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 It is due to be fully withdrawn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
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