The U.S. Food and Drug Administration (FDA) updated the frequently asked questions (FAQs) about this recall on FDA.gov: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions.
The updates include answers to questions such as:
- When will the devices start to be repaired or replaced?
- What is the status of Philips Respironics’ plans for repairing or replacing the devices?
- What is the FDA’s role in the Philips Respironics recall?
- I use one of the affected devices daily. I can’t wait for a new device. What can I do now?
Some of the updated information includes the following.
Q: Can Philips Respironics face any kind of fines or enforcement action by the FDA over its handling of this recall?
A: If a firm’s voluntary action is not rapid or complete, the FDA has the option to take enforcement action. The FDA has identified this as a Class I recall, the most serious type of recall, and the FDA will continue to work with the company to ensure that they provide sufficient evidence demonstrating the safety and effectiveness of its proposed actions to correct the product defect.
The FDA has also initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements.
Q: Are the product codes for CPAP and BiPAP machines on the FDA’s device shortage list?
A: Yes, all the product codes under which CPAP and BiPaP machines are classified are on the device shortage list due to device availability issues. These include product codes BZD, NOU, CBK, MNT, and MNS. The majority of these devices are classified under product code BZD.
In determining whether a medical device is in shortage, the FDA considers the entirety of relevant and reliable information and data available to the FDA at the time of a decision.