The Unintended Consequences
Why ECRI Institute opposes the single medical device naming system approach.
Action Needed: CLICK HERE to make your Public Comments before November 7, 2012.
The U.S. Food and Drug Administration (FDA) is scheduled to release its final rule on Unique Device Identification (UDI) in May 2013, less than 7 months from now. ECRI Institute believes that UDI is a good idea and although we fully support its intent, we are concerned about some unintended and costly consequences that could affect everyone involved with health care facilities and the supply chain.
If implemented correctly, UDI should help healthcare organizations do a better job of tracking and managing their inventories of medical devices. This can help control costs, achieve better standardization, and identify product safety concerns. Patient safety and product development researchers should be able to better identify trends in device problems and develop early safety warnings and product design improvements.
However, in order for UDI to achieve its expected benefits, it needs to be based on solid, sustainable, and accessible naming conventions and database design structures.
ECRI Institute is concerned that FDA’s UDI design will not achieve these goals because the rule is based on a single medical device naming convention—one which has not been publicly available for general review and commentary. More importantly, it has been used by only a very small number of healthcare organizations and medical device manufacturers in the United States, and does not have a publicly available model for how it will be technically and financially maintained and updated over time.
FDA mandates the use of the Global Medical Device Nomenclature (GMDN) as the naming convention for the Device portion of the UDI. Most U.S. healthcare facilities and supply chain providers track devices using either ECRI Institute’s Universal Medical Device Nomenclature System (UMDNS) or the United Nations Standard Products and Services Code (UNSPSC). ECRI Institute has provided free non-commercial access to UMDNS for 41 years and is committed to continue doing so. UNSPSC can also be licensed for free. GMDN is produced and administered by a European agency and charges for access to the nomenclature.
Within the proposed rule, FDA notes that there are plans to make GMDN freely available, but acknowledges that it may not happen. In that case, FDA proposes to use no naming convention for the Device portion of the UDI.
ECRI Institute is not proposing that UMDNS replace the GMDN system in UDI. However, we do believe that UDI should not be limited to any single naming convention. It should be designed to accept various naming systems, which can be utilized by healthcare organizations, medical device manufacturers, researchers, and others, depending on their specific needs and database designs. This is particularly important when considering GS1’s GTIN (Global Trade Item Number) and the Global Data Synchronisation Network (GDSN) which already incorporates UNSPSC as a naming convention and allows the inclusion of UMDNS. In order for these stakeholders to make informed decisions on the tools used to support their data needs, they should be able to access the information this will be based on. And, if the U.S. government is supporting data standards for UDI (e.g., with public funds), the public should be able to vet the standards and have the opportunity to use them on a trial basis before they are formally adopted nationwide.
As you ask yourselves how the mandate to use GMDN will affect your organizational operations, consider the following:
The cost and time required to convert your nomenclature system to GMDN. If you will have an opportunity to review the new nomenclature system to confirm that it will meet your terminology needs (e.g., is it accurate and complete?)
What would be involved in mapping your systems to GMDN.
That ECRI Institute has created UMDNS-UNSPSC and UNSPSC-UMDNS mappings. GMDN is not mapped to UMDNS or UNSPSC at this time. How conversion to another naming convention will impact your processes for managing medical device hazards and recalls. We expect that you will find the current iteration of UDI to have a significant impact on your organization. If you agree, we urge you to share your perspectives with FDA by its November 7, 2012 deadline. Your comments could be as simple as “please allow the UDI rule to incorporate all major medical device naming conventions, including UMDNS” or a statement noting that you agree with the perspectives in this document. Feel free to attach our document with your comments.
Here is a link to FDA’s site for submitting public comments: http://www.regulations.gov/#!home;tab=search
Thank you very much for your support and consideration.
P.S. If you would like to direct any comments to ECRI Institute regarding FDA’s proposed rule on UDI or UMDNS, please e-mail communications@ecri.org or call (610) 825-6000, ext. 5268.
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