Philips Respironics agrees to finalized FDA consent decree
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Key takeaways:
- After agreeing to the proposed FDA consent decree in January, Philips Respironics has agreed to the finalized decree.
- Sale of new devices is prohibited in the U.S. until the company meets decree requirements.
Philips Respironics and Philips Holding USA agreed to the FDA’s finalized consent decree against the company, according to a company press release.
This announcement comes a few months after Philips Respironics stopped selling its sleep therapy and respiratory care devices in the U.S. after agreeing to the FDA’s proposed consent decree.
“Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more,” Roy Jakobs, MBA, CEO of Royal Philips, said in the release. “With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world.”
According to the release, the consent decree, which outlines “defined actions, milestones and deliverables to meet relevant regulatory requirements,” is specifically directed at U.S. operations.
Philips highlighted several action items from the decree in the release, one of which states that the company will continue its work on remediating devices from the voluntary recall in June 2021.
“This ... marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a release from the administration.
Additionally, the decree orders that the business operations of the company meet the FDA’s Quality System Regulation.
Individuals in the U.S. using sleep and respiratory care devices from Philips Respironics will still be able to have their device serviced by the company under the consent decree. Philips Respironics will also supply accessories, consumables and replacement parts for devices already in use.
The sale of new CPAP devices, bilevel positive airway pressure devices or other respiratory care devices is prohibited in the U.S. until the company meets what is outlined in the decree, according to the release. However, the company is allowed to sell new devices, accessories, consumables, replacement parts and services to those located outside the U.S.
“Today’s action reflects our commitment to vigorously enforce federal law and prevent manufacturers from marketing adulterated and misbranded devices to vulnerable patients who need them,” Brian Boynton, BA, JD, principal deputy assistant attorney general and head of the Justice Department’s Civil Division, said in the FDA release.
References:
- Federal court enters consent decree against Philips Respironics following recall of certain sleep therapy machines. https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep. Published April 9, 2024. Accessed April 10, 2024.
- Philips delivers strong full-year results; agrees with FDA on terms of consent decree focused on Philips Respironics in the US. https://www.philips.com/a-w/about/news/archive/corpcomms/news/press/2024/philips-fourth-quarter-results-2023. Published Jan. 29, 2024. Accessed April 10, 2024.
Perspective
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This is welcome news since the recall of Philips devices has been ongoing since June 14, 2021, without a clear end in sight. The harm of the polyester polyurethane sound abatement foam posed to patients was not well defined or adequately communicated. This process will ensure that Philips meets FDA regulation guidelines and deadlines for notifying patients and performing repairs in a timelier manner.
Obstructive sleep apnea can be a life-threatening condition if left untreated. Some patients rely on CPAP machines as the only feasible method of treatment. When the Philips machines may pose a hazard to their health, and replacements or repairs are not available or forthcoming promptly, it can result in immediate risk to life and health.
When patients no longer had functional CPAP devices, or devices that may cause harm, and patients were instructed to stop using their devices initially, it created mass confusion. The potential risks and benefits of continued CPAP use were not communicated to the patients adequately and increased the amount of work for health care providers — namely for sleep medicine professionals, who needed to help stratify risks and convince patients with severe OSA that the risks of no treatment were worse than potential risks from such devices.
The overall response from Philips was not coordinated with health care professionals, which created an undue burden on providers to help patients navigate the recall process, discuss feasible treatment alternatives and obtain alternative devices when none were available during the pandemic from computer chip shortages and shipping logjams. These uncoordinated practices posed logistical difficulties to deliver care to a high volume of affected patients to ensure adequate and safe treatment without harm to these patients. Some patients, to this day, still have not had adequate remediation or their devices repaired or replaced.
There must be a simpler streamlined process. Car manufacturers provided a blueprint on how to conduct a defective product recall and repair. Consumers are notified in public mailings and on-air announcements to reach the most affected. This method helps to ensure patients who have relocated or who no longer have contact with the original vendor of the CPAP devices (durable medical equipment or DME company) still have access to get their CPAP machines repaired or replaced. This is a public health risk and should be treated as such.
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