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Tag: CPAP


Vendors

FDA classifies Philips recall as ‘serious’

July 26, 2021HME News Staff

AMSTERDAM – The U.S. Food and Drug Administration has classified the voluntary recall of certain Philips CPAP devices and ventilators as Class I.   The FDA defines Class I as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”  The agency posted recalls for the various affected devices, along with their classification, to its database on July 13 and July...

CPAP, FDA classification, Philips, Recall, ventilator


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E-SP

Forget COVID

June 29, 2021Theresa Flaherty, Managing Editor

We’ve been doing a lot of talking here at HME News about the Philips recall. In fact, I’m pretty sure that’s all anyone’s been talking about in the industry, on webinars, on state association calls, to me. Forget COVID. "This is going to be far worse,” is a common refrain. It’s not hard to understand why, even as we don’t yet fully know how far the ripple effect will spread. While the immediate concerns have focused on just getting information to communicating...

CPAP, Philips Recall


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Vendors

‘It’s a perfect storm’: Manufacturers prioritize, allocate orders for CPAP devices

June 25, 2021Liz Beaulieu, Editor

YARMOUTH, Maine – Manufacturers like ResMed and 3B Medical are ramping up production to meet increased demand due to a voluntary recall of millions of Philips CPAP devices, but their efforts are complicated by supply chain and other challenges.  “Yes, we’re ramping up production as quickly as possible, while working closely with our global supplier network to navigate the well-known global supply chain challenges impacting this and other industries,” said Jayme...

3B Medical, CPAP, Fisher & Paykel, Philips Recall, ResMed


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Specialty Providers

Philips recall: Sleep stakeholders run scenarios

June 25, 2021Theresa Flaherty, Managing Editor

YARMOUTH, Maine – As sleep stakeholders band together to address the Philips recall, they're grappling not only with equipment shortages, but also risk assessment and who should be at the front of the line for repairs and replacements.  In announcing the recall, Philips advised Bi-Level and CPAP patients to discontinue using affected devices and work with their physicians or HME providers to determine the most appropriate options for continued treatment.   “It should...

American Academy of Sleep Medicine, CPAP, Philips Recall


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Specialty Providers

Providers assess Philips recall

June 18, 2021Theresa Flaherty, Managing Editor

YARMOUTH, Maine – HME providers had far more questions than answers as they scrambled to field patient inquiries and craft game plans in the days following the news of a voluntary recall of Philips’ first generation DreamStation CPAP devices.  Philips announced the recall on June 14 to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in certain Bi-Level, CPAP and mechanical ventilator devices.  “We’re...

CPAP, DreamStation, Philips Recall


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Vendors

Makers of CPAP cleaners distance themselves from recall

June 18, 2021Liz Beaulieu, Editor

PETERSBOROUGH, N.H. – SoClean is standing by its CPAP cleaning device, after Philips said “unapproved cleaning methods, such as ozone,” may be exacerbating the degradation of sound abatement foam in its first-generation DreamStation product family.   Philips made the claim as part of a voluntary recall announced June 14 to address identified potential health risks related to the polyester-based polyurethane foam in certain Bi-Level CPAP, CPAP and mechanical ventilator...

CPAP, DreamStation, Philips Recall, SoClean


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Susheel Patil

Specialty Providers

AHRQ report is ‘call to action’

June 18, 2021Theresa Flaherty, Managing Editor

DARIEN, Ill. – A recent draft report from the Agency for Healthcare Research and Quality that says studies mostly do not support long-term benefits of CPAP therapy on cardiovascular and other health outcomes has sleep professionals “up in arms,” says Dr. Susheel Patil, chair of the American Academy of Sleep Medicine.   “The sleep community is not clear on what the motivation for the report is,” he says. “I think the question becomes whether the AHRQ realizes...

AHRQ Report, American Academy of Sleep Medicine, CPAP, Dr. Patil Susheel


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Specialty Providers

Providers worry about CPAP report’s ripple effect

June 11, 2021Theresa Flaherty, Managing Editor

WASHINGTON – Providers say a recent draft report on the effectiveness of CPAP is questionable, but they worry it could still impact everything from patient confidence in the therapy to adequate access and payment for equipment and services.  The report, released in April by the Agency for Healthcare Research and Quality, states that published studies show little evidence of long-term benefits of CPAP therapy on cardiovascular and other health outcomes.   “I think...

AHRQ, CPAP, Sleep Apnea


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Vendors

SoClean wins legal action

June 7, 2021HME News Staff

PETERBOROUGH, N.H. – The U.S. District Court for the Northern District of Illinois recently issued an order in favor of SoClean in its legal action against 861 websites and web stores for allegedly marketing and selling products that are counterfeit and products that infringe on its intellectual property rights.  The court’s order awards damages against the defendants of up to $100,000 each, which SoClean may seize from the defendant’s accounts, including those held with...

CPAP, intellectual property rights, sanitizer, SoClean


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VGM Fulfillment frees up providers

Vendors

VGM Fulfillment frees up providers

May 28, 2021Liz Beaulieu, Editor

WATERLOO, Iowa – VGM Fulfillment’s new CPAP Direct to Home Fulfillment Program drew interest from more than a dozen provider members in its first week in May. The program, which ships CPAP devices directly to patients on behalf of providers, is another step by VGM Fulfillment to free up providers to do what they do best: care for patients, says Jeremy Stolz, president. “We started to get more and more requests to do this during the pandemic, when things that were usually handed...

CPAP, VGM Fulfillment


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