Concern over the failure rate of the implants, and even worse, the speed at which they were initially approved for the U.S. market, has led to a special two-day session to discuss the issue by experts at the U.S. Food and Drug Administration (FDA).
But it’s not just the hip replacement devices. It’s also the transvaginal mesh implants, used to treat uterine prolapse. Reports surfaced that Johnson & Johnson continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records.
But finally, the FDA is stepping in, proposing a rule to establish a medical device identifier, called unique device identifiers, or UDIs.
Reports stated that the FDA said device makers, like Boston Scientific Corp and Medtronic Inc, now will need to put a special code – much like the bar codes we see in the grocery store – on most of their products, “starting with the riskiest, like implants or pacemakers.”
The FDA would then put the codes (UDIs) in a public database online, where doctors and regulators could detect safety problems more quickly and inform patients about flaws or dangers. Companies and hospitals could pull faulty devices from the market faster and cheaper, instead of waiting after hundreds of patients have been injured or killed, by knowing early on which products are affected.
Congress actually authorized the identifier, designed to better enable users to track devices and enable FDA to identify safety concerns quicker and target recalls, in 2007. But it has faced renewed pressure from members in recent months to implement it.
“A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current product information for that specific device, such as the lot or batch number, the serial number and/or expiration date,” according to an FDA explanation, as reported at healthdatamanagement.com.
It seems like a “duh!” idea. But the FDA is proposing to set up a database with a standard set of basic identifying elements for each specific device model, and will make most of the information available to the public, according to the story.
"Since we have already been waiting five years for UDI, patients can’t wait until 2019 to have confidence that the devices implanted in their bodies are safe and effective,” healthdatamanagement.com quotes Premier Inc., a provider alliance that has long been a proponent of the identifier.
Edited by
Brooke Neuman
