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Table I: As stated in the report by the Eastern Research Group (ERG), FDA has identified several scenarios that illustrate issues potentially associated with insufficient identification or tracking of medical devices. ERG has summarized these scenarios (not all are shown) in its final report, “Unique Identification for Medical Devices.”
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Just as the pharmaceutical industry is getting acclimated to bar coding packages to help hospitals curb errors, FDA is asking whether medical devices should also bear bar codes. Calling such codes “unique device identifiers (UDIs),” the agency is urging manufacturers to share their perspectives regarding their own devices.
Earlier this year, FDA had the Eastern Research Group (ERG) prepare a report on UDIs. The group found that UDIs could help healthcare practitioners and support staff better identify medical devices at several different stages.
One of the primary areas where UDIs can contribute is in recalls, reports ERG. According to the group, medical device recalls take place nearly every month. “The effectiveness of a recall is largely dependent on the manufacturer’s effort, whether healthcare professionals and consumers track recalls effectively, and the help of the media in disseminating recall information,” writes ERG. “UDIs will have the most impact on the second factor—the ability of healthcare professionals to track recalled product.”
Below is a table listing several scenarios in which UDIs could prove useful. (Not every scenario is listed, as some do not involve packaging.)
Comments on FDA’s inquiry are due in November.
