CSA Z387-2013 Safe use of electrosurgical medical devices and systems in health care (First Edition Errata September 2013).pdf

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18、evision HistoryZ38713, Safe use of electrosurgical medical devices and systems in health careRevision issued: ErrataSeptember 2013 Revision symbol (in margin)Clause 6.4StandardsUpdateServiceZ387-13January 2013Title: Safe use of electrosurgical medicaldevices and systems in health careTo register for

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22、ng as “CSA Group”Safe use of electrosurgical medicaldevices and systems in healthcareZ387-13Z387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group1ContentsTechnical Committee on Perioperative Safety 3Subcommittee on Safety of Electrosurgical Medical D

23、evices 5Preface 60 Introduction 71 Scope 72 Reference publications 83 Definitions 84 General requirements 114.1 Policies and procedures 114.1.1 General 114.1.2 Policies 124.1.3 Procedures 124.2 Education, training, and orientation 124.3 Electrosurgery safety committee 124.4 Electrosurgery procedures

24、 144.4.1 Protection of patients and clients 144.4.2 Maintenance and testing 144.4.3 Operational requirements 145 Evaluation and purchase of electrosurgical medical devices 155.1 General 155.2 Manufacturers instructions 166 Dispersive electrodes 166.1 General 166.2 Dispersive electrode contact qualit

25、y monitoring (DECQM) 166.3 Placement of the dispersive electrode 176.4 Capacitively coupled electrodes 186.5 Active electrodes 196.5.1 General 196.5.2 Accessorycords 206.5.3 Reusable and reposable cords 206.5.4 Safety holsters 206.5.5 Coated and non-coated tips 206.5.6 Foot pedals 216.5.7 Use during

26、 minimally invasive or laparoscopic surgery 217 Patient safety 217.1 Fire prevention 217.1.1 General 21Z387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group27.1.2 Alcohol-basedantiseptics 227.2 Airway precautions 228 Pediatric, neonatal, and bariatri

27、c considerations 229 Internal implanted electronic devices (IEDs) 2210 Ground-referenced generators 23Z387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group3Technical Committeeon PerioperativeSafetyS. Taylor St. Josephs Health Care,London, OntarioChai

28、rM. Armutlu Jewish General Hospital,Montral, QubecA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioD. Chartrand Montral Neurological Hospital,Montral, QubecJ. Deslauriers Health Canada,Ottawa, OntarioN. Dolan Drger Medical Canada Inc.,Richmond Hill, OntarioAssociateB. Hunt Class 1 In

29、c.,Cambridge, OntarioC. Landers Weeneebayko General Hospital,Moose Factory, OntarioK. LeDez Memorial University of Newfoundland,St. Johns, Newfoundland and LabradorB. McLeod Maple Ridge, British ColumbiaG. Mendes GE Health Care Technologies,Mississauga, OntarioP. Mendes 3M Canada,London, OntarioAsso

30、ciateJ. Parker London Health Sciences Centre, University Hospital,London, OntarioZ387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group4D. Piper MAQUET-DYNAMED Inc.,Markham,OntarioM. Sagar WorkSafeBC,Vancouver, British ColumbiaR. Shantz Parkin Archite

31、cts Limited,Toronto, OntarioP. Smalley Technology Concepts International,Chicago, Illinois, USAC. Stark London Health Sciences Centre,London, OntarioAssociateH. Thiemann Medical Device Industry Consultant,Perkasie, Pennsylvania, USAK. Warcimaga Selkirk and District General Hospital,Selkirk, Manitoba

32、J. Wilding Drger Medical Canada Inc.,Richmond Hill, OntarioC. Cortissoz CSA Group,Mississauga, OntarioProject ManagerZ387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group5Subcommitteeon Safetyof ElectrosurgicalMedicalDevicesS. Taylor St. Josephs Heal

33、th Care,London, OntarioChairD. Watson Fox Island,Washington, USA Vice-ChairG. Bruce AMT Electrosurgery,Kitchener, OntarioD. Cavaliere Bovie Medical Corporation,Clearwater, Florida, USAI. Massicotte ConMed Canada,Brossard, QubecP. Mendes 3M Canada,London, OntarioD. Palmerton Buffalo Filter,Lancaster,

34、 New York, USAF. Perner Encision, Inc.,Boulder, Colorado, USAM. Samiee Clinical Engineering Program, c/o Health SciencesCentre,Winnipeg, ManitobaP. Smalley Technology Concepts International,Chicago, Illinois, USAG. Vilos St. Josephs Health Care,London, OntarioD. Wood ConMed Canada,Brossard, QubecC.

35、Cortissoz CSA Group,Mississauga, OntarioProject ManagerZ387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group6PrefaceThis is the first edition of CSA Z387, Safe use of electrosurgicalmedical devices and systems in healthcare.This Standard was prepared

36、 by the Subcommittee on Safety of Electrosurgical Medical Devices, under thejurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee onHealth Care Technology and Systems, and has been formally approved by the Technical Committee.Notes:1) Use of the singula

37、r 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 itremains the responsibility of the users of the Standard to judge its suitability for their particular purpose.3) T

38、his Standard was developed by consensus, which is defined by CSA Policy governing standardization Codeof good practice for standardization as “substantial agreement. Consensus implies much more than a simplemajority, but not necessarily unanimity”. It is consistent with this definition that a member

39、 may be included inthe 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 toinquiriescsagroup.organd include “Request for interpretation” in the subject line:a)

40、define the problem, making reference to the specific clause, and, where appropriate, include anillustrative sketch;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 addre

41、ss theissue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governingstandardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.5) This Standard is subject to periodic review, and suggestions for its improveme

42、nt will be referred to theappropriate committee. To submit a proposal for change, please send the following information toinquiriescsagroup.organd include “Proposal for change” in the subject line:a) Standard designation (number);b) relevant clause, table, and/or figure number;c) wording of the prop

43、osed change; andd) rationale for the change.Z387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group 7Z387-13Safe use of electrosurgical medicaldevices and systems in healthcare0 IntroductionElectrosurgery is the intentional passage of high-frequency el

44、ectrical current through tissue in order toa) achieve controlled surgical effects, including the coagulation of blood vessels to minimize bleeding;andb) perform incisions, excisions, or ablations of tissue.Electrosurgery produces “heat” that desiccates tissue, coagulates blood vessels, and can be us

45、ed in avariety of different methods for minimally invasive or open procedures. The use of radio frequency (RF)electrical energy can be hazardous, and medical and nursing personnel need to understand the basics ofelectricity and electrosurgical units (ESUs), how these units function, and how to utili

46、ze them as safely aspossible.The majority of surgical procedures involve the use of energy-based devices (most commonly ESUs andrelated accessories).Positive patient outcomes depend on knowledgeablestaff and the safe and effectiveuse of electrosurgical medical devices in the perioperative setting.1

47、Scope1.1This Standard applies to the use of medical devices and systems for the application of electrosurgicalenergy. It applies to all procedures in all health care settings where such medical devices and systems areused, including, but not limited to, the following:a) surgical facilities;b) dental

48、 clinics;c) medical offices;d) veterinary facilities;e) laboratories and other research facilities;f) cosmetic treatment facilities;g) teaching facilities; andh) professional exhibitions and trade shows.1.2This Standard provides requirements for the education,training, purchasing, installation, use,

49、 service,and maintenance of electrosurgical units (ESUs).1.3This Standard does not include requirements fora) aspects of laser safety (see CSA Z386);b) aspects of other energy-based medical device safety not utilizing electricity to deliver a therapeuticeffect (e.g., ultrasonic scalpels); andZ387-13Safe use of electrosurgical medicaldevices and systems in health careJanuary 2013 2013 CSA Group8c) surgical plume.1.4In this Standard,“shall” is used to express a requirement, i.e., a provision that the user is obliged tosatisfy in order to comp