CSA Z314 15-2015 Storage transportation and distribution of single use and reusable medical devices (Third Edition Incorporating Errata October 2015).pdf

1、REVISED OCTOBER 2015Z314.15-15Storage, transportation, and distribution of single use and 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

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18、acceptance of the terms and conditions of this Legal Notice.Revision HistoryZ314.15-15, Storage, transportation, and distribution of single use and reusable medical devicesErrata October 2015 Revision symbol (in margin)SubcommitteeStandards Update ServiceZ314.15-15August 2015Title: Storage, transpor

19、tation, and distribution of single use and 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 2423887.If you require assistance, p

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22、27 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association, operating as “CSA Group”Storage, transportation, and distribution of single use and reusable medical devicesZ314.15-15Z314.15-15Storage, transportation, and distribution of single use and reusable medical devicesAugust 2015 2

23、015 CSA Group 1ContentsTechnical Committee on Sterilization 3Subcommittee on Warehousing of Medical Supplies 7Preface 90 Introduction 101 Scope 102 Reference publications 123 Definitions 134 Quality system 145 Personnel considerations 145.1 General 145.2 Qualifications 145.2.1 General 145.2.2 Superv

24、ision 155.2.3 Personnel 155.3 Training and education 155.3.1 General 155.4 Attire 165.5 Hand hygiene 166 Environmental conditions 166.1 General 166.2 Temperature, relative humidity, and ventilation 166.3 Protection from airborne contamination 177 Environmental cleaning 197.1 General 197.2 Tiers 1 an

25、d 2 environmental cleaning 197.3 Tier 3 environmental cleaning 227.4 Housekeeping (environmental services) equipment 227.5 Cleaning products 238 Physical and functional storage requirements 238.1 General 238.2 Design 238.3 Area requirements 238.4 Shelving 248.5 Pallets 248.6 Hand-hygiene facilities

26、248.7 Storage conditions 25Z314.15-15Storage, transportation, and distribution of single use and reusable medical devicesAugust 2015 2015 CSA Group 28.8 Equipment 268.9 Waste control 278.10 Tier 1 storage areas 279 Handling 279.1 General 279.2 Picking of supplies and medical devices 2810 Area requir

27、ements 2910.1 General 2910.2 Case carts 3011 Transportation and distribution 3111.1 General 3111.2 Transportation (off-site) 3111.3 Distribution (on-site) 3211.4 Distribution routes (on-site) 3212 Emergencies 32Annex A (informative) High relative humidity in sterile storage areas 34Annex B (informat

28、ive) Guidance on storage and handling 36Annex C (informative) Guidance on selection of an automated storage system 37Z314.15-15Storage, transportation, and distribution of single use and reusable medical devicesAugust 2015 2015 CSA Group 3Technical Committee on SterilizationI. Pequegnat STERIS Canad

29、a Inc, Mississauga, Ontario Category: Producer InterestChairG. Schultz Winnipeg Regional Health Authority, Winnipeg, Manitoba Category: User InterestVice-ChairN. Aelick Health Sciences North / Horizon Sant-Nord, Sudbury, Ontario AssociateR.C. Bauer 3M Canada Company 3M HealthCare, London, Ontario Ca

30、tegory: Producer InterestB. Bolding Consultant, Burnaby, British Columbia Category: General InterestD. Bosnjak Hamilton Health Sciences, Hamilton, Ontario Category: User InterestL. Buist Interior Health Authority, Kelowna, British Columbia Category: User InterestL. Coutoulas Southlake Regional Healt

31、h Centre, Newmarket, Ontario Category: User InterestR. De Medeiros Getinge Canada Limited, Mississauga, Ontario Category: Producer InterestM. Deeves Public Health Ontario-Regional, Orillia, Ontario Category: Government and/or Regulatory AuthorityS. Dufresne TSO3 Inc, Qubec, Qubec Category: Producer

32、InterestZ314.15-15Storage, transportation, and distribution of single use and reusable medical devicesAugust 2015 2015 CSA Group 4C. Hancock Charles O. Hancock Associates, Inc., Fairport, New York, USA Category: General InterestP.M. Haney Keir Surgical Ltd., Vancouver, British Columbia Category: Pro

33、ducer InterestS. Jacka Alberta Health, Edmonton, Alberta Category: Government and/or Regulatory AuthorityL. Jakeman L Jakeman Consulting, West Porters Lake, Nova Scotia Category: General InterestM. Kanlic St Josephs Healthcare - Charlton Campus, Hamilton, Ontario AssociateR. Khotar Providence Health

34、 Care, Vancouver, British Columbia Category: User InterestL. Kingsbury Consultant, Vancouver, British Columbia Category: General InterestC. Landers Weeneebayko Area Health Authority, Moose Factory, Ontario Category: General InterestN. Mazurat University of Manitoba College of Dentistry, Winnipeg, Ma

35、nitoba AssociateP.J. McCormick 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 C

36、SA Directives and guidelines 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. Suggestions for its improvement will be referred to the appropriate committee

37、. To submit a proposal for 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;d) rationale for change.Z314.15-

38、15Storage, transportation, and distribution of single use and reusable medical devicesAugust 2015 2015 CSA Group 10Z314.15-15Storage, transportation, and distribution of single use and reusable medical devices0 IntroductionMedical devices are used in nearly every medical procedure. Patients and heal

39、th care professionals expect these medical devices to be functionally and microbiologically safe. The safety of medical devices begins with the manufacturer and is supported and maintained by a system of national standards and government regulations that includes medical device licensing, constructi

40、on and performance standards, and problem reporting systems.Safe storage of single use and reusable medical devices is necessary to protect these devices from damage. Traditionally single use and reusable medical devices have been stored in sterile storage areas associated with operating room medica

41、l device reprocessing, and storage areas within the health care setting.In recent years, with the regionalization of health care services and the increased use of contract services as well as the purchase of single use sterile medical devices, health care settings have begun to use centralized facil

42、ities such as warehouses or on-site storerooms for the storage of single use and reusable medical devices. In these facilities, shipping containers of medical devices are opened or unpacked, and medical devices are stored in open inventory (split-case), bins, or totes until needed. These facilities

43、also pick medical devices and repack them into bins, totes, or case carts for transportation to the point of use. Off-site storage is also provided by some contract reprocessing and laundry services. These trends have resulted in the need to address warehouses that store and distribute open inventor

44、y.This Standard provides a common set of specifications for health care settings, storage facilities, off-site reprocessors, and warehouses that do open inventory (both third party and health care setting owned), and materials management consultants to use when contracting for, arranging, and managi

45、ng the storage of medical devices.This Standard should be used in conjunction with CSA Z314.0, Medical device reprocessing General requirements, which provides a framework to establish, document, and maintain requirements for the reprocessing of medical devices as part of a quality management system

46、, as well as other requirements for personnel, infection, prevention and control, occupational health and safety, area design, etc.1 Scope1.1 This Standard specifies requirements and recommended practices for the storage, handling, transportation, and distribution of single use and reusable medical

47、devices in facilities where open- inventory (split-case) storage and handling services are provided.Z314.15-15Storage, transportation, and distribution of single use and reusable medical devicesAugust 2015 2015 CSA Group 111.2 This Standard coversa) physical and functional requirements for storeroom

48、s, and other storage facilities that provide open-inventory (split-case) storage of single use and reusable single use or reusable medical devices; Note: See CSA Z314.0 for additional requirements for sterile storage areas for reprocessed products.b) environmental conditions for storage and transpor

49、tation;c) staff qualifications, orientation, and education; occupational health and safety; and other personnel considerations;d) storage and handling of single use and reusable medical devices;e) management of case cart systems;f) onsite distribution; andg) emergency procedures.1.3 The storage facilities covered by this Standard include the following:a) sterile storage areas associated with operating room and medical device reprocessing areas including third party/off site reprocessors (tier 1) (i.e., single use opened case products and reprocessed