My name is Vivian Coates and I am Vice President for Information Services and Technology Assessment at ECRI. I would like to thank you for the opportunity of presenting these remarks today to the Work Group on Computer-based Patient Records of the National Committee on Vital and Health Statistics (NCVHS) on behalf of ECRI.
ECRI is a nonprofit, nongovernmental health services agency and a World Health Organization (WHO) Collaborating Center for Information Transfer on Medical Devices. For more than 25 years, ECRI has developed, maintained, and continuously updated a standard controlled terminology and coding system for medical devices.
(PMRI):
How would you define or describe PMRI?
Patient Medical Record Information must be comprehensive, comparable, accurate, confidential, accessible, and retrievable to support analysis from a broad range of perspectives. It must contain high quality data to support clinical decision making for the individual patient as well as outcomes research and epidemiologic studies of populations. Patient Medical Record Information must capture the essential data at a level of detail granular enough to prevent loss of critical elements. As the developer of a highly specialized terminology, ECRI would like to emphasize the importance of this need for appropriate granularity.
A. Why is comparable PMRI required, what functions does it serve?
B. How comparable does the PMRI need to be for these purposes, i.e., how precise, how accurate? What are the consequences if the PMRI is not accurate?
To support data retrieval for health services research, outcomes studies, technology assessment, postmarket surveillance, or any evaluative purpose where it is necessary to look at administrative data concerning the use of similar interventions, comparable Patient Medical Record Information must be available. If the information is inaccurate or imprecise, or if the data resides in multiple incompatible systems in dissimilar or anomalous formats, analysis is, at best, compromised, and, at worst, impossible.
To illustrate the consequences of imprecise or inaccurate capture of medical device information, consider broadly used coding systems such as CPT and HCPCS that do not, in most cases, explicitly identify devices used in procedures. A procedure may be heavily device-dependent, but this may not be apparent from the CPT or HCPCS code. This has long been a problem, and it is a growing problem as the number of devices continues to increase. The problem is compounded because many of the institutional controls that exist for in-patient care, do not exist in out-patient settings, where increasing amounts of care are delivered.
Hospital admissions in a cost containment and managed care environment are often intended to provide patients with access to a specific technology (medical device). Without device-type-specific coding it is difficult to track the diffusion of devices throughout the healthcare system and ensure payment for their appropriate use.
A.What is the intended purpose of your medical terminology? What is it currently used for?
ECRI’s medical device terminology, the Universal Medical Device Nomenclature System (UMDNS) is intended for classifying medical devices for purposes of indexing, storing, and retrieving device-related information (e.g., inventory control, adverse incident tracking). UMDNS terms and the corresponding five-digit codes are widely incorporated into publications, databases, medical information systems, hazard alerting systems and other software used by government agencies, healthcare systems and facilities, worldwide.
B. What is the clinical domain, scope, or healthcare setting addressed by your medical terminology?
UMDNS covers all medical devices, equipment, supplies, disposables, clinical laboratory instrumentation, reagents, test kits, dental instruments and equipment, selected hospital furniture, casework, systems, and instruments used to test medical equipment. Medical devices thus defined include almost any nondrug item used for patient care. UMDNS includes 6500 preferred terms and codes, and thousands of additional entry terms.
C. What evidence do you have of market acceptance of your terminology?
ECRI’s terminology is in use in thousands of institutions, including regulatory agencies, other agencies within national Ministries of Health, hospitals, and health systems. UMDNS has been translated into 10 languages, including Spanish, French, and German. It is used to index and structure a wide range of clinical and technical information. Applications utilizing UMDNS range from regulatory databases on medical device incidents to software for medical device inventory control in hospitals to bibliographic databases such as ECRI's Health Devices Alerts and the National Library of Medicine's (NLM's) HealthSTAR (Health Services, Technology, and Administration Research) database. UMDNS is used to index the technology assessment content supplied by ECRI for the HealthSTAR database.
Under a Memorandum of Understanding with CEN, the official standards body of the European Union (EU), ECRI's UMDNS has been adopted as the interim standard for electronic communication and medical product registration among regulatory agencies of EU member nations. This nomenclature will also serve as the primary source vocabulary for the final standard (to be known as the Global Medical Device Nomenclature or GMDN). UMDNS will also become the basis for the international standard currently in development under ISO Technical Committee 210.
Under a partnership agreement between ECRI and the U.S. Food and Drug Administration (FDA), ECRI is assisting FDA to harmonize its present nomenclature system with UMDNS (and, ultimately, with the final global standard) to support use by the global community, including health authorities, medical device manufacturers, and healthcare payers and providers.
D. In what areas are you now planning to expand your terminologies?
As part of ECRI’s contribution to the Global Medical Device Nomenclature initiative sponsored by the European Commission and endorsed by ISO, ECRI is expanding and enhancing its terminology to incorporate terms and codes for European products not currently marketed in the US, for assistive devices and aids for the disabled, and for additional in vitro diagnostic test kits and reagents.
UMDNS concepts have been incorporated into NLM's Unified Medical Language System (UMLS). For the past five years, NLM has contracted with ECRI, on a sole source basis, to map and link medical device concepts to other controlled medical nomenclatures in UMLS. Currently UMDNS terms are already linked to MESH, ICD, CPT, SNOMED, and other source vocabularies in UMLS.
ECRI has also mapped its device terminology to the FDA’s product categories, as well as to the nomenclature for devices developed by the Japanese Ministry of Health.
A. If so, what should be the role of the government?
The appropriate government agencies should encourage the adoption of standard terminologies for PMRI, without which there will be no comparability. Government funding should be made available to terminology developers to help them allocate the necessary resources to enhance and maintain their terminologies to meet the highest quality standards. Maintaining and disseminating these vocabularies is expensive, time-consuming and labor-intensive.
B. Is there a need for increased coordination among terminology developers?
If so, what type?
C. Is there a need to coordination between terminology developers and message standard developers? What type or form should it take?
There is always a need for better coordination of efforts in this field, particularly when different standards committees may have overlapping scopes of work (eg, various ISO technical committees) and end up taking very different approaches. The National Library of Medicine, in cooperation with other appropriate federal agencies should sponsor a state-of-the-art conference on standards, data elements and policy issues for PMRI, and publish proceedings.
Thank you for the opportunity of presenting these remarks today.