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GHTF/SG2/N57R8:2006 GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)

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标准简介

GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)[附网盘链接]是Study Group 2于27 June 2006发布的GHTF标准，适用于全球。

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GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)[附网盘链接]
GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)[附网盘链接](截图)

 

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标准部分原文

Study Group 2 – Final Document

Introduction

Manufacturers or their representatives may sometimes need to undertake corrective or

preventative action in relation to their medical devices. These include safety related field

corrective actions taken by the manufacturer to reduce the risk of harm to patients, operators

or others and/or to minimise the re-occurrence of the event.

1.0 Scope

This document identifies elements that should and should not be included in safety related

notifications issued by the medical device manufacturer or its representative.

This document does not cover the distribution method or any requirements for

communications to relevant Competent Authorities prior to publication of the safety related

notifications.

2.0 References

No references

3.0 Definitions

Field Safety Corrective Action

A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk

of death or serious deterioration in the state of health associated with the use of a medical

device.

In assessing the need of the FSCA the manufacturer may use the methodology described in

the harmonised standard EN ISO 14971.

This may include:

the return of a medical device to the manufacturer or its representative;

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device modification ;

device exchange;

device destruction;

advice given by manufacturer regarding the use of the device (e.g. where the device is no

longer on the market or has been withdrawn but could still possibly be in use e.g. implants)

Device modifications may include:

retrofit in accordance with the manufacturer's modification or design change;

permanent or temporary changes to the labelling or instructions for use;

software upgrades including those carried out be remote access;

modification to the clinical management of patients to address a risk of serious injury or

death related specifically to the characteristics of the device. For example:

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Note: device modifications may need to be approved by the NCA or third parties.

27 June 2006 Page 4 of 6

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