CSA Z305 0-2013 Safety of personnel in perioperative environments (First Edition).pdf

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18、ice.Standards Update ServiceZ305.0-13December 2013Title: Safety of personnel in perioperative environmentsTo 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

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20、eproduced to any form whatsoever without the prior permission of the publisher.Published in December 2013 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 Stor

21、e 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”Safety of personnel in perioperative environmentsZ305.0-13Z305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 1ContentsT

22、echnical Committee on Perioperative Safety 3Subcommittee on Management of Perioperative Environments 5Preface 70 Introduction 80.1 General 80.2 Principles of QMS in a perioperative environment 81 Scope 92 Reference publications 103 Definitions 124 Quality management systems (QMS) 144.1 General 144.2

23、 Documentation and records 154.2.1 OHS 154.2.2 General 154.2.3 Control of documents 164.2.4 Control of records 164.3 Policies 164.4 Standard operating procedures (SOPs) 174.5 Senior management responsibility 184.5.1 General 184.5.2 Perioperative safety objective 184.5.3 Key performance indicators 18

24、4.5.4 Responsibility, authority, and communication 184.5.5 Management representative 194.5.6 Internal communication 194.5.7 Management review 194.6 Alerts 194.7 Maintenance 205 Evaluation and purchase of medical devices used in a perioperative environment 205.1 Medical devices 205.2 Manufacturers in

25、structions 226 Personnel 236.1 General 236.2 Qualifications 236.2.1 Supervisory personnel 236.2.2 Perioperative personnel 236.3 Orientation, training, and continuing education 246.4 Competency assessment 25Z305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 27 OHS

26、267.1 General 267.2 OHS documentation 267.3 Attire 267.3.1 General 267.3.2 Gloves 277.3.3 Respiratory protection 277.4 Ergonomic risks 287.4.1 General 287.4.2 Safe patient handling 287.5 Radiation 297.6 Plume evacuation 307.7 Sharps 307.8 Chemical hazards 307.8.1 General 307.9 Anesthetic agents 317.

27、9.1 General 317.9.2 Equipment considerations 327.9.3 Personnel considerations 327.9.4 Procedural considerations 327.10 Medical laser safety 327.11 Waste management 328 Infection prevention and control 338.1 Routine practices and additional precautions 338.2 Hand hygiene 339 Respectful workplace dyna

28、mics 3410 Area design and use 3510.1 General 3510.2 Environment and infrastructure 3510.3 Environmental controls 3510.4 Area cleaning 3610.5 Traffic control 3610.5.1 General 3610.5.2 Visitors 36Z305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 3Technical Committe

29、e on Perioperative SafetyS. Taylor London, OntarioRepresenting General InterestChairM. Armutlu Jewish General Hospital, Montral, QubecRepresenting User ManagementA. Bialachowski St. Josephs Healthcare Hamilton, Hamilton, OntarioRepresenting User ManagementD.A. Chartrand Montreal Neurological Hospita

30、l, Montral, QubecRepresenting Health Care ProfessionalJ.D. Deslauriers Health Canada, Ottawa, OntarioRepresenting Government and/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc, Richmond Hill, OntarioAssociateB. Hunt Class 1 Inc., Cambridge, OntarioRepresenting Producer InterestC. Landers W

31、eeneebayko General Hospital, Moose Factory, OntarioRepresenting General InterestJ.Y. Latreille Clarion Medical Technologies Inc., Montral, QubecAssociateK.L. LeDez Memorial University of Newfoundland, St. Johns, Newfoundland and LabradorRepresenting Health Care ProfessionalB.W. McLeod Maple Ridge, B

32、ritish ColumbiaRepresenting Health Care ProfessionalZ305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 4G. Mendes GE Health Care Technologies, Mississauga, OntarioRepresenting Producer InterestP.I. Mendes 3M Canada, London, OntarioAssociateJ. Parker London Health

33、Sciences Centre University Hospital, London, OntarioRepresenting General InterestD.H. Piper MAQUET-DYNAMED Inc, Markham, OntarioRepresenting Producer InterestM. Sagar WorkSafe BC, Vancouver, British ColumbiaRepresenting Government and/or Regulatory AuthorityR.C. Shantz Parkin Architects Limited, Tor

34、onto, OntarioRepresenting General InterestP.J. Smalley Technology Concepts International, Chicago, Illinois, USARepresenting General InterestC. Stark London Health Sciences Center, London, OntarioAssociateH. Thiemann Medical Device Industry Consultant, Perkasie, Pennsylvania, USARepresenting Produce

35、r InterestK.L. Warcimaga Selkirk and District General Hospital, Selkirk, ManitobaRepresenting User ManagementJ. Wilding Drger Medical Canada Inc, Richmond Hill, OntarioRepresenting Producer InterestC. Cortissoz CSA Group, Mississauga, OntarioProject ManagerZ305.0-13Safety of personnel in perioperati

36、ve environmentsDecember 2013 2013 CSA Group5Subcommittee on Management of Perioperative EnvironmentsB.W. McLeod Maple Ridge, British Columbia ChairC. Stark London Health Sciences Center, London, OntarioVice-ChairA. Bialachowski St. Josephs Healthcare Hamilton, Hamilton, OntarioN. Dolan Drger Medical

37、 Canada Inc, Richmond Hill, OntarioM.A. Girard CHU Sainte-Justine, Montral, QubecR. Khotar Providence Health Care, Vancouver, British ColumbiaC. Landers Weeneebayko General Hospital, Moose Factory, OntarioS. LeQuoc Association Sant Scurit Travail, secteur affaires sociales, Montral, QubecM. Sagar Wo

38、rkSafe BC, Vancouver, British ColumbiaJ. Schubert The Ottawa Hospital General Campus, Ottawa, OntarioL.B. Skene Interior Health; Surgical Services and Medical Device Reprocessing, Kelowna, British ColumbiaS. Taylor London, OntarioK.L. Warcimaga Selkirk and District General Hospital, Selkirk, Manitob

39、aZ305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 6C. Cortissoz CSA Group, Mississauga, OntarioProject ManagerZ305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 7PrefaceThis is the first edition of CSA Z305.0, Safety of person

40、nel in perioperative environments.This Standard was prepared by the Subcommittee on Management of Perioperative Environments under the jurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the

41、 Technical Committee.Notes:1) Use of the singular does not exclude the plural (and vice versa) when the sense allows.2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge

42、its suitability for their particular purpose.3) This Standard was developed by consensus, which is defined by CSA Policy governing standardization Code of good practice for standardization as “substantial agreement. Consensus implies much more than a simple majority, but not necessarily unanimity”.

43、It is consistent with this definition that a member may be included in the Technical Committee list and yet not be in full agreement with all clauses of this Standard.4) To submit a request for interpretation of this Standard, please send the following information to inquiriescsagroup.organd include

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45、 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 governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.5) This Standard is subje

46、ct review five years from the date of publication, and suggestions for its improvement will be referred to the appropriate committee. 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 desi

47、gnation (number);b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.Z305.0-13Safety of personnel in perioperative environmentsDecember 2013 2013 CSA Group 8Z305.0-13Safety of personnel in perioperative environments0 Introduction0.1 Gener

48、alPerioperative environments are found in the traditional acute care hospital, but are increasingly common in a variety of health care settings including but not limited toa) surgical centres;b) vision correction centres;c) physicians offices;d) dental offices; ande) education centres (e.g., dental,

49、 ophthalmology).The perioperative environment contains numerous hazards that can affect the safety of both personnel and patients. The types of risk specific to the perioperative environment can include but are not limited to biological, ergonomic, physical, and psychosocial in nature. This Standard provides strategies and guidance for personnel safety within the perioperative environment based on the premise that this will also further enhance a safer patient environment.This Standard introduces new language related to quality managemen