Outdated MedTech recall system?
Medical device recalls happen. And a majority of people believe they will be promptly notified if a recall concerns them.
Why isn’t that always the case? A recent MedTech Dive article reports the recall system is outdated—“clunky and uncoordinated.”
To begin with, the FDA can take 90 days to categorize the recall. Because postal mail and notifications are still used to inform hospitals of the recall, it can take weeks for them to find out, and months for that information to trickle down to the operating room. Until then, patients are unaware that they’re using, or have been implanted with, a defective device.
Not every recall is serious. They can be something simple such as labeling changes for non-implantable products. Also, a recall doesn’t mean the product needs to be pulled; sometimes it just needs to be checked or fixed, similar to recalls for our cars.
Even though the FDA has the power to require a device maker to recall a product, manufacturers usually voluntarily take the initiative and investigate. However, the lack of standardized procedures and timelines, combined with manufacturers communicating recall information with a paper-based system, too often means the patient is the last to know there’s a problem.
Fortunately, there’s a positive perspective. Instead of a time-consuming overhaul, analysts suggest that small changes could have a big impact on patient safety. Let’s start there.