A broad coalition of doctors, hospitals and consumer groups is pressing the Food and Drug Administration (FDA) to quickly adopt regulations creating a unique device notification (UDI) system for medical devices. In a letter sent Wednesday to FDA Commissioner Margaret Hamburg, the Advancing Patient Safety Coalition says that such a system would help prevent implanting a defective, counterfeit or recalled product; help track the recipient of a faulty product if it is recalled; and help appropriately track adverse events.
"UDI is the missing link to protect the safety of patients by improving processes for device recalls and corrections," the letter says.
The letter points out that more than 700 medical device recalls were issued in 2008. It says the FDA has taken an "unreasonable amount of time "to publish proposed regulations since it was required to do so in 2007."
"With each day that elapses without a UDI system in place," the letter reads, "patients’ lives are put at needless risk."