11 May Latest FDA Update: Philips recall action for CPAP and Bi-Level devices
UPDATE (May 2022):
On May 2nd, the FDA’s centre for Devices and Radiological Health (CDRH) has proposed that an order should be issued to require Philips Respironics to submit a plan for the repair, replacement or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more) of the recalled devices manufactured after November 2015. Philips does have the opportunity for an informal hearing before the FDA issue an order.
“Philips Respironics has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips Respironics devices, including the:
- A-series BiPAP machines
- DreamStation Go
- OmniLab Advanced+
- REMstar SE Auto”
To read the update directly from the FDA Website, follow this link:
In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Additionally, the foam damage may get worse in hot and humid settings and by using ozone or ultraviolet (UV) light cleaners or other cleaning methods not recommended by the manufacturer.
In a press release dated 12/11/2021 the FDA noted:
“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.
However, 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 U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs).”
“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 U.S.”
“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. ”