CONF-3-Niamh-McGrath.pdf

1、Safety,cost and environmental impact of reprocessing single use medical devices(SUDs)An evidence reviewNiamh McGrath(nmcgrathhrb.ie/niamh_mcg93)Catherine Waldron,Leila Keshtkar,Ailish Farragher,Annette Burns,ine Teahan,Jean Longhrb.ieReprocessing“A process carried out on a used device in order to al

2、low its safe reuse including cleaning,disinfection,sterilisation and related procedures,as well as testing and restoring the technical and functional safety of the used device”Typically,of“reusable medical devices”o SUDs also reprocessedSingle use medical devices(SUDs)No manufacturer instructions on

3、 how to reprocess Intended to be used on one individual,during a single procedure SUD reprocessing undertaken with varying levels of quality and safety assuranceso Developed countries moving toward regulationhrb.ieEU Medical Device Regulation 2017(MDR)Opt-in to Article 17(2)-Any entity reprocessing

4、SUDs is viewed as the device manufacturer and must fulfil the full set of manufacturer requirements and obligations of the MDR as they apply to all manufacturers of medical devices.Prohibit all SUD reprocessing activitiesOpt-in to Article 17(3)-Health institutions reprocessing SUDs for reuse in-hous

5、e are exempt from certain manufacturer obligations with the exception of a limited set of specific obligations known as“common specifications.”Opt-in to Article 17(4)-an extension to 17(3),whereby any external reprocessorreprocessing SUDs on behalf of a health institution can benefit from the 17(3)d

6、erogation if the device is returned to the same health institution for reuse there.hrb.ieMixed opinions on SUD reprocessingSafety Belief that the device could not achieve a desired function and maintain patient safety standards No increased health risks(in regulated settings)Economic advantages Cost