SOLICITATION NOTICE
R -- Integration of the GMDN and the UMDNS device nomenclature systems into the CDRH product code classification
- Notice Date
- 6/1/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 223-04-6051
- Response Due
- 6/6/2004
- Archive Date
- 6/21/2004
- Point of Contact
- Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
hbrown@oc.fda.gov
- Description
- It is the intent of the FDA?s Center for Devices and Radiological Health (CDRH) to award a contract on a sole-source basis pursuant to FAR 6.302-1 and 41 U.S.C. 253(c)(1) to ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. CDRH has determined that it is necessary to adopt the Global Medical Device Nomenclature (GMDN) into its current product nomenclature system and to harmonize the Universal Medical Device Nomenclature System (UMDNS), GMDN, and CDRH device classification systems. The GMDN is a system of names, definitions, and codes for medical device products. The UMDNS is also a terminology system for medical devices used internationally. In addition, the U.S. National Library of Medicine incorporates the UMDNS into its Unified Medical Language System (UMLS). Integrating both the GMDN and the UMDNS systems into the CDRH product classification will provide device naming conventions, definitions and terms for currently marketed devices (real world), dedicated maintenance resources, a thesaurus, and device nomenclature harmonization with key nations The National Committee on Vital and Health Statistics (NCVHS), a public advisory body to the Secretary of Health and Human Services in the area of health data and statistics, expressed the need for commitment to the concept of one truly international medical device nomenclature system to Secretary Thompson in January 2004. In order to meet the recommendation of the NCVHS to the Department, CDRH needs to immediately start working on the mapping of the three data structures. The UMDNS and GMDN system each have about 6,700 concepts and over 17,000 terms, organized in a hierarchical structure. In order to map the large number of concepts and terms in the desired timeframe, it is mandatory that the organization responsible for the mapping have an in-depth understanding of how an international device nomenclature is developed and functions. To FDA?s knowledge, ECRI (formerly the Emergency Care Research Institute) is the only company that has developed and maintains a medical device nomenclature that is used internationally. That type of experience is required for the work that FDA needs to accomplish. Device nomenclature is significantly different from other health nomenclatures such as the one used for drugs. ECRI is the U.S. based non-profit health services research agency that developed and maintains the UMDNS system. UMDNS is a standard international nomenclature for medical devices and has been officially adopted by many nations, as well as by the entire European Union (EU). It is used regularly by thousands of healthcare institutions worldwide and the U.S. National Library of Medicine also incorporates UMDNS into its Unified Medical Language System (UMLS). ECRI is also the only group that has an intimate knowledge of all three nomenclature systems, the UMDNS, GMDN and FDA structures. ECRI has many years of experience specifically with these device nomenclatures. The GMDN system is based in large part on an early version of the UMDNS. ECRI has been working with FDA for a number of years and agreed in 1997 to harmonize both UMDNS and FDA's device classification system. A history of input into the development and a good understanding of the three different nomenclatures is a prerequisite to the effective and efficient mapping and consolidation of the different systems. In addition, because of ECRI?s extensive work in identifying, processing, filing, storing, retrieving, transferring, and communicating data about medical devices they are the solitary source of information regarding the development of international nomenclature business rules which will be needed to continue the development of new nomenclature. The Government intends to solicit and negotiate with ECRI as the only one source under the authority of FAR 6.302. This is not a Request for Quotations (RFQ). Sources interested in this requirement must be able to provide convincing evidence that they possess the requisite expertise and experience to successfully perform the services as specified above. Responses must be in writing and must be received at hbrown@oc.fda.gov within fifteen (15) calendar days from the publication date of this notice. Proposals must include pricing information. All responses received in a timely manner will be considered by the Government.
- Place of Performance
- Address: Contractor site
- Record
- SN00595157-W 20040603/040601211713 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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