The U.S. Food and Drug Administration (FDA) has inspected a Philips Respironics manufacturing facility in connection with the Philips’ CPAP, biPAP, and ventilator recall announced in June 2021. The FDA has published the results of its inspection online, along with other updates related to the recall.
“Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices is a top priority for the FDA,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a release. “We recognize that patients rely on these devices, and we are closely monitoring the company’s actions to ensure that the issues are resolved in a timely manner given the impact on patients. We are committed to continuing to regularly update the public about the status of this recall, including any new recommendations or actions regarding Philips Respironics’ devices.”
The FDA inspection was to determine what may have caused or contributed to the foam issues and assess adherence to the agency’s requirements for quality manufacturing. Its 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.
“In connection with the voluntary recall notification in June of this year, the FDA has recently conducted an inspection of a Philips Respironics manufacturing facility in the US,” says Frans van Houten, CEO of Royal Philips, in a release. “We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing. Until we have concluded these discussions, we are not able to publicly provide further details on these responses. We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.”
Since June 2021, Philips Respironics and certified testing laboratories have been conducting a test and research program on the polyester-based polyurethane (PE-PUR) foam at the heart of the recall to better assess and scope potential patient health risks, with support from third-party experts. Philips Respironics plans to make more data available to the relevant competent authorities as soon as possible after completing the assessment of the above mentioned research and tests, which is anticipated to take place in the fourth quarter.
Possible Safety Issues with the Replacement Foam
Following the initial recall, Philips Respironics developed a plan to repair the polyester-based polyurethane 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 on the new foam.
But 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 United States, that failed one safety test for the release of volatile organic compounds (VOCs). Similar testing provided by Philips Respironics to the FDA on devices authorized for marketing in the United States 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 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 United States.
Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue 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. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment.
According to Philips Respironics, it has conducted testing to support the new silicone replacement foam. Silicone foam testing provided by Philips Respironics to the FDA on devices authorized for marketing in the US had demonstrated acceptable results. Philips Respironics continues to coordinate with the FDA and other competent authorities on its testing. The company states, “The test referenced by the FDA did not relate to DreamStation 2, but to an A-Series PAP device. In accordance with normal practice and timeline, Philips Respironics will submit its explanation to this particular finding for review by the FDA, as other VOC testing of the ASeries PAP device with the silicone foam demonstrated acceptable results. The testing to support the use of silicone foam in the DreamStation 2 device was previously submitted to the FDA and demonstrated acceptable results.
“Philips Respironics is working with the FDA to clarify the scope of its request related to the use of an independent laboratory. Philips Respironics has been working with the FDA and other competent authorities to assure that our remediation process is fully compliant and meets all regulatory requirements. For completeness, Philips Respironics regularly works with certified third-party research firms and test labs, and is currently utilizing several certified third-party labs for its testing. It is Philips Respironics’ expectation that the FDA announcement of November 12, 2021, will not result in a delay of the repair and replacement process.”
Additional FDA Observations
In its inspection closeout report, the FDA investigator provided a list of its 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 FDA will review the company’s response and the totality of information available to the agency in determining appropriate next steps.
These observations included the following.
- Risk analysis is inadequate. Analysis does not support Philips’ rationale for which devices using PE-PUR foam are recalled and which aren’t.
- Procedures for corrective and preventative action have not been adequately established.
- Design validation did not ensure the device confirms to defined user needs and intended uses. When evaluating the potential impact of released particulates on users, the FDA says Philips used healthy people’s respiratory systems, not the systems of people who have depressed function and/or tracheostomies, which are the intended user population of the devices.
- Procedures for design change have not been adequately established.
- Procedures to ensure that all products or service conform to specified requirements have not been adequately established.
- Potential consultants were not evaluated and selected based on their ability to meet specified requirements.
In a FAQ, Philips emphasizes:
- Philips takes this matter very seriously and will fully collaborate with the FDA.
- Philips Respironics will submit its response to the inspectional findings for review by the FDA, in accordance with normal practice and timeline.
- 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 FDA has not changed its recommendation to patients and healthcare providers in relation to affected devices.
- Philips Respironics is committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.
- It is Philips Respironics’ expectation that the FDA announcement of November 12, 2021, will not result in a delay of the repair and replacement process.
Was Philips Aware of Foam Degradation and/or VOC Emission Prior to 2021?
Many times in the FDA’s inspection report, the FDA cites instances prior to 2021 in which Philips was alerted to complaints about foam degradation. In a FAQ, Philips addresses this concern: “In prior years, there were limited complaints related to foam degradation, which were evaluated and addressed on a case-by-case basis. Issues relating to VOCs started to surface more recently, with testing and interpretation subsequently taking place with certified thirdparty experts, leading to the actions in the first half of 2021.”
Guidance to Patients
As previously communicated, the FDA recommends that patients currently using a recalled device that has not yet been repaired and replaced consult with their health care provider if they have additional questions or concerns to further determine whether patients should continue using the device, switch to another product or stop use.
The agency recognizes that many patients will have questions about what this information means for the status of their devices. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc. and the American Academy of Sleep Medicine and has included this feedback in the updated “Frequently Asked Questions” to provide helpful information to the public.