The FDA held an open meeting for public comment on the possible establishment of Universal Device Identification (UDI) requirements Oct. 25th in Gaithersburg, Maryland. Over 150 individuals representing different industry sectors – manufacturers, trade groups, GPOs, distributors, providers – attended the meeting. The purpose was to provide medical device manufacturers and others the opportunity to comment on potential issues associated with establishing regulations for medical devices (any item used in medical care, e.g., latex gloves or sutures or implants).

During opening comments, Dr. Janet Woodcock, Deputy Commissioner for Operations, from the FDA noted that the issue of medical device manufacture, distribution and use is now global in nature and the solution can no longer be viewed as US centric. She highlighted needs for efficiency for adverse event tracking, the need to incorporate information technology capabilities to prevent dangerous medical mistakes and improve quality of healthcare. She also noted the potential use of UDIs as having an impact on improving healthcare delivery systems and supply chain efficiency. Several panel discussions and speakers followed Dr. Woodcock and highlighted the needs for UDIs as a means of promoting and protecting public health.

Following Dr. Woodcock’s opening remarks, Dr. Larry Kessler,
director, office of surveillance and biometrics, center for devices and radiological health, for the FDA was introduced as the moderator for the meeting. Dr. Kessler noted the objective for the FDA was to promote and protect public health and the discussions for the day had been structured to provide overviews of the potential costs and benefits from establishing standards and possible regulations for UDIs, and the processes and mechanics for implementation.

The first panel discussion focused on the costs and benefits from use of UDIs and panelists noted the diversity of the healthcare manufacturing and distribution process made it difficult to establish accurate estimates of the costs and benefits. A portion of the benefits is related to having items involved in an adverse medical event identified in a standard manner. This would provide the ability to process recalls more accurately and quickly. The use of the UDIs would also facilitate analysis of events that have occurred. Panelists discussed the need for any standards for UDI to be both human and electronically readable. The benefits discussed were mostly in the area of public health benefits with potential impacts on providers from more efficient recalls estimated at over $30 million. This would require significant investment in scanning systems, training and implementation support.

The other panel groups highlighted how such regulations for a UDI system would be designed and implemented, the related development and maintenance of a repository, and the use of automatic identification technologies. The general assumption was that there would be some movement forward with the major question being the issue of recommending voluntary standards versus mandated requirements. Several different areas of potential benefits were mentioned during the presentations ranging from more efficient processing and maintenance / servicing of bio-medical equipment, improving payment and billing processing, prevention of or reduction of counterfeiting from tighter control over pedigrees (particularly for pharmaceuticals), and enhanced data accuracy in the supply chain for transaction processing. There was also discussion about how voluntary standards would be decided, determined and then encouraged and enforced.

Part of the emphasis for the meeting was that selected high-risk devices used in patient care such as pacemakers are already subject to regulatory tracking. Due to the recent emphasis on patient safety, the FDA asked for public comment on the possibility of establishing regulations to track a much broader range of medical devices, especially as a means to facilitate medical device recall and adverse medical event reporting and tracking.

Participants at the meeting were provided with the opportunity to ask questions or make comments after each of the panel discussions. Some industry, provider and trade group representatives were enthusiastic about the potential benefits that might occur from UDI legislation and felt that the only way to accomplish the potential benefits was to mandate the use of UDI standards. Several representatives of manufacturers and trade groups expressed strong views supporting voluntary efforts over a long period of time without government intervention. At the conclusion of the panel discussions, an opportunity was provided for several different speakers to express the views of their organizations.

Briefly summarized, the FDA priorities are to connect the dots in the patient care marketplace. This is part of a major initiative for safety and use of medical devices pursued vigorously by the FDA in a collaborative manner with input sought from all stakeholders and partners. Participants at the meeting noted the increasing shift towards global markets and the need to address recommendations and regulations in the marketplace from a world perspective/global scale.

The meeting provided industry representatives with the opportunity to make presentations on their thinking about the issues for UDI. The presentations highlighted the diversity of the medical device industry, noted the ties to the issues of patient safety and performance, and to think about the systems and the solutions for the future in a regulatory environment. HPN