Philips Faces Consent Decree that Restricts Sales of New Sleep Apnea Devices

Recently, FDA announced that the US District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America (Philips Respironics), Respironics California, Philips Holding USA, and Roy Jakobs, CEO of Royal Philips, along with several other people named in the decree, which restricts the production and sale of new CPAP and BiPAP machines and other devices at several Respironics facilities in the US until certain requirements are met.

The consent decree comes after the company’s years-long recall of certain ventilators, CPAP, and BiPAP machines due to the degradation of polyester-based polyurethane foam used in the devices to reduce sound and vibrations. The foam used was found to breakdown, resulting in pieces of the material, or certain chemicals, being breathed in or swallowed by the person using the device. The inhalation of foam was associated with problems that could potentially result in serious patient injury which could require medical intervention to prevent permanent injury.

Filed by the Department of Justice on behalf of FDA, the complaint alleged that Philips Respironics had violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) by “introducing devices into interstate commerce that are adulterated because the devices were not manufactured in accordance with current good manufacturing practice requirements,” according to the FDA press release about the decree. “In addition, the complaint alleged that the company introduced devices into interstate commerce that are misbranded because it failed to provide the FDA with information about specific corrections (or removals) the company made to devices, as required by FDA regulations.”

FDA noted that both of the reported violations were also seen in its 2021 inspection of the company’s Murrysville, PA, facility. Additional violations of current good manufacturing practice requirements were alleged to be observed at Philips Respironics’ Mt. Pleasant, PA, facility in 2023, and during several inspections of its subsidiary’s facility in Carlsbad, CA, which has since ceased manufacturing operations.

With exceptions, the consent decree restricts the company from manufacturing and distributing devices at or from Philips Respironics facilities in Pennsylvania and California until it has completed repair, rework, replacement, and refund activities set forth in the recall remediation plan. The company will also need to be in compliance with good manufacturing practice, reporting corrections and removals, and medical device reporting. It will only be after Philips receives written notice from FDA that the company are in compliance that it will be able to resume operations.

The exceptions to the consent decree restrictions include the manufacture and distribution of certain devices FDA has determined to be medically necessary as well as replacement parts and accessories for devices in patients hands.

Detailed in the recall remediation plan are requirements and timeframes for when the company must complete certain remediation option activities for impacted patients. These options include a remediated device — either a new or reworked unit of the same model type, or a new unit of a functionally equivalent model type — with a renewed warranty or, for specific models, refund issuance which factors in the depreciation of the device. To make sure Philips Respironics is ensuring patients receive these options in a timely manner, the company is tasked with making several attempts to contact a patient or durable medical equipment provider within a certain timeframe.

“The finalization of this decree is a significant milestone,” said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health (CDRH), in the release. “Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall. Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”

In addition to the recall remediation plan, the decree also contains provisions to ensure patients receive relief, that the company completes necessary testing, and current good manufacturing practice requirements.

One of these provisions is intended to help US patients be prioritized over the export of product for commercial distribution. “… The decree generally prohibits the [company] from exporting [CPAP and BiPAP devices] for commercial distribution unless: All US patients who registered by a certain date and who could be remediated with the device to be exported have been remediated; [Philips Respironics is] meeting the timeframes for steps in the remediation process set forth in the recall remediation plan; and [it has] enough devices in stock to address US demand for that particular recall remediation device model for the next 12 months.”

Philips Respironics is also required to contract an independent testing expert within 10 days of the entry of the decree to review and evaluate its testing, including biocompatibility data on the new silicone-based foam being used to replace the foam recalled in 2021. “This independent expert will assess, among other things, Philips’ plan for testing the silicone-based foam, including testing that has been completed, is ongoing, or is planned, to ascertain whether that testing will enable a determination that the silicone-based foam does not degrade during the labeled service life of the device and does not introduce any new or similar potential health concerns to the [polyester-based polyurethane] sound abatement foam.”

The expert is then tasked with submitting their findings to FDA for review. The company will be required to submit plans to address gaps in testing, analysis, or other information if found.

Outside of its Pennsylvania and California facilities, an independent expert will inspect the company’s other sleep and respiratory care facilities to evaluate whether they are operating in compliance with the FD&C Act and to correct any issues found. FDA will be able to subject other facilities owned by corporate entity to certain parts of the decree if it is determined that those facilities are not operating in compliance.

"Patient safety and quality is our number one priority," said Steve C. de Baca, Philips chief patient safety and quality officer, in a statement. "We know what we must do to meet the consent decree requirements. Philips Respironics has been working with the FDA, and is already making significant changes in its organization, quality management systems and operations. This includes strengthening the quality management processes and deepening the competencies of the relevant teams. We are fully committed to meeting the terms of the consent decree and continuing to serve the millions of patients who rely on our devices every day.”

CDRH referred MD+DI to the press release when contacted for additional comment.