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.
The next deadline is for medical device manufacturers to affix labels and packages of Class II devices to display a UDI with Class II standalone software also having a UDI, and Class III devices bearing a UDI as a permanent marker on the device if intended to be used more than once and reprocessed before each use. These devices include infusion pumps, powered wheelchairs, medical apps, medical imaging systems and surgical needles, among many other devices in the Class II segment, and such devices as implantable defibrillators and pacemakers considered Class III devices.
Beth Gibson, senior director of industry engagement at GS1 US, the organization that administers information standards and provides education and collaborative support to improve supply chain processes across 25 industries, echoed the concern brought out in the results of the Loftware survey, that many device manufacturers are going to be challenged to hit the deadline.
“We are getting calls today from folks who are just starting. They have known since 2013 of this compliance date,” Gibson said.
In defense of manufacturers, Gibson notes that many are small companies that lack a regulatory department or seasoned regulatory experts on staff. Typically, these small manufacturers have their hands full just making products and getting them to the market.
Further, assessing regulatory compliance may not even be feasible, Gibson adds, because she doesn’t believe anyone knows how many manufacturers of Class II devices are currently in business.
There are steps, however, that providers using UDIs can take now to capture UDIs and pass them into their electronic health record systems to aid in improving supply chain process, says Salil Joshi, senior director of industry development at GS1US. Stage 3 of the electronic health meaningful use program, for instance, requires providers to capture UDIs in their EHR systems.
With the UDI in the EHR, a device used during surgery then can be easily available if the device later faces a recall. A provider organization could run a report and find which patients have the recalled device inside them.
Gibson and Joshi urge providers to work with their device suppliers to set up processes to more effectively benefit from use of medical devices to improve the supply chain. GS1US also offers a variety of educational services, including medical device toolkits, available here. An FDA primer on the basics of UDI is available here.
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