Sleep Treatments | Sleep Review
The US Food and Drug Administration (FDA) has updated the FAQs for this recall on FDA.gov: Philips Respironics CPAP, BiPAP and Ventilator Recall: Frequently Asked Questions.
The updates contain answers to questions such as:
- When will the devices be repaired or replaced?
- What is the status of Philips Respironics’ plans to repair or replace the devices?
- What is the FDA’s role in the Philips Respironics recall?
- I use one of the affected devices every day. I can hardly wait for a new device. What can I do now?
Some of the updated information includes the following.
Q: Can Philips Respironics face fines or enforcement actions from the FDA for handling this recall?
A: If a company’s voluntary action is not quick or complete, the FDA has the option to take enforcement action. The FDA has classified 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 sufficient evidence is presented of the safety and effectiveness of the proposed corrective action for the product.
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 devices on the FDA’s Equipment Shortage List?
A: Yes, all product codes under which CPAP and BiPaP devices are classified are on the device shortage list due to device availability issues. This includes the product codes BZD, NOU, CBK, MNT and MNS. Most of these devices are classified under the product code BZD.
In determining whether a medical device is in short supply, the FDA takes into account all of the relevant and reliable information and data available to the FDA at the time of making a decision.