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Universal Medical Device Nomenclature System WHO Informal Consultation on Nomenclatures for Medical Devices Vivian Coate

Universal Medical Device Nomenclature System WHO Informal Consultation on Nomenclatures for Medical Devices Vivian Coates, Vice President, ECRI Institute. 23-24 March, 2011 Geneva, Switzerland. About ECRI Institute. 42 year-old not-for-profit research institute

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Universal Medical Device Nomenclature System WHO Informal Consultation on Nomenclatures for Medical Devices Vivian Coate

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  1. Universal Medical Device Nomenclature System WHO Informal Consultation on Nomenclatures for Medical Devices Vivian Coates, Vice President, ECRI Institute 23-24 March, 2011 Geneva, Switzerland ©2009 ECRI Institute

  2. About ECRI Institute • 42 year-old not-for-profit research institute • WHO and PAHO Collaborating Center for health technology management and patient safety • More than 380 full time staff in 4 offices (Phila, KL, London, Dubai) • Conduct applied research and provide consultancy on medical devices, health technology assessment and patient safety • Operate under very strict conflict of interest rules • Produce 35 databases and publications • Medical device education and training programs • Developed/maintain Universal Medical Device Nomenclature System (UMDNS) since 1971 ©2009 ECRI Institute

  3. Sustainability and Management of UMDNS: • ECRI’s obligation to maintain UMDNS is recognized by our Board of Trustees • Part of our WHO Collaborating Center Terms of Reference • Used in all our medical device databases and information products and services • Continuously maintained and managed by dedicated technical and clinical staff as a core activity of ECRI • All other professional staff with medical device expertise contribute to nomenclature review and development ©2009 ECRI Institute

  4. About UMDNS • The 2011 UMDNS contains more than 26,000 medical device terms • 9,110 preferred terms • More than 17,000 entry terms • 2,340 licensees in more than 100 countries (many more individual users)

  5. ECRI’s UMDNS: Current Users • 2340 Licensees in 100 countries: actual number of individual hospital and organizational end users much larger (e.g., 1 license to the Malaysian MOH covers 150 hospitals) • Regulatory agencies - post market surveillance, vigilance reporting, product registration, data storage and retrieval • Other govt.agencies (ministries of health, US DOD, VA, NLM) • Private health systems, healthcare facilities, NGO’s: for inventory control, hazard and recall tracking, equipment planning, procurement, technology management, monitoring emerging technology, emergency preparedness (in conjunction with ECRI’s data) • IT software vendors of hospital equipment computerized maintenance management systems • Consulting firms and Websites for procurement and trade

  6. Current Uses • Manufacturers - classifying product line to facilitate communication with hospitals • Application developers utilizing UMLS vocabularies • WHO – embedded in iHTP software tool for resource planning for population-based care in developing countries • eCommerce exchanges – linking ECRI data used by hospitals to eCommerce transactions (via UMDNS-to-UNSPSC mappings) • Australian Patient Safety Foundation – embedded in software system used for coding adverse event reports/analyzing medical errors from all Australian hospitals (APSF system also used in UK and other countries) • New: Medical Device Control Office – Department of Health, The Government of the Hong Kong Special Administrative Region for the Asian Medical Device Nomenclature System [AMDNS] ©2010 ECRI Institute

  7. ECRI’s Technical Approach to UMDNS: • Formal, hierarchical system for organizing device-related information • Not simply a list of products: a database • Dynamic: maintained and updated continuously to reflect advances in medical technology (eg, in 2010, 558 preferred terms added/modified, including 220 for medical software, 1847 new/modified entry terms) • constant monitoring to maintain and improve quality • Worldwide user feedback a critical input for UMDNS • As both a user and nomenclature developer, ECRI understands user perspectives and priorities

  8. UMDNS Content: • Preferred terms and codes • Entry terms • Hierarchy • Parent-child as well as sibling relationships (Cross references) • Attributes • Definitions • Mappings and linkages

  9. UMDNS Scope: • Covers all medical devices and supplies, clinical laboratory equipment and reagents, selected hospital furniture, systems and test equipment • Since 2001, thousands of new terms developed by ECRI for disposables, molecular diagnostic tests, emergency preparedness, medical software and emerging technologies • Related dataset includes 30,000 device manufacturer/supplier/servicer company names and their associated 6-digit codes

  10. UMDNS Organization: • Unique 5-digit numeric code/identifier corresponding to each preferred term • Assigned randomly and sequentially • Codes intentionally do not carry inherent meaning

  11. Examples: • 18504 Defibrillator/Cardioverter/Pacemakers, Implantable • 20376 Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization • 17577 Testers, Implantable Defibrillator/Cardioverter

  12. Entry Terms: • User-friendly entry points to UMDNS • Entry terms include synonyms, quasi-synonyms, lexical variants, initialisms, or acronyms • Also may include imprecise and/or extremely broad or extremely narrow/specific concepts not appropriate for preferred terms • eg, Ophthalmic lasers, MRI units, Bovies, PRN Adapters, Q-Tips

  13. Concept Definitions: • Formal definition for each preferred term/coded concept • Constructed in a standardized way • Describe the device and its intended purpose • Help to prevent ambiguity, redundancy or overlapping of concepts for similar devices

  14. Concept Permanence • Concepts are never removed, but may become obsolete or retired (their status changes) • Codes for retired concepts and terms are never re-used for new concepts • In most cases, a retired preferred term becomes an entry term pointing to the new preferred term or terms • Archival list of retired preferred terms is retained in the master database

  15. Attributes: • Characteristics of particular UMDNS concepts • Each preferred term may be linked to different attributes in the UMDNS database • eg, Implantable device, capital equipment, one or more clinical specialties, price, FDA regulatory class, useful life, “used with”, “part of” etc.

  16. Hierarchical Structure of UMDNS: • Powerful tool for representing devices used in healthcare • Differentiates nomenclature from a flat dictionary or glossary list • Multiple levels of categories broader than the level represented by the preferred terms/device groups in UMDNS • Definitions for uppermost levels inclusive of all devices grouped under each level • UMDNS utilizes multi or polyhierarchy

  17. Hierarchy at the uppermost level • Healthcare Devices: Level 1 • Main Equipment and Systems • Surgical Instruments/Kits/Sets/Ancillary Devices • Supplies • Prostheses/Implants/Orthoses/Grafts • IVD Reagents/Test Kits ©2010 ECRI Institute

  18. Hierarchy at next lowest level • Prostheses/Implants/Orthoses/Grafts – Level 2 • Prostheses & Trial Prostheses • Stents & Stent-Grafts • Implants • Grafts • Orthoses ©2010 ECRI Institute

  19. Hierarchy at Device Group/UMDNS Preferred Term level • Active Implantable Devices • Pacemakers and Defibrillators • Defibrillator/Cardioverter/Pacemakers, Implantable • Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization • Defibrillator/Cardioverters, Implantable • Defibrillator/Pacemakers, Implantable • Defibrillators, Implantable • Pacemakers, Cardiac, Implantable • Pacemakers, Cardiac, Implantable, Resynchronization ©2010 ECRI Institute

  20. Hierarchy at Device Group/UMDNS Preferred Term level • Active Implantable Devices • Leads • Leads Implantable Defibrillator • Leads Implantable Defibrillator/Pacemaker • Leads, Implantable Defibrillator/Pacemaker, Resynchronization • Leads, Pacemaker • Leads, Pacemaker, Implantable • Leads, Pacemaker, Implantable, Endocardial • Leads, Pacemaker, Implantable, Myocardial • Leads, Pacemaker, Temporary • Leads, Pacemaker, Temporary, Endocardial • Leads, Pacemaker, Temporary, Myocardial • Leads, Electrical Stimulator • Leads, Pacemaker, Transesophageal • Leads, Spinal Cord, Implantable • Pacemaker Lead Adaptors, Implantable ©2010 ECRI Institute

  21. UMDNS Licensing and Distribution: • Licensed from ECRI (basic version free of charge to government agencies, individual hospitals, manufacturers, fees for eCommerce sites and commercial software companies; fees for additional data, special formats, other IT services) • Free version available electronically as an ASCII or Excel download from UMDNS Web page, updated monthly • User support by fax, email, telephone • Special arrangements for supporting translation efforts

  22. UMDNS Licensing and Distribution: • Commercial license fee based on level of support and data (eg, Web services, specialized formats, monthly updates, usually with data on suppliers and their product lines) • Commercial licensees do not pay a per-user fee, but per institution (for unlimited use within the institution) • eg, application developer loads UMDNS into the software application

  23. Questions? ©2009 ECRI Institute

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