The American Hospital Association and a large healthcare purchasing group are urging the Food and Drug Administration to accelerate adoption of a proposed unique device identifier (UDI) rule for medical devices.
In recent letters to the FDA, the AHA and Charlotte, N.C.-based Premier Inc. both expressed support for implementation of the proposed rule, which will identify most medical devices with a code designating the model of the device and details such as a production batch number, serial number and, if applicable, an expiration date. The FDA also will create a UDI database available to the public.
The AHA, in a letter to FDA Commissioner Margaret Hamburg, M.D., urged that implementation of the UDI rule be accelerated from the current proposed seven years to three years. A unique device identifier "will provide an important means for hospitals to better track devices used in patient care, act in the event of safety recalls and manage their supply chains," the group said.
Hospitals eager to track devices have developed their own in-house coding systems, the AHA added, an approach it calls insufficient. The association recommends compliance within one year for Class III devices, two years for Class II devices and three years for Class I devices.
Premier, in its letter to Hamburg, recommended an even shorter roll-out timeline of two years from the date of approval. Hospitals already are well on their way to being able to support UDI tracking through investment in electronic barcoding and other systems, Premier said, adding that delays in being able to track certain types of devices compromise patient safety.
Other AHA recommendations include removing exceptions for devices sold at retail establishments, packaged as part of single-use convenience kits and devices in the National Strategic Stockpile. Premier also made several additional recommendations about how the rule is implemented.
It has been five years since Congress passed legislation requiring the FDA to develop a unique device identifier system. Several senators pushed the FDA earlier this year to release the proposed bill, and introduced legislation requiring a final rule be implemented by the end of the year.
To learn more:
- here's the proposed rule
- read the AHA letter
- check out the Premier letter