Medical Devices: Classification and Analysis of Faults Leading to Harms.

Abstract

Harms from medical devices are important, but have been much less well studied than adverse drug reactions. Information provided to device users is of variable quality. Our aim was to define "medical device fault" and "adverse effect of a medical device"; to establish whether medical device faults arise in design, manufacture, or use; and to consider ways of mitigating the adverse effects of medical devices. We analysed 100 consecutive faults reported by the US Food and Drug Administration (FDA)