From Suppliers To Sloppiness, Experts Offer 5 Theories Why Aging Devices Are Recalled Most
• By Shawn M. Schmitt
A CDRH report recently showed that a majority of recalled devices are older, yet the center has provided little insight into how it came to its conclusion. FDA’s relative silence on the matter has left several industry insiders to deduce for themselves why aging product types struggle more with recalls than younger ones. One such expert believes a failure by manufacturers to understand their own products and evolving international standards play a role in the substantial number of older-device recalls. “I don’t think there’s any one thing you can say is causing this problem,” said Monica Wilkins, divisional VP of QA/RA for device-maker Abbott Labs. But in a time of increased global manufacturing and troubles keeping an eye on supply chains, it’s a safe bet that poor supplier control is a culprit.
When FDA’s device center began piecing together a first-of-its-kind report to uncover recall trends, it expected to discover that products in their infancy would comprise most of the recalls in a given year.
After a few years of data analysis, however, the group within CDRH tasked with the research discovered, to their great...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
