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13. User training<br />

13.1 General<br />

Anaesthetists must be trained in the use of all the equipment<br />

that they may use. Training requirements clearly vary widely<br />

between different devices, some requiring little or no additional<br />

training apart from common sense, others being unusable<br />

without complex and specific training. There is little or no<br />

national framework for the standardisation of training in use of<br />

devices in anaesthesia or indeed in any other clinical field, with<br />

the result that currently it is the responsibility of the individual<br />

clinician to ensure that he or she has received the appropriate<br />

training and that it is kept up-to-date. A record of training<br />

received by department members should be kept, and it should<br />

form part of the annual appraisal process.<br />

In more than half of the adverse incidents reported to the<br />

Medicines and Healthcare products Regulatory Agency (MHRA)<br />

there is no readily identifiable equipment fault. Although often<br />

difficult to define precisely, it seems more than reasonable<br />

to assume that many of these have resulted from user related<br />

issues. In some cases it is clear that the user has been the sole<br />

cause of the adverse incident which would not have occurred if<br />

the device had been correctly used.<br />

13.2 Manufacturers’ obligations<br />

Manufacturers of medical devices have a legal obligation to<br />

supply Instructions For Use (IFU) which cover not only how<br />

to use the device but also a description of the intended use of<br />

the device. Using the device outside of the IFU removes much<br />

of the manufacturer’s responsibility and transfers it to the user.<br />

Manufacturers should be encouraged to produce IFUs which<br />

are easy to read and understand; there may be a significant<br />

advantage in producing a summary of the important points or<br />

key instructions. Where practical, these should be available on<br />

the equipment, or held in close proximity.<br />

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