The FDA has released its plan to track medical devices by requiring each to feature a unique identification system, which the agency hopes will improve accuracy of reporting and keep patients safe, The Wall Street Journal reports.
The unique device identifier plan, first proposed in 2007, would require devicemakers to include tracking numbers on all high-risk techs, and the FDA plans to implement the policy by the end of the year, with the first marked devices appearing in 2014, according to the WSJ. Jeffery Shuren, director of the agency's device wing, told the paper that the plan is "a major game-changer" and will allow the agency to better identify problematic devices and react quickly to adverse events.
Some doctors, however, say the rule doesn't go far enough. The FDA's plan would create a database of device-related problems reported by doctors and hospitals, but there is no law that requires physicians to report when and why they remove a device, so any data would be inherently flawed, Robert Hauser, of the Minneapolis Heart Institute, told the Journal. Hauser suggests beefing up the rule by denying Medicare reimbursements to hospitals that don't disclose this information.
The FDA, however, maintains that the system will help reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the last five years. Once rolled out, the ID system will cost the industry $65 million, according to the FDA.