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

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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

Year Devices Drugs

US FDA 2005

2006

180,000

326,000

437,000 (213,000 – 15

day; 84,000 periodic serious injury; 140,000

periodic non serious, 136,000

e-sub)

472,000 (158,000 e-sub)

Australia TGA 2005 174 3,000

Health Canada TPD 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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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

19218-1 Event Type Codes Level 1

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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 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

19218-2 vs. 19218:2005

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Portion of Draft TS19218-2

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Portion of Draft TS19218-2

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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

Level 1 Terms – TS19218-2