ISO/TS 19218
WHO Informal Consultation on
Nomenclatures for Medical Devices
March 23-24, 2011
Leighton Hansel
Convener ISO/TC210 WG3
Symbols and Nomenclature for Medical
Devices
Director, Regulatory Affairs
Abbott Quality and Regulatory
Abbott Laboratories
1999 Proposed NWIP
• Standard for coding device failures suggested to
ISO/TC 210 WG 3, Symbols and Nomenclature for
Medical Devices by FDA/GHTF SG2
• To support adverse event information exchange
between regulatory authorities
• Manufacturer submissions of adverse event reports
to regulatory authorities.
• Could also be used by end users
• Excluded patient outcomes
• For post market events, not for clinical studies
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History of TS 19218
• NWIP approved 2000
• Background information gathered early 2002
• ISO/TC 210 WG 3, concluded that work should result in a
Technical Specification
• WD Prepared mid 2002
• Consulted with GHTF SG2 in 2003
• DTS Voted on early 2004 and revised
• As result of preparing DTS2, WG3 concluded NWIP for
introduction of hierarchical structure should be proposed
• DTS 2 Voted on, revised and published as TS 19218:2005
• NWIP for hierarchical structure approved 2005
• WG3 Decided to split into 2 Documents, Event Type Codes(-1)
and Evaluation Codes(-2)
• 19218-1 Event Type Codes submitted for publication 2010
• Amendment 1 to 19218-1 coding examples under development
• WG3 will review draft of 10218-2 in 2011 with publication in
2012
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Initial Version of TS19218
• Development based on two documents
– FDA Coding Evaluation Report – An Evaluation of
the Coding System for Device Problems and
Patient Effects Used to Report Adverse Medical
Device Events to the FDA MedWatch Program
– Report on Medical Device Fault Conditions
(NKKN, Haukeland University Hospital)
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Revised TS 19218
• WG revised to consist of event types and
cause codes
• Definitions
– The adverse event type code characterizes the
observed use/malfunction/failure of the medical
device at the time the event occurred.
– The adverse event cause code characterizes the
latest conclusions of a cause analysis of the
adverse event.
• Number of codes
– As Issued (2005) – 22 Type and 46 Cause
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Device vs. Drug Report Numbers
Country/Regulatory
Authority
US FDA
Australia TGA
Health Canada TPD
Year
Devices
Drugs
2005
180,000
437,000
(213,000 – 15
day; 84,000
periodic serious
injury; 140,000
periodic non
serious, 136,000
e-sub)
2006
326,000
2005
174
472,000
(158,000 e-sub)
3,000
Drugs,
2005
Devices
2002
730
6500
Note: Over 60% of FDA’s 2005 device submissions utilized alternative summary reporting (ASR)
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EU – Device Reports
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Code Development/Use Considerations
• Use of codes
– Regulatory authorities
• Level of detail related to size of regulatory authority and
number of adverse event reports received
• Level of detail for data exchange
– Manufacturers
– “Buckets”
– Supplemental coding
• IT applications as support tools
• Maintenance
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Example FDA Hierarchical Structure
Device Code Hierarchy
Device Issue

Device Operational Issue - Issue associated with any deviations from specifications relating to
device operations (e.g. deployment, connection, electrical, computer software, infusion/flow,
output, protective measure, and incompatibility issues).
 Computer Software Issue - Issue associated with written programs, codes,
and/or software system that affects device performance or communication with
another device.
 Application Program Issue - Issue associated with the requirement
for software to fulfill its function within an intended use or application.
 Programming Issue - Issue associated with the written
program code or application software used to satisfy a stated
need or objective for functioning of the device. These do not
include issues associated with the operating system
 Incorrect Software Programming Calculations
 Dose Calculation Error due to Software
Problem
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Global Vision of Harmonized Event Type Codes
•
•
•
•
Manufacturer Codes (XXX)
FDA Codes (476)
TS 19218 Level Two Codes (82)
TS 19218 Level One Codes (20)
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19218-1 Event Type Codes Level 1
Activation, Positioning, or Separation
Computer Hardware
Computer Software
Connection or Fitting
Electrical/Electronic
External Conditions
Implantable Device Failure
Incompatibility
Infusion/Flow
Marking, Labeling or Instructions for Use
Material
Mechanical
Non Mechanical
Other
Output Issue
Packaging/
Shipping
Protective
Temperature
Unintended Function
Use Error
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Example of Event Type Codes TS19218-1
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Examples being developed for 19218-1
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19218-2 vs. 19218:2005
19218-2 DRAFT Vs 19218:2005
1. Draft evaluation (cause) codes contains 21 Level 1
terms and 82 Level 2 terms
2. TS 19218:2005 contained 47 cause (evaluation) codes
3. Draft uses 42 TS 19218:2005 terms
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Portion of Draft TS19218-2
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Portion of Draft TS19218-2
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Level 1 Terms – TS19218-2
Biological
Design
Electrical
Interoperability
Labelling
Manufacturing
Materials, chemistry
Mechanical
No device problem or failure detected
Not device related
Off label, unapproved, or contraindicated use
Operational Problem (Functional deficiency)
Optical
Other
Quality System
Reuse of a single use device
Software
Tampering, counterfeiting, sabotage
Test Results
Unidentified
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