German reuse
This article was originally published in The Gray Sheet
Executive Summary
Reprocessing of single-use medical devices without validation of cleaning, disinfecting and sterilization processes "in such a way that the success of these processes is guaranteed in a reconstructable manner" is prohibited in the German Operation Ordinance for Medical Devices, according to a Dec. 21 release from the Federal Association of the Medical Device Industry in Germany (BVMed). Hans-Georg Will, department head at the German Federal Institute for Drugs and Medical Devices, notes at a recent conference that without such documentation "the reprocessing of medical single-use devices is not admissible legally"