Regulations, Recommended Practices & Standards

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Surgical smoke plume is a dangerous by-product generated from the use of lasers, electro-surgical pencils, ultrasonic devices, and other surgical instruments. As these instruments cauterize vessels and destroy (vaporize) tissue, fluid, and blood, they create a gaseous material known as smoke plume. Throughout the world various regulatory bodies, professional organizations and standards organizations set standards, provide position statements, and offer guidance that govern surgical smoke evacuation procedures and other protective measures throughout the world. See what regulations exist for your part of the world.

United States

Regulations:

Occupational Safety & Health Administration (OSHA)

OSHA is the only U.S. regulatory body to date that has legal authority in the United States granted by Congress. They estimate that 500,000 healthcare workers are exposed to surgical smoke and bio-aerosols each year. On a number of occasions OSHA has reiterated that the management of surgical plume is a healthcare worker safety issue. They have also indicated that plume hazards fall under the scope of the following:

  • General Duty Clause
    • "Each employer shall furnish to each of his (sic) employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees."
  • Personal Protective Equipment (PPE)
    • Controlling a hazard at its source is the best way to protect employees.

Recommended Practices & Standards:

National Institute of Occupational Safety and Health (NIOSH)
NIOSH is part of the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services. NIOSH provides recommendations and interventions for the building of a healthy, safe and capable workforce.

  • HC 11 - Control of Smoke from Laser/Electric Surgical Procedures
    • Recommended ventilation techniques include a combination of general room and local exhaust ventilation (LEV). General room ventilation is not by itself sufficient to capture contaminants generated at the source.
The Joint Commission 

The Joint Commission is an independent, not-for-profit organization. The Joint Commission accredits and certifies more than 20,500 health care organizations and programs in the United States and writes standards by which they measure healthcare facilities compliance.

  • Environment of Care EC02.02.01
    •  Healthcare facilities manage their risks related to hazardous materials and waste
    • The hospital minimizes risks associated with selecting, handling, storing, transporting, using, and disposing hazardous gases and vapors
    • Hazardous gases and vapors include, but are not limited to, glutaraldehyde, ethylene oxide, vapors generated while using cauterizing equipment and lasers, and gases such as nitrous oxide
Association of periOperative Registered Nurses (AORN)

AORN is a professional association based in Denver, Colorado that represents the interests of more than 160,000 perioperative nurses. The following are contained in Recommended Practices:

2017 AORN Guideline for Surgical Smoke Safety 

Recommendation I

“The health care organization should provide a surgical smoke free environment.”

Recommendation II

The perioperative team should evacuate all surgical smoke.

“The collective evidence, standards, and guidelines from NIOSH, the Healthcare Infection Control Practices Advisory Committee, and professional organizations indicates that evacuating surgical smoke protects patients and health care workers from the hazards of surgical smoke.”

Recommendation III

“Perioperative team members should receive initial and ongoing education and competency verification on surgical smoke safety.”

Recommendation IV

“Policies and procedures for surgical smoke safety should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting in which they are used.”

Recommendation V

“Perioperative personnel should participate in a variety of quality assurance and performance activities that are consistent with the health care organization’s plan to improve understanding and compliance with the principles and processes of surgical smoke safety."

2017 Guidelines for Perioperative Practice, First Published: December 2016.
Copyright © 2017 AORN, Inc. All rights reserved.

Denmark

Regulations:

Danish Working Environment Authority

Danish Working Environment Authority is an agency under the auspices of the Ministry of Employment. The Danish Working Environment Authority is the authority which contributes to the creation of safe and sound working conditions at Danish workplaces. The agency is responsible for administering the Working Environment Act in Denmark, and guides companies on health and safety rules at the workplace. 

  • AT-Instructions 4/2007 and 11/2008
    • It is mandatory to implement a measurable setup for local evacuation of harmful substances, such as surgical smoke.
    • Such a setup must be equipped with a monitoring feature to indicate if the evacuation system's suction is inadequate.
    • Surgical smoke should be removed with local evacuation and as close to the source as possible.
    • The filtered air must lead out into the open (read: outside the OR).

Canada

Recommended Practices & Standards:

Canadian Standards Association (CSA)

The CSA developed and released one of the furthest reaching standards relating to the management of surgical plume.

  • CSA Z305.13-13 Plume Scavenging In Surgical, Diagnostic, Therapeutic, and Aesthetic Settings
    • This standard details a comprehensive approach to managing plume and extends its mandates to all surgical settings based on risk assessment. General requirements include:
      • Facility policies and procedures shall be written in accordance with (IAW) this Standard
      • Plume shall be evacuated IAW this standard
      • If a facility employs techniques that create plume, they shall have policies that address the potential hazard 

Australia

Regulations:

Ministry of Health, New South Wales, (NSW)
Work Health and Safety - Controlling Exposure to Surgical Plume

Document Number GL2015_002

Publication Date 19-Jan-2015

  • Purpose
    • To provide guidance to NSW Health Organisations in meeting their duty of care under the Work Health and Safety Act 2011 (WHS Act) and Work Health and Safety Regulation 2011 (WHS Regulation) in eliminating risk, and if not reasonably practicable, to minimise risk associated with surgical plume.
    • This guideline applies to all NSW Health Organisations and all other bodies and organisations under the control and direction of the Minister for Health or the Secretary of the NSW Ministry of Health where facilities under their control create surgical plume, such as in: operating theatres; dental clinics; morgues during autopsy; laboratories/research and testing facilities.

Click here to view regulation.

Recommended Practices & Standards:

Australian College of Operating Room Nurses (ACORN)
ACORN is a professional organization that develops standards and recommendations to promote excellence in perioperative care. The following is ACORN's standard:

  • Standard S20
    • Personnel shall utilize appropriate equipment and procedures to prevent exposure to surgical plume
    • Exposure to surgical plume shall be minimized during the surgical procedure
    • Surgical smoke capture devices shall be available for use during procedures in which surgical smoke is generated (ACORN 2006)

Great Britain

Recommended Practices & Standards:

Health and Safety Executive (HSE)
The HSE is the enforcement authority in Great Britain. The following are Health and Safety Executive (HSE) recommended practices and standards:

  • Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The following is MHRA’s recommended practice:

    • MHRA DB2008(03) April 2008
      • Recommends that smoke evacuation systems are to be used during laser surgery. In addition, it is specified that masks and operating room laminar flow systems are not suitable for protection from surgical smoke.

  • Association for Perioperative Practice (AfPP) works to encourage the exchange of professional information between members and co-operation with other professional bodies. They are not a regulatory agency but a recommending agency. The following is AfPP’s standard:

    • Standard 2.6 Lasers - Standards and Recommendations for Safe Perioperative Practice
      •  The standard states that ‘Dedicated smoke evacuation machines must be used to remove the smoke…’ (AfPP 2007).

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