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  1. Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

Update: April 2024

On April 9, 2024, a federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to prioritize patient relief and ensure the company's regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure (BiPAP) machines in June 2021 because of potential health risks—impacting 15 million devices worldwide. Patients impacted by the Philips recall remain a top priority for the agency as the FDA continues to take steps to protect the health and safety of individuals using these devices.

The consent decree includes provisions:

  • Requiring implementation of a Recall Remediation Plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall by way of receiving a new or reworked/remediated device, or for certain devices, providing the option for a partial refund.
  • Restricting, with limited exceptions, the production and sale of new CPAP machines, BiPAP machines, and other devices at several Philips Respironics facilities in Pennsylvania and California until certain requirements are met.

For more information, see the FDA's press release.

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In June 2021, Philips Respironics (Philips) recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines because of potential health risks. 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 of concern, called volatile organic compounds (VOCs) that are not visible, could be breathed in or swallowed by the person using the device. Breathing in certain chemicals or swallowing small pieces of foam that has broken apart could potentially result in potential health risks. The PE-PUR foam breakdown issue may result from exposure to hot and humid conditions and may be worsened by using ozone cleaners or other cleaning methods not recommended by the manufacturer.

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PE-PUR Foam Testing

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.

After the FDA reviewed the information and data provided to the agency by Philips, the FDA explained in October 2023, that we did not believe that the testing and analysis Philips had shared were adequate to fully evaluate the risks posed to users from the recalled devices and that the FDA believed additional testing was necessary. Philips has agreed to conduct the requested additional testing. This testing is underway, and the FDA will provide an update if new, significant information becomes available and when this testing has been completed.

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 ongoing analysis of the potential health risks.

Silicone-based Foam Independent Testing

Following the initial recall in June 2021, Philips developed a plan to repair the PE-PUR foam in the recalled CPAP and BiPAP devices with a different, silicone-based foam. The FDA initially approved this plan based, in part, on testing the company provided to the FDA in June 2021 on the new foam.

  • During the manufacturing facility inspection in 2021, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program.
  • The FDA requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam to determine what, if any, potential safety risks are posed to patients by the silicone-based foam.

While this independent testing of the silicone-based foam is performed, the FDA recommends patients who use a repaired or replaced device continue use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the agency has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available.

FDA Inspection of Philips' Manufacturing Facility

In response to the recall, the FDA conducted an inspection of a Philips' manufacturing facility in Murrysville, PA, between August and November 2021 to determine what may have caused or contributed to the foam issues and assess adherence to the agency's requirements for quality manufacturing. 

FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality. During the inspection, the FDA investigator made several observations that are outlined in an inspection closeout report, also known as an "FDA Form 483." The FDA investigator provided a list of their observations to the company. An FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. The company responded to the inspection findings and continues to provide updates to that response.

Report a Problem to the FDA

If you have any problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

For more information on Philips' recall notification, contact your local Philips representative or visit Philips' medical device recall information page.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

If you have additional questions, contact the FDA's Division of Industry and Consumer Education (DICE).

 

 

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