AMARILLO, TX – Since mid-June, DME industry stakeholders have been in triage mode in responding to the Respironics product recall. With most product recalls that we have witnessed in the past, there have been substitute products manufactured by competitors that have filled the void. Unfortunately, this is not the case with the Respironics recall. Because of Respironics’ market share and because of the number of devices affected by the recall, DME suppliers are unable to find readily available replacement products. This has resulted in patients needing to wait for a number of months, if not longer, for their Respironics devices to be replaced or repaired.
DME suppliers, patients, physicians, CMS, the FDA, and commercial insurers are having to react to the recall “on the fly.” The stakeholders are striving to reach the same goal, but the pathway to the goal is uncertain. On Thursday, July 29, 2021, in an FAQ format, the FDA published its latest guidance. This guidance states:
Q: I use one of the affected devices daily. I can’t wait for a new device. What can I do now?
A: The FDA has provided recommendations for people who use an affected device in its safety communication, Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks, including that you may continue to use your affected device if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
You may also read the FDA’s consumer update, Always Tired? You May Have Sleep Apnea, which includes updates on obstructive sleep apnea treatments.
Additionally, the FDA is engaging professional societies and patient advocacy groups to help connect sleep and dental professionals and patients with information regarding alternative treatment options for obstructive sleep apnea.
Q: When a medical device is recalled, what is the FDA’s role?
A: When the FDA learns of a company’s correction or removal action, it reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the product, determines if the problem is in violation of the Federal Food, Drug, and Cosmetic Act or otherwise fails to comply with FDA requirements, and, if appropriate, assigns the recall a classification (I, II, or III) to indicate the relative degree of risk. After the recall is classified, the FDA monitors the recall to ensure that the recall strategy has been effective.
For the Philips Respironics recall, the FDA has identified this as a Class I recall, the most serious type of recall, and is continuing to work with the company to assure it has sufficient evidence to support the Philips Respironics recall strategy, including its corrective actions. The FDA will continue to monitor the company’s recall.
Q: Philips Respironics has stated they “will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances.” Is the FDA reviewing Philips Respironics submission for clearance of the new foam?
A: As the medical device manufacturer, Philips Respironics has a responsibility not only to ensure the manufacture of safe and effective devices, but also to establish an appropriate mitigation strategy to reduce public harm in the event of device failure or defect.
The FDA is reviewing the information Philips Respironics has provided regarding replacement devices while continuing to work with Philips Respironics on their corrective actions for existing devices. As the FDA reviews this information, the FDA will determine whether the proposed replacement devices pose any additional risk to people who use these devices.
Q: I understand the sound abatement foam may be causing the problems related to the recall. Should I try and remove the foam from my device?
A: No. The FDA recommends that you do not remove the sound abatement foam, as it may impact device performance and possibly introduce foam debris into the device.
Q: Who is responsible for correcting the issue with the affected Philips Respironics devices?
A: The recalling firm, Philips Respironics, is responsible for correcting the issue and developing a recall strategy that takes into account the following factors as they apply to this particular recall:
- Results of health hazard evaluation.
- Ease in identifying the product.
- Degree to which the product’s deficiency is obvious to the consumer or user.
- Degree to which the product remains unused in the marketplace.
- Continued availability of essential products.
The FDA is reviewing the adequacy of Philips Respironics’ proposed recall strategy as it becomes available from Philips and is recommending changes as appropriate.
Q: What else can the FDA require Philips Respironics to do to correct the affected devices?
A: The FDA can use advisory actions, administrative actions, and enforcement actions when a firm’s voluntary action is not rapid or complete, or when the firm is uncooperative.
Q: Should I expect any notification from Philips Respironics?
A: The FDA recommends you register your device on Philips Respironics’ recall website [External Link Disclaimer] to stay informed of updates from Philips Respironics about any new instructions or other corrective actions required by the FDA.
Q: I have registered my recalled device on Philips’ website. What should I expect now?
A: The FDA is working with Philips Respironics to assure the company sufficiently evaluates the device problems, the scope of the recall, and the most appropriate mitigation strategies, including adequate corrective actions by the company. The FDA will continue to share updates with the public as new information becomes available.
Q: What should I do if I am unable to register my device on Philip’s website?
A: For more information or help with the registration [External Link Disclaimer] process, please call Philips Respironics at 877-907-7508, as indicated on their website. The website provides you the instructions on how to locate your device Serial Number for the registration.
Q: If I obtain a new CPAP machine, what should I do with my recalled device?
A: Contact Philips Respironics [External Link Disclaimer] or your health care provider for information [or] your local Philips Respironics representative to receive instructions and directions on how to return your recalled device(s). Do not discard or recycle the recalled device.
AAHOMECARE’S EDUCATIONAL WEBINAR
Buying and Selling a DME Supplier
Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato & Alfonso Zambrano, Esq., Brown & Fortunato
Tuesday, August 17, 2021
1:30-2:30 p.m. CENTRAL TIME
When a person intends to buy or sell a DME supplier, there are a number of documentation and regulatory issues that must be addressed. First, the seller must take a number of steps to make itself more “attractive.” The buyer and seller need to decide whether the transaction will be an “asset” sale or a “stock” sale. The parties will need to engage in the normal transactional steps: mutual nondisclosure agreement, letter of intent, stock purchase agreement/asset purchase agreement, and other closing documents. The buyer will need to engage in three types of due diligence: financial, corporate, and regulatory. And, the parties will need to meet a number of regulatory requirements such as submitting change of ownership notifications. This program will discuss all of these (and other) issues associated with the purchase and sale of a supplier.
Registration will be posted soon for Buying and Selling a DME Supplier on Tuesday, August 17, 2021, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq., and Alfonso Zambrano, Esq., of Brown & Fortunato.
Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or email@example.com.