‘Paradoxical’ FDA Recalls Report Credits Industry Collaboration For Improved Quality, But Uncovers Troubling Data About Older Devices
• By Shawn M. Schmitt
Medical devices on the market for more than five years are recalled more often than younger ones, according to a recent FDA 10-year retrospective report on corrections and removals. “There is an intuitive appeal to the argument that devices that come to the market in an early point in their lifespan – say, the first year – are more likely to be subject to recalls, but that is simply not true,” CDRH Office of Compliance Director Steven Silverman says. Other notable report findings: troubles with components and software are the leading causes for most recalls; problems with AEDs, ventilators and infusion pumps have triggered an increase in high-risk class I recalls; and domestic manufacturers recall products at a much greater volume than those outside the United States.
FDA’s device center is scratching its head after an internal report concluded that the bulk of products recalled since 2010 are medical devices that have been sold to consumers for more than half a decade.
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.
Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.
The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.
