The U.S. FDA will soon publish a proposed rule to implement a unique device identifi cation (UDI) system for medical devices. The primary aim of the system is to increase public safety. When fully implemented, the UDI system should enhance the identifi cation of devices in the case of adverse events, facilitate traceability, and reduce device-related medical errors. Like the VIN number on your car, the UDI will also provide a means for rapid access for product recall or to obtain key attributes of the device.

To satisfy the statutory directive for the establishment of a UDI system of the 2007 Amendments to the Federal Food, Drug and Cosmetic Act, PL 110-85, the FDA is promulgating the UDI regulations. Over the past year, the FDA has received public comment on the UDI system, including on such matters as whether the proposed barcode system should be alphanumeric or numeric and how the labeling may occur. (Note: The FDA appears to favor a UDI coding system, which may be either numerical or alphanumeric as long as it’s unique and represents the key access points by which product information is readily obtainable.)

WHAT IT MEANS It appears that the proposed regulation will follow closely the “nonbinding” guidance proposed by the UDI Ad Hoc Working Group of the Global Harmonization Task Force (GHTF). The GHTF is a voluntary group of worldwide representatives from medical device regulatory agencies and the regulatory industry at large. (Check out the UDI Statement: Development of a Proposed Rule to Establish a Unique Device Identifi er System at www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance.)
Key elements of the GHTF UDI system include that the UDI must contain a unique dynamic part by which a device’s serial number, batch/lot, and expiration or manufacture date is discernable. The UDI must have a means by which the UDI code is “human readable” and also “automatically identifi able.” The second requirement of data capture will likely be met by linear or two-dimensional barcodes. The manufacturers (or organizations otherwise responsible for placing the device on the market) shall be responsible for submitting and maintaining the identifying information and other device attributes on the UDI. (See section 8.2 of the GHTF statement.) In this regard, the GHTF has suggested that the UDI be “technology-neutral.”
Stated otherwise, the UDI should not be restricted to a particular method of automatic identifi cation and data capture. The UDI database should allow for the use of an existing, globally accepted data-exchange process to harmonize the exchange of information. According to the GHTF, the UDI should use nomenclature that is globally accepted.
None of the above should represent substantially new ground for sellers of medical devices, as the medical devices that they often sell already possess alphanumeric or numeric labeling, which contains unique manufacturer product device information. The GHTF draft provides with respect to used or refurbished equipment less guidance: 5.6: “If a new entity/company replaces the original equipment manufacturer (OEM), the UDI carrier of the new entity/company shall be on the label on the device itself in replacement of the OEM UDI carrier. The company removing a UDI in order to place its own UDI – on the label or on the device – shall keep record of the provisions UDI.” (Emphasis supplied.)

FURTHER CLARIFICATION If incorporated into the fi nal document, the new regulations would require that a new UDI code be allocated to the product in the event of a “signifi cant change.” (See section 6.2 of the GHTF.) However, no defi nition of “signifi cant change” has been offered. Though the footnote to the provision concerning new manufacturers provides a caveat that it applied if “remanufactured or reprocessed by any entity other than the original equipment manufacturer,” no defi nition has been offered of what level of remanufacturing or reprocessing constitutes a need to change the UDI.
The International Association of Medical Equipment Remarketers and Servicers (IAMERS), as a representative of the refurbished and remanufacturing industry, will be offering comments to the FDA to aid in discerning standards on this area. Indeed, one of the FDA liaisons with regard to UDI is scheduled to speak at an upcoming IAMERS conference in Paris. Accordingly, if you have any comments or suggestions on the IAMERS UDI positions paper, please send them to IAMERS care of Diana Upton at dupton@optionline.com.