Introduction

Surgical smoke, or plume, is generated when energy devices cut or coagulate tissue, causing intracellular water to vaporize and the tissue to thermally decompose. Analyses of plume identify numerous toxic gases and vapors, as well as ultrafine particulate matter that can deeply penetrate the respiratory tract (Ulmer, 2008). These factors pose a notable occupational hazard for surgeons, nurses, and anesthetists.

In the US, NIOSH and OSHA have documented that the plume contains harmful substances like toxic gases, polyaromatic hydrocarbons, and fine ultrafine particulates, including benzene, formaldehyde, and hydrogen cyanide bioaerosols, along with blood and tissue fragments and viral DNA(NIOSH, 1996; OSHA, 2023). High concentrations of exposure can lead to ocular and upper airway irritation and reduce visibility in the surgical field. While the particle size varies by tissue type and device parameters, substantial fractions of these particles are sub-micrometers, which can more easily reach the alveolar region, making standard surgical masks ineffective at filtering them (Alp et al., 2006).

In an extensive NIOSH survey, only 14% of healthcare personnel reported consistent smoke evacuation during electrosurgery, and 47% during laser surgery, revealing persistent practice gaps. Conventional surgical masks provide limited protection against ultrafine particulates and VOCs. Even fit-tested N95 masks serve as secondary protection, only effective if local exhaust ventilation (LEV) is present. Some respirators with carbon layers can adsorb specific volatile organic compounds (VOCs), but are not substitutes for proper smoke capture (Watson, 2010).

Evidence of Harm

NIOSH and CDC summaries of decades of evaluations indicate that plume exposure can cause eye and respiratory irritation, headaches, and nausea (NIOSH, 1996). Extracts from airborne particles show mutagenic potential in vitro, and various studies have detected formaldehyde and other irritants at concerning levels during procedures (Ball, 2018). While definitive data on long-term carcinogenicity or infectious transmission is still developing, the precautionary principle and existing evidence support the consistent use of engineering controls (AORN, 2022). DNA from HPV and HBV has been found in plume under experimental and clinical conditions, prompting recommendations for Local Exhaust Ventilation (LEV) and full PPE during procedures that risk aerosolization, particularly for airway and mucosal surgeries (Alp et al., 2006). In minimally invasive surgeries, ultrafine particles may recirculate in the peritoneal cavity; ensuring effective filtration and avoiding unfiltered release safeguards both the surgical team and patients (OHSAH, 2007).

Lessons from the Field

In May 2022, the Biloxi VA Medical Center responded by mandating smoke evacuation for all electrocautery procedures through new policies and targeted investments. This initiative resulted in a 24% decrease in staff call-outs, and every surveyed staff member reported feeling safer in the evacuated ORs, supporting ongoing compliance and leadership commitment (AORN, 2022).

A pilot study at a pediatric academic center evaluated pollutant levels during spinal and hip surgeries, comparing scenarios with and without tip smoke evacuation. The results showed dramatic reductions in harmful emissions: CO levels decreased from 27 ppm to 2.5 ppm (−90.7%), formaldehyde from 0.698 to 0.151 mg/m³ (−78.4%), and total VOCs from 0.515 to 0.0175 mg/m³ (−96.6%). These findings highlight the substantial benefits of capturing surgical plume at its source (Ball, 2018).

Furthermore, numerous healthcare facilities in the US have achieved the Go Clear Award for smoke-free practices, including the University of Kentucky HealthCare. These organizations have implemented comprehensive education programs, equipped all relevant procedures with evacuation systems, and standardized compliance through policies. As a result, staff satisfaction has increased and the perioperative environment has become considerably safer, making smoke evacuation the new standard in surgical settings.

The Regulatory Landscape

Europe (EU + UK)

Currently, there is no EU-wide law addressing the surgical plume. While organizations like EORNA (2020) and ESNO promote best practices via guidelines, binding EU directives are lacking. Denmark is the only country with mandates requiring local extraction near the source per the 2001 workplace executive order and the 2010 Working Environment Act. Germany relies on TRGS 525 from BAuA (2019), which incorporates protective measures for surgical smoke; however, implementation remains inconsistent based on survey findings. In the UK, there are no mandatory laws, but guidance from HSE and MHRA establishes clear standards, requiring smoke evacuation during laser procedures and highlighting that general ventilation alone is insufficient (HSE, 2022). Advocacy efforts continue, notably with the Surgical Smoke Coalition emphasizing Denmark’s legislative model and the potential of the EU framework as a policy tool.

United States

OSHA’s guidance and NIOSH hazard bulletins advocate a combined approach to managing surgical smoke through general and local exhaust ventilation within 2 inches of the surgical site. This strategy must remain active throughout smoke generation, employing proper filter selection, maintenance, and infectious waste disposal. Additionally, Quick Safety communications highlight plume dangers and advocate for evacuation strategies in perioperative environments. Yet no federal mandate exists in the US requiring surgical smoke evacuation. This results in varied adoption of practices across facilities and states, leading to avoidable disparities in worker protection.

Though the legislative landscape is evolving at the state level. By early 2025, 18 states, including Arizona, California, and New York, will have enacted surgical smoke-evacuation laws (OSHA, 2023). Washington’s law took effect on January 1, 2024, while Virginia’s will start on July 1, 2025. Additional bills are being introduced in 2025 in states like Texas and Florida. The 2024 NFPA 99 (2024) code emphasizes capturing plume as close to its origin as possible, effectively reinforcing point-of-use evacuation practices.

Canada

Historically, Canada referenced CSA documents regarding plume scavenging, but this content was marked withdrawn in 2025. Organizations like CCOHS still cite this guidance, and a recent CSA (2024) standard concerning energy-based devices now offers broader plume control measures. Facility practices adhere to ORNAC perioperative guidelines.

Australia & New Zealand

Australia has robust workplace health and safety regulations; in 2023, New South Wales mandated risk management and controls, while WorkSafe Victoria provides comprehensive guidance for employers. Additionally, ACORN (2023) standards require smoke evacuation for energy device use.

New Zealand has no specific national requirement yet, though professional groups like NZNO advocate for local policy changes, and some hospitals are launching plume-free programs.

International Standards

ISO 16571:2014 (plume evacuation systems) standard has been withdrawn, leading jurisdictions to rely on national codes and guidelines, including NFPA 99, CSA/ORNAC, and professional standards like AORN, EORNA, and ACORN for direction (WHO, 2021).

What Works

While general OR ventilation (≥15 air changes per hour) is vital, it must be combined with point-of-use capture to effectively lower exposure within the breathing zone (NIOSH, 1996). Local Exhaust Ventilation (LEV), such as portable evacuators and smoke-evacuating pencils, works best when positioned within 50cm of the smoke source, continuously capturing smoke during procedures to reduce residual exposure. Proper filter selection is essential (ULPA/HEPA-class filters) for particulates and activated carbon for VOCs, with regular replacement and proper waste disposal (Edwards and Reiman, 2008). Additionally, establishing protocols for device setup, filter management, and equipment readiness on every case cart. Moreover, the use of fit-tested N95 respirators (or higher) during procedures generating plume as a secondary defence against residual exposure from LEV, preferably models with carbon layers for VOC absorption (Watson, 2010).

Technology Landscape:

There are various technology solutions available for plume evacuation:

On-tip smoke evacuation devices:

• Stryker SafeAir: Standard and telescopic pencils for “on tip” capture are compatible with portable evacuators.
• Megadyne: Telescoping Smoke Evacuation Pencil: Adjustable ports for closer positioning to the site.
• Conmed PlumePen Elite: Features a 360° swivel and reportedly offers up to 25% more flow than competitor products.
• DeRoyal ExtendEVA: Telescoping capture sleeves designed for deeper surgical fields.

Portable and console evacuators:

• Bovie® Smoke Shark® (Aspen Surgical): Multistage filtration (ULPA + carbon) with 99.999% particulate capture efficiency.

Adaptable capture sleeves for existing pencils:

• LumipenPro: Attaches to an electrosurgical pencil and connects with OR suction for smoke and fluid removal. The telescoping arm allows the user to advance the suction end closer to the plume. The device also provides a light source to illuminate the surgical incision.
• Remora: Attaches to an electrosurgical pencil to connect with OR suction for smoke and fluid removal.
• Saf T Vac: A disposable device that connects to existing suction systems.

Minimally invasive surgical plume management requires specific solutions to avoid venting unfiltered gases.

• CooperSurgical SeeClear: A passive laparoscopic filter system that traps particulates and odors without a pump, maintaining pneumoperitoneum while removing plume.

Conclusion

Employee health and productivity improve significantly with enhanced air quality and reduced respiratory irritation. For instance, VA Biloxi reported a 24% decrease in staff call-outs post-system implementation. Initial investments in evacuators, disposable supplies, and filters are offset by modern systems that optimize costs with features like extended-life filters. Facilities can ensure optimal setups by utilizing passive filters for minimally invasive procedures and pairing smoke-evacuating tools with portable systems for open surgeries. Meeting emerging regulatory standards can mitigate compliance risks and demonstrate a commitment to staff safety. These proactive measures bolster accreditation efforts and can enhance workforce recruitment and retention.

Surgical smoke is not merely an inconvenience—it represents a preventable occupational hazard with well-documented toxic, irritant, and potentially infectious components. Effective engineering controls are available, compatible with current OR workflows. Experiences, from individual health impacts to organizational improvements in staff well-being, highlight the urgency and operational benefits of addressing this issue. As policy environments evolve, proactive facilities can now protect their teams by standardizing point-of-use evacuation, reinforcing protocols through education and accountability, and aligning with emerging requirements. The technology is available. The evidence is clear. The path to smoke-free ORs is straightforward and overdue.

Editor’s Note: Dr Stuart Grant is the founder, and Principal Consultant, of MedTech innovation management consultancy, Archetype.

He had 25-year career at Johnson & Johnson MedTech and DePuy Synthes, and is the named inventor on numerous patents for market-leading medical devices.

His expertise spans customer needs and insights, front-end innovation, product innovation management, design and engineering, and  regulation requirements.

References

ACORN (2023) Standards for Perioperative Nursing in Australia. Adelaide: ACORN.

Alp, E., Bijl, D., Bleichrodt, R.P., Hansson, B. and Voss, A. (2006) ‘Surgical smoke and infection control’, Journal of Hospital Infection, 62(1), pp. 1–5.

AORN (2022) Guidelines for Surgical Smoke Safety. Denver: Association of periOperative Registered Nurses.

Ball, K. (2018) ‘Compliance with surgical smoke evacuation guidelines: implications for practice’, AORN Journal, 107(3), pp. 261–270.

BAuA (2019) TRGS 525: Technical Rules for Hazardous Substances. Dortmund: Federal Institute for Occupational Safety and Health.

CSA (2024) CSA Z7001:24 Safe Use of Energy-Based Devices. Toronto: Canadian Standards Association.

Edwards, B.E. and Reiman, R.E. (2008) ‘Results of a survey on current surgical smoke control practices’, AORN Journal, 87(4), pp. 739–749.

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OSHA (2023) Guidance on Surgical Smoke. Washington, DC: Occupational Safety and Health Administration.

Ulmer, B.C. (2008) ‘The hazards of surgical smoke’, AORN Journal, 87(4), pp. 721–734.

Watson, D.S. (2010) ‘Surgical smoke evacuation: Are you ready for the change?’, AORN Journal, 92(2), pp. 142–149.

WHO (2021) Occupational Safety and Health in Healthcare. Geneva: World Health Organization.