FDA Updates Total Number of Deaths in Philips Medical Device Reports

Today, the US food and Drug Administration (FDA) provided an update regarding the safety information about medical device reports (MDRs) associated with the Philips Respironics ventilators, BiPAP machines, and CPAP machines that were recalled in June 2021.¹

Testing is still being conducted on the silicone-based foam used in repaired or replaced devices. After an overall benefit-risk assessment, the FDA recommeded continued use among patients who have a repaired or replaced device.

Reportedly, the breakdown of the polyester-based polyurethane (PE-PUR) foam originally used in the devices prompted the initial recall announcement. As stated by the FDA, there have been no changes to the recommendations from the previous safety communications released in June 2021; this update expanded on the recall with additional information for individuals who use repaired and replaced devices.

Recommendations for BiPAP, CPAP Machines Replaced by Philips

Patients using repaired or replaced devices should continue to do so. The silicone-based foam used in place of the PE-PUR foam is still undergoing independent testing.

After conducting and overall benefit-risk assessment, the FDA has determined that discontinuing the use of these devices may be more detrimental to a patient's health and quality of life. Any concerns had by patients should be addressed with their health care provider.

Results presented by the ongoing tests of the silicone-based foam for replacement devices will be shared with the public as soon as they're available.

Independent Testing of Silicone-Based Foam

The FDA and Philips are working to obtain additional information; the agency stated that, at this time, it's unable to conclude whether there is any risk to individuals in the US who use these devices because the current information is not sufficient.

Philips provided testing on the medical devices that had authorization for US marketing, which demonstrated acceptable results. The company was requested, by the FDA, to continue utilizing the independent laboratory for additional testing to determine if there were any potential safety risks that individuals could be exposed to by the foam.

The PE-PUR foam used in a similar device that's marketed outside of the US failed a safety test during the manufacturing facility inspection due to the release of volatile organic compounds (VOCs), which are considered chemicals of concern. Based on this information, the FDA advised awareness.

Updated Medical Device and Death Reports

The latest update from the FDA reflected the number of medical device reports, and subsequently, the reports of deaths in those reports according to Philips' retrospective review. More than 98,000 medical device reports have been sent to the FDA since April 2021. Of the total MDRs, 346 reported death associated with the PE-PUR foam breakdown.

• April 2021-April 2022: 123 deaths/ >21,000 MDRs
• May 2022-July 2022: 45 deaths/ >48,000 MDRs
• August 2022-October 2022: 96 deaths/ > 21,000 MDRs
• November 2022-December 2022: 82/ 8000 MDRs

When manufacturers are alerted of an occurrence with one of their devices that reasonably suggests contributed to serious injury or death, the company is required to submit medical device reports. This also applies in instances of malfunction, and as demonstrated in this case, including the malfunction of a similar device marketed by the manufacturer.

In April 2021 when Philips first began submitting medical device reports to the FDA related to the breakdown of the PE-PUR foam, the company also communicated their plan to initiate a field action in response to their concerns. The formal submission of Philips' Report of Correction and Removal was June 2021.

References:

1. US Food and Drug Administration. UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Revised February 9, 2023. https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due?utm_medium=email&utm_source=govdelivery#mdr