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COVID-19 NEWS UPDATES

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., 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.

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 whenpatients 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 CPAPtherapy can be used with COVID-19 patients. According to the many experts, theresponse is an overwhelming YES! Josh Farkas MD, associate professor ofPulmonary and Critical Care Medicine at the University of Vermont states,“COVID patients really need positive pressure more than anything else. Forexample, their work of breathing is often tolerable – so they may not need muchmechanical support for the work of breathing (indeed, mechanical support couldlead to injuriously large tidal volumes).” The best modality to provide lots ofpositive pressure is simply Continuous Positive Airway Pressure (CPAP). CPAPmay not seem dramatic, but this modality actually provides the greatest amountof 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 thedisease process than first thought and may prevent deterioration of somepatients to the extent of them not going on to need invasive ventilation.” MercuryMedical markets technology that can provide both CPAP and Bilevel therapiesusing 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 EmergencyMedicine concludes that a disposable CPAP device, (Flow-Safe II Mercury Medical),is just as effective as a mechanical portable ventilator (Philips RespironicsTrilogy 202). A continuum of care protocol can be established by placingCOVID-19 patients on a disposal CPAP/Bilevel device upon entry to the EMSvehicle / ER Department; maintaining the same device during the hospital stayuntil an intensive care ventilator is indicated. The Flow-Safe disposable CPAP/ Bilevel devices are packaged with non-vented full face deluxe masks. When usedwith an expiratory filter, they may reduce the incidence of crosscontamination, are simple to use, require little training and run on medicalgrade 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, M.D., 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, Ph.D., 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 U.S. Food and Drug Administration on the possibility of making the company's INOmax (nitric oxide) gas, for inhalation product available to U.S. patients with pulmonary complications of COVID-19 as quickly as possible through the appropriate regulatory mechanism. INOmax has been on the market in the U.S. 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. Univeristy 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.

 

NEWS

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.


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