FDA Provides Update on Philips Breathing Devices Recall
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
On November 12, 2021, the Food and Drug Administration (FDA) provided an update regarding the June 2021 recall of some Philips Respironics ventilators, CPAP, and BiPAP machines. The recall came following reports of a foam sound abatement component on the machines breaking down and being inhaled during use of the device.
The FDA conducted an inspection of a Philips Respironics' manufacturing facility to try and understand what may have caused or contributed to these manufacturing issues. The FDA investigator who conducted the inspection made several observations, which are outlined in the FDA Form 483 inspection closeout report. It should be noted, however, that this list does not constitute a final determination or statement from the FDA, and the FDA continues to work with and review the company's response in determining the next appropriate steps. We recently reported on the remarkable findings of this inspection on our Drug Injury Watch blog article, "Philips Breathing Devices Recall Update: FDA Releases Explosive New Findings in November 2021".
In the November 12, 2021 update from the FDA, it is stated Philips Respironics had developed a plan on how to replace the foam sound abatement unit in the recalled machines following the initial recall. The FDA approved this plan initially, based on the testing results that Philips provided to FDA in June. The findings of the manufacturing facility inspection led the FDA to request additional independent testing:
However, during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Similar testing provided by Philips Respironics to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
The FDA has reported some patients may have received this silicone-based foam component as a part of the Philips repair and replacement program which is currently underway. The FDA currently does not have enough information regarding this silicone-based foam to determine the potential risk associated with this component. As mentioned in the November 12, 2021 update from the FDA:
The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.
While independent testing is being performed, the FDA is not recommending patients discontinue their use of the product if they have participated in the repair and replace program, as the FDA has determined discontinuing use of one of these devices may be more harmful to a patient's health and quality of life than continuing use. The FDA will communicate the results of the independent testing to the public as soon as they are available, and at that time will determine if the recalled devices pose any risks to the patients.
Patients with additional concerns or those who have not participated in the ongoing Philips repair and replacement program but are still using a recalled device should contact their health care provider if they have any questions or concerns regarding their continued use of the Philips breathing device.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.
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