The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health released its preliminary report calling for more widespread use of postmarket medical device surveillance and is encouraging medical facilities to cooperate with their recommendations.
The agency hopes to strengthen its case for a national, real-time surveillance system with a combination of IT and workflow approaches, from integrating unique device identifiers into electronic health records (EHRs) to upgrading its adverse event reporting system. The report is open to a public comment period before being finalized.
The FDA makes four main recommendations in the report, the first of which is to establish a unique device identification (UDI) system. The agency cites UDI as a means to “enhance postmarket surveillance activities by providing a standard and unambiguous way to document device use in EHRs, clinical information systems, and claims data sources.” UDI documentation will be an important issue in health IT in the coming years, with the FDA and the Office of the National Coordinator of Health IT considering whether to include UDI in stage 3 of the meaningful use incentive program.
Establishing and regulating a medical device identification system isn’t without precedent. The GS1 US group developed and began using a medical device ID and tracking system in 2010. The FDA’s proposed use of UDI is similar to that of the GS1 system. GS1 installed their system because they found it necessary to be able to communicate safety bulletins and other information quickly down the supply chain.
A UDI system has been in development for years, with support from agencies such as the Advancing Patient Safety Coalition (APSC). Proponents argue UDI adoption would help increase patient safety.. A provider can receive updates on the functionality of their machines and avoid treating patients with faulty technology through use of UDI registered machines. UDI technology also provides benefits for a regulatory body, like the FDA. They would be able to track device functionality and trace design flaws in any given device.
The FDA report is a follow-up to their proposed UDI regulation. Medical device manufacturers were advised to label their products in readable form for both humans and machines in that proposal to increase tracking capabilities and communication between manufacturers and providers. Manufacturers will be held to the regulatory standard, but providers will also have to adjust to wider use of UDI. Providers can track device functionality and cost of procedures through UDI technology.