On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.
As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.
Following ongoing dialogue with the FDA, Philips has updated the guidance in its June 14, 2021 U.S. recall notifications for certain CPAP, BiPAP and Mechanical Ventilator devices to align them with the U.S. FDA’s recommendations in connection with these recalls. This updated guidance is not based on new test results and is intended to provide broader options for physicians advising patients of affected devices to better account for a wide variety of clinical use cases for patient medical conditions.
The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
At the time of the June 2021 recall / field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions. Philips continues to monitor complaints received following the recall / field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve.
The notification advises patients and customers to take the following actions:
The November 2021 update provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows:
For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include:
- Stopping use of an affected device
- Using another similar device that is not part of the recall
- Continuing to use an affected device, if a patient’s health care provider determines that the benefits outweigh the risks identified in the recall notification.
- Using alternative treatments for sleep apnea.
For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including:
- Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification.
- Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification- which also notes limitations of this option and areas of caution.
Philips is recommending that customers and patients do not use ozone-related cleaning products.
Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.
The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.
For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update