GAITHERSBURG, Md. — On Feb. 12, the U.S. Food and Drug Administration convened a public workshop on development of a unique device identification system for medical devices under the FDA Amendments Act of 2007, which mandates the UDI.
The FDA has been investigating such a system — which could facilitate device recalls and provde the opportunity to detect early warning signs of a defective device — for several years. When implemented, the system will require that: the label of a device bear a unique identifier, unless an alternative location is specified by the FDA or unless an exception is made for particular devices; such a UDI be identified through distribution and use; and that the unique identifier include the device lot or serial number if specified by the FDA.
The workshop announcement listed the following questions:
1. What types of devices or particular devices should be subject to the requirements of a UDI system? Which types of devices or particular devices should be excepted?
2. What are the characteristics or aspects necessary to uniquely identify a device?
3. What should be the UDI's components? (For example, should the lot or serial number be required?)
4. Where should the UDI be placed? What should be the criteria for alternative placement of the UDI?
5. How should the UDI be presented? (What automatic identification technology would be appropriate?) Should FDA mandate a particular technology or permit different standards to be used depending on the type of device?
6. How should the UDI database be developed and maintained?
7. What is the magnitude of the problem to be addressed by the establishment of a UDI system? For example, the agency would like to obtain information about manufacturers' current practices and the potential impact of adding a UDI as part of their production operations.
According to a report from the American Association for Homecare, a UDI system "has potential to affect the entire HME sector because devices to be included could be power wheelchairs, infusion pumps and oxygen equipment."
Issues raised at the workshop included the categorization of small devices such as surgical needles or rehabilitative parts and accessories, AAHomecare said. "Proponents of identifying small devices spoke of patient safety concerns especially regarding product recalls. Opponents stated the high costs of identifying every medical device. Attendees did not resolve their concerns regarding medical device kits that have many component parts including liquid products or devices that are 'single-use' or 'reissued' devices," the association reported.
Other issues included how software products that work with medical devices would be identified, the need for global harmonization of one standard and the importance that all medical databases should be able to exchange accurate data on the tracking and monitoring of devices seamlessly. Potential coding systems for the UDI system include GS1, HIBCC or NDC using radio frequency identification (RFID), 2D bar coding or linear bar coding.
The FDA is requesting comments, including information on what devices should be exempted, by Feb. 27. A proposed rule on the UDI system is expected later this year, with a final rule in 2010.