As medical devices surgical instruments are important components when performing surgery. They can significantly influence the course and outcome of the surgery. Instruments are mechanically stressed in daily use and resterilized multiple times. The majority of manufacturer documentation for endoprostheses lacks specific information regarding tolerable instrument wear and the maximum number of applications for surgical instruments. So far, there are no mandatory algorithms for the necessity of checking and replacing surgical instruments. The risk of mechanical failure, surface damage and ultimately incidents is illustrated using endoprosthesis instruments as examples.
Keywords: Instrument failure; Manufacturer’s instruction; Medical devices; Medical implants; Reuse.