1©2009 ECRI Institute

Universal Medical Device Nomenclature System

WHO Informal Consultation on Nomenclatures for Medical Devices

Vivian Coates, Vice President, ECRI Institute

23-24 March, 2011Geneva, Switzerland

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

2©2009 ECRI Institute

Sustainability and Management of UMDNS:ECRI’s obligation to maintain UMDNS is recognized by our Board of TrusteesPart of our WHO Collaborating Center Terms of ReferenceUsed in all our medical device databases and information products and

servicesContinuously maintained and managed by dedicated technical and clinical

staff as a core activity of ECRIAll 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 9,110 preferred terms

More than 17,000 entry terms

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

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]

6©2010 ECRI Institute

ECRI’s Technical Approach to UMDNS:Formal, hierarchical system for organizing device-related informationNot simply a list of products: a databaseDynamic: 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 qualityWorldwide user feedback a critical input for UMDNSAs both a user and nomenclature developer, ECRI understands user

perspectives and priorities

UMDNS Content:

Preferred terms and codesEntry termsHierarchyParent-child as well as sibling relationships (Cross references)AttributesDefinitionsMappings 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, Implantable20376 Defibrillator/Cardioverter/Pacemakers, Implantable,

Resynchronization17577 Testers, Implantable Defibrillator/Cardioverter

Entry Terms:

User-friendly entry points to UMDNSEntry terms include synonyms, quasi-synonyms, lexical

variants, initialisms, or acronymsAlso 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 conceptConstructed in a standardized wayDescribe the device and its intended purposeHelp 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 conceptsEach preferred term may be linked to different attributes in the

UMDNS databaseeg, 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 healthcareDifferentiates nomenclature from a flat dictionary or glossary listMultiple levels of categories broader than the level represented

by the preferred terms/device groups in UMDNSDefinitions for uppermost levels inclusive of all devices

grouped under each levelUMDNS utilizes multi or polyhierarchy

17©2010 ECRI Institute

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

18©2010 ECRI Institute

Hierarchy at next lowest level

Prostheses/Implants/Orthoses/Grafts – Level 2 Prostheses & Trial Prostheses Stents & Stent-Grafts Implants Grafts Orthoses

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

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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

20©2010 ECRI Institute

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

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©2009 ECRI Institute

Questions?