Dr Gattinoni and colleagues call this Type L disease, which stands for low elastane, low ventilation to perfusion ratio, low lung weight on CT, and low lung recruitability, which means the patient has a high proportion of aerated lung tissue. Over time, because of either the natural history of the disease or SILI, this may shift to Type H disease, marked by high elastane, high right-to-left shunt, high lung weight, and high recruitability. "If the pulmonary compliance is above 60 [mL/cm H2O], I'm pretty sure it's Type L. If it's 30 [mL/cm H2O] or less, I'm pretty sure it's Type H. Don't ask me about 45-55 [mL/cm H2O]; it's a grey zone," Dr Gattinoni said.

Case Report Details Success of Tankless Delivery System

GENOSYL DS, an innovative tankless delivery system for inhaled nitric oxide (iNO) was used by Stanford Medicine clinicians via telemedicine for outpatient, at-home treatment of a patient with pulmonary hypertension complicated by COVID-19, according to a case report published online in the American Journal of Respiratory and Critical Care Medicine, a premier journal in pulmonary and critical care medicine. Access Case Report here. The case, the first of its kind to report on at-home iNO treatment, involved a 34-year-old female with vasoreactive idiopathic pulmonary arterial hypertension (iPAH) and concomitant COVID-19 This patient was successfully remotely managed by clinicians. The clinicians obtained an Emergency Investigational New Drug Application (EIND) from the US Food and Drug Administration for the use of GENOSYL (nitric oxide) gas for inhalation, manufactured by VERO Biotech, a Georgia-based biotech company. Roham T. Zamanian, MD, Associate Professor of Medicine, Stanford University School of Medicine, Department of Pulmonary and Critical Care Medicine, was the case report’s lead author. “Without well-established treatments, the COVID-19 pandemic is a threat to the health and care of PAH patients. This report is the first to our knowledge of outpatient telehealth management of an iPAH patient with COVID-19, and represents a first step towards support for in home use of iNO in PAH, as well as the potential use of iNO in patients with coronavirusassociated pulmonary disease in the outpatient environment,” said Michael A. Gentile, Vice President of Medical Affairs, VERO Biotech and a co-author on the report. “While hospitals may readily stock the large, weighty tank system required for conventional delivery of iNO, the recent FDA approval of the GENOSYL tankless delivery system opens more realistic opportunities for out-of-hospital or even home use.” “VERO Biotech is pleased to play an important role in the treatment of patients with concomitant cardiopulmonary disease and COVID-19 infection,” commented Brent V. Furse, President and CEO, VERO Biotech. “We designed our novel delivery system to ease the burden of care on respiratory therapists, not only in the hospital setting but also for outpatient use,” he added. Researchers have observed that the COVID-19 pandemic of a novel coronavirus, SARS-CoV-2, is associated with significant cardiopulmonary morbidity in some patients.  As no specific antiviral therapy is available for SARS-CoV-2, treatment has been limited to supportive though sometimes intensive (particularly in older patients and those with comorbidities) measures, and has severely stretched global hospital staffing and equipment capacity in many countries. The advance in therapy reported in this case is an indication that home therapy with iNO may help ease those burdens.

New Grants Approved

The American Thoracic Society announced that GlaxoSmithKline(GSK) has awarded the Society two grants totaling $380,000 to support the ATS COVID-19 Crisis Fund, a newly launched initiative to develop and disseminate research, education and scientific recommendations to providers in the pulmonary and critical care communities, as well as other clinicians in need of expanding their skill set during this emergency. The first grant will fund two new $50,000 grants in the ATS Research Program in COVID-19. The second grant for $280,000 will support the Society’s patient education and outreach efforts related to COVID-19. The COVID-19 pandemic has posed significant challenges for pulmonary and critical care specialists worldwide. As a membership society of health care professionals committed to improving lung health, ATS is a leading voice in the discourse on initiatives to counter the spread of the coronavirus and provide support to those on the frontlines, who are treating patients diagnosed with COVID-19. In order to fulfill its mission to the greatest extent possible as COVID-19 ravages individuals and medical infrastructures worldwide, ATS is seeking industry support. GSK’s generous support comes at a critical time in the COVID-19 pandemic,” said ATS President James Beck, MD. “On behalf of the entire ATS community, I want to thank GSK for their very generous support. These funds will help support time-sensitive research and educational outreach to patients at a time when resources are so stretched. ATS values our partnership with GSK.” “We have a long history of working alongside the pulmonology and critical care community and, especially during this crisis, are proud to support ATS to advance critical research efforts and help educate patients who include some of the highest risk, most under-served members of our communities,” said, Karin E. Rosén, MD, PhD, senior vice president, US Medical Affairs, GSK. “We are committed to contributing to the fight against COVID-19 and this is one of many actions we are taking to help find solutions and provide support to ensure patients can receive the care they need. These efforts also include programs available to help patients access medicines and vaccines, including those impacted by COVID-19.”

High Level Disinfection via Pasteurization – a possible solution to COVID-19 limited supplies

Pasteurization has been used to destroy potentially pathogenic organisms in the food and beverage industry for decades. However, a medical device can also be pasteurized by fully immersing it in heated water for a specific amount of time at a specific temperature to achieve viral deactivation and microbial destruction. Global standards recommend that to achieve HLD, the process should apply, at minimum, a temperature of 65°C (ISO 15883). In the US, the amount of bioburden reduction required to achieve HLD is a 6-log reduction (which equates to a 99.9999% reduction) of the original population of organisms. A full immersion pasteurization using a Cenorin 610 Washer-Pasteurizer/High Level Disinfector at a temperature of 72°C for 30 minutes has been shown to achieve HLD for typical medical devices used in respiratory care, anesthesia, pulmonary procedures, and sleep labs. In a recent study, a ‘worst-case’ (time and temp parameters) method was tested using a Cenorin 610 Washer-Pasteurizer/High Level Disinfector. The wash/pasteurization cycle achieved industry clean levels and a greater than 8-9 log reduction for Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli and a representative of the Klebsiella-Enterobacter group. The Pasteurization cycle also yielded a 7-log reduction of Mycobacterium Terrae. Cenorin customers use the Cenorin 610 to clean and disinfect many devices that are critical in today’s environment. These include oxygen administration masks and head bands, ventilator breathing circuits, ventilator inhalation/exhalation check valve assemblies, and corrugated tubing. If there are additional devices, including PPE like masks and goggles, that you would like to have more information on, please reach out to us – we are available to help.

Getinge contributes to Ventilator Manufacturers Group to form Ventilator Training Alliance

Today several of the world’s ventilator manufacturers announce a newly formed Ventilator Training Alliance (VTA) to support frontline medical providers to access a centralized repository of ventilator training. The content can be found in a mobile app managed by Allego. “Supporting our customers and facilitating ventilator training continues to be key to all stakeholders in this project”, says Charles Merchant, Senior Director Global Therapy Development Acute Care Therapies at Getinge. “Dräger, GE Healthcare, Hamilton Medical, Medtronic, Philips, Vyaire Medical and Nihon Kohden, together with Getinge, have joined this humanitarian training coalition”. The VTA app — powered by learning and readiness platform provider Allego — connects respiratory therapists, nurses and other medical professionals with ventilator training resources from alliance member companies, including instructional how-to videos, manuals, troubleshooting guides, and other ventilator-operation expertise critical to treating patients suffering from COVID-19-related respiratory distress. Ventilators play a critical role in the management of patients who require assistance because they cannot breathe effectively due to severe respiratory illness, such as COVID-19. Speed and ease of access to ventilator training has a direct impact on patients’ health during the COVID-19 crisis. Content on the VTA app can be accessed on iOS and Android devices — even in environments with little to no Wi-Fi access — or from a web browser. The app provides healthcare professionals’ multi-language closed captioning and mobile background audio when multitasking. The app is provided at no cost to medical professionals. To download the Ventilator Training Alliance knowledge hub application, visit the Apple App Store or Google Play store, or access the hub from any Web browser.

Disposable CPAP Devices Donated

Mercury Medical, a healthcare manufacturer focused on introducing new critical care medical device technologies, announces the donation of 2,500 Flow-Safe II Disposable CPAP devices to the state of New York for treating COVID-19 patients. The FDA recently issued guidelines indicating that BiPAP and CPAP devices can be used to effectively help treat COVID-19 patients in Respiratory Distress. CPAP therapy has been shown to be very efficacious in preventing these patients from deteriorating to the point where they require mechanical ventilation. With the current shortage of mechanical ICU ventilators, these CPAP devices can play an important role in meeting New York's surge capacity to treat the influx of COVID-19 patients. Currently, the New York City Fire Department (FDNY) has been using Mercury Medical’s Flow-Safe II EZ disposable CPAP device for patients exhibiting symptoms of Respiratory Distress for the last few years. The Flow-Safe II family of products are disposable ventilatory support devices that deliver CPAP and/or Bilevel CPAP therapies. They do not require a mechanical machine or electrical power; simply connect to an oxygen source within the hospital to deliver adjustable CPAP pressures; can be disposed of after use to eliminate cross contamination; are simple to use and are very cost effective. John Gargaro, MD, Mercury Medical president and CEO, states, “We have been following daily updates regarding the growing spread of COVID-19 and the resulting health impact on the State of New York, especially in New York City and surrounding areas. We are donating 2,500 each of our Flow-Safe II product to help New York’s efforts in saving lives during this COVID-19 crisis. We believe that this product can be used effectively on coronavirus patients with the goal of minimizing the need for mechanical ventilators, thus freeing them up to be used on more critical cases.”

COVID-19 Global Disease Dynamics and Hands-on Treatment Best Practices

Join us on April 9 at 8 am PST for an important webinar report by Pr. Luciano Gattinoni on managing critical parameters of ventilatory support for COVID-19 patients. As a researcher and a mentor to clinicians across Europe, Pr. Gattinoni has a unique, comprehensive perspective on COVID-19 care. In this webinar, he will share his observations of the disease as well as basics on how to ventilate a COVID-19 patient. A live Q&A session will follow this webinar presentation.

WHAT WILL BE COVERED

  • Differences between COVID-19 and ARDS lung dynamics
  • Criteria for non-invasive support versus mechanical ventilation
  • Suggested ventilator settings
  • The right moment to wean

WHO SHOULD ATTEND

  • Intensivists, ICU Clinicians, Respiratory Therapists, Respiratory Experts, Anesthesiologists, Hospitalists and Physicians and Healthcare Providers caring for COVID-19 patients.

Pr. Luciano Gattinoni is currently a Guest Professor at the University of Göttingen (Germany). He is world-renowned for inventing the “Extracorporeal CO2 Removal” technique in acute respiratory failure, promoting the “baby lung” model of lung injury (1980’s) and identified mechanical power variables to assess risks of mechanical ventilation (2016). He has previously served as President for the Italian National Society of Anesthesia and Intensive Care, the European Society of Intensive Care, and the World Federation of Societies of Intensive and Critical Care Medicine.

His research focuses on the pathophysiology and treatment of acute respiratory failure, sepsis, and acid base disorders. He has published more than 400 research articles in peer-reviewed journals. He is Honorary Member of the German Society of Anesthesiology and Intensive Care, Fellow of the Royal College of Physicians, and was awarded with the Life Time Achievement Award by the American Society of Anesthesiology, the American Society of Critical Care Medicine and the European Society of Intensive Care and the French Society of Intensive Care.

Visit gehealthcare.com for more.

St. Luke's University Health Network One of the First in the World to Pilot Masimo SafetyNet

Masimo announced that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. The telehealth solution uses a tetherless, wearable single-patient-use sensor to monitor patients with clinically proven Masimo SET pulse oximetry, and is designed to help manage the surge in COVID-19 patients while maintaining the safety of other patients and providers, allowing hospitals to expand patient remote monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness." Designed to track the blood oxygen saturation and respiration rate of patients who are hospitalized or quarantined at home, Masimo SafetyNet combines tetherless SET pulse oximetry with a proprietary remote data capture and surveillance platform accessible from a patient's Android or iOS smartphone or smart device. Monitoring key physiological data can help provide clinicians with an accurate snapshot of a patient's systemic health and facilitates awareness of the need for rapid execution of treatment decisions that can be life-saving. Patients are provided with a multi-day supply of single-patient-use sensors and access to the Masimo SafetyNet mobile app. With clinical feedback from St. Luke's led by Dr. Carmona and from University Hospitals led by Dr Peter Pronovost, Masimo SafetyNet has been designed for easy, intuitive use to provide customized, interactive CarePrograms that align with expert guidance on COVID-19. Monitoring data collected by the sensor is shared with the patient’s smartphone using a secure Bluetooth® connection. Twice daily, or as directed, the CareProgram can be configured to actively notify patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and pushes these responses along with the monitoring data to clinicians for evaluation. CarePrograms are fully customizable to accommodate each institution's protocols, each patient’s needs, and any changes in COVID-19 guidance – and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. In addition to COVID-19 CarePrograms, Masimo SafetyNet can be configured for more than 150 other CarePrograms for use with COPD, heart failure, oncology, and other patients.

On March 30, patients at St. Luke's University Health Network Bethlehem diagnosed with COVID-19 were outfitted with Masimo SafetyNet. Non-COVID-19 patients are also being monitored with this system in general medical-surgical units. St. Luke's plans to use the Masimo SafetyNet tetherless sensor and cloud-based surveillance system to monitor upwards of 2,000 hospitalized patients and lower acuity cases in the home. These may also include staff and patients who are quarantined at home with the virus. "Our patients at St. Luke’s have the most sophisticated and reliable respiratory monitoring available anywhere," Carmona says. "We know that continuous physiologic monitoring with Masimo’s Patient SafetyNet improves outcomes and saves lives. The ability to extend that capability to patients in non-traditional settings and at home during this crisis with Masimo SafetyNet is transformative. Only through our relationship with Masimo could this have been possible."

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is proud to be able to work with St. Luke’s to help protect the health and safety of medical professionals and the patients they serve during this global pandemic."

Device Mitigates Risks to Workers

In today’s unprecedented challenge to protect healthcare workers on the front lines as they battle the coronavirus pandemic, one Arizona company is providing a unique nebulizer system that is designed to optimize aerosol therapy and mitigate caregiver exposure to the contagion. Westmed, Inc., https://westmedinc.com, a leader in pulmonary medication delivery, introduced the original Circulaire Aerosol Drug Delivery System in 1997. In 2008, the company modified the Circulaire II with new features to create a quasi-closed device that significantly improved drug delivery performance, as well as the safety of the system. One enhancement included a unique Medication Reservoir, designed to retain the excess aerosol produced during nebulization which would subsequently be inhaled by the patient during inspiration, thus providing maximum output delivery of the nebulizer. As a result, only the Circulaire II System effectively doubles the dosage of medication with every breath. In addition to functioning as a holding chamber, conserving medication and enhancing aerosol delivery, the Reservoir also prevents room air dilution of medication to achieve the highest Fraction of Inhalable Aerosol in the industry. In fact, multiple studies confirm, the Circulaire System delivers more drug mass in less time than any other conventional nebulizer. Plus, a One-Way Valve virtually eliminates the risk of the patient re-breathing into the nebulizer, to protect the nebulizer and the Reservoir from contamination by exhaled pathogens. Further, of particular importance today, while not a complete solution, an integral Exhalation Filter in the Circulaire II, with bacterial >99.99% and viral >99.98 efficiencies, mitigates exposure to exhaled patient droplets and medication during aerosol therapy. The Circulaire II is the only aerosol delivery system available that includes an integral Exhalation Filter as a standard feature. https://westmedinc.com/circulaire-ii/

FDA Clears Blood Gas Analyzer Used for Critically Ill Patients in Acute Care Settings

Siemens Healthineers announced that its latest critical care testing solution, the RAPIDPoint 500e Blood Gas Analyzer, has received clearance from the US Food and Drug Administration. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room. Already available in countries requiring the CE mark, the RAPIDPoint 500e Blood Gas Analyzer is now available for critical care testing in the United States. “Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers. “The RAPIDPoint 500e Blood Gas Analyzer has become a trusted instrument in Europe’s endeavor to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients.” The RAPIDPoint 500e Blood Gas Analyzer is an essential instrument supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation. Arterial blood gas tests provide the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required. The analyzer elevates confidence in patient results with Integri-sense Technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. “As an ICU physician, I know that the values I am handed during an emergency allow me to confidently make life-saving decisions. The RAPIDPoint system is easy to use and allows me to not worry about the machine and focus my attention on my patients,” said Dr Daniel Martin, Royal Free Hospital, London. Additionally, the RAPIDPoint 500e Blood Gas Analyzer integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers convenient, remote management of operators and devices located across multiple sites. For more information about the RAPIDPoint 500e Blood Gas Analyzer, visit https://www.siemens-healthineers.com/rapidpoint500e.

Company Ramps Up Production

Getinge, the world market leader in advanced ventilators for intensive care units, announced another ramp-up in production capacity, to 26,000 ventilators in 2020. The increase equals a growth of 160% compared to 2019, when 10,000 ventilators were produced. The demand for advanced ventilators for the intensive care units in hospitals continue to increase globally as a result of the COVID-19 pandemic outbreak. Getinge is ramping up the production capacity stepwise at its production facility in Solna, Sweden, and is now increasing production capacity to 26,000 in 2020, compared to the previous planned 16,000 unit level that was communicated on March 17. The ramp up will start immediately and progress in close collaboration with Getinge’s suppliers. “We continue to ramp up to be able to respond to the increasing demand from our customers”, says Elin Frostehav, Vice President Critical Care at Getinge. “We work closely with our sub-contractors and the ramp up is of course pending availability of supply parts”. In 2019, Getinge produced 10,000 ventilators at the production facility in Solna. Since the start of 2020, Getinge has increased its production capacity with 160%, compared to 2019. The estimated increase in demand and production capacity of ventilators is expected to be accretive to Getinge’s result. Learn more about Getinge’s products at www.getinge.com.

Should CPAP Therapy be used with COVID-19 Patients?

Some clinicians are currently inquiring if CPAP therapy can be used with COVID-19 patients. According to the many experts, the response is an overwhelming YES! Josh Farkas MD, associate professor of Pulmonary and Critical Care Medicine at the University of Vermont states,“COVID patients really need positive pressure more than anything else. For example, their work of breathing is often tolerable – so they may not need much mechanical support for the work of breathing (indeed, mechanical support could lead to injuriously large tidal volumes).” The best modality to provide lots of positive pressure is simply Continuous Positive Airway Pressure (CPAP). CPAP may not seem dramatic, but this modality actually provides the greatest amount of positive pressure to allow for the most powerful recruitment.” Importantly, recently communicated new findings from the Intensive Care Society, (ICS), state, “CPAP may be of benefit to patients, (COVID-19), earlier on in the disease process than first thought and may prevent deterioration of some patients to the extent of them not going on to need invasive ventilation.” Mercury Medical markets technology that can provide both CPAP and Bilevel therapies using low cost Flow-Safe CPAP and Bilevel CPAP disposable devices. Current research supports the use of Flow-Safe Disposable CPAP devices. In addition, The American Journal of Emergency Medicine concludes that a disposable CPAP device, (Flow-Safe II Mercury Medical), is just as effective as a mechanical portable ventilator (Philips Respironics Trilogy 202). A continuum of care protocol can be established by placing COVID-19 patients on a disposal CPAP/Bilevel device upon entry to the EMSvehicle / ER Department; maintaining the same device during the hospital stay until an intensive care ventilator is indicated. The Flow-Safe disposable CPAP/Bilevel devices are packaged with non-vented full face deluxe masks. When used with an expiratory filter, they may reduce the incidence of cross contamination, are simple to use, require little training and run on medical grade air/oxygen systems currently available in hospitals today.

Help Offered to Fill Blood Shortages

Masimo announced that, in response to current worldwide blood shortages driven by the coronavirus pandemic, it is making rainbow licenses available for no additional charge to hospitals where rainbow-ready devices are already in use. The Masimo rainbow platform allows for the noninvasive and continuous monitoring of 12 parameters, including hemoglobin (SpHb), oxyhemoglobin (SpO2), and methemoglobin (SpMet). Once rainbow is enabled, hospitals can purchase RD rainbow sensors at discounted prices during this pandemic. The program is available globally and is planned to continue until the pandemic subsides. SpHb provides real-time visibility to changes, or lack of changes, in hemoglobin between invasive blood samples – and has been shown to help clinicians improve patient blood management. In multiple outcome studies, SpHb has been shown to help clinicians reduce blood transfusions. SpHb is available on a variety of Masimo Pulse CO-Oximeters, including the Root Patient Monitoring and Connectivity Platform, Radical-7, and Rad-97, as well as patient monitors from 25 other patient monitoring manufacturers, including Dräger and Philips. "Our goal is to make the biggest difference we can during this challenging time. This is our third initiative in the past four days to help clinicians deal with COVID-19. Many hospitals have seen the value of rainbow®, and we hope every hospital can now benefit from proven rainbow® noninvasive blood constituent monitoring technology," said Joe Kiani, Founder and CEO of Masimo. One of the many burdens COVID-19 is placing on health systems around the world is a shortage of blood products, as hospitals rush to treat an extraordinary surge of patients – at the same time that many blood drives have been cancelled. Therefore, hospitals are needing to manage blood supplies as efficiently and conservatively as possible. A growing body of evidence from around the world has shown that Masimo SpHb may help clinicians reduce unnecessary blood transfusions in both low- and high-blood-loss surgeries: A randomized trial of 327 patients undergoing elective orthopedic surgery found that the use of continuous, noninvasive hemoglobin monitoring with SpHb reduced the rate of transfusions by 87% when compared to standard care without continuous, noninvasive hemoglobin monitoring. A prospective cohort study of 106 neurosurgical patients found that adding SpHb monitoring to standard-of-care blood management resulted in decreased blood utilization in high-blood-loss neurosurgery by 41%, while also decreasing time to transfusion when indicated by 41 minutes. A study of 100 patients undergoing abdominal cancer surgery found that SpHb monitoring decreased blood utilization by 39%, while facilitating earlier transfusions when indicated by 33 minutes. A study of 237 patients undergoing hip trauma surgery found that continuous SpHb monitoring during high-blood-loss surgery reduced the percentage of patients needing blood transfusions by 7% and number of transfused units per patient by 13%. In addition to SpHb, the rainbow family of advanced noninvasive parameters includes SpMet, which helps clinicians noninvasively and continuously monitor methemoglobin levels in the blood. Elevated methemoglobin levels can be caused by inhaled nitric oxide (iNO) therapy, which is currently being investigated as a potential treatment for lung complications associated with COVID-19. By allowing clinicians to monitor methemoglobin levels, SpMet may be an important monitoring tool during iNO therapy. SpHb and SpMet are not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors, patient condition and laboratory diagnostic tests using blood samples.

Study Looks at Integrated Clinical Surveillance Monitoring

Masimo announced the results of a recently published ten-year retrospective study in which researchers at Dartmouth-Hitchcock Medical Center investigated the impact of an integrated clinical surveillance monitoring system, using Masimo SET and Patient SafetyNet technologies, on mortality related to the use of prescribed opioids in the general ward. Over the ten years studied, of 111,488 patients in units with surveillance available, there were zero patient deaths and no patients were harmed by opioid-induced respiratory depression while continuous monitoring was in use. In contrast, among patients in units without surveillance available, there were three deaths. The surveillance monitoring system provided continuous monitoring using Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, and was comprised of Masimo Radical-7 and Rad-87 Pulse CO-Oximeters, Root Patient Monitoring and Connectivity Hubs, and Masimo Patient SafetyNet, which provided supplemental remote monitoring at central view stations and alarm and alarm escalation notifications to clinicians' pagers. Monitored parameters included oxygen saturation (SpO2) and pulse rate (PR). The researchers reviewed ten years of data collected from 2007 to 2017, over which time there were 126,697 general care unit discharges. Dr Sue McGrath and colleagues at Dartmouth-Hitchcock Medical Center found that, over the 10 years, of the 111,488 patients in units with surveillance monitoring available, "none died or were harmed by opioid-induced respiratory depression when surveillance monitoring was in use." Of the 15,209 patients in unmonitored units, three patients died from opioid overdose. The reduced death rate when surveillance was available, compared to when it was not available, was statistically "significant" (p=0.03). A fourth patient died in a unit where surveillance monitoring was available but Masimo technology was not being used at the time of the adverse event. The researchers noted, "The fact that one patient with known risk for opioid sensitivity died while in a unit where monitoring was available but not in use highlights the importance of system adoption and adherence to standards of care." The researchers concluded, "For a 10-year period, the rescue system with continuous surveillance monitoring had a profound effect on death from sedative/analgesic administration in the general care setting. This approach to patient safety can help address the risk of sedative/analgesic-related respiratory arrests in hospitals." Regarding the cost of deploying such a system, the researchers noted, "Although cost is often raised as a barrier to implementation, a previously performed financial analysis demonstrated cost-effectiveness of surveillance monitoring due primarily to intensive care unit patient days avoided when early detection of patient deterioration occurs." They continued, "This study confirms that surveillance monitoring for pharmacologically induced respiratory arrest in hospitalized patients can virtually eliminate deaths due to this serious but treatable complication. In other high-risk, safety-focused industries, the level of evidence that currently exists for continuous surveillance monitoring to mitigate the risk of accidental sedative/analgesic overdose would likely prompt immediate calls for widespread implementation of safety interventions." Joe Kiani, Founder and CEO of Masimo, commented, "We are incredibly grateful to Dr McGrath, her colleagues, and everyone at Dartmouth-Hitchcock Medical Center for demonstrating the value of continuous monitoring of post-surgical patients over a ten-year period. Hundreds of other hospitals have adopted our technology and have reported similar results. We hope that this new study will inspire every other institution to implement Masimo SET on their general floor to eliminate preventable deaths due to opioid overdose, especially at this time when illnesses that impact the respiratory system, such as COVID-19, are so prevalent." In previously published studies at Dartmouth-Hitchcock Medical Center, researchers found that after deploying the continuous monitoring system in the original 36-bed unit, there was a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU. After five years of use, they reported zero preventable deaths or brain damage due to opioids, as well as cost savings of $7 million, and after ten years, they reported maintaining a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increases in patient acuity and occupancy.

Mallinckrodt and Novoteris Receive Clearance from Health Canada

Mallinckrodt plc, a global biopharmaceutical company, and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy's safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days. "Inhaled nitric oxide may have an antiviral effect, as well as improve oxygenation and pulmonary arterial pressure in patients suffering from COVID-19," said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We're proud to be partnering with Novoteris on this pilot trial and are committed to increasing understanding of this potentially important therapeutic option for healthcare providers on the front lines of this unprecedented health emergency." COVID-19 is a contagious respiratory illness caused by a novel coronavirus. Patients with COVID-19 have mild to severe respiratory illness that can include symptoms such as cough, fever and shortness of breath.1 In severe cases, COVID-19 can cause acute respiratory distress syndrome (ARDS) – a disorder in which fluid leaks into the lungs, making breathing difficult or impossible – and can lead to multi-organ failure and sometimes death. "Our collaboration with Mallinckrodt to study high-dose inhaled nitric oxide to treat patients with COVID-19 and associated lung complications is an exciting step in both companies' commitment to helping the world battle this global pandemic," said Alex Stenzler, Founder and President at Novoteris. Inhaled nitric oxide (iNO) has been evaluated in randomized controlled trials, both in pediatric and adult patients with ARDS, and demonstrated partially dose-dependent improvement in blood oxygenation and decreased pulmonary artery pressure and, in one trial, improvements in the composite measure of days alive or free of ventilator support at day 28 of the trial (the last day evaluated). There have been other trials evaluating iNO in the context of ARDS, which have demonstrated mixed results. In an in vitro study, inhaled nitric oxide has demonstrated an inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV). Furthermore, a small clinical trial in SARS-CoV patients demonstrated improvements in blood oxygenation, a reduction in supplemental oxygen and a reduction in the amount of ventilator support. "This is an important day for patients and healthcare providers," said Chris Miller, PhD, Assistant Professor, Faculty of Medicine at University of British Columbia and Founder and Scientific Advisor at Novoteris. Dr Miller, team lead for the study at Vancouver Coastal Health Research Institute, and an expert in nitric oxide therapies, with a research career spanning more than 25 years studying the antimicrobial effect of high-dose nitric oxide to treat lung infections, said, "I am very pleased to be working with Mallinckrodt and Novoteris on this study using high-dose inhaled nitric oxide for patients with COVID-19." Mallinckrodt is currently working with the US Food and Drug Administration on the possibility of making the company's INOmax (nitric oxide) gas, for inhalation product available to US patients with pulmonary complications of COVID-19 as quickly as possible through the appropriate regulatory mechanism. INOmax has been on the market in the US since 2000, and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Please see Important Safety Information below. The safety and efficacy of INOmax and iNO for pulmonary complications associated with COVID-19 have not been established. For more information, visit clinicaltrials.gov.

Cuff Pressure Management While Keeping a Safe Distance

Safety with HVLP cuffs. The TRACOE smart cuff manager can be used with tracheostomy tubes as well as endotracheal tubes. This innovative product allows a visual control at a safe distance. Being a single patient product, the risk of cross infection is reduced to a minimum. The main function of this product is to keep the cuff pressure at a stable range between 20 and 30 cm H2O. This helps minimize the risk of silent aspiration and improper sealing which can cause damage to the respiratory system. Additionally, it reduces the risk of aerosol formation due to insufficient cuff pressure. Find more information at https://www.tracoe.com/en/products/technic/article/article/ref-730-5-tracoe-technic-smart-cuff-manager/

Fighting COVID-19 is Our Mission

The mission of IngMar Medical is to decrease patient suffering and improve outcomes is fueled by the actions you are taking right now, and we want to help you win this fight. We hope this knowledge base will help you enable others to act in this crisis. Thank you for your unwavering courage and dedication to healthcare. Watch and share our recorded presentations to learn essential information on mastering the art of mechanical ventilation, particularly for patients diagnosed with COVID-19. These presentations provide e-learning content as well as hands-on demonstration of training scenarios. Download complimentary scenario simulations that you can run on your ASL 5000 Breathing Simulator. These simulations will enable you to provide hands-on training and develop your staff’s competency in treating a patient diagnosed with COVID-19, supported by mechanical ventilation. Browse the resources we used to inform our COVID-19 scenario simulations as well as basic training tools and videos meant to help clinicians understand the proper use of most major ventilators. Visit https://www.ingmarmed.com/covid19/ for more details.

Protecting Healthcare Workers from Patients with COVID-19

COVID-19 is a highly contagious virus, with an infectivity rate even higher than SARS. Patients progress from simple upper respiratory symptoms to requiring supplemental oxygen to intubation and mechanical ventilation. During the period of requiring supplemental oxygen and particularly during the periods where they may require aerosol therapy, healthcare workers at their bedside are exposed to aerosolized particles exiting their oxygen delivery devices. In most cases, when just using an oxygen mask, the aerosolized particles exiting laterally from holes in the mask for exhalation, bath the healthcare worker in particles that may not be visible to the naked eye. During the SARS epidemic the design team from 12th Man Technologies developed the Hi-Ox oxygen mask, that has no holes in the mask and all inspired and exhaled gas is delivered to the patient through one-way valves. Not only is it able to deliver higher FiO2s than a NRBM, all exhaled air flows down the front of the patient’s body and not towards the healthcare workers standing at their side. Some centers have added a filter to the expiratory limb to capture the exhaled contaminants. The Ontario Ministry of Health has recommended the Hi-Ox as the mask to use for oxygen delivery during respiratory pandemic outbreaks. Tri-Anim Healthcare is a distributor of the Hi-Ox.

Best Practices for COVID-19

For the prevention of COVID-19 spread, the focus has been correctly placed on the issue of community transmission. This includes clinical settings like hospitals or health practices where there is now increased respiratory testing demand due to the virus. It is important that Bacterial Viral Filters (BVF) be in use during these procedures to reduce the contamination risk to equipment such as spirometers as well as the surrounding test environment. This practice, in addition to routine cleaning procedures, will significantly reduce the chance of transmission among patients and staff. Professor Colum Dunne of the University of Limerick and colleagues tested Vitalograph BVFs to assess their effectiveness in preventing bacterial or viral transfer to and from respiratory testing equipment. Results showed >99.99% effectiveness for the prevention of microbial transfer to the testing equipment. BVFs also reduced potential transfer from the equipment to the users to a level below detectable limits. This suggests that BVFs should be used whenever possible during the use of respiratory diagnostic equipment. Vitalograph also recommends surface cleaning of flowheads between each patient using 70% isopropyl alcohol. Professor Dunne believes that these practices will reduce the risk of spreading COVID19, and other bacteria or viruses, between patients in clinical settings.

Ventilator Specs Shared

Medtronic, is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) ventilator to enable participants across industries to evaluate options for rapid manufacturing to help doctors and patients dealing with COVID-19. This decision is consistent with the recent FDA Guidance and in accordance with the public health and medical response of governmental agencies globally.

Introduced in 2010, the PB 560 is sold in 35 countries around the world and can be used in a range of care settings. PB 560 product and service manuals, design requirement documents, manufacturing documents, and schematics are now available at Medtronic.com/openventilator. The PB 560 design specifications are available today, software code and other information will follow shortly. The PB 560 ventilator is a compact, lightweight, and portable ventilator that provides airway support for both adults and children. It can be used in clinical settings and at home and provides mobile respiratory support. Bob White, executive vice president and president of the Minimally Invasive Therapies Group at Medtronic, said: “Medtronic recognises the acute need for ventilators as life-saving devices in the management of COVID-19 infections. We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett 980 ventilators. But we also know we can do more, and we are. By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19.” Ventilators play a critical role in the management of patients with severe respiratory illness, such as COVID-19, who require assistance because they cannot breathe effectively. By placing a patient on a ventilator, the patient’s lungs are permitted to rest and recover while the ventilator performs the functions of supplying oxygen and simulating the actions of breathing. Without ventilation support, some patients with severe respiratory disease might not survive.

Hospitals Facing Ventilator Shortage

A New York hospital system has begun treating two patients instead of one on some ventilators, a desperate measure that could help alleviate a shortage of the critical breathing machines and help hospitals around the country respond to the surge of coronavirus patients expected in the coming weeks. NewYork-Presbyterian Hospital, began “ventilator sharing” this week, said Dr Laureen Hill, chief operating officer at the Presbyterian/Columbia University Irving Medical Center system. Doctors have developed protocols for the maneuver and now are rapidly scaling it up while also sharing their methods with the federal and state governments and other hospitals. Ventilator sharing has been explored in a few scientific studies and has been used twice in crisis situations — the immediate aftermath of the 2017 Las Vegas shooting and, as of several days ago, by an emergency physician, Dr Marco Garrone, for coronavirus patients in Italy. This is believed to be the first time that it has been put forth as a longer-term strategy in the United States. “We’re doing something that hasn’t really ever been done before,” said Dr. Jeremy Beitler, a pulmonary disease specialist at NewYork-Presbyterian/Columbia. “Now is the time to do it.” Gov. Andrew M. Cuomo of New York said on Thursday that the state had approved the new method, which is also being studied by federal officials. And this week, the Food and Drug Administration granted emergency use approval to a device called VESper, developed by the South Carolina-based Prisma Health, that adapts one ventilator for use with four patients. The New York action reflects the intense need felt worldwide to make ventilators serve more of the sickest Covid-19 patients. Generally, when patients are mechanically ventilated, a flexible tube is placed into their windpipe, and a finely calibrated pump sends oxygen-rich air into the lungs. In a video, a doctor uses a T-tube and three adapters to split two valves into four ports, and suggests positioning the patients headfirst around the machine. Dr Babcock and her colleague Dr Greg Nyman had published a study of the hack in 2006 — but tested it on four lung simulators, not patients. “Here’s my disclaimer: This is off-label use for a ventilator,” she says in the video. “If it was me, and I had four patients, and they all need intubation, and I only had one ventilator, I would simply have a shared discussion meeting with all four families and say, ‘I can pick one to live, or we can try to have all four live.’” NewYork-Presbyterian is using ventilator sharing for only two patients at a time who need settings on the ventilator that are very similar. Dr Beitler emphasized that each patient is still receiving the same amount of oxygen and level of care as previously. Sharing will not immediately double ventilator access, he added, because many patients will need their own. The hospital has not yet run out of ventilators, but Dr. Beitler said it was better to try the technique now than “when you have absolutely no choice.” Notably, he believes the technique will not increase staffing needs. With about 175,000 ventilators in hospitals and the federal stockpile, other states are also braced for shortages. Coronavirus patients often need to stay on ventilators for days or weeks. The subject of splitting ventilators is “highly controversial” among respiratory specialists, said Dr Josh Farkas, an assistant professor of pulmonary and critical care medicine at the University of Vermont. “While this is a technique that potentially could work for maybe a few hours, there are some significant hurdles,” said Dr MeiLan Han, a pulmonologist at the University of Michigan Health System and a spokeswoman for the American Lung Association. Among the concerns are the inability to monitor the impact on each individual; the potential for cross-contamination of infectious pathogens; and the possibility that instead of one person receiving lifesaving treatment, multiple patients would get dangerously subpar therapy.

Best Practices for Infection Control

As concern over the COVID-19 virus continues to grow and many labs are discontinuing all non-essential testing, MGC Diagnostics has received many inquiries as to the best practice for infection control when using our devices. Our products, although not critical care or emergency medical devices, are used to assess, diagnose and monitor the effect of COVID-19 on patients. The safety of our customers, their staff and patients is of utmost importance to us. Having clear and defined infection control policies is important for your protection. As such, we wanted to provide some guidance regarding infection control and cleaning options. MGC Diagnostics gives you three options for infection control — letting you make the choice that is right for your facility. 1. CHANGE — Simply change the filter and keep the same preVent flow sensor and BreathPath patient circuit. 2. RE-USE — Change the flow sensor and patient circuit between patients and replace with disinfected components. 3. DISPOSE — Dispose of the flow sensor and patient circuit after each patient. Changing out the patient test supplies can be done in 1 min with no warm-up time or recalibration of the system.

Safety Net Announced

Masimo and University Hospitals (UH), one of the largest health systems in Northeast Ohio, today jointly announced Masimo SafetyNet, an innovative, economically scalable patient management system designed to help clinicians care for patients remotely. The telehealth solution combines tetherless Radius PPG pulse oximetry, driven by breakthough Masimo SET Measure-through Motion and Low Perfusion technology, with Doctella, a secure, home-based, remote patient surveillance platform accessible from a patient's iOS or Android smartphone or smart device. The COVID-19 health emergency has significantly increased the demand for remote monitoring and patient engagement solutions in multiple settings. To proactively prepare for a surge in COVID-19 patients while maintaining the safety of other patients and providers, this new solution allows UH and other hospitals to expand patient monitoring to the home or to other facility locations set up temporarily to care for the increased demand. Current WHO guidelines recommend the monitoring of suspected or confirmed COVID-19 patients' oxygen saturation (SpO2), respiration rate (RR), and temperature, and Masimo and UH are meeting this increased demand by adapting existing technology to deliver a secure remote solution. Masimo SafetyNet offers care teams a single-platform solution that couples a secure, cloud-based surveillance platform with clinically proven SET pulse oximetry, estimated to be used on more than 200 million patients each year. In addition to SpO2, Radius PPG is capable of continuously monitoring pulse rate (PR), perfusion index, PVi, and RRp, respiration rate from the photoplethysmograph. Patients can be sent home with a multi-day supply of single-patient-use Radius PPG sensors and access to the Doctella mobile app, designed for easy, intuitive patient use via a digital home-care plan, or CareProgram, that aligns with expert guidance on COVID-19. Radius PPG shares its SpO2, PR, and RRp data with Doctella using secure Bluetooth wireless technology. In addition, Doctella can manually collect other physiological data, such as temperature. Twice daily, or as directed, the Doctella CareProgram actively notifies patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and securely pushes these responses along with physiological monitoring data to hospital-based clinicians for evaluation. The Doctella clinician portal allows providers to easily track patient compliance, helping them identify when intervention may be needed, as well as providing insight to help providers prioritize patients. CarePrograms are fully customizable to accommodate each institution’s protocols, each patient's needs, and any changes in COVID-19 guidance—and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. "We appreciate Masimo’s immediate collaboration to stand up this innovative platform that will significantly aid in our ability to scale up remote monitoring and meet the demand for patient care while addressing capacity and safety issues," explained Peter Pronovost, MD, UH Chief Clinical Transformation Officer. "For our patients with congestive heart failure or chronic obstructive pulmonary disease (COPD), we can provide them with this remote monitoring capability so they do not risk a COVID-19 infection by being near potentially infected patients. Similarly, for patients with a confirmed COVID-19 diagnosis, we can appropriately isolate them from other patients while ensuring they have the access to state-of-the-art care for managing their health through the recovery process." Joe Kiani, Founder and CEO of Masimo, said, "We thank the nurses and doctors who are bravely toiling in hospitals taking care of us all during this pandemic. We are delighted that we can help them triage and effectively take care of COVID-19 patients the best they can with Masimo SafetyNet. It has been a delight to work with UH to bring this technology to the health care industry to help them address the challenges they face during this unprecedented time." "This alliance demonstrates UH's strategy to drive improvements in population health," said Daniel I. Simon, MD, UH Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center. "By deploying 'outside-in' tactics and forming this partnership with Masimo, our patients receive cutting edge treatment approaches while we help enhance the product for future users and industry transformation."

MGCD Partnership with University to Develop Low-cost Ventilator

As spread of COVID-19 continues throughout the country, demand for medical ventilators could skyrocket. Many are already expressing concerns about potential shortages, but there’s a doctor at the University of Minnesota who says he just created a simpler, cheaper ventilator that could save lives. University of Minnesota Anesthesiology fellow Dr Steve Richardson started work on his ventilator last Sunday, sourcing equipment and resources from biomedical engineer friends and other private companies. MGC Diagnostics is a partner in the project. Within hours of starting, Richardson finished a simple, effective prototype that he is now perfecting. He says if the FDA clears a path for production, he could scale it quickly, producing thousands within three weeks at a fraction of the cost of a traditional hospital ventilator. “People have just been working around the clock every day since Sunday morning, and we have a ventilator that I would be comfortable being anesthetized with,” Richardson said. If you would like to donate resources, supplies, research, manpower or funds to continue this project, visit www.coventors.com.

Tube Holder Ready to Use

As you prepare for the possibility of treating COVID-19 patients, Dale Medical stands ready to assist. The Dale Stabilock Endotracheal Tube Holder is the preferred holder for prone position ventilation. Since the Stabilock is soft and low profile, the holder is a comfortable way to secure the tube and minimize risk of pressure sores. Clinicians have access to the patient's mouth to monitor and care for the ET tube. The Dale Stabilock Endotracheal Tube Holder helps prevent accidental extubation by providing a secure method of stabilization. The Stabilock provides fast and easy application to secure endotracheal tubes sized 7.0-10.0mm. With four placement options for its Adhesive Base, the Dale Stabilock Endotracheal Tube Holder covers the full spectrum of patient needs.

Company Working to Keep You Safe

A message from ResMed CEO Mick Farrell: “As a global leader in respiratory medicine, ResMed stands with the world in the face of the latest coronavirus disease COVID-19 and is ready to help mitigate its effects, helping people breathe while their immune system fights this virus. More than 7,500 ResMedians are working in over 140 countries for this purpose. We are working with governments, health authorities, hospitals, physicians, and patients worldwide to assess their needs, and to deliver the ventilation therapy that is essential to treat the respiratory complications of COVID-19. Our primary focus is to maximize the availability of ResMed ventilators and other respiratory support devices for the patients that need them most. As global leaders in digital health, we’re proud that many of our ventilators and bilevel respiratory devices are cloud-connected, enabling physicians and respiratory specialists to remotely monitor their patients. There could not be a clearer case for the use of digital health and remote monitoring of patients than this current crisis with a virus that is so contagious stemming from direct human contact. I’m grateful to our global team for working through today’s challenges to help treat an increasing number of COVID-19 patients. I’d like to call out first-responder ResMedians in China’s Hubei province, the epicenter of the coronavirus outbreak, in particular one ResMed hero who, since early January, has donned a positive pressure hazmat suit, and helped set up thousands of people on ResMed ventilators and ResMed masks. There are also 100-plus ResMedians from Malaysia who in mid-March volunteered to keep working in our Singapore manufacturing plant when Malaysia closed its borders, relocating to live near our plant in Singapore, spending weeks away from their families, so they can continue to produce as many lifesaving ventilators and ventilation masks as possible. ResMed is taking every measure possible worldwide to maximize the production of ventilators, masks, and other respiratory devices. We are looking to double or triple the output of ventilators, and scale up ventilation mask production more than tenfold. Our team is also taking precautions such as a work-from-home policy for all employees who can do that, social distancing, and ensuring world-class quality, safety, good manufacturing practices, and top-level hygiene procedures at our manufacturing, service, and distribution centers to help ensure quality, safety, and business continuity. I urge all of us to do our part to help reduce the spread of the coronavirus, whether that is self-quarantining, working from home, sheltering in place, or just staying healthy for our families, particularly the elderly and those with compromised immune systems. Let me close with this: I would like to personally thank the front-line clinical heroes – many thousands of respiratory therapists, respiratory nurses, pulmonary and critical care medicine physicians, as well as hospital and clinical staff who set up our ventilators and masks for patients in need and deliver the lifesaving gift of breath... You are the superheroes of this COVID-19 crisis, and we salute you!”

Ventilation Production Stepped Up

GM and Ventec Life Systems, in cooperation with StopTheSpread.org, the nation's coordinated private sector response to COVID-19, are collaborating to enable Ventec to increase production of its respiratory care products to support the growing fight against the COVID-19 pandemic. Ventec will leverage GM’s logistics, purchasing and manufacturing expertise to build more of their critically important ventilators. To support these efforts, StopTheSpread.org will continue to unite business leaders across the country to collect resources to complement and support government efforts. “With GM’s help, Ventec will increase ventilator production,” said Chris Kiple, Ventec Life Systems CEO. “By tapping their expertise, GM is enabling us to get more ventilators to more hospitals much faster. This partnership will help save lives.” “We are working closely with Ventec to rapidly scale up production of their critically important respiratory products to support our country’s fight against the COVID-19 pandemic,” said Mary Barra, GM Chairman and CEO. “We will continue to explore ways to help in this time of crisis.”

As Coronavirus Looms, Mask Shortage Gives Rise to Promising Approach

3B Medical filed an Emergency Use Application (EUA) with FDA seeking authorization to market Lumin to reprocess N95 face masks. There is a huge shortage in protective apparel for healthcare workers. Lumin exceeds the UVC irradiance output required to kill human coronavirus and is useful for disinfecting N95 masks for re-use. We have been bombarded with healthcare workers urging us to file an EUA application with FDA, which we have now done. As an example, see the attached. Facing a dire shortage of protective face masks for health care workers, administrators at the University of Nebraska Medical Center decided they had no choice. Masks are certified for one-time use only. But on Thursday, the center began an experimental procedure to decontaminate its masks with ultraviolet light and reuse them. Administrators plan to use each mask for a week or longer. To the knowledge of the program’s administrators, the medical center is the first to disinfect and reuse masks. “We have talked with a lot of others around the country who are going after a similar approach,” said John Lowe, the medical center’s assistant vice chancellor for health security training and education, who designed the program. When administrators made the decision, they knew the procedure violated regulations promulgated by the Centers for Disease Control and Prevention, which said that if masks were decontaminated they could no longer be certified for use. But agency has issued new guidance, saying that “as a last resort, it may be necessary” for hospitals to use masks that were not approved by the National Institute for Occupational Safety and Health. That change would seem to mean it is now acceptable for hospitals to decontaminate and reuse masks during the coronavirus pandemic, said Shawn Gibbs, a professor of environmental health at Indiana University. If that were not the case, he added, then many hospitals would find themselves in a tightening bind as gear shortages spread: “What is preferred — not using respirator protection equipment, or using a decontaminated respirator whose certification is voided?” No one thinks reuse of face masks is ideal, and the practice may raise legal liability issues. But there seemed to be little choice. Doctors and administrators at the University of Nebraska Medical Center calculated that if they continued to use masks only once, they would run out of masks in just weeks. “We are making the best of bad choices,” said Dr Mark Rupp, the medical center’s chief of infectious diseases. He feels confident that the masks will still protect health care workers. “The data is very clear that you can kill and inactivate viruses with UV germicidal irradiation,” he said. “It is also very clear that you will not damage the respirators.” The alternative, Lowe said, would be to ask health care workers to carefully store their masks and reuse them without cleaning them. Handling a mask repeatedly also increases the chances that it will be contaminated. “Health care workers are very apprehensive about that,” he said.

Continuous Surveillance for Caregivers

There may not be an adequate number of skilled caregivers to manage the increased numbers of patients in respiratory distress that require assisted invasive and noninvasive ventilation. Adding continuous surveillance allows caregivers to view medical device settings, measurements and alerts for changing patient conditions from a centralized location. It can also help staff limit their exposure to infection, with fewer bedside visits, while still managing patients closely. Continuous clinical surveillance can help extend the reach of ICU staff over the full range of intensive care patients, wherever they receive care in the facility. Capsule Ventilated Patient Surveillance workstation (using the Bernoulli One Enterprise Software) can provide: Centralized view of ventilator data (FiO2, Set Tidal Volume, Exhaled Tidal Volume, Set RR; Total RR, Peak Inspiratory Pressure, Positive End Expiratory Pressure for each patient); Centralized alarming and alerting based on Surveillance pre-configured rules (smart rules) reviewed and approved by clinical decision makers. During the COVID-19 pandemic, Capsule are offering to add continuous clinical surveillance for ventilated patients to your Capsule Medical Device Information Platform (MDIP) installation: No-charge software license access for limited time use; Capsule Ventilated Patient Surveillance; Discounted implementation services; Remote, turnkey solution to speed deployment; Additional configuration beyond the base, may be billed at standard hourly rates; Hardware runs on any workstation that meets specifications. Upon request, Capsule will work jointly with customer on procurement.

Production Accelerated

Hillrom announced actions it is taking to support customers and caregivers with critical care products necessary to meet COVID-19 patient needs. Hillrom’s business operations continue with no material interruption as global demand for several critical products has grown substantially. The company is working to significantly ramp up production of these products, with the goal of more than doubling capacity in the following areas: Respiratory health, especially Life2000, a non-invasive ventilator currently approved in the US that is portable, lightweight and ideal for treating patients with mild to moderate respiratory distress across various acute care settings, including the emergency department, med-surg and post-ventilator weaning support. Expanded use of non-invasive ventilation can free up capacity for invasive ventilators for the most serious COVID-19 patients. Hillrom is working to increase its production capacity of Life2000 five-fold on an annualized basis. ICU and med-surg unit smart beds, including the company’s Progressa ICU bed, Centrella; Smart+ bed, and, for international markets, the Hillrom 900 and Hillrom 900 Accella. Patient monitoring and diagnostics, including the company’s Connex and Spot Vital Signs monitors as well as physical assessment tools and consumables, including thermometry, probe covers and blood pressure devices and cuffs. “We are committed to scaling production as rapidly as we can to meet the challenges the world is facing with COVID-19,” said Hillrom President and CEO John Groetelaars. “Hillrom’s critical care, vitals monitoring and respiratory products can help caregivers and patients as coronavirus continues to cause severe illness around the world. We are focused on our employees’ health and safety, and on ensuring that our products are available when and where our customers and patients need them.” Hillrom relies on a global supply chain and has a balanced global manufacturing footprint, with manufacturing facilities located in the US, Europe, Asia and Mexico. The company has seen no material disruption in its supply chain to date. Hillrom’s suppliers are a critical component of successfully meeting customer demand, and the company is working with its supply chain partners to minimize any potential disruption. Given the fluidity of the coronavirus pandemic, Hillrom will continue to monitor and assess business operations, and will provide additional information as appropriate.

Hillrom Makes Donations

Hillrom announced it is donating an additional $3 million in medical devices well-suited for critical and intensive care environments to 25 US hospitals fighting COVID-19. Combined with prior donations in Asia, Europe and other philanthropic activities in our communities, Hillrom donations to assist caregivers and patients in the current pandemic total more than $5.5 million to date. “Hillrom’s diverse portfolio is uniquely suited to help caregivers and patients fighting the COVID-19 pandemic,” said Hillrom President and CEO John Groetelaars. “We feel a deep responsibility as a healthcare company to help our communities expand access to critical care. We are honored that the American Hospital Association is supporting our initiative by spreading the word among the nation’s hospitals so that we can get the Critical Care and Respiratory Support products where they are needed most.” The Hillrom for Humanity Critical Care and Respiratory Support Program includes ICU beds, patient monitoring and respiratory health devices. Hospitals selected for the donations will each receive: Two Progressa ICU beds, One Welch Allyn Connex vital signs monitor; and three respiratory health technologies: the Life2000 non-invasive ventilator; the MetaNeb System, for oscillation lung-expansion therapy; and The Vest, which provides high-frequency chest-wall oscillation. Interested hospitals must meet certain eligibility criteria, including demonstration of need, community transmission of COVID-19, and the ability to put the devices to immediate clinical use. Applications may be submitted by any US hospital and will be vetted solely by Hillrom’s Global Compliance Office and Medical Affairs and Informatics Department. Hospitals meeting the criteria will be chosen to receive the Hillrom for Humanity Critical Care and Respiratory Support Program donations on a first-come, first-served basis. The medical devices received as part of this program are unrestricted donations to the hospitals without any relationship to any current or future business opportunities. Interested US hospitals should visit the Hillrom COVID-19 Resource Center on Hillrom.com for more information and to apply. “The women and men of America’s hospitals and health systems are on the front lines every day, treating and helping prevent the spread of COVID-19,” said American Hospital Association President and CEO Rick Pollack. “We appreciate Hillrom’s important donations to help hospitals, health systems and health care providers expand access to critical care technologies as they respond to the novel coronavirus pandemic.”

“Close cooperation with the private sector has been a key piece of the Trump Administration’s response to the COVID-19 outbreak, and Hillrom’s donation of equipment for critical care units is the latest example of how those partnerships are bearing fruit,” said HHS Secretary Alex Azar. “The active engagement we’ve seen from companies like Hillrom will be essential to ensuring that American healthcare providers have the supplies they need to combat the COVID-19 outbreak and save American lives.” In January, Hillrom donated more than $2 million in vital signs monitors to the Chinese Red Cross to assist with efforts to better diagnose and help treat COVID-19 during the initial spread of the coronavirus within China. Today, Hillrom made a $50,000 cash donation to the American Nurses Foundation to build upon the organization’s efforts to support the needs of US nurses during and after the COVID-19 outbreak. And the company continues to provide local support in its communities as well.

 

 

RT NEWS

Leader in Respiratory Solutions Acquires Manufacturer and Developer

CAIRE Inc., a leader in respiratory solutions for the global health care community, announced the acquisition of Spirosure, Inc. Spirosure is a California-based developer and manufacturer of an innovative technology for measuring Fractional Exhaled Nitric Oxide (FeNO), a key indicator of allergic inflammation in asthmatic patients. It is estimated that asthma affects more than 300 million individuals worldwide and recent Global Initiative for Asthma (GINA) guidelines recommend FeNO measurement as an assessment tool in the management of asthma patients. FeNO is directly associated with infiltration of eosinophils in the airways and is elevated in individuals with allergic asthma. FeNO can be used to diagnose asthma, to detect nonadherence to inhaled corticosteroids (ICS), to be an early sign of worsening asthmatic inflammation and to manage difficult-to-control asthma because an elevated FeNO level can be predictive of a good response to ICS. Japan-based NGK SPARK PLUG CO., LTD. acquired CAIRE in December 2018 to establish a global foothold in the respiratory therapy business and had previously invested in Spirosure as the latter company’s technology was in development. Spirosure will operate as a division of CAIRE to be known as CAIRE Diagnostics Inc., further expanding CAIRE’s portfolio into the diagnostic segment of respiratory care. “We are very pleased to have found an excellent strategic buyer in CAIRE through one of our key investors,” said Solomon Ssenyange, PhD, CEO and Chairman of Spirosure. “CAIRE shares our commitment to technological leadership and, with its large international organization, is well-positioned to realize the full potential of our proprietary technology both commercially and with regard to our development pipeline. We look forward to an exciting future as part of CAIRE.” Spirosure recently launched its first product to market, the Fenom Pro, a reliable and convenient to use device that accurately measures FeNO at parts-per-billion levels using a proprietary sensor technology. The product is intended to be used in the clinic setting and is currently available in the United States, the EU and India. “We are pleased to add Spirosure’s technology to our market-leading oxygen solution portfolio. FeNO is quickly becoming recognized by the clinical community as an important diagnostic and management tool for clinicians who treat asthma patients,” said Earl Lawson, President and CEO. “The acquisition of Spirosure further diversifies our portfolio and provides access to the 5 billion dollar respiratory diagnostic sector, a market segment where we anticipate rapid growth and adoption.”

Companies Reinforce Partnership

Masimo and Royal Philips, both global leaders in patient monitoring, announced that they have reinforced their partnership, whereby Philips will integrate additional Masimo measurement technologies into select IntelliVue MX-series multi-parameter monitors, to help clinicians assess cerebral oximetry and ventilation status. Core Masimo noninvasive measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry and advanced rainbow SET Pulse CO-Oximetry parameters like noninvasive hemoglobin (SpHb), have long been available on a wide range of Philips multi-parameter monitors. In 2016, Masimo and Philips entered into a multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. Now, in 2020, Philips becomes one of Masimo's first industry partners to launch additional advanced Masimo measurements, NomoLine and O3, in their own patient monitors, sharing Masimo's expertise in capnography and regional cerebral oximetry with caregivers and patients around the world. NomoLine capnography and O3 regional oximetry measurements are available now on Philips MX500 and MX550 monitors in select markets throughout the world, and are also available directly from Masimo on its Root Patient Monitoring and Connectivity Platform and when connected to select Philips patient monitors via Philips' IntelliBridge module: NomoLine "no-moisture" sampling lines are designed for low-flow applications and can be used in a variety of clinical scenarios and care settings, on both intubated and non-intubated patients of all ages, in both low- and high-humidity applications. O3 regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

Letter of Intent Signed

Monaghan Medical Corporation announced it has signed a letter of intent to enter into a sales agreement with Adherium Limited (ASX:ADR), a provider of digital health solutions for remote monitoring and data management. The partnership will combine Monaghan’s knowledge and expertise in improving patient outcomes through innovative respiratory solutions with Adherium’s digital platform that addresses sub-optimal inhaler medication use for patients with chronic disease. The agreement will see Monaghan launch the Hailie platform in the US, complementing a recently announced collaboration between Adherium and the disease management group HGE Health, and meshing well with Adherium’s global commercial strategy. “We are excited to bring this technology to our customers and provide them with a platform to help guide treatment decisions based on real-life data. Monaghan is dedicated to improving the lives of people with respiratory conditions, and our partnership with Adherium will allow us to advance that goal”, says Bill Seitz, Monaghan’s Vice President of Sales and Marketing. “Our strong customer relationships provide Adherium with a unique opportunity to bring the Hailie platform to targeted facilities across the US. It will complement our current product offering and provide us with the opportunity to expand into the digital space, while offering clinicians new ways to manage their patients remotely.” Adherium’s Hailie platform is a system of remote sensors for inhaled medication devices, mobile apps and a data cloud that empower both patients and healthcare teams. Patients and Physicians can receive reminders and track medication use, which trials have shown improves compliance to their treatment program, reduces asthma exacerbations and improves their quality of life. These insights are more important than ever to clinicians looking to keep their patients well and out of hospital. “This is a big first step in bringing extended offerings to our current and future customers,” commented Gerald Slemko, CEO of Trudell Medical Limited and President of Monaghan Medical Corporation. “There is a real synergy between the Hailie platform and the Monaghan portfolio, including our market-leading AeroChamber brand of Valved Holding Chamber. This as a real opportunity especially for uncontrolled, paediatric and adult patients, initially focused in asthma, where there is a high burden of disease and consumption of healthcare time and costs in secondary/tertiary care.” Monaghan’s parent company Trudell Medical Limited, is also committed to the partnership, having acquired an ownership interest representing 17% of Adherium’s shares.

Endowment Announced

As part of an ongoing commitment to the advancement of respiratory care, Dräger announced that it has granted the American Respiratory Care Foundation (ARCF) a $50,000 endowment to support the Craig D Smallwood Early Investigator Fellowship. This newly established program, which will be announced at the 2020 American Association for Respiratory Care (AARC) International Congress in Orlando, honors the late Craig D Smallwood, PhD, RRT, who died unexpected at the age of 36 in April 2020. Dr Smallwood was an innovative, collaborative and productive researcher who served as a mentor to up-and-coming researchers in the field of respiratory care. Before his untimely passing, he was working on the design and deployment of respiratory assist devices for treatment of COVID-19 patients in the developing world. The ARCF fellowship is designed to provide the chosen fellow with financial, experiential and mentoring resources; thereby continuing Dr Smallwood’s tradition of promoting the role of the respiratory therapist in supporting neonatal and pediatric research. “We are very pleased to receive such generous support from Dräger, a forward-thinking company that understands the importance of mentorship in respiratory care,” said ARCF Chairman Michael Amato. “This unique program remembers the valuable contributions of Dr Smallwood, and will help prepare the next generation of researchers. By supporting the ARCF, Dräger is investing in the future of respiratory care.” Dräger is one of several companies in the respiratory industry to establish an endowment to the ARCF for the purpose of creating research fellowships. This program recognizes the ongoing need for effective clinical research specifically to support neonatal and pediatric patients. “Technology advancement, innovation and new clinical practices require research,” said President and CEO for Dräger in North America, Lothar Thielen. “Establishing an annual award to support neonatal/pediatric research fosters an environment of collaboration and continues the scholarly work necessary to advance and improve patient outcomes.”

EU Panel Backs First Triple Combo Asthma Inhaler With Digital Sensor

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Enerzair Breezhaler, the first triple-combination asthma therapy that includes an optional digital sensor. Enerzair Breezhaler, from Novartis, consists of a fixed-dose combination of three active substances ― the long-acting beta-agonist indacaterol acetate (IND), the muscarinic anticholinergic glycopyrronium bromide (GLY), and the corticosteroid mometasone furoate (MF) ― which are administered using the "dose-confirming" Breezhaler device. Enerzair Breezhaler is indicated as maintenance asthma therapy for adults whose asthma is not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and a high dose of an inhaled corticosteroid and who have experienced one or more asthma exacerbations during the previous year. It's taken once daily. An optional electronic sensor can be attached to the base of the inhaler to collect data on the use of the inhaler by the patient. The data are sent to an app on a smartphone or other suitable device. The positive CHMP opinion is "a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma," Linda Armstrong, MD, Respiratory Development Unit head, Novartis Pharmaceuticals, said in a news release. "Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence," she said. The safety and efficacy of Enerzair Breezhaler for adults patients with persistent asthma were evaluated in a phase 3 randomized, double-blind study involving more than 3000 patients. Results showed "clinically meaningful improvements in lung function and reduction of exacerbations," the EMA said in a statement. The main side effects included asthma exacerbation, nasopharyngitis, upper respiratory tract infection, and headache. The safety and efficacy of Enerzair Breezhaler have not been established in patients younger than 18 years.The CHMP also adopted a positive opinion for Zimbus Breezhaler (indacaterol, glycopyrronium, and mometasone furoate), which is a duplicate of Enerzair Breezhaler for the treatment of asthma. The CHMP opinion will now be sent to the European Commission, which will make the final decision on marketing in the European Union.

Study Looks at Options

Masimo announced the findings of a study published in the Journal of Anesthesiology and Reanimation Specialists’ Society in which researchers compared two methods of intraoperative fluid management during orthopedic spinal surgery, including Masimo PVi. In comparison to invasive and intermittent central venous pressure (CVP) measurement, noninvasive and continuous pleth variability index (PVi) provided “better cardiac stabilization with less fluid replacement, and more accurate results in the evaluation of intravascular volume status.” Dr Eralp Çevikkalp and colleagues at Celal Bayar University in Turkey, noting the importance of intraoperative fluid management during surgery and the drawbacks of traditional invasive, static fluid assessment methods such as CVP and mean arterial pressure (MAP), investigated whether PVi might provide an effective noninvasive and dynamic alternative. In a randomized, controlled trial of 100 adult patients undergoing elective posterior lumbar stabilization surgery, they compared fluid loading-induced changes as guided by PVi and by CVP. The patients were divided into two equally sized groups. In the PVi group, patients were continuously monitored using a Masimo Radical-7 Pulse CO-Oximeter, and a PVi threshold of > 14% was used to determine whether fluid was administered. (For patients with a PVi > 14%, a 250 mL crystalloid solution was administered every 5 minutes; for patients with a PVi < 14%, a 4 mL fluid infusion was administered.) In the control group, fluid administration was determined using CVP, other traditional parameters, and the 4-2-1 rule. In both groups, lactate, hemoglobin, and hematocrit levels were also recorded. The researchers found that the mean volume of intraoperative fluid replacement was 1914 ± 542.86 mL in the PVi group and 3522 ± 1098.1 mL in the control group (p < 0.05). They found that the mean units of intraoperative red blood cells (RBC) transfused was 0.08 ± 0.27 units in the PVi group and 0.42 ± 0.57 units in the control group (p < 0.05). Differences between the groups in postoperative RBC units transfused and intraoperative hemoglobin levels were not significant. The researchers concluded, “The present study has indicated that PVi monitoring is more valuable than CVP monitoring because it is noninvasive, provides better cardiac stabilization with less fluid replacement, and [provides] more accurate results in the evaluation of intravascular volume status. Failure to follow up the duration of surgery and postoperative complications are the most important limitations in our study.”

Observational Registry Moves to Next Phase

Mallinckrodt, a global biopharmaceutical company, announced that its observational registry comparing the safety and effectiveness of INOmax (nitric oxide) gas, for inhalation, in term and near-term neonates to that in preterm neonates with pulmonary hypertension (PH) was ended early due to achievement of the pre-specified primary outcome measure, non-inferiority (95 percent confidence interval: -0.0021, 0.1158, with a pre-defined margin of -0.1452). The decision was made following the second planned interim analysis at 75 percent enrollment. The company intends to share the results of this study in an appropriate scientific forum soon. INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax in premature neonates has not been evaluated by the US Food and Drug Administration. Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life. The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population. "Mallinckrodt is extremely pleased to be able to end this registry based on positive findings much earlier than anticipated," said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. "The real-world data provided by this registry underscores our commitment to continue to expand upon the body of scientific knowledge on treatment of vulnerable patient populations, such as premature infants with pulmonary hypertension." The observational registry study was conducted across 31 sites and was designed to evaluate the effectiveness and safety of INOmax in 168 premature neonates vs term and near-term neonates (1:1) with PH. The interim analysis assessed 54 premature and 84 term and near-term neonates and demonstrated that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25 percent decrease in oxygenation index (OI) or surrogate OI (SOI) during the INOmax treatment period. No drug-related serious adverse events were attributed to study drug. At the time of the interim analysis, there were 17 adverse events of special interest reported in 16 subjects, most of which were in the preterm group and deemed not related or unlikely related to study drug. INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Company Expands Array of Devices

CAIRE Inc.’s strong portfolio of oxygen therapy solutions in China has expanded yet again with the recent release of the award-winning FreeStyle Comfort portable oxygen concentrator. Credited with pioneering the first portable oxygen concentrator, CAIRE engineers have designed this latest product with an innovative ergonomic, curved shell, and delivery features to ensure oxygen is provided with each breath. “CAIRE oxygen therapy brands – specifically the FreeStyle series – have long been relied upon to aid individuals suffering from Chronic Obstructive Pulmonary Disease. The FreeStyle Comfort is an innovative update to a proven brand with clinical enhancements and smart O2 delivery features that will further improve the delivery of oxygen to patients, also benefitting clinicians and caregivers who support their healthcare needs,” said Earl Lawson, President and CEO of CAIRE Inc. The release of the FreeStyle Comfort in China, available and distributed through the company’s Chengdu facility, meets a critical need of providing oxygen therapy, one of several treatment options, to those individuals suffering from COPD, or other long-term respiratory conditions. In April of 2018, ScienceDaily published an article regarding Tulane University’s study of the largest group of COPD across age groups in China. Research found that almost 100 million adults have COPD in China with many not aware they have the chronic lung disease. “The release of the FreeStyle Comfort in China marks an important step in serving this population of people who want to breathe better and enjoy the latest innovation and technologies in a lightweight package,” Lawson added. This is the third major release of the new portable oxygen concentrator since its official US debut in 2018, which drew top honors from industry peers and publications, and its European release in 2019. Weighing only 5 lbs., the FreeStyle Comfort offers on-demand oxygen flow and features a uniquely-designed ergonomic shape that rests comfortably against the curves of the body. Enhanced proprietary smart oxygen delivery features including CAIRE’s UltraSense technology, which ensures that oxygen is delivered in conjunction with the patient’s breath rate, and autoDOSE, which ensures delivery of oxygen even if no breath is detected, help ensure the clinical efficacy of the product. Portable oxygen concentrators, operational via battery or electrical power, take ambient air, filter it and then deliver up to 95 percent purified oxygen to the user. This convenience of being able to plug-in and recharge anywhere has contributed to portable oxygen concentrators increasing in popularity as compared with other oxygen modalities like cylinder tanks and liquid oxygen portables which rely on being refilled by a gas supplier. The device meets FAA guidelines for use on commercial air flights and offers wireless connectivity to CAIRE’s telehealth solution, CAIREview.

Respiratory Therapy proud to add Dr Ruben Dario Restrepo to its Editorial Advisory Board

Los Angeles, CA — Health journal Respiratory Therapy today announced the addition of Dr Ruben Dario Restrepo to its respected Editorial Advisory Board. Dr Restrepo is Coordinator of Research Division of Respiratory Care with UT Health San Antonio, Department of Respiratory Care, San Antonio, Texas. “We’re proud to add someone of Dr Restrepo’s caliber to the Editorial Advisory Board of Respiratory Therapy,” said Steve Goldstein, Publisher of Respiratory Therapy. “With the spread of COVID-19, the field of Respiratory Therapy is more important now than ever and our publication is dedicated to offering cutting-edge insight into how health-care professionals are handling this crisis. Dr Restrepo will help us achieve that mission.” Dr Restrepo is a Fellow of the American Association of Respiratory Care (FAARC) and the American College of Chest Physicians (CHEST), a Distinguished Teaching Professor and Distinguished CHEST Educator, and has been inducted into the Kenneth I Shine Academy of Health Science Education, and received the Regents Outstanding Teaching Award. “I am a very passionate educator,” said Dr Restrepo. “Teaching respiratory care at a global and interprofessional level has been my motto from the time I started teaching.”

OR Management Softward Launched

Getinge globally launches Torin – a complete OR management software that helps surgical departments advance their surgery planning, execute efficiently on the schedule, and continuously improve the utilization of resources in and across collaborating departments. “Torin will make a difference for all hospitals that are looking to work more efficiently with their surgical planning and daily management of appointments. With Torin, Getinge provides one tool for both optimized long-term planning and reliable real-time execution. The goal is to minimize disruptions, reduce costs and improve patient care,” explains Charlotte Enlund, Vice President Integrated Workflow Solutions at Getinge. The user-friendly scheduling tool promotes planning, prioritization, and rescheduling of both day-to-day and long term appointments. Torin automatically checks for resource and staff conflicts to avoid double bookings as well as inconvenient and expensive waiting time. Additionally, it provides a business intelligence tool that enables management to identify trends and potential inefficiencies and act accordingly. Overall, Torin creates a calm environment for the patients, as they get to experience the reassurance of a well-organized hospital with surgeries that run on time and that always have the necessary resources and staff available in the right place.” Torin is available in three levels, that each focuses on different hospital needs. Torin Planning is the user-friendly planning tool with visual overviews for optimized surgery scheduling and increased OR utilization. Torin Progress level it up by also ensuring on-time execution of the daily schedule and complete documentation of all surgery steps. “Then we have Torin Optimization, which captures and provides access to an extensive business intelligence tool, allowing hospital management to learn from their data and further optimize the way their surgical department is run.”

MTI Enables Lab Quality Spirometry at Home

Monitored Therapeutics Inc. is focused on solutions for the management of diseases that affect respiratory function such as COPD, Asthma, Lung Transplant, ALS, and Cystic Fibrosis. We provide remote patient monitoring solutions for in-home use and to support pharmaceutical clinical trials. MTI’s GoSpiro Spirometer with Avatar-Assisted Technology delivers hospital lab quality Spirometry in the home without the need of a technician to go to the home, keeping both the patient and technician safe. “Lisa” is the world’s FIRST and ONLY Avatar based Spirometry Coach on the market, increasing measurement quality and providing patients with immediate post-test feedback. MTI’s unique solution solves the long-standing challenge of remote monitoring of respiratory patients. Lisa speaks 29 languages and all of the spirometry data is immediately available for viewing on the MTI CarePortal. The MTI CarePortal is a HIPAA and GDPR compliant cloud-based information portal designed for home and clinic site data collection and processing. “If the purpose of remotely monitoring respiratory patients is to obtain meaningful data that guides their care and prognosis...only the MTI GoSpiro has passed the more stringent test requirements for home use.” Kevin McCarthy, Member, ATS Pulmonary Function Lab Certification Program Committee and former Cleveland Clinic Pulmonary Function Lab Manager. In addition to GoSpiro with Avatar-Assisted Technology, MTI’s products also include the GoHome a telehealth communications hub for remote monitoring, communication, and care of patients at home. The GoHome provides simplified patient physiologic data collection for spirometry, blood pressure, SpO2, weight, FeNO, Glucose and other measurements. Contact MTI at info@monitoredrx.com to learn more about how the GoSpiro with Avatar-Assisted Technology and the full range of patient monitoring tools can solve your remote patient monitoring needs.

CAIRE expands global efforts to provide essential oxygen solutions

Bringing early experience to the fight against COVID-19, CAIRE President and CEO Earl Lawson issued this statement: “For more than 50 years, CAIRE Inc. oxygen solutions have been on the front lines of serving the global healthcare community – its top-tier health systems and medical institutions, clinicians, home care and durable medical equipment providers, the military and global aid nonprofits – all to provide the support required to care for patients who require life-sustaining or the therapeutic benefits of oxygen therapy. Today, we find ourselves playing a key role in fighting the novel coronavirus, COVID-19, on the world stage as it moves at a rapid pace touching the fabric of life in almost every country across the globe. Rest assured, the entire CAIRE team is “all-in” in meeting this challenge to provide its customers with a broad portfolio of equipment that can serve patients in need in hospitals, temporary treatment centers, in long-term care and even at home. Here is how we are bringing our experience to the task at hand. Providing access to oxygen delivery solutions for the critically ill, CAIRE offers a complete continuum of care of oxygen equipment solutions from the wearable portable oxygen concentrator designed for the individual suffering from Chronic Obstructive Pulmonary Disease to the commercial turnkey on-site oxygen generation system supporting the variable needs of a medical facility. As the COVID-19 virus has spread in recent weeks, we have seen a dramatic increase in demand for stationary oxygen concentrators, liquid oxygen vessels and commercial generators from our customers globally – particularly from those who are providing emergency aid in pandemic hot zones. Administering highly-concentrated oxygen therapy, delivered via a nasal cannula to an infected person, is one of the key supportive medical therapies identified by the World Health Organization to bring relief and healing to individuals whose respiratory function has been severely impacted by the virus. While most people with COVID-19 develop only mild or uncomplicated illness, approximately 14 percent develop severe disease that requires hospitalization and oxygen support, and 5 percent require admission to an intensive care unit. Expanding production to support our healthcare partners – The company has responded quickly to meet the rapidly increasing demand for its oxygen therapy solutions. With a heightened level of focus and intensity, CAIRE has added production shifts, extended work hours and is expanding production lines to address the increased need for oxygen equipment in its manufacturing facilities in Ball Ground, GA, Buffalo, NY, and Chengdu, China. Appropriate resources are also being allocated at its service and distribution facilities in Anjo, Japan; Langenfeld, Germany; Padova, Italy; San Diego, CA; and Wokingham, UK. CAIRE’s employees are in ongoing communication with our healthcare partners, our suppliers and local, state and government officials to ensure continuity of business and optimize access to our technologies. All of this work is being done with our ongoing commitment to provide products and service of the highest quality. Protecting our employees - When early reports began to surface regarding the highly-contagious coronavirus in Asia, CAIRE took swift action at its Chengdu location to comply with safety and quarantine recommendations made by the Chinese government. We learned valuable lessons in our China facility, that we have applied all around the globe to ensure continuity of supply of this critical equipment. Our decisive action enabled our production team in Chengdu to resume work in early February after a short down period, which is now making a difference in serving our European customers. Following the increase of virus cases in the US and Europe, CAIRE leadership made the decision to send all non-production CAIRE employees based at all of our facilities to work remotely while continuing all core business operations; and the remainder of employees in these plants continue production, but with new safeguards to protect them from potential exposure to the virus. These safeguards include regular screening before entering the facilities, heightened hygiene and sanitization schedules within the facilities, and structured social distancing on the manufacturing floor and in common areas. The situation is dynamic, and we are reacting to this new business environment in real-time. We are communicating at all levels of our business internally to rise to this unprecedented challenge, and externally to our suppliers and government leaders to ensure our essential manufacturing operations are not disrupted during this critical time. On behalf of the entire CAIRE organization, we appreciate the higher calling that this moment in time brings to us as a company and to each of us individually. We are ready and equipped to serve like never before because YOUR CAIRE MATTERS!”

Continuing Education for Students Enrolled in a Respiratory Therapy Program

Due to the restrictions placed on hospitals and schools during the COVID-19 (corona virus) quarantine, Intensive Care-on Line Network (ICON) is providing access to continuing education for all students currently enrolled in a respiratory therapy program. ICON will provide live webinars in addition to self-paced on line presentations covering basic topics to bridge the gap for respiratory therapy students while they are unable to attend clinical rotations at hospitals or classroom training. Topics to be covered include:

Vitalograph Publishes Infection Control Efficiency Rates for Respiratory Diagnostic Filters

In order to address concerns over COVID-19 exposure during respiratory function testing, Vitalograph has released a Certificate of Cross-Infection Efficiency for their Bacterial Viral Filters (BVFs) used during these procedures. The BV filters have a 99.999996% efficiency rate against bacteria such as MRSA and tuberculosis and a 99.999711% efficiency rate against viruses such as influenza and COVID-19. This extreme level of protection will help ensure that both patients and medical staff are protected from infection during testing for respiratory functioning. Every Vitalograph spirometer has such a compatible filter available and they often cost substantially less than other non-filtered mouthpiece options. As such, Vitalograph BVFs can play an important role alongside traditional safety measures like masks, gloves and good device hygiene to protect the respiratory care population from dangerous pathogens. “Our filters are specifically designed to stop the spread of COVID-19 and other infectious diseases during respiratory testing procedures,” said Troy Pridgeon, Vitalograph’s Executive Vice President of Sales and Operations in the US. “In light of the current pandemic, it is more important than ever for spirometry devices to be filtered and completely safe to use as the need for this type of testing is only likely to increase in the aftermath.” Vitalograph is one of the world’s leading providers of respiratory diagnostic devices and clinical trials. Their extensive range of respiratory testing devices include Pulmonary Function Test (PFT) equipment, spirometers, peak flow meters, COPD screeners, asthma monitors, and trainers for metered dose and dry powder inhalers. With a pioneering heritage spanning half a century, Vitalograph continues to produce innovations for safe and effective respiratory care and enhanced quality of life.

Getinge increases production capacity of ventilators by 60% to support the needs of global Intensive Care Units

Getinge has since the outbreak of the COVID-19 pandemic seen an increased global demand for ventilators, extra corporeal life support (ECLS) equipment and advanced monitoring for Intensive Care Units. To meet the global demand Getinge will temporary increase its production of ventilators by 60% in 2020 compared to 2019 at its production facility in Solna, Sweden. According to the World Health Organization, approximately 14% of COVID-19 affected people develop severe disease that requires hospitalization and oxygen support, and 5% require admission to an intensive care unit. To meet the increased global demand for various products and therapies, specifically ventilators, Getinge will temporary increase its production of ventilators at its production facility in Solna, Sweden by 60% in 2020 compared to 2019. “To meet the increased demand for ventilators we are adding a second production shift in our production facility”, says Elin Frostehav, Vice President Critical Care at Getinge. “The produced ventilators will be shipped globally based on current customer demands”. In 2019, Getinge produced more than 10,000 ventilators which translates into around 3 BSEK of its net sales (including service and spareparts). The production in 2020 has been up and running without interference, and Getinge will ramp up the production further, pending availability of supply parts from its sub-contractors. The ramp up will start immediately and be balanced in close collaboration with Getinge’s suppliers. “Our teams are doing their outmost every day to support our customers help saving lives”, Elin Frostehav continues. “I am very proud of our engaged sales teams and service technicians that on a daily basis are supporting our customers”. The expected increase in demand and production capacity of ventilators is expected to be accretive to Getinge’s result. Learn more about Getinge’s products on www.getinge.com.

Respiratory Treatment Options Receives FDA Clearance

Monaghan Medical Corporation announced the newly approved combination for two of its groundbreaking products—the Aerobika oscillatory positive expiratory pressure (OPEP) device and the VersaPAP positive airway pressure device—to create a low cost, safe and effective “tandem therapy” which allows clinicians to treat a variety of pulmonary conditions requiring lung expansion and airway clearance. Lung expansion therapy is designed to prevent or treat atelectasis—the complete or partial collapse of the lungs—and can also reduce air trapping on exhalation caused by conditions such as asthma or chronic obstructive pulmonary disease (COPD). The overall goal of this tandem therapy is to improve lung volumes by maximizing lung re-expansion (alveolar recruitment) while optimizing airway clearance. The combination of Aerobika OPEP and VersaPAP devices allows for an efficient and effective synergy when used in tandem, optimizing the function of each. Augmentation of maximum flow from the VersaPAP device creates airway expansion on inhalation, allowing for the patient to take in a larger breath. This, in turn, means the patient will have more air to exhale. Oscillations from the Aerobika OPEP device are then maximized on exhalation to improve airway clearance and further lung expansion by the added resistance of both devices. This results in patients receiving positive pressure on inhalation and exhalation, simultaneously optimizing lung expansion and airway clearance. Tandem therapy is yet another added value to a complete system of care for respiratory ailments. The Aerobika OPEP, VersaPAP device, and AeroEclipse II Breath Actuated Nebulizer (BAN) can be used individually or in a variety of combinations to efficiently and effectively treat a patient’s pulmonary condition, and easily adjust therapeutic regimens as a patient’s condition changes. This “plug and play” model is not only cost effective, but also a true benefit to patients in a hospital setting and as they transfer to a residential setting.

Multicenter Study Evaluates Trend Accuracy of Noninvasive, Continuous Masimo SpHb and Two Invasive Hemoglobin Testing Methods

Masimo announced that in a multicenter study recently published in the Journal of Clinical Monitoring and Computing, researchers at three institutions – Loma Linda University in California (LLU), the University of California at Irvine (UCI), and Mayo Clinic in Jacksonville, Florida (MCF) – evaluated the trend accuracy of three hemoglobin (Hb) monitoring methods, including noninvasive, continuous Masimo SpHb.

Dr Applegate and colleagues prefaced their investigation by noting that Hb measurement "informs patient-specific perioperative transfusion decisions within the context of symptoms, comorbid conditions, surgical procedure, observed bleeding and hemodynamic performance." They also noted, however, that "the time needed for blood sampling and analysis can cause Hb measurement to lag clinical situations. In surgical settings in which blood loss may not be apparent or be difficult to estimate, continuous rather than intermittent Hb monitoring could provide earlier warning of decreasing Hb." Thus, they sought to determine whether noninvasive, continuous hemoglobin monitoring using Pulse CO-Oximetry (SpHb) might provide useful real-time information about changes in Hb.

The researchers compared noninvasive SpHb measurement and two invasive methods of determining intraoperative Hb changes – arterial blood gas CO-oximetry (ABGHb) and point-of-care hemoglobin using arterial blood (aHQHb) – to laboratory determined hemoglobin changes (tHb) for trend accuracy. SpHb was measured using Masimo Radical-7 Pulse CO-Oximeters with rainbow fingertip sensors at all sites. Based on the institution, ABGHb was measured using either a Radiometer ABL800, Nova Biomedical CCX or PhOX, or Siemens RAPIDLab 1265; aHQHb was measured with a HemoCue HB 301; and tHb was measured using either a Sysmex XE5000 or Coulter AcT-diff or LH 750, also depending on the institution.

The researchers independently enrolled 135 adult patients undergoing non-cardiac surgery in which arterial catheterization was planned and repeated intraoperative blood gas analysis was expected (51 at LLU, 26 at UCI, and 58 at MFC). During surgery, whenever arterial blood analysis was performed, SpHb (as displayed at the time blood was drawn) was recorded, and samples were analyzed within ten minutes using ABGHb, aHQHb, and tHb. On average, patients had 4 samples obtained (ranging from 2 to 13), with a total of 551 blood gas samples analyzed, providing 416 sequential changes in Hb for trend assessment.

Using modified Bland-Altman analysis, the researchers assessed trend accuracy for the three methods compared to laboratory analysis, calculating mean bias (95% limits of agreement) of 0.10 (-1.14 to 1.35) for SpHb, -0.02 (-1.06 to 1.02) for ABGHb, and 0.003 (-0.95 to 0.95) for aHQHb. Defining a change in SpHb, ABGHb, or aHQHb as ± 0.5 g/dL and a change in tHb as ± 0.25 g/dL, the researchers found that changes in direction agreed with tHb changes in direction as follows: in 94.2% (88.9-97.0%) of SpHb changes, in 98.9% (96.1-99.7%) of ABGHb changes, and in 99.0% (96.4-99.7%) of aHQHb changes.

The researchers concluded, "We found that SpHb, ABGHb and aHQHb changes more than ± 0.5 g/dL have similar correlation to the direction but not necessarily the magnitude of tHb change during surgery. The similar agreement in trend direction suggests that clinicians can choose which to use based on availability or preference, although continuous SpHb monitoring may provide useful ongoing Hb trend information. Continuous noninvasive SpHb decreases exceeding -0.5 g/dL may prompt a decision to obtain a confirmatory tHb measurement if low tHb is clinically suspected, but not replace blood Hb measurement in guiding transfusion decision making."

Comparing their results to two previous single-center studies involving changes in SpHb compared to changes in tHb, the researchers noted that their multicenter study produced “similar” results in both cases: one study (of volunteers) found 95.4% SpHb change agreement in 22 samples with tHb < 10.0 g/dL, while the other study (of 70 trauma patients) reported bias of -0.05, with limits of agreement of -0.62 to 0.51.

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition and laboratory diagnostic tests using blood samples.

Study Says This Device is ‘Feasible’

Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI Technology, announced that a paper published in the Journal of Clinical Respiratory Diseases and Care, titled “Assessing the Clinical Effect of High Velocity Nasal Insufflation on Improving Ambulation in Patients with Dyspnea: A Feasibility Study” demonstrated that use of Vapotherm Hi-VNI Technology during ambulation is feasible and showed that patients with dyspnea participating in this study who used Hi-VNI Technology as respiratory support walked farther and recovered faster when compared to standard oxygen treatment. “These results show that the Vapotherm Transfer Unit not only provides support for hospital transfers across all deparments, but also offers an important respiratory support option for clinicians managing inpatients requiring ambulation as part of their treatment,” said Joe Army, President and CEO of Vapotherm. “This study offers an additional proof point for clinicians that Hi-VNI Technology may help their patients, not just in general settings as Mask-Free NIV for spontaneously breathing patients, but also during ambulation and recovery.” The feasibility study was a prospective cross-over trial that compared oxygen treatment as usual (TAU) to treatment with Hi-VNI Technology—which delivers high velocity nasal insufflation (HVNI)—in 28 patients during ambulation in both inpatient and outpatient settings. The goal was to compare how far and for how long patients could ambulate on Hi-VNI Technology versus the standard TAU. Vital signs and recovery time were measured as secondary outcomes. 25 of the 28 patients were analyzed. Among the inpatients in this study, Hi-VNI Technology during ambulation was not only feasible, but also showed improved patient distance walked by 12.4% and duration of time walked by 8.5%. It also improved recovery time by 32.5%. Use was also feasible among outpatients undergoing ambulation, although outpatients performed worse than the inpatient subgroup studied. These results are very encouraging for further research as well as demonstrating feasibility of using Hi-VNI Technology in respiratory patient ambulation. While this study was comparing Hi-VNI Technology to oxygen support, previous studies have demonstrated that Hi-VNI Technology is comparable to noninvasive positive pressure ventilation (NiPPV) when treating patients in undifferentiated respiratory distress. The Vapotherm Transfer Unit is a self-contained mobile means of delivering Hi-VNI Technology for patients on the move in the acute setting.

Companies Announced Distribution Partnership

A “monumental distribution partnership” has been announced between Pharma Systems and CAREstream America. Pharma System manufactures the humidification and filtration products that you currently purchase. CAREstream America, based out of Orlando, Florida, offers a variety of premium product and therapy solutions for Aesthetics, Anesthesia, Pain Management, and Respiratory care specialties across the US. Effective January 1, 2020, CAREstream America will become the exclusive distributor of Pharma Systems products in the US. To ensure a seamless transition, the existing product numbers, terms and prices will stay the same. To place an order now with CAREstream America, email orders@carestreamamerica.com, or fax your request to 407-960-2758. If you have any questions, please reach out to our main office at 855-892-3872 or info@carestreamamerica.com.

‘Breathing Company’ gets FDA Clearance

Vyaire Medical, Inc., the healthcare industry’s dedicated “breathing company,” announced the US Food and Drug Administration (FDA) has granted FDA 510(k) clearance for two of its latest Pulmonary Function Testing (PFT) technologies: Vyntus ONE, Vyntus BODY with SentrySuite Software. The Vyntus ONE is designed to be a convenient PFT station available in a fixed or mobile configuration that is patient-friendly and easy for clinicians to use. Vyntus BODY is engineered to conduct body plethysmography to measure lung capacity and other pulmonary functions for patients of all sizes and mobility, offering larger interior space to accommodate patients of any size without increasing the footprint of the cabin. Both Vyntus ONE and Vyntus BODY include a newly designed Ultrasonic Flow Sensor that represents significant improvements in efficiency and accuracy of pulmonary function testing. All Vyntus technologies run on the SentrySuite Software, which is easy-to-operate and designed completely around the user experience for accurate results and optimal workflow. SentrySuite provides seamless integration and secure connectivity with both the clinical infrastructure and the electronic medical records (EMR) platform. “These new Vyntus products offer a modern ergonomic design, state-of-the-art ultrasonic sensor technology for consistent and accurate respiratory testing as well as more efficient hygiene and maintenance protocols for customers.” said Dave Eckley, Vyaire’s Chief Executive Officer. “These benefits are absolutely meaningful in today’s respiratory diagnostics clinical environment and demonstrate the value of the Vyaire technologies.” Vyaire believes this product launch represents the most progressive innovation in the Respiratory Diagnostics field in many years. Vyntus ONE and Vyntus BODY are the continued expansion of the portfolio – including Vyntus CPX, Vyntus SPIRO, Vyntus WALK, and VyntusTM ECG – all of which run on the SentrySuite Software platform. Learn more at vyaire.com.

Telemetry Adapter Now Available in the US

Vyaire Medical has announced the US availability of its smaller, reusable ApexPro FH telemetry adapter for use with the GE ApexPro FH System. Designed with input from clinicians, the new version of the adapter connects to the GE ApexPro FH telemetry system. The smaller design offers a more secure connection making it easier for patients to move about the hospital while receiving ECG monitoring. The adapter can be used in conjunction with Vyaire's Multi-Link X2 ECG portfolio. "The new ApexPro FH adapter demonstrates our commitment to putting customers and patients first. The smaller size improves patient comfort and mobility. The compatibility with our disposable leadwires reduces cross-contamination exposure, because the leadwires can stay with the patient throughout the hospital. Both lead to improved patient outcomes, which is a win for everyone." Joel Brandon, VP Marketing, Vyaire Medical. The ApexPro FH uses one of our Multi-Link X2 solutions that allows for standardization of single patient use leadwires across multiple monitoring platforms including: GE, Philips, Mindray, Nihon Kohden and Spacelabs. Additionally, the new adapter helps optimize patient flow through the hospital allowing patients increased mobility. Infection prevention is a key metric in healthcare systems. By using our single patient use leadwires it can help eliminate the risk of cross contamination often seen with reusable leadwires.

Device Offers Rapid Change in Therapies for Clinicians

Vyaire Medical, Inc.’s bellavista 1000e ventilator has been granted 510(k) clearance from the US Food and Drug Administration (FDA). It is the newest addition to Vyaire’s high-end ventilation portfolio offering a comprehensive solution for hospitals with the integration of high flow oxygen therapy and advanced synchrony support for neonatal to adult patients in a single device. Clinicians can rapidly change therapies on a broad range of patients in an effortless way. “We began using bellavista exclusively in 2017, when it was available in Europe. It allows us to ventilate invasive, non-invasive, nasal CPAP and perform high flow oxygen therapy with one device enabling targeted, efficient patient care in any situation” said Vincenzo Cannizzaro, MD, PhD, Deputy Chief Physician of PICU/NICU, University Children’s Hospital, Zurich, Switzerland. Designed exclusively around enhancing the caregiver’s experience, the bellavista 1000e’s intuitive touch screen provides advanced graphics to easily visualize the patient’s pulmonary status, enhancing situational awareness for the caregiver. Whether its escalating care or weaning a patient efficiently, the bellavista 1000e ventilator simplifies the process by delivering optimal workflows with the goal of reducing operator error and ventilator lengths of stays. “Clinicians, respiratory therapists and bedside caregivers provided critical input in the design of this ventilator and helped us ensure we addressed their challenges in all patient care circumstances,” said Lisa Rose, Chief Marketing and Innovation Officer, Vyaire Medical. “The bellavista 1000e is a solution that provides the ultimate versatility in therapy and it can be adjusted quickly depending on patient need in time sensitive situations. These differentiators are critical in a healthcare environment which expects innovative products to improve patient outcomes. Vyaire is dedicated to developing the kinds of systems and products that meet the needs of healthcare providers.” Today, there are more than 8,200 bellavista 1000e ventilators in use across 92 countries outside of the United States. The bellavista 1000e ventilator was introduced to the US healthcare market at the American Association of Respiratory Care Congress (AARC), November 9-12, 2019 in New Orleans.

Nihon Kohden Launches New Ventilator System

Nihon Kohden, a US market leader in precision medical products and services, announced the launch of its new NKV-550 series ventilator system that offers a full suite of applications necessary in a critical care setting for patients of all ages – from neonate through adult. The NKV-550, introduced for the first time at the annual American Association for Respiratory Care Congress 2019 in New Orleans, is an innovative ventilator that features an integrated touchscreen, intuitive user interface, and onscreen help functions. The NKV-550 was developed to seamlessly transition between invasive ventilation, noninvasive ventilation and high-flow oxygen therapy, allowing clinicians to respond to a patient’s respiratory support needs without having to change devices. “Every product we bring to market is designed to simplify workflow for clinicians and benefit patients,” said Yasuhiro Yoshitake, president and CEO of Nihon Kohden America. “We saw a tremendous need in the respiratory market for a comprehensive ventilator that could respond to any patient situation while also providing excellent usability using modern technology.” The NKV-550 is a unique ventilator to offer Protective Control, a feature that uses a second graphic user interface placed outside the isolation room of a contagious patient who is under mechanical ventilation. The respiratory therapists and clinicians can view the ventilator monitors and alarms, adjust ventilation settings and alarm settings, and audio pause the alarm sound, through the second graphic user interface outside the isolation room, as long as the patient is within the sight of the clinician through the room’s glass window. When managing a patient who has a communicable disease case and is in isolation, this feature protects both the clinician and the patient because respiratory therapists and clinicians will not lose valuable minutes donning protective gowns, gloves and masks before responding to the needs of an infectious patient. This minimizes a potential hazard many healthcare workers face. An estimated 42 healthcare workers per million employed die each year from infections acquired at work. The NKV-550 was created based on the lung protective approach to ventilation and features the Gentle Lung suite of applications to provide clinically relevant, easy-to-use tools for the open-lung approach to ventilation. The ventilator offers highly customizable screen configurations enabling the ventilator to fit into your paradigm rather than require you adapting to it. The app-based design provides guided processes to help create a more streamlined, systematic way for clinicians to optimize care of their ventilated patients. The NKV-550 also offers on-screen help tools to walk clinicians through critical ventilator troubleshooting. Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the US, Europe and Asia. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide.

Monaghan Receives Prestigious Award

Monaghan Medical Corporation (MMC) has received the prestigious American Association of Respiratory Care (AARC) Zenith Award for the fifth consecutive year. The award was presented at the 65th International Respiratory Care Convention and Exhibition in New Orleans, Louisiana. The Zenith Award is a “people’s choice” award of excellence voted on annually by members of the respiratory care profession. Recipients are selected based on such criteria as outstanding service, quality, accessibility, truth in advertising and support of the respiratory care community. “Winning the coveted Zenith Award from the AARC is a tremendous honor for which our entire organization is grateful,” said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical. “Receiving this recognition from our industry peers for a fifth straight year validates our team’s commitment to providing our customers with the very best in respiratory care products and support.” AARC is the leading national and international professional association for respiratory care. With more than 47,000 members worldwide, AARC encourages and promotes professional excellence, advances the science and practice of respiratory care, and serves as an advocate for patients, their families, the public and the profession. Monaghan Medical Corporation, headquartered in Plattsburgh, New York (USA), is a leader in the research, development, manufacture and marketing of respiratory devices including the AEROCHAMBER Brand of Valved Holding Chambers, AEROECLIPSE II Breath Actuated Nebulizer, AEROBIKA OPEP device, and the newly released VersaPAP device. MMC’s products are developed, tested and validated at the Global Aerosol and Research Center of affiliate Trudell Medical International and are supported by more than 500 peer-reviewed and published articles. To learn more about Monaghan Medical products, visit www.monaghanmed.com.

Ventilator Gets Clearance

Vyaire Medical, Inc.’s bellavista 1000e ventilator has been granted 510(k) clearance from the US Food and Drug Administration (FDA). It is the newest addition to Vyaire’s high-end ventilation portfolio offering a comprehensive solution for hospitals with the integration of high flow oxygen therapy and advanced synchrony support for neonatal to adult patients in a single device. Clinicians can rapidly change therapies on a broad range of patients in an effortless way. “We began using bellavista exclusively in 2017, when it was available in Europe. It allows us to ventilate invasive, non-invasive, nasal CPAP and perform high flow oxygen therapy with one device enabling targeted, efficient patient care in any situation” said Vincenzo Cannizzaro, MD, PhD, Deputy Chief Physician of PICU/NICU, University Children’s Hospital, Zurich, Switzerland. Designed exclusively around enhancing the caregiver’s experience, the bellavista 1000es intuitive touch screen provides advanced graphics to easily visualize the patient’s pulmonary status, enhancing situational awareness for the caregiver. Whether its escalating care or weaning a patient efficiently, the bellavista 1000e ventilator simplifies the process by delivering optimal workflows with the goal of reducing operator error and ventilator lengths of stays. “Clinicians, respiratory therapists and bedside caregivers provided critical input in the design of this ventilator and helped us ensure we addressed their challenges in all patient care circumstances,” said Lisa Rose, Chief Marketing and Innovation Officer, Vyaire Medical. “The bellavista 1000e is a solution that provides the ultimate versatility in therapy and it can be adjusted quickly depending on patient need in time sensitive situations. These differentiators are critical in a healthcare environment which expects innovative products to improve patient outcomes. Vyaire is dedicated to developing the kinds of systems and products that meet the needs of healthcare providers.” Today, there are more than 8,200 bellavista 1000e ventilators in use across 92 countries outside of the United States.

Hamilton Medical Receives Approval

Hamilton Medical received 510(k) approval for the optional high flow oxygen therapy on the HAMILTON-G5, HAMILTON-C1 and HAMILTON-T1 ventilators, as well as for the speaking valve compatibility option on the HAMILTON-C1 and HAMILTON-T1. The option of integrated high flow oxygen therapy on the HAMILTON-G5/C1/T1 ventilators is now available for all patient populations. With this enhancement, these ventilators offer you a wide range of ventilation and therapy options, including invasive and noninvasive ventilation, and high flow oxygen therapy, all in one single device. In just a few steps, you can change the interface and use the same device and breathing circuit to accommodate your patient’s needs. To minimize the risks of hyperoxia and associated complications caused by the inaccurate administration of oxygen, Hamilton Medical ventilators offer a continuous display of all relevant monitoring parameters for high flow oxygen therapy, such as oxygen concentration, flow rates, SpO2 (optional), and trends. On the HAMILTON-G5, high flow oxygen therapy can be combined with an integrated Aerogen nebulizer (optional) to help improve therapy efficiency through nebulized drug administration. For adult and pediatric patients in pressure-controlled modes (PCV+, SPONT, PSIMV+), the SpeakValve option enables the use of conventional speaking valves with the HAMILTON-C1 and HAMILTON-T1. The use of a speaking valve in mechanically ventilated patients facilitates independent vocalization in mechanically ventilated patients, allowing them to become active participants in their healthcare. Improving communication between the patient and the healthcare team can help to reduce the patients’ anxiety and improve their sense of well-being, dignity, and motivation to wean.

Capsule Acquires Company

Capsule Technologies, Inc., a leader in medical device integration and non-critical care patient monitoring solutions, announced it has acquired Bernoulli Health. The acquisition includes Bernoulli One, a real-time clinical surveillance solution that gives care teams contextual information on a patient’s condition that can facilitate early intervention, improve patient safety and enable better clinical outcomes. The acquisition grows Capsule Technologies’ leadership position by extending the reach of its clinical platform into additional use cases by adding patient data visualization to the platform’s existing data management and connectivity capabilities. Today, hospital clinical leadership is focusing on more direct ways to improve patient safety by increasing continuous surveillance on patients throughout their entire course of stay in the hospital. Bernoulli Health’s clinical surveillance solution provides early detection of critical events so care teams can intervene before deterioration occurs. The addition of this capability furthers Capsule Technologies’ focus on improving patient safety by providing clinicians with tools that simplify clinical workflow and provide data-driven insights at the point of care. “Capsule Technologies’ success is built on our vendor-neutral approach, giving hospitals the flexibility and freedom to deploy almost any medical device,” said Kevin Phillips, Capsule Technologies’ vice president of product management. “Our customers are assured that we can connect to their devices, process data on the fly, and integrate normalized relevant physiologic and treatment data to any downstream clinical system that best meets their needs. Integrating Bernoulli Health’s clinical surveillance solution into our medical device Integration platform provides yet another option for those customers who want a tightly connected turnkey experience.” “Bernoulli Health and Capsule Technologies have a shared vision to unlock the power of medical device data to provide better clinical insights across all levels of patient acuity,” said Janet Dillione, chief executive officer of Bernoulli Health. “With the emergence in the market of clinical surveillance, predictive analytics and real-time healthcare, we are confident that bringing together these two organizations will be highly beneficial to all our stakeholders and especially customers.”

Medical Company Hosts Free Seminar

Are you going to be in the Seattle, WA area on July 30th, 2019? Hayek Medical invites you to register for a one-day free seminar that offers 6 AARC approved CRCE Units focused on Biphasic Cuirass Ventilation. Breakfast and lunch included! When: July 30th, 2019, 9:00am to 3:00pm. Where: Hilton Seattle, 1301 6th Ave, Seattle, WA 98101, USA (Windward Room). https://mailchi.mp/hayekmedical/ceuseattle

Device Unveiled to Reduce Inhaler Errors

Monaghan Medical Corporation introduced new product enhancements to continue their mission to ensure device quality for patients. Close to 50 million Americans suffer from asthma or chronic obstructive pulmonary disease (COPD) — lung conditions that seriously interfere with airflow and make it difficult to breathe. These individuals need critical daily medical treatments administered by means of an inhaler, a device that delivers medication into the body through the lungs. Related medical expenses compounded by absences from work and school total billions of dollars each year, costs which may have been prevented with proper treatment. Today, there are more than 250 inhaler brands on the market providing targeted delivery of medication to the lungs with reduced side effects when compared to oral medications. Users typically own more than one inhaler, and with so many brands available, problems can result if these inhalers are designed to operate in different ways. It should come as no surprise that less than 10 per cent of people use their inhalers correctly. To help reduce errors associated with inhaler use, guidelines recommend the addition of a valved holding chamber — a device that attaches to an inhaler and captures medication as it sprays out. Valved holding chambers streamline delivery of medication and maximize how much medication is delivered into the lungs. The most commonly prescribed metered-dose and soft-mist inhalers recommend the use of an AeroChamber Plus Flow-Vu chamber in their product information to ensure that the optimal dose of medication is received. Since its introduction in 1983, the AeroChamber brand of chambers has been continually updated, the most recent improvement being the introduction of an Intermediate Mask to its family of small-, medium- and large-sized masks. An inhaler mask is a cone-like device that fits over the nose and mouth and helps enhance the amount of medication that reaches the lungs. ComfortSeal masks are anatomically designed for different face sizes and shapes, reducing unwanted gaps and minimizing the distance between the mask and the user. Masks help users overcome challenges they may experience while determining when to inhale after activating the inhaler, resulting in optimized medical benefits and improved outcomes. With the introduction of the new intermediate mask size, the AeroChamber Plus Flow-Vu chamber product line becomes the only chamber currently FDA 510(k) cleared for use with both metered-dose inhalers and the new soft-mist inhaler formats.

New Catheter Securement Product Unveiled

Dale Medical Products, Inc. (Dale), the company known for its high quality, patient-friendly medical device securement solutions, is expanding its offering with its new Hold-n-Place® Catheter Securement Products. Like the Dale® Hold-n-Place® General Purpose Securement Devices, the new catheter securement products are Engineered Stabilization Devices (ESD) and feature a soft, comfortable, flexible design with no hard plastic parts. No skin prep is required for application, and no alcohol is required for removal. Hold-n-Place Catheter Securement Devices are available in two sizes: one for IV, arterial and mid-line catheter securement and another for CVC, PICC and arterial sheath securement. Either device is available by itself, with a transparent dressing, or with a PrevahexCHX™ Antimicrobial Transparent Film Dressing by entrotech life sciences, inc. Hold-n-Place is the first and only catheter ESD available with the PrevahexCHX dressing. Together, the two products combine the effectiveness of an ESD with the first and only CHX chlorhexidine dressing cleared by the FDA with complete antimicrobial protection throughout the transparent areas, and with the adhesive strength and transparency clinicians are looking for in a seven-day securement solution. "Clinicians tell us they appreciate the safety and security of Dale Hold-n-Place products," says John Brezack, President of Dale. "We are pleased to expand the offering with our new catheter securement devices." For more information about Dale's new Hold-n-Place Catheter Securement line, or to request a product sample, please visit https://www.dalemed.com/product/hold-n-place-catheter-securement/ or call 800-343-3980

Flow-Safe II+ Disposable BiLevel CPAP Device Now Available

Flow-Safe II+ is the only available Disposable BiLevel CPAP system. Now clinicians can easily choose either BiLevel or CPAP treatments with the twist of a dial. Includes a manometer for verifying pressures. Easy set-up. Ideal for transport and where backup Bilevel equipment is unavailable. For more information and a video, visit: https://mercurymed.com/product/flow-safe-ii-disposable-bilevel-cpap/?utm_source=ems1.com&utm_medium=banner

Device Earns Hot Products Award

Mercury Medical and JEMS (Journal of Emergency Medical Services) are proud to announce the selection of Flow-Safe II+ Disposable BiLevel CPAP device and the WoundClot Next Generation Hemostatic Agent as winners of the Hot Products Award from the JEMS EMS Today Conference and Exposition, which was held February 20-22 in National Harbor, MD. Mercury Medical was the only company to win multiple awards. Flow-Safe II+ and WoundClot were selected after a panel of judges consisting of emergency medical services (EMS) product specialists, physicians, educators, managers and paramedics reviewed a host of product contenders designed to not only improve the ability to deliver optimal emergency medical care to sick and injured patients, but also allow EMS agencies to do it safely, more efficiently and with enhanced comfort for the patient. Products were evaluated based on four distinct categories: 1) Originality; 2) Functionality; 3) Ease of use; and 4) Need in the EMS setting. Flow-Safe II+ and WoundClot were two of only 14 products selected as Hot Products after the EMS Today Hot Products team reviewed and rated dozens of products submitted by a number of companies. Mercury Medical CEO and President John M. Gargaro, M.D. said, “We were delighted to be a multiple winner of the 2019 Hot Product Award at the recent JEMS EMS Conference and Exposition. This speaks volumes about our employees at the Company and their continuous focus on nurturing and developing leading edge products in the markets we serve.” Flow-Safe II+ is the first disposable Bilevel CPAP system in the United States. This customized system provides clinicians every item needed for delivering BiLevel CPAP and CPAP therapy. Flow-Safe II+ is a single patient use device that includes an adjustable full-face mask and manometer that provides verifiable CPAP and BiLevel IPAP and EPAP pressures which are critical in delivering timely and continuous therapy. This third-generation system uses 50% less oxygen than the original Flow-Safe CPAP System. In addition, it eliminates the need for costly capital equipment maintenance and helps prevent the potential cross contamination from patient to patient from the typical expensive respiratory capital equipment in hospitals, surgery centers and pre-hospital environments. WoundClot, the Next Generation Hemostatic Agent is a patented advanced bleeding control hemostatic gauze that will prove to be a game-changer in immediate and life-saving use situations by providing for the temporary stoppage of severe blood loss. This, for example, will enable EMS providers and the ER at hospitals the capability to address accident victims’ wounds whether they be punctures, lacerations or abrasions. Once WoundClot comes into contact with blood, the solid gauze converts to an expanding gel and can absorb 2,500% its’ weight, quickly and effectively stopping severe blood loss. The biodegradable gauze is non-exothermic and contains proprietary molecular groups created in the manufacturing process which then work directly with the body’s own repair process to form a natural clot in the wound. Once the patient reaches definite treatment, the gelatinous membrane is easy to remove. Mercury Medical is the exclusive distributor of WoundClot Hemostatic Gauze. JEMS Editor-in-Chief and EMS Today Conference Chairman A.J. Heightman said, “There were an amazing group of Hot Product submissions for our reviewers to review and rate this year. All of the products reviewed were extremely innovative and well designed for the EMS industry, showing that our industry is keeping pace with the current science of emergency medicine and developing or upgrading their products to stay out in front of the science and technology curve.”

Optimizing Ventilation Via The Hayek Open Lung Concept

Did you know BCV can likely reduce the need of a tracheostomy in many patients, including ALS patients? Biphasic Cuirass Ventilation controls both phases of the respiratory cycle and has been proven to increase pulmonary muscle strength preventing the loss of chest mobility and the inability to inspire deeply in ALS patients. With the loss of bulbar function, ALS patients may also have issues with aspiration and resulting pneumonia. BCV’s secretion clearance (HFCWO) and cough option can help manage the build-up of secretions and prevent further infections. And, BCV can be used in place or in conjunction with other forms of ventilation. Are you going to be in the Arizona area on January 30th, 2019? Hayek Medical invites you to register for a one-day free seminar that offers 6 AARC approved CRCEs focused on Biphasic Cuirass Ventilation. Optimizing Ventilation Via The Hayek Open Lung Concept:
Remarkable Results With Biphasic Cuirass Ventilation runs from 8:00am to 3:30pm at the Banner Desert Medical Center in the Saguaro Conference Room. You can register at https://mailchi.mp/hayekmedical/ceu For more information on BCV, visit http://www.hayekmedical.com

Company Wins Fifth Zenith Award

Aerogen, the global leader in aerosol drug delivery, has been recognized with the prestigious 2018 Zenith Award for respiratory care excellence by the American Association of Respiratory Care (AARC). The win represents the fifth time that Aerogen has received the award. Widely recognized as the top award of the respiratory care profession, the Zenith Award is voted on by over 47,000 AARC members based on their experience and expertise with a wide range of respiratory products. Judging criteria included outstanding service, product quality, accessibility and helpfulness of sales staff, responsiveness, truth in advertising and support of the respiratory care profession. “We are honored to be recognized by the respiratory therapy community in this way. As a fifth time recipient, we are proud to retain the confidence and trust of respiratory care professionals. Aerogen is committed to work daily to maintain this valued relationship.” John Power, CEO of Aerogen. Aerogen officially received the Award at the opening ceremony for the 64th International Respiratory Congress this December in Las Vegas, NV. It will be received by two of Aerogen’s long standing employees Susan Sickal, Sales Operations and Customer Support Manager and Peter Kahane, Senior Critical Care Specialist, both of whom exemplify the traits of customer centric approach and help to make Aerogen a leader in the industry.

FeNO Monitoring Gets Recommended

Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease, announced that Fractional Exhaled Nitric Oxide (FeNO) monitoring is recommended in the latest Global Initiative for Asthma (GINA) guide, “Difficult-to-Treat & Severe Asthma in Adolescent and Adult Patients – Diagnosis and Management”. Asthma is a chronic inflammatory respiratory disease. During airway inflammation associated with allergic/eosinophilic asthma, higher-than-normal levels of nitric oxide (NO) are released from epithelial cells of the bronchial wall. Measuring the concentration of NO in exhaled breath, or fractional exhaled nitric oxide, can help identify airway inflammation. Circassia’s innovative NIOX® technology provides objective and accurate FeNO measurement of airway inflammation, and is the only FeNO testing device in the US available at point-of-care. The new GINA guide recommends FeNO measurement as an assessment tool to determine whether patients who are on high-dose inhaled corticosteroids (ICS) or low-dose oral corticosteroids (OCS) have residual inflammation. This can provide a potential predictor of good response to anti-immunoglobulin E (anti-IgE) therapy for patients with severe, allergic asthma, and is a tool to identify refractory type 2 inflammation in patients on high-dose ICS therapy. The guide suggests repeating FeNO measurement up to three times when asthma worsens before deciding if it is non-type 2. For patients with elevated type 2 biomarkers on high-dose ICS, FeNO monitoring is recommended to assess adherence before prescribing a biologic. Lastly, FeNO measurement is suggested as a means of monitoring tapering of oral corticosteroid treatment. Circassia announced earlier in 2018 that major insurer Aetna updated its policy to deem FeNO by NIOX as “medically necessary” as a part of comprehensive asthma diagnosis and management. NIOX testing is considered affordable and accessible for both patients and their physicians, as an estimated 80 percent of American lives have insurance coverage for NIOX testing. Asthma often begins in childhood, but can affect people of any age. The disease is characterized by attacks (exacerbations) of breathlessness and wheezing of varying severity and frequency, which if left untreated, can be life-threatening. Asthma is a common condition, with the World Health Organization estimating 235 million people have the condition worldwide. Asthma affects approximately 25 million people in the United States. GINA estimates that 17 percent of asthma patients are considered “difficult-to-treat”, such that their asthma is uncontrolled despite treatment with a medium or high dose inhaled corticosteroid, with a second controller and maintenance oral corticosteroid therapy, or requires such treatment to maintain good symptom control and reduce the risk of exacerbations. An estimated 3.7 percent of asthma patients are considered “severe” in that asthma is uncontrolled despite adherence with maximal optimized therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased. According to GINA, type 2 inflammation is found in approximately half of people who have severe asthma. GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute (NIH) and the World Health Organization. Embracing the issue of severe asthma was a critical goal for the GINA Board of Directors and Science Committee, as their mission remains focused on maximizing benefit for patients with asthma while minimizing healthcare provider burden.

ResMed to Acquire Propeller Health

ResMed, a leader in cloud-connected medical devices and out-of-hospital software-as-a-service (SaaS) business solutions, today announced it has entered a definitive agreement to acquire Propeller Health, a digital therapeutics company providing connected health solutions for people living with chronic obstructive pulmonary disease (COPD) and asthma. Named a “2017 Most Innovative Company” by Fast Company, Propeller helps people and their doctors better manage their COPD and asthma. Propeller’s digital medicine platform consists of small sensors that easily attach to consumers’ inhalers and pair with a mobile app to automatically track medication use and provide personal feedback and insights. Propeller’s clinically validated solutions have demonstrated a 58 percent improvement in medication adherence, 48 percent increase in symptom-free days and 53 percent reduction in emergency room visits.Propeller’s ability to support people in stage II and III severity levels of their COPD are complementary to ResMed’s own suite of cloud-connected ventilators for those with stage III and IV COPD, including Astral, Stellar and AirCurve 10 ST-A with iVAPS – plus ResMed’s new portable oxygen concentrator Mobi. “Acquiring Propeller is a significant step for ResMed toward becoming the global leader in digital health for COPD," said ResMed CEO Mick Farrell. “By working with Propeller’s existing partners to offer digital solutions for respiratory care pharmaceuticals and building on our proven ability to support digital solutions at scale, we can positively impact the lives of even more of the 380 million people worldwide who are living with this debilitating chronic disease.” “Helping inhaler users improve adherence and avoid hospitalizations perfectly serves ResMed’s mission: to improve people’s quality of life, reduce the impact of chronic disease and save healthcare costs across the out-of-hospital care spectrum,” said ResMed Respiratory Care President Richie McHale.“ResMed shares our belief that connected health solutions create vastly better experiences and outcomes for people with chronic respiratory disease,” said David Van Sickle, co-founder and CEO of Propeller. “Joining forces enables us to accelerate the adoption of Propeller’s solutions at a global scale, and serve as a powerful platform for a broad set of pharmaceutical and healthcare partners.” Propeller is privately funded, and based in Madison, Wisconsin, with an office in San Francisco. It will continue to operate as a standalone business within ResMed’s Respiratory Care portfolio. There will be no immediate changes to management, locations or business processes. Van Sickle will continue in his current role, now reporting to McHale.

Hayek Medical Expands its Brand

Medical device company Hayek Medial is expanding its brand by starting up an Instagram account. The company, which bills itself as the ‘world’s home of Biphasic Cuirass Ventilation’ can be found at the @hayekmedical Instagram account. The account features helpful information and photos and diagrams of its devices. You can also tag them with #HayekBCV on the social network.

FDA Approval for Device

Lonhala Magnair is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the US and the first use of the Magnair, which is based on the closed eFlow technology system, developed by PARI Pharma GmbH, to treat COPD. This technology is a virtually silent, portable, closed system nebulizer that is designed to deliver the drug in two to three minutes and allows people to breathe normally while using the device. “We are proud that the FDA has approved Lonhala Magnair as the first nebulized, long-acting muscarinic antagonist treatment option for people in the US living with COPD,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “The approval of Lonhala Magnair underscores our leadership in nebulization and the value we place on providing innovative treatment options for people living with COPD. Lonhala Magnair is an important addition to our portfolio of approved COPD therapies for people at various stages of COPD, providing the flexibility to choose handheld or nebulized products based on individual needs.” Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication, said Gary Ferguson, MD, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique handheld nebulizer that allows a person to breathe normally while taking their medication. Approximately 15.7 million adults in the US report they have been diagnosed with COPD, a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute. The disease makes it hard for people to breathe and subsequently may limit their ability to perform some routine activities, including the proper inhalation of medication. This improper medication technique may impact treatment over time and may also result in an inadequate amount of the drug reaching the lungs, potentially worsening a person’s COPD. For people with moderate-to-very-severe COPD, nebulized treatments offer an alternative to inhalers, allowing a person to breathe normally while taking their medicine. The approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing LONHALA MAGNAIR with placebo in adults with moderate-to-very-severe COPD. At study endpoints, individuals treated with Lonhala Magnair demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in one second at Week 12 versus placebo. An additional study, GOLDEN-5, was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long-term safety and tolerability of Lonhala Magnair in adults with moderate-to-very-severe COPD and included the active comparator Spiriva (tiotropium bromide) delivered by the HandiHaler device. Lonhala Magnair was generally well-tolerated in clinical studies, with the most common side effects being exacerbations and cough. The overall treatment emergent adverse events (TEAE) incidences were similar for glycopyrrolate and tiotropium groups over 48 weeks.

Company Shows Off High IQ

nSpire Health, a leading provider of pulmonary diagnostic systems, has announced the introduction of Iris IQ, a respiratory department analytics platform. The new framework of integrated technologies eliminates incongruences between pulmonary function test results, other respiratory diagnostic exams and/or symptomology adversely affecting clinical decisions in as many as 50% of the millions of cases where pulmonary functions testing is indicated each year. Iris IQ unlocks the underlying power of Pulmonary Function Testing while helping to eliminate an estimated three billion dollars in direct and indirect healthcare costs associated with poor quality testing or lack of testing and resulting misdiagnosis and treatment of respiratory diseases. Scalable in costs for single device users to complete healthcare enterprises with several devices, the new department management platform leverages nSpire Health’s patent pending PFT calibration reference standards and Iris’ unique network architecture to ensure providers consistently deliver valid results for all PFT systems’ clinical indications using any manufacturer’s PFT device. The modular solution provides interpreting and treating physicians, respiratory therapists, and department administrators new levels of trusted insights into the complete pulmonary function testing process from pre-test staging through interpretation and result delivery including verification of instrument accuracy, precision and testing practices. “We believe the lack of practical quality management tools has been concealing the true physiologic detection capabilities of pulmonary function testing,” said Michael Sims, President and CEO of nSpire Health. “Offering a comprehensive quality management solution compatible with any vendor’s PFT devices raises the quality of care for all patients in all pulmonary labs.” For the first time in the history of pulmonary function testing and in less than a few minutes per day end users can irrefutably validate a PFT devices output performance to a manufacturers stated specification limits (or to peer reviewed standardization criteria) for each lung function measurement output as required by the FDA and ISO and more importantly required for efficient clinical decision-making by treating physicians. Outdated simulators and biologic testing controls cost too much to use, take too long to perform, and have enormous limitations in detecting a PFT devices true accuracy and precision limits. Beyond clinical results, Iris IQ dashboards and custom reporting capabilities provide users intuitions into clinical operations, asset management and device utilization while supporting risk management and regulatory compliance. Based on real time quality assessments for every patient exam, an integrated learning management module securely provides specific corrective action training for technicians, department managers, and physicians using any browser or Iris Decision Workstation. “Iris IQ provided us with a deeper understanding of our lung function testing quality and cost drivers while offering our team focused training on corrective action procedures for more effective and efficient patient care. We saw instant results across facilities.” said Rodney Folz, M.D., PhD, Chief of Pulmonary, Critical Care, and Sleep Medicine at University Hospitals Cleveland Medical Center. According to Tad Scheiblich, Director of Product marketing, “nSpire Health is currently performing PFT Quality Webinars and free Department Quality Assessments.”

Positive Results for Device

CSA Medical Inc. presented positive results of its feasibility study of the RejuvenAir Metered Cryospray system at the 2018 European Respiratory Society (ERS) Congress in Paris. In an analysis of 30 patients at 6-month follow up, treatment with RejuvenAir resulted in clinically meaningful improvement in Quality of Life, as measured by Saint George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT). The procedure demonstrated a strong safety profile and was well tolerated. Dirk-Jan Slebos, MD, PhD of the Department of Pulmonary Diseases, at the University Medical Center Groningen, The Netherlands reported that “The RejuvenAir therapy appears to have a beneficial response with a decrease in cough and mucus production even in our patients who had optimized medical management. The overall improvement in breathing resulted in increased physical activity supporting the potential for RejuvenAir to measurably improve quality of life in chronic bronchitis patients.” As reported at ERS, RejuvenAir therapy demonstrated strong safety and tolerability profile during the study with minimal procedure related adverse events and serious adverse events. Importantly, there were no pneumothorax or pneumomediastinum events. Patients were able to be discharged from outpatient bronchoscopy suite on day of treatment. On SGRQ, patients treated with RejuvenAir improved by an average of 10.9 points (p<0.02) at 6-month follow-up. According to peer-reviewed literature, an improvement of 4 points on SGRQ is considered to be clinically meaningful. On CAT, patients treated with RejuvenAir improved by an average of 3.4 points (p<0.02) at 6-month follow-up. According to peer-reviewed literature, an improvement of 2 points on CAT is considered to be clinically meaningful. “We are encouraged by these positive safety and feasibility results and we’re moving forward with plans to initiate a worldwide pivotal study of RejuvenAir in chronic bronchitis in 2019,” said Wendelin Maners, CSA Medical’s Chief Commercial Officer, who further stated, “We look forward to advancing this novel therapy toward commercialization to provide relief to the millions of patients suffering from COPD with chronic bronchitis.” The Safety and Feasibility Study of RejuvenAir for Treating Chronic Bronchitis Patients (NCT02483637) is a prospective, open label, single arm study of COPD patients with known chronic bronchitis is being conducted at three sites in The Netherlands, United Kingdom, and Canada. The study strongly supports the feasibility of using Liquid Nitrogen Metered Cryospray (MCS) throughout the central airways to ablate inflamed bronchial epithelium allowing non-inflamed tissue to regenerate after treatment. Phase A of the study enrolled 11 patients and treated a single lobe to assess safety, feasibility and histologic/immunologic response. In Phase B of the study, Phase A patients had their remaining lobes treated and 24 additional patients were enrolled and treated. All patients have received complete treatment of both lungs and they are being periodically followed for safety and physiologic response of their underlying chronic bronchitis to this novel treatment. Primary endpoints include, 1) adverse and serious adverse events and ability to complete all three treatments, and 2) mean change from baseline total SGRQ score. Secondary endpoints include CAT, 6-minute walk test, spirometry testing, and other objective pulmonary function tests and patient reported outcome instruments. Exacerbation rate was measured as an exploratory endpoint. Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). Bronchitis is inflammation of the bronchial airways. A chronic bronchitis diagnosis is defined by cough with productive sputum of three months duration for two consecutive years. In addition to a chronic inflammation, cough and increased production of mucus, chronic bronchitis may or may not present with obstruction/partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea). In the United States, there are an estimated 12.7-14.7 million people with COPD, and in 2011 approximately 10 million people sought medical attention for chronic bronchitis, a subset of COPD. Approximately 700,000 people are hospitalized for symptoms/exacerbations of chronic bronchitis every year. In Europe, there are approximately 23 million people with COPD. There are approximately 1.5 million hospitalizations per year for COPD. The RejuvenAir Metered Cryospray System is designed to spray liquid nitrogen at –196°C in a circumferential pattern within the airway. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells. The RejuvenAir System is currently under clinical investigation and is not commercially available.

Devices Design to Hold in Place

Dale Medical Products, Inc., the company known for its high-quality, patient-friendly medical device securement solutions, is again advancing the field with its new Hold-n-Place General Purpose Securement Products. With three sizes, 950 Small, 951 Medium and 952 Large, the devices are sized to fit a wide variety of applications. They secure lines and tubes in place on the patient’s body using the familiar "hook and loop" technique with a high-quality adhesive to enhance patient comfort. Hold-n-Place General Purpose Securement devices are made with skin-friendly materials, are breathable and are made without natural rubber latex to reduce the risk of allergic reactions and skin irritation. "Keeping lines and tubes safe and secure is vital to both clinicians and patients," says John Brezack, President of Dale. "Hold-n-Place Securement devices do so reliably while keeping patient comfort a top priority." These general purpose devices feature a soft, comfortable, flexible design with no hard plastic parts. No skin prep is required for application, and no alcohol is required for removal. By securing the lines and tubes from the top, bottom and sides, the devices provide superior securement for both vertical and horizontal accidental line pulls. For more information about Dale’s new Hold-n-Place Catheter Securement line, or to request a product sample, please call 800-343-3980.

FeNO Testing Deemed 'Medically Necessary' for Asthma Patients

Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease, announced that Aetna, one of the largest health insurance companies in the United States, has updated its Exhaled Breath Tests Clinical Policy to include the measurement of exhaled nitric oxide as “medically necessary” for the evaluation of asthma and for monitoring the response to long-term control therapy. Circassia’s innovative NIOX technology provides objective and accurate fractional exhaled nitric oxide (FeNO) measurement of airway inflammation at the clinical point of care. NIOX is based on the discovery that patients with allergic/eosinophilic airway inflammation, the major underlying characteristic of asthma, generally have higher than normal levels of nitric oxide in their exhaled breath.By measuring the concentration of FeNO, NIOX enables clinicians to evaluate airway inflammation in patients with underlying asthma, aiding diagnosis and helping guide treatment and reduce exacerbations. NIOX is the only FeNO device for clinical use at the point of care available in the US. David Acheson, Senior Vice President, US Commercial, said: “Aetna’s updated policy is excellent news for people with asthma and parents of children who live with asthma. The update includes data from a recent US Agency for Healthcare Research and Quality report that highlights the use of FeNO testing as a valuable part of comprehensive asthma diagnosis and management. We are pleased to see Aetna update its Clinical Policy Bulletin to include FeNO and provide expanded coverage to its members who have this serious condition.” Aetna serves more than 22 million medical members and 1.2 million healthcare professionals. The Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. Aetna reaches these conclusions based upon a review of currently available clinical information, including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas and other relevant factors.

CAIRE launches oneCAIRE

CAIRE Inc. announced the launching of a new global campaign, oneCAIRE, designed to recognize the unique individual needs of each business partner, and ensure both the company and their partners succeed. “We want a relationship, and an opportunity to build trust through our expertise in this space and through the support we provide. O2 is what we do, and oneCAIRE is our global vision to promote the CAIRE brand by spotlighting our Quality, Business Solutions, Product Portfolio, and Clinical Efficacy. These strengths bring value to the bottom line for our business partners,” said Chris Southerland, Vice President of Respiratory at Chart BioMedical. CAIRE’s consultative-selling style differentiates the CAIRE brand in the marketplace and identifies those programs that are designed to be customizable to fit large, mid-size and small customers. Programs include the Retail Partner Program, Non-Delivery Program, O2 Discharge Program, and CAIRE-sponsored training are just some of the things that CAIRE offers to their business partners. Behind each of these programs is a clinically-proven portfolio that includes liquid, stationary, and portable oxygen therapy solutions, enabling the provider to cover the entire patient lifecycle. Oxygen delivery technologies such as autoSAT, UltraSense, and now patient safety features have long made CAIRE a go-to for clinicians, providers, and the US Military who utilizes specially-designed oxygen therapy products for battlefield use. Also in the CAIRE provider toolkit is the new telehealth solution, CAIREview powered by SynsorMed. Through wireless connectivity on select CAIRE concentrators, this mobile application allows the medical equipment provider to track the location of their CAIRE concentrators, troubleshoot alerts, periodically monitor oxygen flow rates, and to help avoid costly after-hours visits. CAIREview can provide that critical link between the patient and the provider to encourage prescription compliance, and ultimately grow physician referrals. “Our full depth and breadth of products cover the entire patient lifecycle from initial diagnosis to final high-flow needs. Our portfolio is just one element in how you will experience the CAIRE brand, and our support programs make it a win-win for our preferred business partners from an affordability and operational efficiencies standpoint,” said George Coppola, CAIRE Director of Marketing.

Company Announces Upgrades to Ventilators

ResMed, a global leader in cloud-connected respiratory care devices, announced key upgrades to its Astral life-support ventilators, including Optional AutoEPAP in iVAPS for U.S. patients, a high-demand therapy option. AutoEPAP (automatic expiratory positive airway pressure) automatically adjusts a patient’s expiratory pressure in response to flow limitations or obstruction of the upper airway. AutoEPAP is now available in the United States, and already in use in other markets. It’s an option when in Astral’s iVAPS (intelligent Volume-Assured Pressure Support) mode that automatically adapts to a patient’s changing pressure needs as their respiratory disease progresses. In addition to AutoEPAP, Astral users worldwide can now: Easily change interfaces: Patients can easily change between a mouthpiece and a full face, nasal or pillows mask from a single limb circuit; customize program names: Clinicians can now name programs on a patient’s Astral device for fast, easy access. “These significant upgrades make Astral one of the most advanced life support ventilators on the market,” said Richie McHale, president of ResMed’s Respiratory Care business. “It’s already proven to stabilize ventilation in significantly fewer breaths than its leading competitor and today’s innovations offer greater ease of use and even more peace of mind to patients across a wide range of respiratory diseases than ever before.”

Portable Oxygen Concentrator Makes Official Debut

CAIRE Inc., manufacturers of oxygen therapy devices including the AirSep, SeQual and HELiOS brands, announced the official debut of the new portable oxygen concentrator, the FreeStyle Comfort, at their global manufacturing headquarters and respiratory Center of Excellence in Georgia. Following a quiet, controlled launch in January with select CAIRE partners, the company is officially putting the spotlight on the new 5-pulse-setting model featuring an innovative comfort curve and weighing only 5 pounds. “We are proud to introduce the latest in a long line of leading oxygen therapy equipment. The FreeStyle Comfort blends together durability, clinical efficacy and comfort for its user. We remain focused on providing our DME/HME providers, clinicians and their patients the products and services they need to provide the best of care,” said Earl Lawson, President of the BioMedical Group at Chart Industries, Inc. One of the major things users will notice on the FreeStyle Comfort is the shell of the device features a comfort curve that is designed to skim the natural curve of the body and make it truly a comfortable device to wear in comparison to other portable oxygen concentrators that come in oval and more square shapes that do not offer a contour. “Today’s launch is the culmination of a lot of hard work and innovation,” said George Coppola, CAIRE Director of Marketing. “Our team has taken the development of this project extremely personal from the technological aspects to ergonomics. We pushed ourselves on all of the details – Is it comfortable? Where is the center of gravity? Can it be worn with or without a bag? We ultimately want the oxygen user to live their life to the fullest and maximize their comfort as they do it.” Operational via wall outlet (AC) power, motor vehicle (DC) power, or by rechargeable battery power, the device is designed for travel including its FAA approval for use on commercial air flights. The FreeStyle Comfort offers an easy-to-use interface with glow-in-the-dark buttons and LCD display screen that shows prescribed flow setting and remaining battery charge. User-replaceable battery packs come in two sizes, 8-cell and 16-cell, and can operate up to 4 and 8 hours, respectively, at pulse setting 2, extending the user’s time away from electrical power. The FreeStyle Comfort delivers up 1050 milliliters of oxygen per minute and is equipped with CAIRE’s UltraSense technology, ensuring a pulse of oxygen is delivered quickly in the early stages of the breath, reducing skipped breaths. And, should a no-breath alarm occur, the device will deliver oxygen therapy rapidly at its current setting at a rate of 20 breaths per minute until this alarm condition has been resolved. The first smart portable oxygen concentrator, the FreeStyle Comfort comes with wireless connectivity capabilities for providers to periodically monitor location and usage through CAIRE’s telehealth solution, CAIREview™ powered by SynsorMed. This helpful mobile application can provide a critical link between the patient and the provider, dedicated to supporting their respiratory health care needs. According to the National Heart, Lung and Blood Institute, approximately 12 million adults in the US are diagnosed with COPD, and there are an additional 12 million adults in the US who are thought to have undiagnosed COPD. Oxygen therapy is often prescribed for the treatment of COPD and to encourage its user to maintain an active lifestyle.

Glucose Hospital Meter System Approved for Testing

Nova Biomedical has announced that the StatStrip Glucose Hospital Meter System has been cleared by the US Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K181043). StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all patients including critically ill. The use of any other meter with critically ill patients is considered off label by the FDA and high complexity testing by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA). The FDA granted 510(k) clearance to StatStrip for capillary testing with critically ill patients following extensive prospective and retrospective studies performed at the Mayo Clinic in Rochester, MN, and Johns Hopkins Bayview Medical Center in Baltimore, MD. The submission data comprised 16,778 patients ranging from one month to 106 years old, all who were receiving intensive medical intervention/therapy in critical and intensive care settings including burn, cardiac, medical, orthopedic, neurological, and surgical. StatStrip’s capillary results were equivalent to the arterial and venous plasma results measured on a central laboratory IDMS traceable reference method. The FDA clearance indicates that StatStrip is safe, effective, and reliable for use by CLIA-waived operators with critically ill patients. StatStrip’s glucose technology is the primary reason for the clinically acceptable agreement between the capillary and plasma glucose results. StatStrip is the only glucose technology for point-of-care testing (POCT) that measures and corrects for abnormal hematocrit and has no clinically significant interferences, which can lead to the mismanagement of critically ill patients. Capillary specimens are easy to collect and the least invasive glucose test at the point of care. Capillary specimens provide benefits such as rapid and actionable glucose results for immediate glycemic assessment and intervention, saving time for health care providers and improving safety and outcomes for patients. StatStrip’s new capillary clearance eliminates the need for hospitals using StatStrip to define “critically ill.” Hospitals using other glucose meters cannot test critically ill patients with those devices with any specimen type (arterial, capillary, or venous); such use is considered off label. In 2014, StatStrip became the only glucose meter to receive FDA clearance for arterial, venous, neonatal arterial, and neonatal heel stick use in all hospital and all professional healthcare settings including with critically ill patients (K132121), based upon a multicenter, four-year, prospective study conducted at five prestigious university medical centers. In that study, whole blood glucose measurements of 1,698 critically ill patients spanning 257 different medical conditions and over 8,000 medications were found to be equivalent to plasma glucose central laboratory IDMS traceable methods.

Firms Join Forces on Sleep Apnea Research

ResMed, a global leader in sleep apnea treatment and connected health solutions, and Verily, an Alphabet company, has announced their agreement to form a new joint venture. Combining ResMed’s expertise in sleep apnea and Verily’s advanced health data analytics technologies, the U.S.-based joint venture will study the health and financial impacts of undiagnosed and untreated sleep apnea, and develop software solutions that enable healthcare providers to more efficiently identify, diagnose, treat and manage individuals with sleep apnea and other breathing related sleep disorders. Sleep apnea is a sleep breathing disorder that affects an estimated 54 million Americans (calculated based on a 16-country prevalence data study),1 and is associated with heart disease, stroke, type 2 diabetes and other life-threatening conditions. Despite the condition’s high prevalence and increasing public awareness, past research has shown that approximately 80 percent of individuals with obstructive sleep apnea are undiagnosed, 2 untreated and therefore unaware of their own risk and of the benefits that therapy could provide. “The vast majority of people with sleep apnea don’t realize they have it, and therefore don’t seek accessible, effective treatment to mitigate its effects and long-term health risks,” said ResMed Chief Medical Officer Carlos M. Nunez, M.D. “The combined industry expertise, scalable infrastructure, and data analytics capabilities of ResMed and Verily can unlock meaningful ways to identify these individuals and support their journey to improved sleep, health and quality of life.” “Approaching a widespread health problem like sleep apnea through collecting, organizing and activating health data is central to Verily’s mission,” said Jessica Mega, M.D., M.P.H., Chief Medical and Scientific Officer at Verily. "By better identifying at-risk individuals as well as generating real-world evidence regarding the value and effectiveness of treatment, this collaboration has the potential to improve outcomes for millions of people living with sleep apnea, and potentially other related conditions." The joint venture, subject to customary closing conditions, including regulatory approvals, will operate as a separate venture from ResMed and Verily.

 

COVID-19 SPECIAL NEWS