Risk Management and Biomedical Devices

A method of ranking devices for replacement has been successfully trialled at Flinders Medical Centre (FMC). Software developed by Flinders Biomedical Engineering (see www.fbe.org.au) has been distributed to a network of device managers throughout FMC for the entry of easily determined parameters which relate to the likelihood of a device problem occurring and to the consequence of the problem. Algorithms developed by empirical methods calculate total risk scores that correlate well with previously used subjective methods of ranking devices for replacement, safety testing, preventative maintenance or repair.