https://aasm.org/clinical-resources/guidance-philips-recall-pap-devices/

From the desk of Elizabeth A. Lynch, MD

July 12, 2021

 

Dear Patients and Colleagues,

On June 14, 2021, Phillips Respironics issued a recall for certain CPAP, BiPAP and ventilator machines secondary to potential health risks from a type of polyurethane foam used in those machines.  Many of these CPAP and BiPAP machine were prescribed to treat central and obstructive sleep apnea.

The manufacturer has recommended discontinuing CPAP and BiPAP machines until the machine can be replaced or a new machine is obtained. For more information about this recall and to register your device, please visit the Phillips Respironics site at https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html

Additional information can be obtained on the FDA site at https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks or American Academy of Sleep Medicine https://aasm.org/clinical-resources/guidance-philips-recall-pap-devices/

There may be some patients in whom the risks of discontinuing treatment outweigh the benefits. These patients may elect to continue with CPAP or BiPAP treatment. If you have questions for your healthcare provider, please contact the Sleep Institute of New England for further discussion.

Sincerely,

Elizabeth Lynch, MD

Medical Director, Sleep Institute of New England

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