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Nie obrażaj więc mojej inteligencji poprzez czynione na pokaz zaniżanie własnej.
//-->.pos {position:absolute; z-index: 0; left: 0px; top: 0px;}WFHSSGuideline No.03Reprocessing unit categoryRisk group of medicaldevice (MD) to bereprocessedHealthcare establishmentsworld forum for hospital sterile supplyeducation groupNovember 2011Requirements for Reprocessing Units for Medical Devices (RUMEDs) in healthcare establishmentsINon-critical, semi-critical A,critical A(1)e.g. (homes for the elderly / nursing homes,outpatient departments, medical practices(2)IINon-critical, semi-critical A, B,critical Ae.g. healthcare establishments withoutsurgical unitsAppropriate quality assurance measures(minimum requirements as perRobert Koch Institute - RKI)--IIIAll groupse.g. healthcare establishments with surgicalunitsQM systempreferablybased on, for critical Cdevices based on EN ISO 13485:2003Dedicated premisesSeparate unclean/clean/ sterile premises(4)Quality assurance-Appropriate quality assurance measuresDedicated areaPreferably with separate unclean /clean/ sterile zones (temporalseparation possible)Management and staff at least SpecialistCourse I(5)-Structural requirements-Dedicated reprocessing roomSeparate unclean/clean/sterile zones(3)--Staff qualificationsManagement: at least Specialist Course IIStaff: at least Specialist Course ISteam sterilizers (big or small) as perEN 285 or EN 13060Endoscope WD as per EN ISO 15883If necessary, rotary sealing machineIf necessary, ultrasonic cleaningequipmentManagement and deputies: Specialist CourseIIIStaff: at least Specialist Course I--If necessary small steam sterilizer(Class B recommended) as per EN13060If, necessary ultrasonic cleaningequipmentIf necessary, washer-disinfector (WD)as per EN ISO 15883If necessary, heat sealing machine----Steam sterilizers (big) as per EN 285If necessary, equipment for specialsterilization processes (e.g. low-temperature sterilizers)Endoscope WD as per EN ISO 15883Rotary sealing machineUltrasonic cleaning equipmentTechnical equipment------(1) Call for special consideration; (2) with the exception of lumened endoscopes (Cat. II) and surgical procedures (Cat. III), except for management of small wounds; (3) For newendoscopy units – centralisation and separate unclean/clean premises are recommended; (4) For new, extended or converted premises, clean area should meet requirements of ISOclass 8 as per ISO 14644-1, as far as possible also for existing establishments; (5) deemed to have been met for degree-level nursing staff or for medical personnelpage 1/ 2WFHSSGuideline No.03COURSEworld forum for hospital sterile supplyeducation groupNovember 2011Concept for continuing professional development courses for "Reprocessing medical devices in/for healthcare establishments"SPECIALIST COURSE ISemi-skilled staff and assistants;Dental staff ** or dental assistantsSPECIALIST COURSE IISemi-skilled staff with special duties (e.g.able to release MDs) and graduates withresponsibility for a section80 hours:40 hours theory16 hours practical exercises24 hours practical workSuccessful completion of Specialist Course I.and at least 1 year’s experience in a MDreprocessing unitSPECIALIST COURSE IIITARGET GROUPManagers and deputy managersEXTENT80 hours:theory and practical exercises80 hours:40 hours theory40 hours concluding assignmentADMISSIONREQUIREMENTSNoneorSuitably recognised Qualification (inaccordance with national requirements)andwith successful examination on content ofSpecialist Course I (without attending course)Suitably recognised Qualification (inaccordance with national requirements) andsuccessful completion of Specialist Course IIREQUIREMENT FORDEADLINE FORCOMPLETIONEXAMINATIONManagement of RUMED Cat. I **,Staff of RUMD Cat. I **, II, IIIWithin 2 years of taking up positionExamination of knowledgeManagers and deputy managers of RUMEDCat. IIResponsibility for section of RUMED Cat. III.Within 2 years of taking up positionExamination and assignmentManagers and deputy managers of RUMEDCat. IIIWithin 2 years of taking up positionExamination and final assignment* if not covered in specialist OR course, ** except for degree-level nursing staff or for medical personnelSource: Austrian Society for Sterile Supply (ÖGSV), www.oegsv.compage 2/ 2
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