Sleep Disorders | Sleep Review
The US Food and Drug Administration (FDA) has inspected a Philips Respironics production facility in connection with the recall of CPAP, biPAP and ventilators from Philips announced in June 2021. The FDA has posted the results of its inspection, along with other related updates, online for recall.
“The FDA’s top priority is ensuring that patients and providers have the most up-to-date information on the recall of these critical devices,” said Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, in a publication. “We understand that patients rely on these devices and we closely monitor the company’s actions to ensure that problems are resolved in a timely manner given the impact on patients. We are committed to continuing to provide the public with regular updates on the status of this recall, including any new recommendations or actions relating to Philips Respironics devices. “
The FDA inspection should determine what was causing or contributing to the foam problems and assess compliance with the agency’s requirements for quality manufacturing. The inspections include review and evaluation of records, training of personnel, operation of the facility, manufacture and testing of medical devices, and the systems in place to ensure product quality.
“In connection with the voluntary recall notification in June this year, the FDA recently carried out an inspection of a Philips Respironics manufacturing facility in the United States,” said Frans van Houten, CEO of Royal Philips, in a press release. “We will work closely with the FDA to clarify and follow up the inspection results and their recent requests for comprehensive testing. Until we have completed these discussions, we will not be able to post any further details about these responses. We remain fully committed to serving the community of patients who depend on the affected devices, as well as the clinicians and customers who are dedicated to meeting patient needs. “
Since June 2021, Philips Respironics and certified test laboratories, with the support of third parties, have been carrying out a test and research program on the polyester-based polyurethane foam (PE-PUR) at the center of the recall in order to better assess and limit potential health risks for patients. Party experts. Philips Respironics plans to provide further data to relevant authorities as soon as possible after the completion of the assessment of the above research and testing, which is expected 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 machines with a different silicone-based foam. The FDA initially approved this plan based in part on tests the company presented to the FDA in June of the new foam.
However, upon inspection of the manufacturing facility, the FDA received additional information not previously available to the agency regarding the silicone-based foam used in a single, similar device marketed outside the U.S. and a safety test for the release of volatile organic compounds Substances not passed compounds (VOC). Similar tests submitted by Philips Respironics to the FDA on devices approved for marketing in the United States had shown acceptable results.
The FDA has asked Philips Respironics to commission an independent laboratory to perform additional tests to determine the potential safety risks for patients from the silicone-based foam.
The FDA is aware that patients have already received devices with silicone foam as part of the repair and replace program. At this time, the agency does not have sufficient information to determine whether the silicone-based foam used in the repaired devices poses a risk to patients in the United States.
While these independent tests are currently in progress, the FDA recommends that patients who have participated in the repair and replacement program not cease using their product. The FDA made this determination based on a comprehensive risk-benefit assessment. Currently, the agency has determined that discontinuing use of any of these devices may be harmful to a patient’s health and quality of life. The results of the independent tests are needed to determine whether the silicone-based foam used in the repaired devices actually poses a risk to patients, and the FDA will share these results with the public as soon as they become available. Patients who have additional concerns should speak to their healthcare provider about the plan for their care and treatment.
Tests have been conducted to support the new silicone replacement foam, according to Philips Respironics. Silicone foam tests submitted by Philips Respironics to the FDA on devices approved for marketing in the United States had shown acceptable results. Philips Respironics continues to coordinate its testing with the FDA and other relevant authorities. The company explains: “The test cited by the FDA did not refer to the DreamStation 2, but to an A-series PAP device. In accordance with standard practice and schedule, Philips Respironics will submit its statement on this particular result for FDA review as other VOC tests on the A-Series PAP device with the silicone foam showed acceptable results. The tests to support the use of silicone foam in the DreamStation 2 device had previously been submitted to the FDA and showed acceptable results.
“Philips Respironics is working with the FDA to clarify the scope of their inquiry regarding the use of an independent laboratory. Philips Respironics has worked with the FDA and other relevant agencies to ensure our remediation process is fully compliant and meets all regulatory requirements. For the sake of completeness, Philips Respironics works regularly with certified external research companies and test laboratories and currently uses several certified external laboratories for its tests. It is Philips Respironics’ expectation that the FDA’s announcement of November 12, 2021 will not delay the repair and replacement process. “
Additional FDA observations
In his final inspection report, the FDA auditor provided the company with a list of his observations. An FDA investigator’s list of inspection observations does not constitute a final decision by the FDA as to whether a condition violates the Federal Food, Drug, and Cosmetic Act or any of its statutes. The FDA will review the company’s response and all information available to the agency to determine appropriate next steps.
These observations included the following.
- The risk analysis is insufficient. The analysis does not support Philips’ justification as to which devices with PE-PUR foam are being recalled and which are not.
- Corrective and preventive action procedures have not been adequately established.
- Design validation has not ensured that the device meets the defined user requirements and uses. When assessing the potential impact of released particles on users, Philips indicated that the FDA used the respiratory systems of healthy people, not the systems of the impaired and / or tracheostomy, which is the intended user group for the devices.
- Procedures for design changes are not well established.
- Procedures to ensure that all products or services meet specified requirements have not been adequately established.
- Potential consultants have not been evaluated and selected based on their ability to meet specific requirements.
In a FAQ, Philips emphasizes:
- Philips takes this matter very seriously and will work fully with the FDA.
- Philips Respironics will submit its response to the inspection results for review by the FDA in accordance with standard practice and schedule.
- An FDA investigator’s list of inspection observations does not constitute a final decision by the FDA as to whether a condition violates the Federal Food, Drug, and Cosmetic Act or any of its statutes.
- The FDA has not changed its recommendation to patients and healthcare providers regarding affected devices.
- Philips Respironics is committed to serving the community of patients who depend on the affected devices, as well as the clinicians and customers who are committed to serving patients’ needs.
- It is Philips Respironics’ expectation that the FDA’s November 12, 2021 announcement will not delay the repair and replacement process.
Was Philips aware of foam degradation and / or VOC emissions prior to 2021?
In the FDA’s inspection report, the FDA frequently cites cases before 2021 where Philips was made aware of complaints about foam breakdown. Philips addresses these concerns in a FAQ: “In previous years there have been few complaints related to foam breakdown, which have been assessed and addressed on a case-by-case basis. More recently, problems related to VOCs have arisen. Then tests and interpretations with certified external experts took place, which led to the measures in the first half of 2021. “
Instructions for patients
As previously advised, the FDA recommends that patients currently using a recalled device that has not been repaired and replaced should consult their physician if they have additional questions or concerns in order to determine whether patients should continue to use the device. switch to another product or stop using it.
The Agency understands 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 organizations including the American Sleep Apnea Association, the chronic obstructive pulmonary disease (COPD) Foundation, the Muscular Dystrophy Association, Mended Hearts, Inc., and the American Academy of Sleep Medicine to provide this feedback updated Frequently Asked Questions to provide helpful information to the public.