The Global Harmonization Task Force is soliciting public comment on a proposed worldwide tracking system for medical devices it says will increase patient safety, improve corrective actions and better fight against counterfeiting.
The 17-year-old task force, which is made up of “a voluntary group of representatives from medical device regulatory agencies and the regulated industry,” will be soliciting public comment until March 31. The 13-page paper, released last month, was disseminated by the Food & Drug Administration Jan. 6. “Unique Device Identification (UDI) System” can be downloaded online.
The GHTF is seeking input on how the system could be used by manufacturers, regulators, purchasers and final users, as well as input on the design of a tracking database that would be free and open to the public.
The task force said the system would be rolled out according to the risk of the device, meaning implants would be the first devices tracked. Implementation would then be phased in, with disposables likely being the last types of devices it would track.
The system would include a requirement that all devices be tagged with a globally standardized tracking code that can be both scanned and read with the naked eye. In addition, manufacturers would be responsible for maintaining the “uniqueness of its UDI code for a medical device throughout all jurisdictions worldwide,” according to the paper.