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  4. CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam
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CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam

FOR IMMEDIATE RELEASE
Oct 5, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health

The FDA remains steadfast in our commitment that patients impacted by the June 2021 recall of certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines deserve relief. While this matter is ongoing, the agency continues to monitor the company's recall progress and share new information with device users, patient care facilities, and other stakeholders. The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.

In June 2021, the FDA alerted people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks – impacting 15 million devices worldwide. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The alert was based on problems reportedly associated with the PE-PUR foam breakdown that could potentially result in serious injury and may require medical intervention to prevent permanent injury.

Independent Testing: PE-PUR Foam

Following the initiation of the recall by Philips in June 2021, the company, at the FDA's request, began extensive additional testing on the PE-PUR sound abatement foam to better assess potential health risks related to the possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs). In a notification order issued to Philips under section 518(a) of the Federal Food, Drug, and Cosmetic Act (see further information below), the FDA ordered the company, in part, to provide a link for health care providers and registrants to access all available testing results and third-party confirmed conclusions on findings from testing PE-PUR foam used in devices manufactured by Philips for particulates and VOCs, regardless of the Philips devices that the foam may have been tested in.

Philips has issued updates about its independent testing program to assess the health risks related to the PE-PUR sound abatement foam found in certain recalled Philips ventilators, BiPAP machines, and CPAP machines. The FDA has reviewed the available information and data provided to FDA by Philips. We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices. Although Philips concluded that the exposure to foam particles and VOCs from these devices is "unlikely to result in an appreciable harm to health in patients," the FDA believes additional testing is necessary. Philips has agreed to conduct the requested additional testing. Based on the currently available information, the FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices. The FDA will review any additional information provided by Philips and continue to monitor medical device reports to further inform our on-going analysis of the potential health risks.

FDA Activities

Today, as part of our continued efforts to ensure consumers have the latest information on the Philips' recall, the FDA published a new resource section on FDA.gov, including a comprehensive timeline of FDA activities related to the June 2021 recall. Patients, consumers, and health care providers have played an integral part in providing feedback to the FDA about the Philips' recall, and their feedback is reflected in this new resource to ensure it provides timely and accurate information.

Recall Response Team

From the start of the recall in 2021, we have mobilized a dedicated response team across the agency to work on the regulatory efforts related to this recall and address questions and concerns raised by patients and health care providers. This team meets regularly with Philips to monitor and track its handling of this recall. The team has a wide range of expertise and is dedicated to developing FDA's safety communications, monitoring the status of the recall, reviewing test results and other submissions related to the recall, communicating with patients and health care professionals affected by the recall, and mitigating shortages of these important devices.

Addressing Device Shortages

Recognizing the critical need for these devices, the FDA has worked with other manufacturers and government partners to help make more machines available over the course of the recall. The supply of CPAP and BiPAP devices has since increased, and these products have been removed from the FDA's device shortage list.

Order Issuance

On March 10, 2022, the FDA issued a notification order to Philips requiring the company to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers about the recall and the health risks posed by the foam used in the recalled products. The FDA determined the order was necessary to eliminate the unreasonable risk of harm posed by the recalled devices because the company's notification efforts at that time had been inadequate. The order also directs Philips to maintain prominently displayed information regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall and to provide instructions for device users to register their devices on the Philips website.

Along with these actions, the FDA recommended additional measures to better communicate with the public regarding the recall, including:

  • That Philips provide monthly updates to patients and consumers who register their devices on the Philips website that include information on expected time for a replacement device and current rate of replacement of recalled devices.
  • That Philips provide detailed information for device users, DME suppliers, distributors, retailers, and healthcare providers on the replacement process.

Issuing the order enabled the FDA to mandate that Philips improve its communication about the recall and the serious risk posed by the PE-PUR foam used in the recalled devices with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.

Notice of Opportunity for an Informal Hearing

Additionally, the FDA issued to Philips a notice of opportunity for an informal hearing on CDRH's proposal that a section 518(b) order should be issued, an authority that has not been used by CDRH in the past 10 years. This notice proposed that an order should be issued requiring the company to submit a plan for the repair, replacement, and/or refund of the purchase price of devices subject to the recall that were manufactured after November 2015. Philips did not request a hearing but instead submitted a written response relating to, among other things, the recall remediation plan and repair, replacement and/or refund.

Additional FDA Recall-related Activities

  • Communicating frequently with consumers about the recall, including updates on medical device reports the FDA has received.
  • Holding listening sessions and message testing focus groups with patients and health care professional organizations.
  • Designating a CDRH Recall Response Team in CDRH's Division of Industry and Consumer Education, a dedicated group of employees committed to ensuring patients and providers have ongoing contact with the FDA for information about the recall.
  • Conducting several inspections of facilities performing rework activities related to the recalled devices and continuing to review and monitor Philips' operations.
  • Continuing to support the work of other government agencies in matters related to this recall.
  • Taking regulatory actions in response to this recall and issuing multiple press releases, recall summaries, letter to health care providers, and FAQs related to this recall.

Looking Ahead

The FDA continues to take steps, including regular monitoring of Philips' reported progress on the remediation and replacement of these critical devices, to ensure patients receive accurate and transparent information about this recall. We understand the importance of transparency as these are critical devices. Consumers need to understand estimated wait times and have accurate information in order to do so. We continue to encourage individuals with an affected device who have not yet registered their device to do so, and those who have already registered to ensure their contact information is up to date.

We understand the recalled devices deliver critical care and serve an important public health need for a widespread patient community. Ensuring patients and providers have the most accurate and up-to-date information about the Philips recall remains of utmost importance to the FDA, and we are committed to doing everything we can to protect the health and safety of patients affected by this recall. We will continue to keep the public informed as new information becomes available.

Related Information

 

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