CSA Z7001:24

Preface This is the first edition of CSA Z7001, Safe use of energy-based medical and surgical devices in health care . It supersedes CSA Z386, Safe use of lasers in health care; CSA Z387, Safe use of electrosurgical medical devices and systems in health care; and CSA Z305.13, Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings. CSA acknowledges that the development of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard was prepared by the Subcommittee on Energy-Based Medical and Surgical Devices, under the jurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee on Health and Well-Being, 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. Scope 1.1 Safety guidance for use of energy-based medical and surgical devices This Standard presents guidance to ensure the safety of persons at risk in locations where energy-based medical and surgical devices are used. This includes but is not limited to guidance on purchasing, education, training, installation, use, servicing, maintenance, engineering and administrative controls, and personal protective equipment (PPE). 1.2 Application This Standard applies to the use of energy-based medical and surgical devices, which include but are not limited to laser systems, ultrasonic instruments, and electrosurgical devices, whenever they are used during medical, clinical, cosmetic/aesthetic, and surgical procedures. 1.3 Inclusions This Standard applies to all practice settings where energy-based medical and surgical devices are used, including but not limited to a) health care facilities; b) dental clinics and outpatient facilities; c) veterinary facilities; d) laboratories and other research facilities; e) physician offices; f) cosmetic and aesthetic treatment facilities; g) teaching facilities; h) professional exhibitions and trade shows; and i) energy-based medical and surgical device servicing organizations. 1.4 Controls for safe use of energy-based medical and surgical devices This Standard presents the engineering, procedural, and administrative controls, as well as personal protective equipment, necessary to ensure the safety of persons at risk during the use of health care energy-based medical and surgical devices, based on a risk assessment. Note: A risk assessment is a thorough analysis of the workplace to identify situations and processes that could cause harm. A risk assessment performed before policies and procedures are developed is useful for determining engineering, administrative, and procedural controls and work practices to reduce exposure risks by a) identifying hazards; b) analyzing or evaluating the risks associated with those hazards; and c) determining appropriate ways to eliminate or control the hazards. 1.5 Control measures The control measures described in this Standard do not restrict or limit the use of energy-based medical and surgical devices of any type that can be intentionally administered for diagnostic, therapeutic, cosmetic/aesthetic, or research purposes. It is intended to apply to all persons within the area where energy-based medical and surgical devices are in use. 1.6 Exclusions This Standard does not comment on specific manufacturers, equipment, or devices. Technology assessment and risk assessment are the responsibility of the health care facility and providers; however, best practices and evidence-based recommendations in their safe use are included. 1.7 Terminology 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 which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.