Many Device Manufacturers May Miss Looming UDI Deadline

Vendors that sell medical devices to healthcare organizations will be scrambling to meet a mid-September deadline to get unique identifiers and meet requirements to match them with devices and accompanying software. Loftware, a vendor of unique device identifier labeling solutions, recently conducted a survey of about 120 medical device professionals and found that only 15 percent of respondents said they believe their organizations are ready for the September 24 deadline.

That deadline is the latest in a series established by the Food and Drug Administration, which in 2013 finalized a rule requiring medical device manufacturers to label products with unique device identifiers (UDIs). The intent was to enable users to track devices and improve supply chain processes and help the agency identify safety or effectiveness concerns quicker to better target device recalls.

Compliance started almost immediately and will continue to 2020. The rule set out different classifications for devices—ranging from Class I, Class II and Class III—depending on the uses and risks of devices. Some UDIs were required by September 2014 for certain devices licensed under the Public Health Services Act and in September 2015 for certain implantable and life-supporting or sustaining devices...