Intended for healthcare professionals

Rapid response to:

Education And Debate Quality improvement report

Learning from adverse incidents involving medical devices

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7358.272 (Published 03 August 2002) Cite this as: BMJ 2002;325:272

Rapid Response:

Risk assessment: an aid to reduce incidents involving medical devices?

Novel or new medical devices with the CE mark as well as in-house
built or modified medical devices have the potential to cause an incident.
A risk assessment of such a medical device, before it is used by hospital
staff, will enable the identification of potential issues such as: lack of
user training and user instructions (1). Amoore and Ingram
(2)highlighted the value of learning from experiences. We at the Clinical
Technology Department have developed a risk assessment tool (3), based on
the BSEN ISO 14971: Medical Devices-Application of risk management to
medical devices. This enables one to assess risks associated with any one
of the following:

1. Existing medical devices linked to frequent incidents

2. Non-CE marked medical devices that are subjected to a clinical
evaluation for the purpose of obtaining a CE mark

3. In-house built or modified (with the approval of the manufacturer)
medical devices before they are used with patients.

The tool is a series of questions relating to human error,
environmental hazards as well as those generated by the device itself, and
requires one to first assess the level of risk and then provide how they
are eliminated or reduced to an acceptable level.

On the issue of quality improvement the actions taken at the Royal
Infirmary of Edinburgh is commendable. Learning from best practices such
as these together with effective risk assessment would constitute an
excellent incident preventive action.

Dr. Yapa Wickramasinghe,
Consultant Scientist and Hon Senior Lecturer,

Department of Clinical Technology, University Hospital of North
Staffordshire, Stoke-on-Trent, ST4 6QG

(1) Spencer SA, Nicklin SE, Wickramasinghe Y, Nevill A, Ellis SJ. An
essential "health check" for all medical devices. Clin Med 2003;3:543-5

(2)Amoore J, Ingram P. Quality improvement report: Learning from
adverse incidents involving medical devices. BMJ 2002;325:272-275.

(3) Wickramasinghe Y. Risk analysis 2003.
www.partnersinpaediatrics.org.uk, see papers and reports/other reports

Competing interests:
None declared

Competing interests: No competing interests

20 February 2004
Yapa Wickramasinghe
Consultant Scientist and Hon Senior Lecturer
Department of Clinical Technology, University Hospital of North Staffordshire, NHS Trust, ST4 6QG