Risk Management for Medical Devices

RISK MANAGEMENT FOR MEDICAL DEVICES INTRODUCTION

Medical Devices often involve balancing benefit against risk. The Medical Device Directive refers to this in Annex I – the Essential Requirements as follows
“ provided any risks which may be associated with their use constitute acceptable risks when weighed against any benefits to the patient…..”

The manufacturer is required to:

Eliminate or reduce risks as far as possible
Take adequate protection measures
Inform users of residual risks

In that order.

EN 1441:1997 - risk analysis for medical devices ( including IVDs) is currently the Harmonised European Standard which specifies the risk analysis procedure to be taken. It is due to be fully withdrawn by March 2004 and replaced by EN ISO 14971:2000.

EN ISO 14971:2000 – risk management for medical devices is more embracing, covering risk analysis, evaluation, control and post production information. However, the risk analysis element of EN 1441 is retained within the new standard.

Definitions used in Risk Management of Medical Devices
Refer to EN ISO 14971 for full and complete definitions

Harm	Physical injury or damage to the health of people, or damage to property or the environment
Hazard	Potential source of harm
Risk	Combination of the probability of occurrence of harm and the severity of that harm P*S
Risk Analysis	Systematic use of available information to identify hazards and estimate the risk
Risk Evaluation	Judgement, on the basis of the risk analysis, of whether a risk is acceptable.
Risk Control	Process for implementing protective measures to reduce and maintain risks within specified levels.
Risk Management	Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risk.
Safety	Freedom from unacceptable risk

THE PROCESS FOR MEDICAL DEVICES

Risk
Management

Risk Analysis

Risk Evaluation

Risk Control

Post Production Feedback

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