1、REVISED MARCH 2014Z314.0-13Medical device reprocessing GeneralrequirementsLegalNotice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approvedby the Standards Council of Canada. This process brings together v
2、olunteers representing varied viewpoints and interests to achieve consensusand develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus,it doesnot independently test, evaluate, or verify the content of standards.Disclaimerand exc
3、lusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation,implied warranties or conditions concerning this documents fitness for a particularpurpose or use, its merchantability, or its non-infrin
4、gementof any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or currency of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this documents compliancewith any applicablestatute, rule, or reg
5、ulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OROFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES,HOWSOEVER CAUSED,INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQU
6、ENTIAL DAMAGES, LOST REVENUE,BUSINESS INTERRUPTION, LOST OR DAMAGED DATA,OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS,WHETHERBASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OFLIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROU
7、P HAS BEENADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA Group is not undertaking to render professional or other servicesfor or on behalf of anyperson or entity or to perform any duty owed by any person or entity to
8、 another person or entity. The information in this document is directedto those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoeverarising in any way from any and all use of or reliance on the information contained in this d
9、ocument.CSA Group is a private not-for-profit company that publishes voluntary standards and related documents. CSA Group has no power, nor does itundertake, to enforce compliancewith the contents of the standards or other documents it publishes.Intellectualpropertyrights and ownershipAs between CSA
10、 Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the authorizedlicensee,of all works contained herein that are protected by copyright, all trade-marks (except as otherwisenoted to the contrary), and allinventions and trade secrets that m
11、ay be contained in this document, whether or not such inventions and trade secrets are protected by patentsand applications for patents. Without limitation, the unauthorized use, modification,copying, or disclosure of this document may violate lawsthat protect CSA Groups and/or others intellectual p
12、roperty and may give rise to a right in CSA Group and/or others to seek legal redress forsuch use, modification,copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights inthis document.Patent rightsAttention is drawn to the possibility
13、 that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be heldresponsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any suchpatent rights is entirely their own respon
14、sibility.Authorizeduse of this documentThis document is being provided by CSA Group for informational and non-commercial use only. The user of this document is authorized to doonly the following:If this document is in electronic form: load this document onto a computer for the sole purpose of review
15、ing it; search and browse this document; and print this document if it is in PDF format.Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA Group to have such copies,and only if this Legal Notice appears on each such copy.In addition, u
16、sers may not and may not permit others to alter this document in any way or remove this Legal Notice from the attached standard; sell this document without authorization from CSA Group; or make an electronic copy of this document.If you do not agree with any of the terms and conditions contained in
17、this Legal Notice, you may not load or use this document or make anycopies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutesyour acceptanceof the terms and conditions of this Legal Notice.Revision HistoryZ314.013,Me
18、dicaldevice reprocessing General requirementsRevision Issued: Errata March 2014 Revision symbol (inmargin)Clauses 3 and 10.2.2StandardsUpdateServiceZ314.0-13March 2013Title: Medical device reprocessing General requirementsTo register for e-mail notification about any updates to this publication go t
19、o shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2422159.If 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
20、 personalinformation.ISBN 978-1-77139-058-3 2013 CSA GroupAll rights reserved.No part of this publication may be reproduced in any form whatsoever withoutthe prior permission of the publisher.Published in March 2013 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100
21、, Mississauga, Ontario, Canada L4W 5N6To purchase standards and related publications, visit our Online Store at shop.csa.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”MedicaldevicereprocessingGeneralrequirementsZ314
22、.0-13Z314.0-13Medical device reprocessing General requirementsMarch 2013 2013 CSA Group 1ContentsTechnical Committee on Sterilization 4Preface 60 Introduction 71 Scope 82 Reference publications 103 Definitions 134 Quality management system (QMS) 204.1 General 204.2 Documentation and records 214.2.1
23、General 214.2.2 Control of documents 214.2.3 Control of records 224.3 Policies 224.4 Procedures 234.5 Senior management responsibility 254.5.1 General 254.5.2 Customer focus 254.5.3 Quality policy 254.5.4 Planning 254.5.5 Key performance indicators (KPI) 254.5.6 Responsibility, authority, and commun
24、ication 264.5.7 Management representative 264.5.8 Internal communication 264.5.9 Management review 264.6 Resource management 274.6.1 Provision of resources 274.6.2 Human resources Competence, awareness, and training 274.7 Environmental conditions and infrastructure 274.8 Product realization 284.8.1
25、General 284.8.2 Planning 284.8.3 Risk Management 294.9 Customer-related processes 294.9.1 Review of product requirements 294.9.2 Customer communication 294.10 Introduction of new product or processes 294.11 Purchasing 304.12 Production 304.13 Non-conforming product 304.14 Customer property 30Z314.0-
26、13Medical device reprocessing General requirementsMarch 2013 2013 CSA Group 24.15 Product preservation 314.16 Control of monitoring and measuring devices 314.17 Measurement, analysis, and improvement 314.18 Audits 314.18.1 General 314.18.2 Internal audit 314.18.3 External audit 314.19 Analysis of da
27、ta 324.20 Improvement 324.20.1 General 324.20.2 Corrective action 324.20.3 Preventive action 325 Evaluation and purchase of reusable medical devices and reprocessing equipment 325.1 Reusable medical devices 325.2 Reprocessing equipment 335.3 Manufacturers instructions 345.4 Consumablesfor reprocessi
28、ng 366 Personnel 366.1 General 366.2 Qualifications 376.2.1 Supervisorypersonnel 376.2.2 Reprocessing personnel 376.3 Orientation, training, and continuing education 376.4 Competency assessment 396.5 Occupational health and safety 396.5.1 General 396.5.2 Communicable diseases 406.5.3 Sharps 406.5.4
29、Spills of hazardous substances 406.6 Routine infection prevention and control practices 416.6.1 General 416.6.2 Hand hygiene 416.7 Attire 426.7.1 General 426.7.2 Personal protective equipment 436.7.3 Gloves 447 Work areas and design 457.1 General 457.2 Reprocessing design 457.3 Hand hygiene faciliti
30、es 477.3.1 Designated hand-hygiene sinks 477.3.2 Alcohol-basedhand rub (ABHR) 477.4 Clean and sterile storage area 477.5 Area cleaning 487.6 Traffic control 517.7 Environmental controls 51Z314.0-13Medical device reprocessing General requirementsMarch 2013 2013 CSA Group 37.7.1 Ventilation 517.7.2 Te
31、mperature and relative humidity 527.8 Water quality 527.9 Designs for occupational health and safety 537.9.1 General 537.9.2 Equipment automation 547.9.3 Environmental monitoring for chemical sterilants 547.9.4 Safety and security 547.10 Reprocessing equipment 547.11 Maintenance and quality assuranc
32、e 557.11.1 General 557.11.2 Repair or refurbishing of reusable medical devices 558 Reprocessing principles 568.1 General 568.2 Instrument care and handling 588.3 Cleaning 588.4 Disinfecting 598.5 Packaging 598.6 Sterilization 598.7 Storage and transportation 609 Process verification, monitoring,and
33、adverse events 609.1 Process verification 609.2 Recalls and alerts 619.2.1 General 619.2.2 Recall procedure 619.2.3 Recall order 629.2.4 Recall report 6210 Storage 6410.1 General 6410.2 Sterile storage area 6410.3 Inventory management 6510.3.1 Shelf life 6510.3.2 Inventory control 6510.4 Distributio
34、n 66Annex A (informative) Micro-organisms and infection 67Annex B (informative) Guidance for the design of medical device reprocessing areas 75Annex C (informative) Additional sterile storage considerations 83Annex D (informative) Risk management and sterility assurance 86Annex E (informative) Water
35、 quality 89Annex F (informative) Sample forms and tools for MDRDs 99Z314.0-13Medical device reprocessing General requirementsMarch 2013 2013 CSA Group 4Technical Committeeon SterilizationI. PequegnatSTERIS Canada Inc,Mississauga, OntarioChairG. SchultzWinnipeg Regional Health Authority,Winnipeg, Man
36、itobaVice-ChairN. AelickCentral Service Association of Ontario(CSAO)R. Bauer3M Canada Company,London, OntarioB. BoldingAdvanced Sterilization Products,Burnaby, British ColumbiaL. BuistInterior Health Authority,Kelowna, British ColumbiaM. ChaunetTSO3 Inc,Qubec, QubecL. CoutoulasSouthlake Regional Hea
37、lth Centre,Newmarket, OntarioAssociateG. GarneauGetinge Canada Limited,Mississauga, OntarioC. HancockCharles O. Hancock Associates, Inc.,Fairport, New York, USAP. HaneyKeir Surgical Ltd.,Vancouver, British ColumbiaL. JakemanL Jakeman Consulting,West Porters Lake, Nova ScotiaR. KhotarOperating Room N
38、urses Association ofCanada (ORNAC)L. KingsburyConsultantVancouver, British ColumbiaS. LaffertyAlberta Health Services,Edmonton, AlbertaC. LandersWeeneebayko Area Health Authority,Moose Factory, OntarioP. McCormickBausch b) provide an explanation of circumstances surrounding the actual field conditio
39、n; andc) where possible, phrase the request in such a way that a specific “yes” or “no” answer will address theissue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governingstandardization and are available on the Current Standards Activities page at sta
40、ndardsactivities.csa.ca.5) This Standard is subject to review five years after publication, and suggestions for its improvement will bereferred to the appropriate committee. To submit a proposal for change, please send the followinginformation to inquiriescsagroup.org and include “Proposal for chang
41、e” 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.Z314.0-13Medical device reprocessing General requirementsMarch 2013 2013 CSA Group 7Z314.0-13Medicaldevicereprocessing Generalrequi
42、rements0 IntroductionMedical devices are used in nearly every medical procedure. Patients and health care professionalsexpect these medical devices to be functionally and microbiologically safe. The safety of medical devicesbegins with the manufacturer and is supported and maintained by a system of
43、national standards andgovernment regulations that includes medical device licensing, construction and performance standards,and problem reporting systems.Within this structure, areas or departmentsthat reprocess medical devices within or for a health caresetting play an essential role and face uniqu
44、e challenges. Unlike a medical device manufacturer, medicaldevice reprocessing personnel work with a wide array of medical devices manufactured by differentcompanies,received in varying states of cleanlinessand repair. It is the responsibility of the MedicalDevice Reprocessing Department (MDRD) to d
45、econtaminate, inspect, perform necessarymaintenance,and disinfect or sterilize each medical device using the device manufacturer validated methodologies.The goal is to provide medical devices that perform as intended by the manufacturer and are safe forreuse.Health Canada requires manufacturers of t
46、he more critical classes of reusable medical devices toestablish and maintain Quality Management Systems (QMS) in accordance with international standards.Under QMS, manufacturers are required to validate their recommendedreprocessing instructionsthrough the use of extensive testing. Health care sett
47、ings do not have the resources or expertise to dothis type of validation for their own reprocessing equipment and must instead develop procedures toverify that they are correctly performing the validated processes recommended by the manufacturer.This Standard sets out requirements for health care se
48、ttings to establish, document, and maintain theirown policies and procedures for the reprocessing of medical devices, forming a unique internal QMS.These policies and procedures are based on several inputs, including government regulation, nationalstandards, and the specific requirements that make u
49、p the quality system of the individual organization.The main function of a QMS is to establish consistency and control of the required processes anddocumentation in order to produce quality products. A QMS for MDRDs requires management of thereprocessing area to be considered analogous to that of a manufacturing facility. The products of theMDRD are therefore decontaminated and sterilized medical devices (or any other output that would be aresult of following controlled processes within the MDRD).The MDRD referenced in this Stan
