FDA Workshop Outlines UDI System

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.