We have scored our Medical Devices as either High, Medium or Low risk to enable us to prioritise device training. To do so we used a "risk matrix" - this scores the likelihood of risk against the consequence of the risk.
Before this can be employed certain asumptions have to be made i.e.
- that the device is safe to use (not faulty)
- that the user knows why they are using the device
- that the user has not received training to use the device
This helps to achieve an objective (& repeatable)opinion on the the risk score to be reached.
The "risk matrix" was based on a standard tool but tweaked slightly to make it work for individual medical devices - yes, originally we were told to use our Trust's standard tool that was being developed, but after consulting our H&S people they agreed to modify their tool along the lines of our tool. The reason for this being that a single medical device could cause a death, but still not be considered a high risk in the big scheme of things!
Some of this risk matrix developed from ideas from various sources including various medical device trainers & their input is acknowledged.
Anyone who would like to see the Risk Tool & a table of scores reached for various Devices can contact me.
Mark
