CSA Z387:19

National Standard of Canada

Safe use of electrosurgical medical devices and systems in health care

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  CSA Z387:19

  March 2019

  
  

  Title: Safe use of electrosurgical medical devices and systems in health care

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National Standard of Canada

CSA Z387:19

Safe use of electrosurgical medical devices and systems in health care

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ICS 11.040.30

ISBN 978-1-4883-1914-3

© 2019 Canadian Standards Association

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Contents

Technical Committee on Perioperative Safety 3 Subcommittee on Safety of Electrosurgical Medical Devices 6 Preface 7

0 Introduction 8

1. Scope 8

   
   

2. Reference publications 9

   
   

3. Definitions 9

   
   

4. General requirements 12

   1. Policies and procedures 12

      1. General 12

      2. Policies 12

      3. Procedures 13

   2. Education, training, and orientation 13

   3. Electrosurgery safety committee 13

   4. Electrosurgery procedures 15

      1. Protection of patients and clients 15

      2. Maintenance and testing 15

      3. Operational requirements 15

         
         

5. Evaluation and purchase of electrosurgical medical devices 16

   1. General 16

   2. Manufacturer’s instructions 17

      
      

6. Dispersive electrodes 17

   1. General 17

   2. Dispersive electrode contact quality monitoring (DECQM) 17

   3. Placement of the dispersive electrode 18

   4. Capacitively coupled electrodes 19

   5. Active electrodes 19

      1. General 19

      2. Accessory cords 21

      3. Reusable and reposable cords 21

      4. Safety holsters 21

      5. Coated and non-coated tips 21

      6. Foot pedals 21

      7. Use during minimally invasive or laparoscopic surgery 22

         
         

7. Patient safety 22

   1. Fire prevention 22

      1. General 22

      2. Fire and explosion 23

      3. Alcohol-based antiseptics 24

   2. Airway precautions 24

      
      

8. Pediatric, neonatal, and bariatric considerations 24

   
   

9. Internal implanted electronic devices (IEDs) 25

   
   

10. Ground-referenced generators 25

Annex A (informative) — Review criteria recommended for patient safety on check in for surgery where ESU will be used 27

Annex B (informative) — Additional fire and explosion hazard controls for endotracheal (ET) tube procedures 29

Technical Committee on Perioperative Safety

R. Khotar Providence Health Care,

Vancouver, British Columbia, Canada

Category: User Management

Chair

B.W. McLeod Maple Ridge, British Columbia, Canada

Category: Health Care Professional

Vice-Chair

A. Bialachowski St. Joseph’s Healthcare Hamilton,

Hamilton, Ontario, Canada

Category: User Management

K. Bowden O-Two Systems Limited, Mississauga, Ontario, Canada

Non-voting

L.D. Boyer Public Health Ontario, Sudbury, Ontario, Canada

Category: Government and/or Regulatory Authority

K. Brown Hôpital de Montréal pour Enfants/Montreal Children’s Hospital,

Montréal, Québec, Canada

Non-voting

G.D. Burrill Teegor Consulting Inc.,

Fredericton, New Brunswick, Canada

Category: General Interest

T. Coonan Dalhousie University,

Halifax, Nova Scotia, Canada

Non-voting

S. Dain Ontario Mobile Anesthesia, London, Ontario, Canada

Category: Health Care Professional

M.B. Dolovich St Joseph’s Hospital/McMaster University,

Hamilton, Ontario, Canada

Non-voting

S. Hiremath University of Ottawa and Ottawa Hospital, Ottawa, Ontario, Canada

Non-voting

B. Hunt Class 1 Inc.,

Cambridge, Ontario, Canada

Category: Producer Interest

L. Ladouceur McMaster University, Ottawa, Ontario, Canada

Non-voting

C. Laflamme Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Category: Health Care Professional

C.P. Landers Landers Consulting, Timmins, Ontario, Canada Category: General Interest

K.L. LeDez Memorial University of Newfoundland,

St. John’s, Newfoundland and Labrador, Canada

Category: Health Care Professional

J. Levett College of Physicians and Surgeons of British Columbia,

Vancouver, British Columbia, Canada

Category: Government and/or Regulatory Authority

T. Martire GE Health Care,

Mississauga, Ontario, Canada

Category: Producer Interest

G.J. Mendes Mississauga, Ontario, Canada Non-voting

P.I. Mendes-Baldinelli 3M Canada,

London, Ontario, Canada

Category: Producer Interest

P. Nellis Medtronic,

St-Laurent, Québec, Canada

Category: Producer Interest

C. Over Class 1 Inc.,

Cambridge, Ontario, Canada

Non-voting

R. Padwal University of Alberta, Edmonton, Alberta, Canada

Non-voting

D.R. Palmerton International Council on Surgical Plume,

Ft. Lauderdale, Florida, USA

Category: Producer Interest

A.W. Prost Southern Alberta Institute of Technology, Calgary, Alberta, Canada

Non-voting

F. Qureshi Air Liquide Healthcare/GH Medical, Brampton, Ontario, Canada

Non-voting

R. Sethi Medtronic,

Vancouver, British Columbia, Canada

Non-voting

R.C. Shantz Parkin Architects Limited, Toronto, Ontario, Canada Category: General Interest

P.J. Smalley Technology Concepts International, Chicago, Illinois, USA

Category: General Interest

C. Stark London Health Sciences Centre, London, Ontario, Canada Category: User Management

S. Vinden Vancouver Island Health Authority, Nanaimo, British Columbia, Canada Category: Health Care Professional

C. Gullia CSA Group,

Toronto, Ontario, Canada

Project Manager

Subcommittee on Safety of Electrosurgical Medical Devices

G. Bruce Diploma Healthcare Group, Toronto, Ontario, Canada

Chair

D.S. Watson Medtronic,

Boulder, Colorado, USA

Vice-Chair

S. Taylor London, Ontario, Canada Vice-Chair

D. Armstrong McMaster University & Hamilton Health Sciences,

Hamilton, Ontario, Canada

R. Crate PENTAX Medical, Kitchener, Ontario, Canada

M. Ogg AORN,

Denver, Colorado, USA

D.R. Palmerton International Council on Surgical Plume,

Ft. Lauderdale, Florida, USA

J. Poirier AMT Surgical,

Kitchener, Ontario, Canada

M. Samiee Clinical Engineering Program, c/o Health Sciences Centre, Winnipeg, Manitoba, Canada

P.J. Smalley Technology Concepts International, Chicago, Illinois, USA

G.A. Vilos St. Joseph’s Health Care, London, Ontario, Canada

S. Fetterly CSA Group,

Toronto, Ontario, Canada

Project Manager

Preface

This is the second edition of CSA Z387, Safe use of electrosurgical medical devices and systems in health care. It supersedes the previous edition published in 2013.

This Standard was prepared by the Subcommittee on Safety of Electrosurgical Medical Devices, under the jurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee on Health Care Technology and Systems, and has been formally approved by the Technical Committee.

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. 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 its suitability for their particular purpose.

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CSA Z387:19

Safe use of electrosurgical medical devices and systems in health care

0 Introduction

Electrosurgery is the intentional passage of high-frequency electrical current through tissue in order to

1. achieve controlled surgical effects, including the coagulation of blood vessels to minimize bleeding; and

2. perform incisions, excisions, or ablations of tissue.

Electrosurgery produces “heat” that desiccates tissue, coagulates blood vessels, and can be used in a variety of 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 of electricity and electrosurgical units (ESUs), how these units function, and how to utilize them as safely as possible.

A majority of surgical procedures involve the use of energy-based devices (most commonly ESUs and related accessories). Positive patient outcomes depend on knowledgeable staff and the safe and effective use of electrosurgical medical devices in the perioperative setting.

1 Scope

1.1

This Standard deals with the following subjects:

1. the use of electrical surgical units (ESUs) — medical devices and systems for the application of electrosurgical energy;

2. training for the use of ESUs; and

3. the installation of ESUs in any health care facility (HCF), as defined in Clause 3.

1.2

This Standard provides requirements for the education, training, purchasing, installation, use, service, and maintenance of ESUs.

1.3

This Standard does not include requirements for

1. aspects of laser safety (see CSA Z386);

2. aspects of other energy-based medical device safety not utilizing electricity to deliver a therapeutic effect (e.g., ultrasonic scalpels); and

3. surgical plume.

1.4

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that