[International expert group for safety in medical device reprocessing (smdr)--patient safety has the foremost priority].
Unsafe reprocessing of medical device carries severe health hazards. Definite guidelines for reprocessing were drawn up by the german supreme federal authorities Robert-Koch-Institute (RKI) and Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Their joint statement covers both the devices declared for single and multi use. But however, there are problems in safety, resulting from ignorance or non-application of these guidelines especially in the ambulatory/outpatient area. To improve this deficiency, the international expert group for safety in medical device reprocessing (smdr) was founded at the end of 2006 by medical, technical and legal experts from Europe and Asia.
Koczorek
Michael
M
D003257:Consumer Product Safety / Q000592:standards*; D017743:Equipment Reuse / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D007390:International Agencies / Q000592:standards*; D038622:Internationality; D017060:Patient Satisfaction