On March 14, 2022, the US Food and Drug Administration (FDA) updated its frequently asked questions about the Philips Respironics CPAP, BiPAP, and ventilator recall to include information about Philips Respironics’ prioritization strategy for replacement devices. The administration notes that a first-come, first-served replacement strategy may not address health risks for some patients.
After discussions with health care providers, experts in sleep medicine, and patient groups, the FDA shared with Philips Respironics the concerns of health care professionals and people who use these recalled devices, that for some patients, stopping use of the recalled device without an adequate alternative may involve significant risks to individual and public health.
The FDA has recommended Philips Respironics implement a prioritization approach that ensures patients who are most vulnerable to poor healthcare outcomes with continued use or ceasing use of the recalled products receive replacement devices as quickly as possible. The FDA received input from patients and health care providers regarding characteristics of patients at the highest risk of stopping use and continuing use of the recalled device and relayed that data to Philips Respironics to inform their prioritization approach.
For people with a recalled device: Philips Respironics’ online patient portal now allows them to provide additional information to be considered for prioritized replacement.
The FDA also recommended Philips Respironics develop a tracker or method for consumers to look up the status of their replacement device. Patients may now check the status of their replacement device on the Philips Respironics online patient portal.
The FDA has also partnered with stakeholders to distribute a voluntary survey to better understand patient experiences related to specific recalled medical devices. The survey informs the FDA’s work overseeing the effectiveness of the recall.