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IMDRF/AE WG/N43FINAL:2020 (Edition 4) Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)

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Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)[附网盘链接]是IMDRF Adverse Event Terminology Working Group发布的GHTF标准，适用于世界范围。

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Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)[附网盘链接]
Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)[附网盘链接](截图)

 

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标准文档类型为Terminologies for Categorized Adverse Event Reporting (AER) terms, terminology and codes - PDF (1.21Mb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

1. Introduction

This document has been prepared by the IMDRF Adverse Event Working Group, charged with

developing a harmonized terminology for reporting adverse events related to medical devices

including in-vitro diagnostics (IVDs).

Widespread use of a single, appropriate adverse event terminology and coding system is

expected to improve signal detection by adverse event management systems enabling a faster

response by both industry and regulatory authorities.

Use of defined terms as well as associated codes to describe problems encountered with

medical devices provides several benefits:

(1) it improves the accuracy of capturing and reporting of medical device related adverse

events;

(2) it reduces ambiguity and hence increases effectiveness of the evaluation process; and

(3) it is readily usable, in contrast to narrative text, for more sophisticated approaches to

signal detection (i.e. the identification of potential novel risks) and trending analysis by

incident management systems including advanced querying functions and data

visualization. Thus enabling a faster response by both regulatory authorities and device

manufacturers.

A globally harmonized terminology and associated codes also has the following benefits:

 For manufacturers (including local distributors/authorized representatives): it

provides consistency for manufacturers reporting to multiple jurisdictions, reducing

the burden of managing multiple coding systems when preparing medical device

adverse event reports for multiple jurisdictions;

 For regulatory authorities: by providing common terms and definitions, it supports

analysis of safety, quality and performance information in a manner that can readily

be shared globally: common terms will increase accuracy and reliability of

information exchanged about medical device adverse events between regulatory

authorities, and may facilitate more rapid detection of potential safety signals when

pooled at inter-regional levels;

 For patients: it protects patients by enabling faster local and international

response to medical device adverse events including those related to medical device

malfunctions/deteriorations;

 For healthcare providers: the use of common terms with manufacturers and

regulators may enhance accuracy, reliability and utility of the reports, especially when

larger datasets can be pooled and analyzed. It may also, provide terms and

definitions, some of which are within a hierarchical form, to be used for adverse event

reporting within or between healthcare facilities.

18 March 2020

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