Draft Details

Designation:Z7001
Source:CSA
Review start date:May 13, 2024
Review end date:Jul 12, 2024
Contact email:bradyn.lawrenson(at)csagroup.org
Draft Scope/Description:

1.1 Safety guidance for use of energy based medical and surgical devices

This Standard presents guidance to ensure the safety of persons (e.g., personnel and patients/clients, etc.) 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.

1.2 Standard 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 Standard inclusions

This Standard applies to all practice settings where energy based medical and surgical devices are used, including, but not limited to, the following:

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.

1.2 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 upon a risk assessment.

Note: A risk assessment is a thorough analysis of the workplace to identify situations, processes, etc. that can 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) identification of hazards;

b) analysis or evaluation of the risks associated with those hazards; and

c) determining appropriate ways to eliminate or control the hazards.

1.2.1 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.

1.3 Standard 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.

1.4 Standard language

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.

You may comment on any section of this document by clicking the “Submit Comment” link at the bottom of the relevant section.