[Reuse of "single use" medical devices after quality assured reprocessing: hygienic, legal and economic aspects. Potential for cost savings in interventional cardiology]

Abstract

The increasing limitation of resources has stimulated the discussion of the reuse of medical devices labelled for "single use" by the manufacturer. The prerequisites for employment of reprocessing measures are patient safety and cost saving potential. Although reprocessing of single use medical devices has been general practice by many institutions, health care providers and authorities have remained insecure as to hygienic and functional risks, liability and legal aspects. Changes in legislation (German Medical Device Act), guidelines of the Robert Koch Institute (and position of the FDA) and the high quality guaranteed by innovative reprocessing technology have now created the basis for expanded but controlled use of reprocessing techniques for medical devices as a contribution to cost containment. A significant cost saving potential is calculated for the cost-intensive field of interventional cardiology.