Run to Fail Devices Defined

 

 

This non-testing catagory of devices include mechanical thermometers, Oto-opthalmoscopes, sphygmomanometers and many 2-wire devices that have no ground pin. These are generally no/low DC voltage, or hand-held battery operated, devices that pose little risk to either the user or patient. Users should do a cursery inspection before use. These devices do not need to be included in the medical equipment inventory. Lastly, should the OEM of the device state that the device does not need a biomedical safety inspection, this device will also be deemed run-to-fail, per the manufacturers recommendation.