In brief: Philips testing, F&P changes, Medline donation
By HME News Staff
Updated 8:56 AM CDT, Wed July 26, 2023
AMSTERDAM – Testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows volatile organic compounds and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients, the company announced July 24.
Additional visual assessments on used/returned first-generation DreamStation devices also confirmed the previously established low prevalence of significant visual foam degradation reduction/volume reduction in these devices, the company announced.
More specifically, the testing found:
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Exposure to VOC emissions from the assessed devices treated with ozone cleaning is unlikely to result in appreciable harm to health in patients. ISO 18562-3 VOC testing was conducted after up to 500 ozone cleaning cycles with each cycle simulating one night of use and then ozone cleaning. The VOC toxicological risk of this ozone-induced degradation determined that exposure to VOC emissions from the assessed System One devices exposed to ozone cleaning suggests no appreciable risk to health for patients.
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Exposure to PM emissions from the assessed devices treated with ozone cleaning is unlikely to result in appreciable harm to health in patients. Regarding risks associated with respirable and non-respirable particulates, testing to date has been performed on devices with known ozone exposure. The third-party collective analysis concluded that exposure to particulate matter from ozone-induced degraded foam in System One devices is unlikely to result in appreciable harm to health in patients.
The visual assessments found:
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An additional analysis using an algorithm to assess collected images of foam within a representative random sample of 100,000 used devices from the U.S. and Canada (devices were selected to represent different manufacture dates) showed that 2,011 devices (~2%) were identified as having significant visual degradation/volume reduction.
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A comparison of ozone use among these devices found that devices for which the user self-reported ozone use were approximately 17 times more likely to have significant visual foam degradation/volume reduction (1,368 out of 14,971 or 9.1%) than those where the user reported no ozone use (357 out of 68,702 or 0.5%).
Philips is in the process of completing various remaining tests and analyses. For the Trilogy 100/200 and OmniLab Advanced Plus ventilator devices, VOC and PM testing continues, as well as chemical evaluation and toxicological risk assessment. These devices contain a different type of PE-PUR foam than the first-generation DreamStation devices. It expects to provide an update on this in the third quarter of 2023.
NCPA names finalists for student competition
ALEXANDRIA, Va. – The National Community Pharmacists Association has announced that teams of pharmacy students from the University of Georgia, University of South Carolina and University of Texas have been named finalists in the 2023 Good Neighbor Pharmacy NCPA Pruitt-Schutte Student Business Plan Competition. The three teams will present their business plans in a live competition on Oct. 14, 2023, at the NCPA Annual Convention in Orlando, Fla., and the winning team will be announced on Oct. 15 as part of the first general session. “For innovative and forward-looking students like these, there’s no better part of the industry to be in than the independent pharmacy space,” said Hugh Chancy, RPh, president of the NCPA. “It’s where you can structure your business plan as you see fit to best serve the people in your community and support the team you work with. By participating in this competition, students have a head start on becoming successful pharmacy owners and entrepreneurs.” The teams will compete for first place ($3,000 to the NCPA student chapter and $3000 to the school in the dean’s name to promote independent pharmacy); second place ($2,000 to the NCPA student chapter and $2,000 contributed to the school in the dean’s name to promote independent pharmacy); and third place ($1,000 to the NCPA student chapter and $1,000 contributed to the school in the dean’s name to promote independent pharmacy). The Student Business Plan Competition, which is supported by Good Neighbor Pharmacy, Pharmacists Mutual Insurance Company and the NCPA Foundation, honors two great champions of independent community pharmacy, the late Neil Pruitt Sr. and the late H. Joseph Schutte. It aims to motivate students in pharmacy school to create a thought-out plan for either purchasing an existing pharmacy or opening a pharmacy from the ground up, and to prepare tomorrow’s pharmacy entrepreneurs for a successful future.
VARON closes in on goal with VP-2
SEATTLE – VARON has launched an addition to its VP series of portable oxygen concentrators, the VP-2. "We are more excited than anyone to introduce the new product to the market," said Darren Wang, CEO of VARON. "Our goal is to make oxygen therapy more accessible by providing reliable, efficient, and affordable solutions for anyone in need. With VP-2 coming out, we believe we are much closer to the goal." The VP-2 features a dual oxygen supply mode, so, in addition to traditional pulse flow oxygen supply, it automatically releases oxygen every three seconds when no inhalation is detected. The company says the feature helps to solve the problem of POCs in normal pulse mode sometimes not sensing gentle or shallow breathing during sleep or due to certain pulmonary diseases. VARON hit a milestone of more than 50,000 units sold in 2022, with a 40% increase in annual sales. It now has multiple products to meet various needs for supplemental oxygen and several warehouses in Europe and America for faster delivery. Before launching as VARON in 2021, the company was an OEM of Omron accessories.
Medline helps to fund accessible playground
MUNDELEIN, Ill. – Medline’s Community, Action, Resources, Education and Solutions (CARES) program provided a $10,000 grant to help build an accessible playground at Kracklauer Park in Mundelein, Ill. The new playground offers a variety of features and multi-sensory experiences designed to promote play among all children, especially those with disabilities. “Medline is committed to strengthening and supporting the communities where we live and work,” said Karen Frey, senior manager of philanthropy. “The new playground at Kracklauer Park will provide the area with a much-needed and impactful community resource.” In addition to helping fund the playground, Medline continues to provide year-over-year support for two northern Illinois organizations offering employment, counseling, social and other programs and assistance for individuals living with intellectual and developmental disabilities: the Center for Enriched Living in Riverwoods and TotalLink2Community in Northbrook. Medline also works with Aspiritech, an Evanston-based quality-assurance, accessibility and data services organization, to provide testing for its software, including the MedPak app. More than 90% of Aspiritech staff are on the autism spectrum.
F&P Healthcare changes up board
AUCKLAND, New Zealand – Fisher & Paykel Healthcare has announced that Donal O’Dwyer will retire as director of the company effective Dec. 31, 2023. The company has also announced that it has appointed Graham McLean to the board as a non-executive director effective Oct. 1, 2023. “With Donal preparing to step away, we are very pleased to have secured Graham as a director,” said Scott St John, board chair. “Similar to Donal, Graham has carved out a successful global career in the medical device field and we are confident he will be an impactful addition to the board.” McLean, an Australian resident, is currently director and CEO of CleanSpeaceHoldings and chair of Universal Biosensors, two ASX-listed health care companies. He previously spent 16 years as an executive at Stryker Corp., most recently as president of the Asia Pacific region. McLean will also serve as a member of the F&P’s Audit and Risk Committee.
Medline recognized for solar project
ALBANY, N.Y. – Medline Industries got a shoutout from New York Gov. Kathy Hochul in July for completing the state’s largest rooftop solar project. Located atop a distribution center owned by Medline in Montgomery, the 7.2 megawatt community solar project is helping to reduce energy costs for both the company and residents in the mid-Hudson region. “Medline is unwavering in its commitment to building an environmentally sustainable business by investing in green technologies,” said Francesca Oliver, vice president of ESG. “The installation of New York’s largest rooftop solar project at our Montgomery distribution center exemplifies our dedication to making health care more sustainable for providers and their patients in the state.” The project comprises more than 17,000 panels and generates 8.5 million kilowatt-hours (kWh) of clean power annually, enough to power more than 1,600 homes, while reducing carbon emission by nearly 6,000 metric tons annually, the equivalent of taking over 1,200 cars off the road, according to Medline. The more than $8 million project was built with nearly $5 million in private investment from the developer, PowerFlex – a national provider of solar, storage and electric vehicle (EV) charging solutions for commercial customers that is now owned by Medline. The project supports New York’s Climate Leadership and Community Protection Act goal to install six gigawatts of distributed solar by 2025 and accelerates progress toward ten gigawatts by 2030.
Inspire names former Medtronic exec as chief strategy officer
MINNEAPOLIS – Inspire Medical Systems, the maker of an FDA-approved neurostimulation device to treat obstructive sleep apnea, has appointed Carlton Weatherby as chief strategy officer effective July 24. “We are very excited to welcome Carlton to the Inspire team,” said Tim Herbert, president and CEO of Inspire Medical Systems. “Carlton’s vast experience in leadership roles across medtech, as well as his strategic vision, will be very valuable to us as we continue to grow and scale as an organization.” Weatherby joins Inspire from Medtronic where he most recently served as vice president and general manager of their Spine & Biologics Business since 2021. Prior to this role, he served as vice president of strategic sales and held various roles in corporate development since joining Medtronic in 2011.
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