The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.
The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified. The actions include when companies remove products from the market, correct products or update use instructions due to potentially high safety risks.
The program will provide “early alerts” of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology and urology, according to the FDA’s Center for Devices and Radiological Health. The center added, “At this time, there is no change to any other recall process or recall communication timelines for other areas.”
Michelle Tarver, the new CDRH director, said in a statement that the program is meant to increase transparency.
Product safety issues involving medical devices, including Philips’ recall of more than 15 million respiratory products, health risks tied to Bayer’s Essure birth control device and cancer risks and deaths associated with breast implants, have put the FDA’s recall system in the public glare in recent years.
The Government Accountability Office, a federal watchdog, in January accepted a request to review the CDRH’s medical device review process from Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., that cited the massive Philips recall.
Product safety advocates have long criticized the FDA’s device recall process as ineffective and putting patients at risk. Calls for the FDA to notify patients and the public more quickly when there is a recall or other safety issues have been a consistent theme.
The CDRH, in the announcement, said it committed to minimizing the time between when the FDA and the public know about a recall after a 2021 advisory committee meeting, adding that the “pilot demonstrates the important role of incorporating patient input into our regulatory efforts.”
Product and patient safety remain a crucial topic in the device industry as new technologies and treatments for advanced health conditions hit the market because recalls are often tied to patient deaths and serious injuries.
As of Friday, the FDA has posted 93 Class I medical device recall notices this year.
