Safe use of energy based medical and surgical devices in health care

Note: The title and scope for this NOI (originally published on February 14, 2023) were updated by the responsible SDO on April 23, 2024.

1.1

This Standard applies to the use of energy based medical and surgical devices, which includes but is not limited to laser systems, ultrasonic instruments, and electrosurgical devices, whenever they are used during medical, clinical, cosmetic/aesthetic, and surgical procedures.  

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.

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

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.

1.3

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.

1.4

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.