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.
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Transcript 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.
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
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©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
Developed/maintain Universal Medical Device Nomenclature
System (UMDNS) since 1971
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©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
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©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 populationbased care in developing countries
eCommerce exchanges – linking ECRI
data used by hospitals to eCommerce
transactions (via UMDNS-to-UNSPSC
mappings)
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©2010 ECRI Institute
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]
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
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, 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
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
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©2010 ECRI Institute
Hierarchy at next lowest level
Prostheses/Implants/Orthoses/Grafts – Level 2
Prostheses & Trial Prostheses
Stents & Stent-Grafts
Implants
Grafts
Orthoses
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©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
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©2010 ECRI Institute
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
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©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
Questions?
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©2009 ECRI Institute