ISO/TS 19218:2005 specifies requirements for a coding structure for describing adverse events related to medical devices. This code is intended for use by medical device users, manufacturers and regulatory authorities.
This is a Draft for Development, it is not a British Standard. It reproduces verbatim ISO/TS 19218:2005. It is being issued in the Draft for Development series of publications and is of a provisional nature because no state of the art model was available upon which a standard could be based. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained.
The adverse event coding structure specified in this Technical Specification envisages that the reporting of medical device adverse events will originate from one of two sources, either the user or the manufacturer of the device concerned. Users, in this context, may be healthcare professionals, but may also be the general public. This document provides a coding structure by which an adverse event type and/or the observable cause/effect can be used so as to collect medical device surveillance information. The observable cause/effect comes from an initial assessment of the adverse event. It also enables this information to be easily exchanged on an international basis using the common codes.
This Technical Specification can be utilized by the users, manufacturers and regulatory authorities in the following ways:
- Users can report to a manufacturer or a regulatory body a code number to describe an adverse event that will be universally understood by both.
- Manufacturers and regulatory authorities can easily recognize universally understood adverse event types, can assign understood initial assessment cause/effect codes which can be globally recognized by regulatory authorities.
- Both users and manufacturers can apply the use of these codes as part of a medical device surveillance or reporting system.
This document is not intended for the purpose of taking a decision whether an incident is reportable or not.
Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the international organization responsible for the Technical Specification. A review of this publication will be initiated not later than 3 years after its publication by the international organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards.
According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into an international standard, to extend the life of the Technical Specification for another 3 years or to withdraw it.
Comments should be sent in writing to the Secretary of BSI Subcommittee CH/210/3, General terminology and symbols, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text.
A list of organizations represented on this subcommittee can be obtained on request to its secretary.