FDA meeting emphasizes economics, patient safety, supply chain efficiency

The U.S. Food and Drug Administration held its second open meeting on the Unique Device Identification (UDI) requirements February 12 in Gaithersburg, MD. The first meeting was held three years ago to discuss the possibilities of establishing the UDI as a means of improving medical device tracking and patient safety by reducing use of defective devices and facilitating recalls. The meeting in February was called to garner industry comments on how best to meet the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Section 226). More than 300 people representing manufacturers, trade groups, group purchasing organizations (GPOs), distributors and providers attended the meeting as many others participated via video teleconferencing.

Briefly, this legislation amended the Federal Food, Drug, and Cosmetic Act by requiring the establishment of a UDI system. The specific requirements of the act call on the Secretary of Health and Human Services to "promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number."

Because the actual wording of the legislation about the enactment of section 519(f)1 generated numerous questions about the specific requirements, this meeting was held to garner input from all segments of industry that will be affected by these requirements.

Jay Crowley, FDA Senior Advisor for Patient Safety, opened the meeting with an overview of the day’s agenda, highlighting the topics to be discussed and the "device information life cycle." Crowley said the FDA’s focus is on formulating workable standards for device tracking and regulation and that they are not trying to recreate the National Drug Code (NDC) numbering system, although he noted the NDC is a consistent and unambiguous method to track manufacture and distribution of pharmaceuticals, facilitate billing, usage, etc.

In fact, the UDI medical device requirements resemble drug tracking needs – particularly with expanding traffic in counterfeits. Crowley highlighted problems with more than 66,000 medical device recalls in 2007 with 15 percent of the reports lacking model or catalog information, 50 percent of the reports lacking lot or other relevant manufacturer information and 10 percent lacking both. Crowley indicated that the FDA particularly is interested in gaining a better understanding of marking alternatives that might be used for UDIs, such as radio-frequency identification (RFID) and various bar-code formats.

The day’s line-up

The meeting was comprised of four panels of industry representatives addressing key topics and questions related to the UDI initiatives. To establish the UDI system, according to Crowley, requires developing standards for the UDIs; alternatives for placement of UDIs (human readable and/or AutoID) on devices, packaging or both; creation and maintenance of a UDI database; and perspectives on implementation and adoption of the UDI regulations developed.

Following presentations by each of the panels, attendees were encouraged to ask questions or provide additional perspectives. The presentations throughout the day highlighted the diversity of needs, issues and perspectives on UDIs from various medical device industry segments with ties to issues of patient safety, clinical performance, and manufacturing and distribution efficiencies.

UDI requirements

The first panel discussion concentrated on developing the UDI requirements. Panelists representing two different standards organizations (GS1 and the Health Industry Business Communications Council or HIBCC) and a healthcare provider (Association for Healthcare Resource & Materials Management Past President Jean Sargent from University of Kentucky Medical Center presented perspectives on different standards – GS1, HIBCC, NDC – and the impacts of using and maintaining these for manufacturers, distributors and use by providers.

The panelists discussed the difficulties in developing initial product identification standards and noted the same issues in today’s global economy for track-and-trace needs. Panelists and audience respondents recommended that the FDA needs to clearly define UDIs and that the use of serial numbers is appropriate for selected items, but not all. Further, there are some items that consist of multiple components that will be marked/tracked with UDIs that will, in turn, need to have their own UDI. Panelists and attendees also discussed how the UDI regulations would impact reuse or multiple use of devices (including those that may be considered as single-use.)

UDI labeling

The second panel focused on packaging and marketing with presenters noting concerns associated with different types of items, especially small parts or packages, and items used in the manufacture or creation of kits. In discussing packaging or direct marking concerns, panelists and audience participants explored needs for human readable and/or AutoID labeling.

Tom Werthwine from Johnson & Johnson spoke on behalf of AdvaMed (the Advanced Medical Technology Association) and commented that the FDA UDI database should not attempt to track individual items in kits due to their dynamic, ever-changing nature. Rick Naples, BD’s vice president of corporate regulatory affairs, concurred because some items were too small for bar coding but still were imprinted with human readable lot numbers or expiration dating.

Another concern about packaging was that the standards be implemented in a manner that improved patient safety while promoting cost efficiencies through removing costs and reducing waste throughout healthcare – again through use of a single standard for global harmonization.

UDI storage

The third panel shifted attention to the creation and maintenance of a UDI database. Panelists discussed needs for the minimum data set, including typical supply chain identification and distribution data, such as packaging and unit-of-use data, country of origin and whether items were classified for single or multiple use. Other elements for the UDI database included content of known allergens (e.g., latex) and sterility and storage conditions.

Dennis Black, BD’s director of e-business and GHX’s M.J. Wylie – both veterans in standards development – commented on global harmonization needs and a phased approach for implementing the standards. Kathy Garvin from the Department of Defense (DoD) noted that the UDI constructs for a database would further facilitate the DoD Product Data Utility Pilot Project as a supply chain catalyst. David McCombs, vice president for ERP and supply chain management at Bon Secours Health System, emphasized the need for data normalization, data synchronization, and frequent updates to both the UDI database and those of end users. He further stressed the need for a database that is 90-95 percent complete to drive synchronization and change processes.

UDI implementation

The last panel of the day discussed perspectives on implementation and adoption of UDI regulations developed. Joe Pleasant, CIO for Premier Inc., spoke about standards adoption to foster improvements to, and interoperability of, key supply chain processes – both of which are essential to reducing healthcare costs, enhancing efficiency and promoting patient safety. Gene Kirster from Mercy ROi, expanded Pleasant’s comments by sharing his own perspectives on benefits of data standards for better patient care and positive impacts on financial performance. Kirster also shared ROi’s contract language detailing use of data standards for vendors and providing penalties for non-compliance. Kirster urged the industry to move toward agreement and use of a single set of standards facilitated by guidance from the FDA.

Steve Phurrough, M.D., MPA, director, Coverage and Analysis Group, Centers for Medicare and Medicaid Services (CMS), indicated that CMS claims forms have provisions for annotation with the UDI codes once they are implemented. This is in keeping with CMS’ Quality Standards last updated in October 2008 that require providers to document information in the beneficiary’s record that is sufficient to facilitate payment, "i.e., the make and model number or any other identifier of any non-custom equipment and/or item(s) provided (CMS Claims Processing Section 1, D. Consumer Services)." This will happen over time since CMS’ claims processing software will have to be modified.

In addition to the four panels, the meeting also included individual presentations made by representatives from various industry segments. Some stressed the need for clearly defined timelines, while others noted the need for open standards. Some felt that success would only be achieved through mandates for UDI use by FDA, while many spoke about costs.

Fundamentally, the meeting highlighted the FDA’s priorities to implement the UDI regulations in support of public health needs and patient and provided industry representatives with the opportunity to make presentations on their thinking about the issues for implementing UDI regulations.

Looking back

The tone and comments voiced by meeting participants were significantly different from the meeting three years ago. Participants in this meeting were much more accepting of the role the FDA is playing in promulgating the UDI standards and noted the need to clarify regulations to make progress.

Key themes from the FDA UDI’s discussions included the following:

•Clarifying UDI Standards – Manufactures and providers expressed concerns with clarifying which devices and items should be "labeled" with UDIs. Most agreed that implants were the most important and logical group of items with which to start. There was also discussion of item/device exemptions, the exemption application process, and how the requirements would be developed.

•Global Economy Needs and Impacts – Medical device manufacturing, distribution and use is now part of the global economy. Panelists and meeting participants indicated the UDI recommendations and regulations needed to address in requirements for global harmonization with the continuing shift towards global markets as critical to the domestic economy. Implementation of the FDA UDI regulations cannot be viewed only from the U.S. perspective.

•Open Standards vs. Single Standard – Many of the panelists expressed their support for a single set of standards to be selected for UDI use. Given the global economy, however, many noted this would be extremely difficult and outside the purview of the FDA to successfully accomplish. They argued that perhaps the best approach will be to use open standards such as the ISO 15434 and 15459 standards used by the DoD for their comparable unique item identification system that allows for the use of the GS1 data standards for Global Location Numbers (GLNs) and Global Trade Item Numbers (GTINs) or the HIBCC standards.

• Medical Device Information Life Cycle – IT is essential for efficient tracking of adverse events and providing timely notification of end-users to prevent additional dangerous medical mistakes and improve quality of healthcare.

References

1 [Federal Register: January 15, 2009 (Volume 74, Number 10)] [Page 2601-2605]