CSA Z314 8-2014 Decontamination of reusable medical devices (Fourth Edition).pdf

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1、Z314.8-14Decontamination of reusable medical devicesLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representi

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18、andards Update ServiceZ314.8-14February 2014Title: Decontamination of reusable medical devicesTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2422788.I

19、f you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legalto find out how we protect your personal information.ISBN 978-1-77139-416-1 2014 CSA GroupAll rights reserved. No part of this publication may be reproduced to

20、 any form whatsoever without the prior permission of the publisher.Published in February 2014 by CSA Group A not-for-profit private sector organization 5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6 To purchase standards and related publications, visit our Online Store at shop.cs

21、a.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association, operating as “CSA Group”Decontamination of reusable medical devicesZ314.8-14Z314.8-14Decontamination of reusable medical devicesFebruary 2014 2014 CSA Group 1ContentsTechnical Committee on St

22、erilization 5Subcommittee on Reprocessing 8Preface 111 Scope 122 Reference publications 133 Definitions 144 Handling of contaminated medical devices at point of use 164.1 General 164.2 Initial handling and containment 164.3 Soaking 175 Retrieval and transport 185.1 General 185.2 Scheduling and routi

23、ng 185.3 On-site transportation 185.4 Off-site transportation 196 Decontamination 206.1 General 216.2 Verification 226.2.1 General 226.2.2 Installation qualification 226.2.3 Operational qualification 226.2.4 Performance qualification 226.2.5 Manifolds 226.3 Detergents, disinfectants, and chemical ad

24、ditives 227 Sorting, disassembly, pre-cleaning, cleaning, and rinsing 237.1 Sorting and disassembly 237.2 Pre-cleaning 237.2.1 General 237.3 Cleaning 247.3.1 General 247.3.2 Manual cleaning 257.3.3 Ultrasonic cleaners 257.3.4 Contact time 267.3.5 Automated cleaning 277.4 Rinsing 298 Disinfection 308

25、.1 General 30Z314.8-14Decontamination of reusable medical devicesFebruary 2014 2014 CSA Group 28.2 Liquid chemical disinfection 308.2.1 General 308.2.2 Selecting a liquid chemical disinfectant 318.2.3 Preparation and use of LCDs 338.2.4 Using intermediate- or low-level disinfectants 358.2.5 Using a

26、liquid chemical HLD 368.2.6 Manual high level disinfection 378.2.7 Automated high-level disinfection 378.3 Thermal disinfection 389 Lubrication, drying, reassembly, and inspection 409.1 Lubrication 409.2 Drying 419.3 Reassembly and inspection 4110 Respiratory and anaesthesia devices 4310.1 Decontami

27、nation 4310.2 Sorting, disassembly, pre-cleaning, and rinsing 4310.3 Manual cleaning 4310.4 Automated cleaning 4310.4.1 General 4310.4.2 Loading 4310.4.3 Unloading 4310.5 Liquid chemical disinfection 4410.6 Thermal disinfection 4410.7 Pasteurization 4410.8 Washer-disinfectors 4510.9 Drying, reassemb

28、ly, and inspection 4510.10 Maintenance 4511 Flexible endoscopes 4611.1 General 4611.2 Records 4611.3 Endoscopes 4711.4 Personnel 4711.4.1 Education and training 4711.4.2 Qualification of personnel 4711.5 Reprocessing area for endoscopes 4711.6 External providers 4811.7 Reprocessing of endoscopes 481

29、1.7.1 General 4811.7.2 Tracking 4911.7.3 Timely reprocessing 4911.7.4 Pre-cleaning at bedside 5311.7.5 Transportation of endoscopes 5311.7.6 Leak testing and flexible endoscope inspection 5311.7.7 Cleaning of endoscopes 5411.7.8 Rinsing following cleaning 5511.7.9 Automated endoscope reprocessing 55

30、Z314.8-14Decontamination of reusable medical devicesFebruary 2014 2014 CSA Group 311.7.10 Manual high-level disinfection 5811.7.11 Drying 5911.7.12 Storage 5911.8 Special requirements for bronchoscopes and cystoscopes 6011.9 Special requirements for endoscopic accessory devices 6111.9.1 General 6111

31、.9.2 Water bottle, cap, flushing pump, and connecting tubing 6211.10 Damaged endoscopes and other related devices 6311.10.1 General 6311.10.2 Cleaning and disinfecting damaged endoscopes 6311.10.3 Transportation of contaminated flexible endoscopes for repair 6411.11 Quality assurance and record keep

32、ing for endoscope reprocessing 6411.11.1 General 6411.11.2 Endoscope inspection process 6411.11.3 Record keeping 6512 Ultrasound transducer probes 6612.1 General 6612.2 Personnel 6712.2.1 Education and training 6712.2.2 Qualification of personnel 6712.3 Reprocessing area for ultrasound transducer pr

33、obes 6812.4 Reprocessing of ultrasound transducer probes 6912.4.1 General 6912.4.2 Tracking 6912.4.3 Pre-cleaning at bedside 6912.4.4 Transportation 6912.4.5 Electrical leak testing 7012.4.6 Manual cleaning 7012.4.7 Rinsing following cleaning 7012.4.8 Automated reprocessing (disinfection) 7012.4.9 M

34、anual high-level disinfection 7112.4.10 Drying 7212.4.11 Storage 7212.5 Quality assurance and record keeping for ultrasound probe reprocessing 7212.5.1 Preventative maintenance 7212.5.2 Defective or damaged ultrasound probes 7212.5.3 Probe inspection process 7212.5.4 Record keeping 7313 Electronic a

35、nd powered devices 7413.1 General 7413.2 Personnel 7413.3 Decontamination of electronic and powered devices 7413.3.1 Pre-cleaning 7413.3.2 Surface disinfection 7413.3.3 Automated decontamination 7413.3.4 Final rinse 7513.3.5 Inspection 75Z314.8-14Decontamination of reusable medical devicesFebruary 2

36、014 2014 CSA Group 413.3.6 Drying and storage 7514 Non-critical medical devices 75Annex A (informative) Characteristics that make a medical device difficult to clean 77Annex B (informative) Bibliography 78Annex C (informative) Sample foil test 79Annex D (informative) Automated washers 80Annex E (inf

37、ormative) Liquid Chemical Disinfectants (LCDs) 82Annex F (informative) Sample cleaning protocol for large and/or non-immersible equipment 92Annex G (informative) Endoscopy reprocessing log 93Z314.8-14Decontamination of reusable medical devicesFebruary 2014 2014 CSA Group5Technical Committee on Steri

38、lizationI. Pequegnat STERIS Canada Inc, Mississauga, OntarioCategory: Producer InterestChairG. Schultz Winnipeg Regional Health Authority, Winnipeg, ManitobaCategory: User InterestVice-ChairN. Aelick Sudbury, OntarioCategory: User InterestR.C. Bauer 3M Canada Company, London, OntarioCategory: Produc

39、er InterestB. Bolding Consultant, Burnaby, British ColumbiaCategory: General InterestL. Buist Interior Health Authority, Kelowna, British ColumbiaCategory: User InterestM. Chaunet TSO3 Inc, Qubec, QubecCategory: Producer InterestL. Coutoulas Southlake Regional Health Centre, Newmarket, OntarioCatego

40、ry: User InterestM. Deeves Public Health Ontario-Regional, Orillia, OntarioCategory: Government and/or Regulatory AuthorityD. Friesen Getinge Canada Limited, Mississauga, OntarioCategory: Producer InterestC. Hancock Charles O. Hancock Associates, Inc., Fairport, New York, USACategory: General Intere

41、stZ314.8-14Decontamination of reusable medical devicesFebruary 2014 2014 CSA Group 6P.M. Haney Keir Surgical Ltd., Vancouver, British ColumbiaCategory: Producer InterestL. Jakeman L Jakeman Consulting, West Porters Lake, Nova ScotiaCategory: General InterestR. Khotar Providence Health Care, Vancouve

42、r, British ColumbiaCategory: User InterestL. Kingsbury Consultant, Vancouver, British ColumbiaCategory: General InterestS.H. Lafferty Alberta Health Services, Edmonton, AlbertaCategory: User InterestC. Landers Weeneebayko General Hospital, Moose Factory, OntarioCategory: General InterestP.J. McCormi

43、ck Bausch b) provide an explanation of circumstances surrounding the actual field condition; andc) where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.Committee interpretations are processed in accordance with the CSA Directives and guidelines

44、 governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.5) This Standard is subject to review five years from the date of publication and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal fo

45、r change, please send the following information to inquiriescsagroup.org and include “Proposal for change” in the subject line:a) Standard designation (number);b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.Z314.8-14Decontamination o

46、f reusable medical devicesFebruary 2014 2014 CSA Group 12Z314.8-14Decontamination of reusable medical devices1 Scope1.1 This Standard describes essential elements and methods in the safe handling, transportation, and biological decontamination of contaminated reusable medical devices and is to be us

47、ed in conjunction with CSA Z314.0. Where differences exist, the requirements of this Standard apply.Note: The biological decontamination process includes thorough cleaning and, whenever necessary for personnel or patient safety, appropriate application of a disinfection or sterilization process.1.2

48、This Standard includes requirements fora) decontamination areas and equipment;b) immediate handling of contaminated medical devices at the point of use;c) transport of contaminated medical devices; andd) decontamination policies and procedures (in general, as related to reusable diagnostic and thera

49、peutic medical devices, and specifically, as related to reusable respiratory/anaesthesia devices, flexible fibre optic endoscopes, ultrasound transducer probes, and electronic patient-applied devices).Notes:1) More detailed procedures can be required for specific medical devices or applications.2) See Figure 1 for an overview of the medical device reprocessing steps specified in this Standard.1.3 This Standard does not apply toa) the terminal sterilization of reusable medical devices;Note: See CSA Z314.0, CSA Z314.3, CSA Z314.23, and CAN/CSA-ISO 1