Philips updates patient guidance for recalled BiPAP/CPAP machines
November 16, 2021
This week, manufacturer Philips Respironics will issue letters to its US-based BiPAP, CPAP, and mechanical ventilation device users providing an update on the company’s June recall.
Due to recommendations from the Food and Drug Administration (FDA), Philips updated its recall notification and is encouraging device users to work with their health care providers before making a change to their therapy. The updated recall notification no longer calls for patients to immediately discontinue use of the recalled BiPAP/CPAP devices prior to discussing with their health care providers. The updated advice better enables shared decision-making among patients and providers to assess risks and benefits.
For users who have not yet consulted with a health care professional, Philips encourages these individuals to reach out to their clinicians to talk about appropriate next steps for their therapy, including whether they should continue use of their device until they receive a replacement. To those who have already consulted with their health care providers, the letter states that no further action is required.
There are not any changes in Philips’ guidance for patients using mechanical ventilation devices.
In the letter, Philips also states that the device repair and replacement program in the US will last through September 2022.