Intended for healthcare professionals

Education And Debate Quality improvement report

Learning from adverse incidents involving medical devices

BMJ 2002; 325 doi: (Published 03 August 2002) Cite this as: BMJ 2002;325:272

Human capability, a quality definitely worth investing in

EDITOR - Amoore and Ingram highlight one of the most fundamental
aspects underpinning the safe use of medical devices, learning from
experience so that the same kind of incidents do not recur.1 Globally
harmonised regulations require medical devices be designed and
manufactured in such a way that their performance and properties remain as
intended throughout their whole operation life and that they do not
compromise the safety of the patient or any other person. On one hand,
there is thus a strong presumption that medical devices are acceptably
risk-free and appropriate for their intended purposes, but on the other,
absolutely zero-risk devices are never possible.

When an incident involving a medical device happens, careful
resolution of the course of all related events and actions, probable
cause of the incident and its potential link to device properties or
performance, as well as a prompt notification to the manufacturer (or his
representative) and relevant national authority (irrespective of whether
mandatory or not) largely determine what we can really learn from these
incidents. Should the incident remain a secret of small circles, virtually
nothing useful is learned. The users constitute thus the first and most
crucial link in the chain, making their co-operation a true cornerstone of
this process.2 Inherent fear of being blamed apparently impedes the users’
willingness to report on incident(s), but the blame can be put on the user
only and only if he/she knows: (a) that an error has actually occurred,
(b) how to correct the error, and (c) how to prevent the error. If not
all of these three conditions are met, the error should be considered a
fault of the system.3

While keeping the medical devices in appropriate operating order,
health care organisations should also arrange ongoing training programmes
on medical devices to their personnel. The training should not only focus
on hands-on skills necessary for the use of devices but also on providing
adequate understanding of their basic operating principles. This, in
conjunction with constructive feedback about performance, e.g., through
feedback notes on incidents,1 most likely help the users gain the
capability4 needed to cope effectively with uncertain and surprising
circumstances that may well arise while using the devices. This has come
particularly concrete today as novel medical devices evolve all the time,
many different brands and generations of similar devices are being used
side by side and possibly made compatible with a variety of adapters, many
ageing devices lack adequate safeguards etc.. Under these circumstances,
it is the human capability that in the form of compensations and
adaptations to changing and potentially hazardous circumstances represents
one of the most important safeguards against adverse incidents.5

Harri Sievanen, ScD, Senior Officer

Medical Devices Centre, National Agency for Medicines, P.O.B. 55, FIN-
00301, Helsinki, Finland

1. Amoore J, Ingram P. Learning from adverse incidents involving
medical devices. BMJ 2002;325:272-275.

2. Sievanen H. Review of the EU medical device vigilance system: Finland’s
experience in 2001. The Regulatory Affairs Journal (Devices) 2002;10:119-

3. Gambino R. Most laboratory errors are system dependent – not people
dependent. Lab Med 1989;20:123.

4. Fraser SW, Greenhalgh T. Coping with complexity: educating for
capability. BMJ 2001;323:799-803.

5. Reason J. Human error: models and management. BMJ 2000;320:768-770.

Competing interests: No competing interests

20 August 2002
Harri Sievanen
Senior Officer
Medical Devices Centre, National Agency for Medicines, FIN-00301, Helsinki; Finland