Healthcare organisations are responsible for the routine testing of medical devices but many lack the resources to fully follow the device manufacture’s recommendations. Australian Standards currently provide the option of testing on an annual basis, or using risk management techniques. Australian Standards may soon remove the option of testing on an annual basis, leaving healthcare organisations with no option other than to practise risk management.
The Children’s Hospital at Westmead implemented a risk management system fifteen years ago to vary the manufacturer’s recommended test interval which was considered a more risk adverse strategy than changing the manufacturer’s recommended testing regime.
The function, consequences of failure, environment of use and maintenance requirements are considered and risks specific to these four factors assigned a numeric weighting, called the risk level. For each device the risk levels are then summed to give a risk factor.
After a device falls due for testing, we calculate the percentage overdue the device is for testing and multiply this by the risk factor to give a risk number for each device. The risk number for reach device is summed to give the total risk for the hospital. These three indicators are calculated daily.
This system allows us to prioritise routine testing and balance this responsibility with other tasks. If after a period of time we observe no adverse events with a particular device under the risk management system we may consider extending the test interval, in which case we document the evidence for such a decisions.