08/02/2021

Respironics Recall: Latest FDA Guidance

Medtrade Monday Guest Article by Jeffrey S. Baird, JD

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.

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.

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.

Additional information and Q&As....

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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 jbaird@bf-law.com.