Royal Philips has issued a voluntary field safety notice to non-US markets regarding certain sleep and respiratory care devices. The devices affected include CPAP, BiLevel PAP, and Mechanical Ventilators. A complete list of the affected devices can be found here: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update. The American Academy of Sleep Medicine has posted information for the US market on their website.
What is the reason for the field safety notice?
Philips has identified two issues related to the sound abatement foam used in certain Philips Continuous and Non-Continuous Ventilators.
- The foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user.
- The foam may off-gas certain chemicals.
The degradation of the foam may be exacerbated by certain factors, including high heat, high humidity, and certain cleaning procedures.
Potential risks of the foam degradation include respiratory and headache problems. There have been no reported deaths due to this issue.
What guidance has been given for the use of affected devices?
Philips has advised patients to discontinue use of affected BiLevel PAP and CPAP devices and to consult with their physicians to weigh the risks and benefits of continued use of the device while replacement is in process.
Philips has advised patients to not stop or alter prescribed therapy on affected life-sustaining mechanical ventilator devices without physician consultation.
What will be done to resolve the issues with affected devices?
Philips has initiated a process to either replace the sound abatement foam with a new material in affected devices or provide patients with a new or refurbished unit that incorporates the new material.
More information and guidance
American Academy of Sleep Medicine
The American Academy of Sleep Medicine (AASM) has issued guidance in response to the Philips recall of PAP devices, considering patient notification, patient care, and in-lab titration studies.
On Friday, June 18, AASM hosted a free, live panel discussion regarding the recall of certain PAP devices, including representatives from AASM, American Academy of Neurology, American College of Chest Physicians, American Thoracic Society, Canadian Sleep Society, and Canadian Thoracic Society.
You can find the complete recording of the panel discussion here: https://www.youtube.com/watch?v=H80vyhFb5vc
Medical Device recall notification (U.S. only) / field safety notice (International Markets)
Sleep and Respiratory Care update: Clinical information for physicians
Information for physicians and other medical care providers