Universal Medical Device Nomenclature System WHO Informal Consultation

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 1 © 2009 ECRI Institute

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 2 Developed/maintain Universal Medical Device © 2009 ECRI Institute

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 3 © 2009 ECRI Institute

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

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

Current Uses Manufacturers - classifying product line to facilitate communication with hospitals Application developers utilizing UMLS vocabularies 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) WHO – embedded in i. HTP software tool for resource planning New: Medical Device Control Office – Department of Health, for population-based care in developing countries The Government of the Hong Kong Special Administrative Region for the Asian Medical e. Commerce exchanges – linking Device Nomenclature System ECRI data used by hospitals to [AMDNS] e. Commerce transactions (via UMDNS-to-UNSPSC mappings) 6 © 2010 ECRI Institute

ECRI’s Technical Approach to UMDNS: Formal, hierarchical system for organizing devicerelated 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

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

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

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

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

Entry Terms: User-friendly entry points to UMDNS Entry terms include synonyms, quasisynonyms, 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

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

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

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.

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

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 17 © 2010 ECRI Institute

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

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 19 © 2010 ECRI Institute

Hierarchy at Device Group/UMDNS Preferred Term level Active Implantable Devices Leads ― 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 20 © 2010 ECRI Institute

UMDNS Licensing and Distribution: Licensed from ECRI (basic version free of charge to government agencies, individual hospitals, manufacturers, fees for e. Commerce 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

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

Questions? 23 © 2009 ECRI Institute