Casebook Vol. 16 no. 2 - May 2008

Acting Head of Medical Services (London) Dr Alison Metcalfe introduces this issue’s selection of case reports, which feature the problems caused by medical devices

MPS members are sometimes worried that they will be liable for problems caused by faulty machines or medical devices. In the UK recently, there was concern when the SmartCheck INR meter was withdrawn after checks revealed that it gave inconsistent readings.

Doctors do have responsibilities when using devices, and in this issue of Casebook we look at two cases where this has caused problems. However, there are limits to your responsibility and these are, broadly speaking, the limits of common sense.

A medical device can be defined loosely as any instrument or appliance, including any necessary software, that is used for diagnosis, prevention, treatment or monitoring of disease. Before using a particular device you should ensure that:

• You have been properly trained in its use
• You only use it for its intended purpose
• The maintenance and testing of the device is up to date
• The device is not broken or damaged

If you have purchased or are responsible for a particular device, then you should make sure that the staff who use it follow these rules, and that the maintenance schedule is adhered to. In addition, if you are involved in procuring the device, you should ensure that it has been approved by the appropriate regulatory authorities for the purposes you intend.

Finally, if there is an adverse incident, you should report it to the appropriate authorities. If you have been following this advice then, if there is a problem with the device cause by a fault in its design or manufacture, you should not be held liable. Any resulting claim would be against the manufacturer. Thankfully these incidents, and claims, are relatively rare, a reflection of the high standards of scientific research and the generally strict regulation that is in place. In the case of the SmartCheck INR meters, these were withdrawn even though there had been no adverse incidents reported.

For medical professionals, the dangers are from not following advice on the proper use of devices. In this issue, problems arise for a GP who was using an ECG machine but did not know how to interpret the results, and for an anaesthetist who used a tracheotomy tube with which staff were unfamiliar.