In the July 17 edition of the Weekly Jolt, we covered the FDA’s new proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier (UDI). An FDA representative told 24×7 it expects that a standardized identifier will help clinical engineers and biomedical equipment technicians manage devices better, and help, for example, more quickly identify recalled devices. It said a UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety.
How will this actually impact CEs and BMETs? Will implementation be simple, or will it create a more arduous process? One industry professional posted valid questions on the Biomedtalk listserv, noting that while the idea is good, it will require a database that the FDA keeps current with new updates right away.
Does a UDI make sense to track equipment and make sure it isn’t counterfeit? Share your thoughts here.
Also, as a proposed rule, interested parties have 120 days to submit comments. The FDA has six months to finalize the rule after the close of the comment period, so go to the FDA Web site and submit your suggestions.