CE ONLINE SURGICAL SMOKE: WHAT WE · PDF fileCE ONLINE SURGICAL SMOKE: WHAT WE KNOW ... and provide verification, if necessary, ... non-invasive procedures, and endoscopic

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An Online Continuing Education ActivitySponsored By

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Welcome to

SURGICAL SMOKE:WHAT WE KNOW

(An Online Continuing Education Activity)

CONTINUING EDUCATION INSTRUCTIONSThis educational activity is being offered online and may be completed at any time. Steps for Successful Course CompletionTo earn continuing education credit, the participant must complete the following steps:

1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective.

2. Review the content of the activity, paying particular attention to those areas that reflect the objectives.

3. Complete the Test Questions. Missed questions will offer the opportunity to re-read the question and answer choices. You may also revisit relevant content.

4. For additional information on an issue or topic, consult the references.5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion. Pfiedler Enterprises will maintain a record of your continuing education credits

and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner.

If you have any questions, please call: 720-748-6144.

CONTACT INFORMATION:

© 2016All rights reserved

Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196

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OvERvIEW Thermal destruction of tissue produced by use of a laser or electrosurgical unit during surgical procedures, exposes operating room personnel (including surgeons, perioperative nurses, surgical technologists, and anesthetists) and patients to surgical smoke containing potentially hazardous breathable aerosols and cell fragments. This online continuing education activity has been designed to assist perioperative professionals deliver safe and effective patient care when smoke evacuation is used during operative and invasive procedures. The topics presented will include: what we know about surgical smoke; the best defenses against surgical smoke; recommended U.S. practices, guidelines, standards and regulations as well as international recommendations/guidelines on surgical smoke; and suggested steps for implementing a smoke evacuation program.

OBjECTIvESAfter completing this continuing nursing education activity, the participant should be able to:

1. Discuss the contents, distribution, and risks of surgical smoke. 2. Describe the best defenses against surgical smoke. 3. Review the practices, guidelines, standards, and recommendations for evacuation

of surgical smoke in the U.S. 4. Identify the recommendations/guidelines around the world for evacuation of surgical

smoke. 5. Outline a plan to develop a surgical facility smoke evacuation program.

INTENDED AUDIENCE This continuing education activity is intended for perioperative registered nurses who are interested in the latest information about providing a safe environment of care by using smoke evacuation and filtration during surgical, non-invasive procedures, and endoscopic procedures.

CREDIT/CREDIT INFORMATIONState Board Approval for NursesPfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hour(s).

Obtaining full credit for this offering depends upon completion, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes.

The certificate of course completion issued at the conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of attendance.

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RELEASE AND EXPIRATION DATEThis continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in July 2016 and can no longer be used after July 2018 without being updated; therefore, this continuing education activity expires July 2018.

DISCLAIMERAccredited status as a provider refers only to continuing nursing education activities and does not imply endorsement of any products.

SUPPORTGrant funds for the development of this activity were provided by Medtronic.

AUTHORS/PLANNING COMMITTEE/REvIEWERjulia A. Kneedler, RN, MS, EdD Aurora, COProgram Manager/ReviewerPfiedler Enterprises

Judith I. Pfister, RN, BSN, MBA Aurora, COProgram Manager/PlannerPfiedler Enterprises

Dondra Tolerson, BS, MA Woodstock, GAMedical Writer/Author

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Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this continuing education activity. “Relevant financial relationships” are those in any amount, occurring within the past 12 months that create a conflict of interest. A commercial interest is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

Activity Planning Committee/Authors/Reviewers:

Judith I. Pfister, MBA, RN No conflict of interest

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julia A. Kneedler, EdD, RN No conflict of interest

Dondra Tolerson, BS, MA No conflict of interest

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INTRODUCTIONSurgical smoke has been identified in the patient-care environment wherever surgical and/or invasive procedures are done.1 Surgical smoke has been described as part of the airborne chemical soup that is present during the care of perioperative patients. The air quality in operating rooms around the world has been a concern for over three decades. The progression is summarized from 1975 to 1995 (Table 1).2

Table 1 – Evolution of Surgical Smoke Concerns2

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As discussion of the contents of surgical smoke continued in the 1990s, the Association of periOperative Registered Nurses (AORN) hosted its first multidisciplinary round-table discussion on smoke in January 1996. This was an historic event that brought together experts from the Occupational Safety and Health Administration (OSHA), the National Institute of Occupational Safety and Health (NIOSH), ECRI, researchers, surgeons, registered nurses and health-care manufacturers. The outcome of the round table was chronicled in Giordano’s 1996 article, “Don’t be a Victim of Surgical Smoke.”3

A result of the conference was that in September 1996, NIOSH sent out a hazard-control alert to all hospitals in the United States recommending that smoke from lasers and electrosurgical units be evacuated and filtered (Figure 1).4

Figure 1 – Control of Smoke From Laser/Electric Surgical Procedures4

AORN continued to raise awareness about the hazards of surgical smoke by hosting a second conference on smoke in February 1997. The second meeting brought together experts from the same groups as the 1996 meeting, but added representatives from the American Society of Anesthesiology (ASA), the American College of Surgeons (ACS), the American Nurses Association (ANA) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The goal was to include as many organizations as possible to build consensus on best methods to affect change in the regulation of surgical smoke.5 The most important outcome of the second smoke conference was the development of a guidance document from OSHA that was intended to support

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evacuation of surgical smoke. The detailed 20-page document was sent out to reviewers in 1998 in anticipation of publication, and was similar in scope to the 1996 NIOSH alert.6 By 2000 the guidelines had not been published. In July 2000, OSHA announced the delay was due to a need for more evidence.7

With no government guidelines published, concern and controversy surrounding surgical smoke and air quality in the operating room continues. The impact of work environment on the health of caregivers is of ever- increasing concern, and is now discussed as well by professional organizations in other countries. In 2003, AORN first published the Position Statement on Workplace Safety. The position statement lists the hazards faced by perioperative professionals and among those is smoke plume and notes: 8

“The workplace safety culture is of increasing importance as workloads increase, due to the effects of the nursing shortage, increased patient acuity and an emphasis on higher productivity. The multiple occupational hazards that create a risk of personal injury that perioperative nurses face in the workplace are both physical and psychosocial.”

WHAT IS SURGICAL SMOKE? Surgical smoke is called by a variety of names, including cautery smoke, electrosurgery smoke, diathermy plume, plume, aerosols, bio-aerosols, vapor and air contaminants. Surgical smoke can be seen and smelled (Figure 2).

Surgical smoke is the result of the interaction of tissue and mechanical tools and/or heat- producing equipment, such as those that are used for dissection and hemostasis. Both the visible and the odorous components of surgical smoke are the gaseous byproducts of the disruption and vaporization of tissue protein and fat.9

Figure 2 – Electrosurgery Pyrolysis of Human Tissue Produces Smoke

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HOW IS SMOKE PRODUCED? The primary mechanism to achieve hemostasis and tissue dissection during surgical procedures is with heat-producing devices. These include electrosurgery units, lasers, ultrasonic devices, high-speed drills, burrs and saws. All of the devices produce heat, which allows the surgeon to achieve the desired tissue effect. The most common device used is the electrosurgery unit. Electrosurgery uses high-frequency electrical current, called radiofrequency current. The two basic waveforms are cut, also called vaporization, and coagulation, also referred to as fulguration. The cut waveform is a continuous (undampened), low-voltage modality. The continuous current flow heats cell contents to the boiling point of 100 degrees Celsius, thereby exploding the cell wall.10 The vaporization releases the cellular fluid as steam, and simultaneously spews the cell contents into the air forming surgical smoke.

The coagulation waveform is a high-voltage, interrupted (dampened) wave pattern. The interruption in the wave pattern is a rest period in the delivery of the electrical current, causing a more gradual rise in the temperature of the cellular fluid. Above 90 degrees Celsius cellular liquid evaporates and proteins are denatured, losing structural integrity. Once the temperature reaches 100 degrees Celsius the tissue is carbonized (Figure 3). The depth of necrosis in the tissue is more superficial, unless the active electrode is held in contact with the tissue, which is called desiccation. This method of delivering electrosurgery current will result in greater thermal tissue effect.11 Desiccation using the coagulation current is used by many practitioners, and the carbonized tissue contributes to the cellular debris released into the air.

Figure 3 – Temperature and Tissue Damage

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Lasers are the second most common heat-producing device used by surgeons. Laser is an acronym (Light Amplification by Stimulated Emission of Radiation), which refers to the process in which light energy is produced. This energy is a concentrated beam of light. It is distinguished from an ordinary light beam because it is monochromatic, collimated and coherent. Monochromatic light is composed of photons of the same wavelength or color. Collimated laser beams are waves that are parallel and can be focused through a lens. Coherent waves are orderly and travel in the same direction, providing power to the laser beam. Thermal effects vary with the wavelength, beam fluency, tissue color, consistency and water content. This allows for selective and specific tissue effects among the various types of lasers.12 Surrounding tissue is also heated because it borders the impact site. The degree of adjacent tissue damage depends on the duration of the laser beam exposure. Lasers produce high heat — 100 degrees to 1,000 degrees Celsius — that boils and explodes the cells. This cellular vaporization releases steam and cell contents.13 The characteristics of the cellular matter are determined by the type of laser being used and the type of tissue.

Lasers and electrosurgery units both work by using high thermal energy, and both release cell contents. When the particulate matter of both laser and electrosurgical smoke are compared they look very similar, as identified by ECRI (Figure 4). Because of the similarities, facility policies on smoke evacuation should be the same for electrosurgery units and for lasers.14

Figure 4 – Comparison of Contents of ESU and Laser Smoke

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Ultrasonic devices have gained popularity as dissection and hemostasis tools. Ultrasonic dissection removes tissue by rapid mechanical action. It does not produce sound waves. It is called ultrasonic because vibrations that occur are from 23-55 kHz, and are above the sonic range of human hearing.

Ultrasonic aspirators have hollow tips. With a hollow tip, only the tissue in direct contact with the circumferential edge or core of the tip is impacted. Minimal thermal damage occurs because the heat generated by the tip is conducted away via the irrigation fluid. The tip irrigation does produce a fine mist, but the surgical field is continuously cleared by the suction at the tip.

Ultrasonic scalpels use solid tips or blades. When the tips vibrate, thermal heat is produced by the edge of the blade. This technology allows surgeons to coagulate and divide tissue. The tip vibrates at a frequency of 55,000 times per second, stimulating collagen molecules to denature and form a coagulum.

15 The motion of the tip produces a vapor, which because of lower tip temperatures could carry infectious aerosols.16

Both types of ultrasonic devices produce rapid mechanical motion with transducers within the hand pieces. Two types of transducers are used – piezoelectric crystals and magnetostrictive laminations. The piezoelectric ceramic transducer is composed of a series of ceramic disks mounted together. When electrical energy is applied, the disks change shape and cause the tip to vibrate. The ceramic discs are air cooled, so the hand piece is lighter. It is also more fragile, and may break if dropped. The magnetostrictive transducer has 22 to 24 nickel alloy laminations that are layered together. The electrical energy stimulates the laminations to lengthen and shorten, creating tip excursion. The laminations do get hot, but the heat is dissipated via an internal closed continuous water-cooling system. Magnetostrictive transducers are capable of higher amplitudes and are more durable.

Often overlooked sources of air contamination in the operating room are bone saws, drills and other high-speed electrical devices used to dissect and resect tissue. These instruments produce heat by rapidly rotating or sawing, thereby disrupting tissue. Because the saw blades, drills and burrs do heat up, irrigation is often dripped over them to reduce the heat buildup. The mechanical motion of the saw, drill or burr, combined with irrigation sends a mist of aerosols into the surgical field. Research has shown that blood- containing aerosols have the potential of invading the breathing zones for scrub team members during power tool use.17 Further research raises the issue of viable bloodborne pathogens, which may be contained in power tool aerosols.18

CONTENTS OF SURGICAL SMOKE Surgical smoke is made up of 95% water or steam, and 5% cellular debris in the form of particulate material. The 5% particulate matter is composed of chemicals, blood and tissue particles, viruses and bacteria.19 The contents of surgical smoke have been described at the very least as being a nuisance, and at worst carcinogenic. Since Mihashi, et al raised concerns about the contents of surgical smoke in 1975, researchers

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and practitioners have continued to look at smoke and what is in it, and document findings.2 One point yet to be decided is if any smoke is safe. Indeed, some staunchly believe there is no such thing as safe smoke. It seems prudent to err on the side of safety, and protect patients and health-care workers from any potential dangers from surgical smoke. Anderson stated it best in 2005 by asking a provocative question:

“In hindsight, will health-care professionals be embarrassed about their cavalier attitudes toward surgical smoke as they once were with cigarette smoke?” 20

There has long been interest in defining the exact risk of surgical smoke. Designing research studies has been challenging. Reviewing the work of researchers is a good starting point to assess potential risks and formulate plans to protect against hazards.

Determining aerosolized particle size is important. Particles that remain airborne are smaller than 100 micrometers in diameter. Particles that are 5.0 micrometers or larger are deposited on the walls of the nose, pharynx, trachea and bronchus. Particles that are less than 2.0 micrometers in size are deposited in the bronchioles and alveoli — the gas exchange region of the lungs (Figure 5).21 By comparison, an average human hair is about 200 micrometers in size. Viruses are the smallest in size, ranging from about 0.01- 0.3 micrometers (Table 2).22

Table 2 – Typical Particle Sizes22

DesCoteaux and colleagues in Canada used a cascade impactor to collect smoke according to particle size and weight.

They used an electrosurgery unit and analyzed the

smoke with electron microscopy. They demonstrated the presence of breathable aerosols and cell fragments in the smoke.23

Taravella and colleagues in Colorado set out to determine if respirable-size particles were present following laser use. Particles collected were measured with an electron microscope and had a mean diameter of 0.22-0.056 micrometers. The researchers concluded the particles were in the respirable range, but the study could not make a determination about the health hazards of breathing the particles.21

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Miller and associates found that long time exposure to fine particulate air pollution is associated with an increased incidence of cardiovascular disease and death among postmenopausal women. When one compares this research to the average age of a perioperative nurse, concern about inhaling polluted air in surgery is greatly elevated.24

Of the surgical smoke or plume generated in the operating room, each technology produces a different size particle. The smaller the particle size, the further it can travel, which can impact people circulating during a procedure as well as those scrubbed. The chemical composition of surgical smoke has been well documented. Barrett and Garber identified a long list of chemicals present in surgical smoke (Table 3).16 Two of the chemicals of concern were acrylonitrile and hydrogen cyanide. Acrylonitrile is a volatile, colorless chemical that can be absorbed through the skin and lungs. Acrylonitrile liberates hydrogen cyanide. Hydrogen cyanide is toxic, colorless and can also be absorbed into the lungs, through the skin and via the gastrointestinal tract.16

Figure 5 – Particle Sizes in Respiratory Tree21

Hollmann and colleagues in Switzerland conducted experiments to determine the chemical composition of surgical smoke. Using laser photoacoustic spectroscopy they identified 11 different gases that could be classified as toxic and mutagenic. Of concern was the furfural present in surgical smoke, which was found at a level of 12 times higher than recommended occupational exposure limits. Furfural is a solvent that acts as a strong irritant affecting the eyes, mucous membranes, lungs and the central nervous system. The researchers noted the “potential danger from toxic and mutagen gas compounds, particulate material and partly virulent virus DNA cannot be overemphasized.”25

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Benzene is another chemical identified in surgical smoke. The OSHA sets permissible exposure limits (PELs) to protect workers from the hazards associated with inhaling benzene. Protection from inhaling benzene is mandated by OSHA because benzene is documented as being a trigger for leukemia.6

Table 3 – Chemical Contents of Surgical Smoke

Awareness of some of the chemical components of smoke, recommended exposure limits and the associated health effects is an important consideration in the education of surgical staff members. Along with the OSHA PELs, NIOSH sets relative exposure limits (RELs), and the American Conference of Governmental Industrial Hygienists (ACGIH) sets threshold limit values (TLVs) of toxic chemicals (Table 4).

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Table 4 – Chemical components of smoke and associated health risks26

In addition to the chemical components of surgical smoke, concerns have been raised about the presence of blood particles, virus and bacteria in the smoke particulate matter. Plappert and associates in Germany designed a study to evaluate the cytotoxic, genotoxic, clastogenic and mutagenic potential of the byproducts of laser pyrolysis of tissue.27 After subjecting the aerosols to several scientific laboratory tests, the research team reported, “we were able to prove that the particulate fraction of laser pyrolysis aerosols originating from biological tissues undoubtedly have to be classified as cytotoxic, genotoxic, clastogenic and mutagenic.”27 They also recommended that operating room personnel should be protected from the health hazard of surgical smoke.27

To answer the question of blood-containing aerosols in smoke and whether or not the blood particles can invade the breathing zones of operating room personnel, Jewett, Heinsohn and colleagues conducted two studies. Both used a bone saw, drills and an electrosurgery unit in both the cut and coagulation mode. The staff wore 10-stage, low- pressure cascade impactor respirators to determine aerosol particle size distribution and Hemastix to determine hemoglobin content. Both studies revealed all the tools which

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were tested produced blood-containing aerosols in the respirable range of less than 5 micrometers (Table 5).17, 28

EXPOSURE TO BLOOD CONTAINING AEROSOL Table 5 – Inspirable Blood Particles in Smoke28

The potential of transmitting virus and bacteria to health-care workers has long received the attention of researchers. The topic of human papillomavirus (HPV) and human immunodeficiency virus (HIV) infectivity was looked at by a number of groups in the late 1980s and 1990s:

• Garden et al, demonstrated the presence of intact viral DNA in smoke29

• Ferenczy and associates sampled 110 patients and smoke evacuator contentsfollowing surgery and found one in five of the canisters contained HPV DNA30

• Sawchuk and colleagues studied human papillomavirus in wart vapor followinglaser and electrosurgery treatment; they found HPV DNA in five out of eight lasersamples, and in four out of seven electrosurgery samples31

• Baggish and associates sampled tubing used to evacuate smoke from HIV-infected tissue and found positive samples present in the tubing32

In 1998 Capizzi and colleagues looked at the viability of bacteria during laser resurfacing done on 13 patients. Specimens were collected and tested following the procedure. Of 13 bacterial cultures, five resulted in coagulase-negative Staphylococcus growth. Of the five, one had growth of Corynebacterium and one showed Neisseria growth. The researchers concluded there was potential for transmitting bacteria to operating room personnel, and that smoke evacuation should be used.33

Garden and associates studied viral disease transmission through exposure to smoke aerosols. They exposed bovine papillomavirus to carbon dioxide laser. The smoke was collected and then reinoculated onto the skin of the cows. The collected plume was tested and the presence of papillomavirus DNA was positive. They found that tumors developed at the laser-plume inoculated sites. Histology and chemical analyses revealed that the tumors were infected with the same type of virus as was in the laser smoke. The researchers concluded they had proved that laser plume could transmit disease.34

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HOW IS SMOKE DISTRIBUTED? There is no doubt that the smell of surgical smoke can permeate an entire surgical suite. In spite of the pervasive smell, a common belief is that the scrubbed members of the surgical team are at greatest risk from inhaling the smoke. Brandon and Young have conducted studies to determine the particle size and distribution of smoke in the operating room. Reported results reveal that without smoke removal, particle concentration can increase from a baseline of about 60,000 particles per cubic foot, to about 1 million particles per cubic foot within five minutes after the electrosurgery unit is activated. The concentration levels remain elevated throughout the use of the ESU. The concentrations were also documented as high throughout the operating room, indicating everyone in the operating room is subjected to particle concentrations comparable to those of scrubbed team members. They further documented that it took about 20 minutes for the operating room ventilation to return the room to baseline levels.35

The results from a 2002 study by Nicola and associates in Brazil help explain how all surgical team members could be exposed to similar levels of surgical smoke. They measured the speed and distance that smoke particles were ejected from lased animal skin. Laser Doppler Velocimetry (LDV) measured the speed of smoke particles to be in the range of 9 to 18 meters per second. Once the particles were set in motion, the residual kinetic energy could send the particles about 0.87 meters from the skin surface.36

Tanpowpong and Koytong in Bangkok, Thailand, compared suspended particulate matter in an office and laser smoke particles in a laser operating room. Suspended particles in the 15, 10 and 2.5 micrometer size were measured using a laser diode dust monitor. All three particle sizes were within safe levels when measured in the office. The suspended particles in the operating room before laser use were higher than measurements in the office. The suspended particulate matter during and after laser use was much higher, and deemed dangerous to both patients and operating room personnel.37

RISKS TO PERIOPERATIvE PERSONNEL What are the risks of inhaling surgical smoke? Are the potential dangers cumulative? A specific link between exposure to surgical smoke and adverse health effects to perioperative personnel has not been made. There is anecdotal information, and an abundance of recommendations. There are no mandatory regulations in the United States that surgical smoke must be evacuated, but the voluntary standards from professional organizations are clear that there is potential danger in continuously inhaling substances present in surgical smoke. Alp and colleagues from The Netherlands developed a list of potentials risks (Table 6). The symptoms and potential risks identified are consistent with reports from health-care professionals and researchers over the last two decades.

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Table 6 – Surgical Smoke Inhalation Symptoms38

As early as 1988, Baggish and colleagues conducted animal research establishing a link between inhaling unfiltered surgical smoke and pulmonary changes. Laboratory rats were exposed to unfiltered smoke and smoke filtered through a smoke evacuator. The rats that breathed the unfiltered smoke showed pathological pulmonary changes. Those that breathed smoke that was passed through an ultra-low penetration air filter (ULPA) showed no pathological changes.39 A study by Wenig and colleagues in 1993 supports Baggish’s work on animal pulmonary changes, such as alveolar congestion and emphysema.40

Concerns have been documented among practitioners about the possibility of contracting infections from inhaling the viral components of surgical smoke. A 44-year-old laser surgeon in Norway developed laryngeal papillomatosis. In situ DNA hybridization of his tumor biopsies revealed human papillomavirus DNA types consistent with the anogenital condylomas lased from his patients.41 Information about the potential risks is readily available. Still, we ask for more proof. Cunnington at the Leicester Royal Infirmary in the United Kingdom insightfully observes “Evidence may be a long time coming — as with smoking — [while] staff are literally absorbing the risk.”42

RISKS TO PATIENTS Surgical smoke can be a risk for patients during laparoscopic surgery. A study from University of Minnesota measured levels of carbon monoxide inside the peritoneal cavity during laparoscopic cholecystectomy. The study found that carbon monoxide was present

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in the abdomen five minutes after the use of electrosurgery at a median concentration of 345 parts per million (ppm). By the end of the procedure the median concentration had risen to 475 ppm. This was in excess of the 35 ppm upper limit for a one-hour exposure set by the Environmental Protection Agency.43

Danger of smoke inside the abdomen has also been documented at Mercer University School of Engineering. As smoke is produced inside the abdomen, it is absorbed through the peritoneal membrane. The subsequent result in the patient’s bloodstream is an increase in the methemoglobin and carboxyhemoglobin concentrations, thereby reducing the oxygen carrying capacity of red blood cells.44 One potential hazard for the patient is falsely elevated pulse oximeter readings. Pulse oximeter readings are compromised in the presence of dyshemoglobinemia. Carboxyhemoglobin and methemoglobin are dyshemoglobinemias, and give a falsely elevated oxygen reading which could result in unrecognized patient hypoxia.9

An additional risk to the patient from surgical smoke inside the abdomen is port-site metastases. The theory has been that if malignant tissue is cauterized and aerosolized inside the abdomen, the cancerous cells could reimplant at another site. A study conducted by Fletcher and colleagues in Canada concluded that when electrocautery is applied to melanoma cells they are released into the plume. The researchers concluded that the cells were viable and could be grown in culture. This could explain port metastases at sites that were not in direct contact with the tumor.45

Furthermore, a study published in 2015 examined cancerous tumor cells that were cauterized with electrocautery, radiofrequency ablation and ultrasonic scalpel. Their findings indicated that the subsequent surgical smoke contained viable tumor cells.46

THE BEST DEFENSE AGAINST SMOKE What can you do to protect yourself from the potential dangers of inhaling surgical smoke? Former AORN Journal Editor Brenda Gregory Dawes stated in 2000 that a “stop smoke campaign begins with you.”47 Professional organizations, government bodies and healthcare organization guidelines recommend the use available tools and knowledge to minimize exposure to surgical smoke. In particular, there are strong recommendations for surgical smoke to be evacuated at the source by local exhaust ventilation.48 Until there are regulations that reduce the occupational hazard of surgical smoke, become an expert in what can be done.

GENERAL OPERATING ROOM vENTILATION The operating room air exchanges through the general air circulation should be maintained at a minimum of 15 exchanges per hour in U.S. hospitals. All rooms should be maintained at positive pressures.49 It is also important to ensure filters for the general ventilation system are maintained and changed as recommended by the manufacturer. Dirty air filters will impede room air exchanges.

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SURGICAL MASKS The original purpose of the surgical mask was to protect patients from infection from members of the surgical team. Now the need is to also protect health-care professionals from aerosols released into the atmosphere in surgical smoke. The filtration efficiency of masks varies.50

Surgical masks generally filter particles to about 5 microns (micrometers) in size. High-filtration masks, also referred to as “laser” masks, filter particles to about 0.1 microns in size. Approximately 77% of the particulate matter in smoke is 1.1 microns and smaller.51 Wearing the higher filtration masks does afford some respiratory protection. Viral particles however, can be much smaller than 0.1 microns.

A 2016 study evaluated the performance of select masks in clinicians exposed to surgical smoke.52 The researchers’ findings indicated that surgical mask respirators (SMR) offer measurably improved protection against surgical smoke than surgical masks. The N100 filtering facepiece respirator (FFR) (that included a prototype face seal) showed substantially more improvement over the SMRs. The researchers acknowledged that the N100 FFR is not practical for use in the O.R.; however, their results suggest the potential for further exploration of face seal technology in the surgical environment.

There is the ongoing controversy about how masks are worn and how long surgical masks should be worn. A mask worn loosely or worn too long is less effective.53 Masks should be worn snugly and changed often. Masks should not however, be the only defense against surgical smoke. Additional means are necessary to protect surgical team members from inhaling surgical smoke.

WALL SUCTION Operating room wall suction has been the most popular way to evacuate smoke. Wall suction usually pulls less than 5 cubic feet per meter (CFM), so this suction will only be effective in procedures that produce a small amount of smoke. If wall suction is used, an inline filter must also be used (Figure 6). If an inline filter is not used to filter the smoke, then a buildup of particles from the smoke can begin to occlude the suction line. For wall suction to be effective, the suction lines must always be patent. Inline filters must be used according to the manufacturer’s instructions and changed as recommended. An overused filter affords no protection. After use, disposal of inline filters should be in accordance with standard precautions.

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Figure 6 – Wall/Canister Suction with Inline Filter

SMOkE EvACUATION SySTEM – PORTABLE Portable smoke evacuation systems are presently the most versatile choice for operating rooms (Figure 7). The most effective smoke evacuation system is the triple filter system equipped with an ultra-low penetration air (ULPA) filter. ULPA filters are made up of a depth media material capable of capturing 0.12 micron and larger particulate matter at an efficiency rate of 99.9999 percent. At that rate, only one in 1 million particles will escape capture.26 The system is made up of a prefilter that captures large particles. The ULPA filter is the second stage of the filter, and captures the smaller particles of smoke. The final filter is made up of a special charcoal that captures the toxic chemicals found in smoke (Figure 8). The triple filter systems normally have variable suction volume capacity to accommodate various levels of smoke production. An effective portable smoke evacuation system should be able to pull a minimum airflow of 35 CFM to be able to capture surgical smoke.54

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Figure 7–Portable Smoke Evacuation Systems Consist of a Capture Device, vacuum Source and Filtration Systems

Figure 8 – ULPA Four Stage Filter System

A variety of capture devices can be used with the smoke evacuation systems. A small carriage unit that attaches to the electrosurgery pencil or is within the design of the electrosurgery pencil allows for smoke capture at the site of its generation (Figure 9). The recommendation is that the capture device be within 2 cm from the point of smoke production. Larger size tubing can also be used with smoke evacuators when it is not feasible to use the pencil carriage device. The larger tubing can be used farther

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away from the electrosurgery pencil site, but care should be taken to ensure the tubing is close enough to capture smoke effectively. The larger tubing also requires greater capture velocity from the evacuator, therefore, the smoke evacuator setting will need to be increased. The perioperative team should anticipate the amount of smoke that will be produced during the procedure and choose the system most appropriate for the procedure. When disposing of used smoke evacuation disposables following a procedure, standard precautions should be used. Gloves should be worn as a contaminated filter presents an occupational hazard to healthcare professionals.

Figure 9 – Smoke Pencil Capture Devices

CENTRAL SMOKE EvACUATION SYSTEMS Newly constructed operating rooms have the option of installing a central smoke evacuation system. These evacuation systems are located outside the operating room, and are therefore quieter than portable systems.

LAPAROSCOPIC SMOKE EvACUATION Surgical smoke should be evacuated and filtered during laparoscopic procedures. The creation of smoke during minimally invasive procedures can hinder the surgeon’s view. Using devices that produce less smoke, such as bipolar electrosurgery units or tissue fusion systems, can help reduce the production of smoke.55 Laparoscopic smoke can be evacuated and filtered through special laparoscopic smoke evacuation devices.

In addition to allowing better visibility during surgery, evacuating smoke will reduce the amount of methemoglobin and carboxyhemoglobin in the patient’s bloodstream postoperatively. When the pnuemoperitoneum is released at the end of the procedure, the insufflation gases and contaminants should also be evacuated and filtered through a

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smoke evacuation system to prevent spewing these inhalation hazards into the faces of surgical team members.

RECOMMENDED PRACTICES, GUIDELINES, STANDARDS AND REGULATIONS Through the efforts of the California Nurses Association (CNA), in May 2016 California lawmakers approved a bill (A.B. 2272) that requires the state to adopt rules that enhance protections for healthcare workers and patients exposed to toxic fumes in the surgical environment.56, 57 However, to date there is a not a federal or national mandate regarding the evacuation of surgical smoke. Recognizing the serious risks involved with exposure to surgical smoke, numerous organizations have adopted recommendations, voluntary guidelines and professional standards to protect healthcare professionals from surgical smoke. Perioperative teams have implemented these guidelines and standards and included them as part of their educational programs. For one team, post-implementation quantitative data showed a 14.6% increase in surgical smoke-evacuation use, an increase in staff awareness of reducing the presence of surgical smoke in the OR and helped ensure a safer environment for patients, staff members, and the surgical team.58 As such, a review of current recommendations can assist perioperative practitioners in developing policies and procedures in individual institutions.

AMERICAN CONFERENCE OF GOvERNMENTAL INDUSTRIAL HYGIENISTS (ACGIH) ACGIH is a voluntary organization concerned with issues of air quality and exposure to potentially harmful contaminants. They have set threshold limit values (TLVs) for exposure to some known carcinogens and other potentially harmful compounds (Table 4). While the threshold limit values are not binding requirements by any organization, they are recognized as a resource for concerns related to environmental air quality.59

AMERICAN NURSES ASSOCIATION (ANA) ANA has been a partner with AORN on surgical smoke since AORN’s major initiatives began in 1996. ANA has urged nurses to be proactive in working with government officials to develop specific smoke guidelines, and has contacted government officials, including those at OSHA to push for stronger controls.60

ASSOCIATION OF PERIOPERATIvE REGISTERED NURSES (AORN) AORN, the professional organization for perioperative registered nurses, has been a strong proponent for protection from surgical smoke. AORN’S Standards and Recommended Practices (RPs) are used in operating rooms globally as a standard for the perioperative environment. Since 1994, these standards and recommendations have called for evacuating and filtering surgical smoke. AORN held national conferences on surgical smoke in 1996 and 1997 to raise awareness about the issue and to facilitate adoptions of standards and guidelines from partner organizations.

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In 2006, AORN formed an alliance with OSHA to collaborate on workplace safety 61-- not just for its 40,000 members, but for anyone who provides or receives care during operative and invasive procedures. At the 2008 AORN Congress an official Position Statement was adopted on surgical smoke and bio-aerosols, and is the strongest practice recommendation from AORN to date. The statement identified surgical smoke as a hazard, urged perioperative personnel to use personal protective equipment, evacuate and filter smoke through appropriate systems and educate perioperative personnel about the dangers of surgical smoke.8 The following year, AORN introduced its inaugural Surgical Smoke Evacuation Tool Kit.62

This tool kit contains a sample smoke evacuation policy, a sample competency for smoke evacuation practices, creative smoke evacuation signs that can be copied and posted as reminders for smoke evacuation, a bibliography of surgical smoke research and information, and links to vendors who sell smoke evacuation devices and equipment.

In 2016, AORN partnered with Medtronic and announced the launch of a comprehensive recognition program to ensure a smoke-free environment wherever surgical smoke is generated. 63 The program includes a new Management of Surgical Smoke Tool Kit64 as well as awarding the Go Clear Award to hospitals, ambulatory surgery centers or office-based practices who demonstrate commitment to a surgical smoke-free environment for their perioperative team and patients. When healthcare facilities commit to the Go Clear program, they receive access to free Go Clear resources that will assist them with testing, interprofessional education, gap analysis and compliance monitoring.65, 66

AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI)67 ANSI is a multidisciplinary group that has identified a set of voluntary standards developed by members from professional societies, trade associations and other organizations. ANSI standard Z136.3 is recognized as the definitive document on healthcare laser safety and provides guidance for the safe use of lasers for medicine, diagnostic, cosmetic, preventative and therapeutic applications. Their standards direct healthcare facilities to implement policies and procedures to control surgical plume hazards. Furthermore, they have relayed in their standards that it is their expert opinion that there is not a half-mask respirator suitable to exclude all plume, therefore airborne contaminants should be controlled by exhaust ventilation techniques as the first line of protection.

NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND HEALTH (NIOSH) NIOSH is under the Centers for Disease Control (CDC) within the U. S. Department of Health and Human Services. It investigates potential occupational health risks and makes recommendations to OSHA. NIOSH has no regulatory or enforcement authority, but conducts health hazard evaluations and issues health hazard alerts. NIOSH recommendations are referenced on the OSHA Web site on smoke evacuation. Following AORN’s 1996 smoke conference at which NIOSH was represented, the strongest

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recommendation to date was issued. The NIOSH Hazard Control Alert on the Control of Smoke from Laser/Electric Surgical Procedures is one of the most important documents available to health-care professionals. It recommends evacuation and filtration of surgical smoke. The Hazard Control has remained on the NIOSH Web site since its development in 1996 (Figure 1).4

ECRI ECRI, formerly the Emergency Care Research Institute, is a nonprofit agency in Plymouth Meeting, Pennsylvania. ECRI evaluates products used in the health-care arena, and makes recommendations about the safe use of those products. ECRI provides consultation and evaluation services to patient care organizations, and provides education. ECRI has consistently recommended the use of smoke evacuation and filtration, while acknowledging the lack of national regulation. ECRI’s position is that it is prudent for facilities to minimize staff exposure to surgical smoke.54

THE jOINT COMMISSION The Joint Commission (formerly known as the Joint Commission on Accreditation of Healthcare Organizations – JCAHO) evaluates health-care organizations and programs, and provides accreditation to facilities that meet their requirements. Hospitals voluntarily seek Joint Commission accreditation since it essentially alerts the public that the hospital complies with safe standards in delivering patient care.

In 2004, the Joint Commission (TJC) entered into an alliance with OSHA to address safety and health issues in healthcare facilities. The agreement between OSHA and TJC focused on reducing exposure to biological and airborne hazards in health care. 68 TJC’s updated Environment of Care standard, EC02.02.01, requires that organizations maintain evidence that they are managing risks related to hazardous materials and waste, including gases and vapors from cauterizing equipment and lasers.69, 70

In fact, TJC recommends filtering and evacuating surgical smoke through the use of room ventilation and LEV methods.71

Although TJC standards were updated in 2009 to specifically mention surgical smoke, TJC representatives have spoken out to say that they have always interpreted the smoke generated in the OR as hazardous. Early on healthcare organizations did not make the connection, so TJC has clarified that facilities should have a written policy on how they are managing the issue and holding the surgical team accountable.72

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) OSHA is the federal agency that enforces laws and regulations ensuring U.S. employees work in a safe, healthy environment. 73 While OSHA does not have specific regulations related to the evacuation of surgical smoke, OSHA officials have consistently stated that

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regulations are already on the books to protect workers from surgical smoke. OSHA’s General Duty Clause, the standards for respiratory protection and bloodborne pathogens are routinely cited as those that should be used to enforce safe workplace standards, including smoke evacuation.

In 1998, when OSHA wrote a guideline on surgical smoke, Laser/Electrosurgery Plume safety was added to the OSHA.gov website.6

The OSHA guideline was never released, but the protection recommendations mirrored those of the CDC/NIOSH Hazard Alert (Figure 1). OSHA has added a Hospital eTools section to its website, a portion of which addresses perioperative workplace safety and the hazards of smoke plume.74

Using the combined resources available from the agencies and organizations listed above can be a strong resource for perioperative practitioners.

INTERNATIONAL RECOMMENDATIONS/GUIDELINES ON SURGICAL SMOKE Perioperative nurses throughout the world have noted that inhalation of surgical smoke is a definite workplace hazard. The need to evacuate and appropriately filter surgical smoke is being recognized around the world as countries move to provide a safer environment for perioperative personnel and patients. Here are some accounts of what is happening around the world.

NORDIC COUNTRIES The guidelines in the Nordic countries is currently one the most prescriptive on surgical smoke. Translated, the document states:

“Comparisons between laser smoke and diathermy smoke (electrocoagulation) show that even diathermy smoke can contain insanitary substances, and measures should be

taken to eliminate such smoke.” 75

UNITED KINGDOM The British Occupational Hygiene Society (BOHS) has developed a guidance document on surgical smoke to be used by managers in the National Health Service. 76 The document acknowledges the harmful effects of the contents of surgical smoke and recommends that local exhaust ventilation (LEV) be used to evacuate and filter the smoke:

“Theatres usually have high rates of general ventilation. This does not, however, prevent the emission of smoke into the room or the exposure of staff. Local exhaust ventilation (LEV) is required to achieve this. The known irritancy,

the other hazardous properties of the component contaminants, and the persistent concerns of chronic effects combine to lead to the conclusion that effective LEV

should be considered a required control measure.” 76

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The document goes on to say that the smoke evacuator should pull smoke at a minimum of 22 liters/minute to effectively capture the smoke. It further states that anyone experiencing respiratory symptoms be referred to the occupational health service. 76

CANADA The Canadian Standards Association (CSA) has developed standards for smoke evacuation in perioperative environment in Canada. CSA standard Z305.13-13 identifies the dangers of surgical smoke and goes into significant detail about the importance of safe work practices, the use of personal protective equipment, and evacuating and filtering smoke/plume wherever it is produced. The standard was most recently revised in 2013 with key updates to ensure that current best practices are met. 77

NURSING ORGANIZATIONS AROUND THE WORLD In addition to AORN, nursing organizations around the world have taken the step of developing recommended practices on surgical smoke. All are similar in scope in documenting the hazards of surgical smoke and recommending the evacuation and filtering of surgical smoke to protect healthcare workers.

THE INTERNATIONAL FEDERATION OF PERIOPERATIvE NURSES (IFPN) IFPN is a worldwide organization whose members are 13 perioperative organizations in countries around the world. The IFPN represents approximately 80,000 perioperative nurses globally and is the only perioperative association to be an affiliate of the International Council of Nurses. In July, 2007, IFPN adopted a guideline aimed at protecting perioperative personnel for surgical smoke:

“It is important that Employers and Employees are aware of the problem of smoke... and ensure that there are policies in place to reduce the exposure to smoke ... and that such policies also comply with workplace health and safety laws, or other legislative guidance,

and with International Electro-technical Commission (IEC), standards pertinent to the particular healthcare setting.”78

ASSOCIATION FOR PERIOPERATIvE PRACTITIONERS The Association for Perioperative Practitioners (AfPP) is an association in the United Kingdom dedicated to enhance the quality of care within the National Health Service. The AfPP document, “Surgical Smoke: What Do We Know” identifies the need to evacuate surgical smoke during procedure. 75

AUSTRALIAN COLLEGE OF OPERATING ROOM NURSES (ACORN) ACORN represents professional nurses across Australia. Members practice across many perioperative environments that include operating theatres, day surgery units,

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anesthetics, post anesthetics, x-ray departments, the military, management and educational settings. The organization’s practice guidelines recommend the prevention of patients’ and healthcare personnel’s exposure to surgical smoke (S20) and the evacuation of this inhalation hazard by means of appropriate procedures and smoke capture devices. 79

In 2015 the state of New South Whales, Australia, with the support of the Australian Ministry of Health, issued a ruling to all facilities under their control that generate surgical plume (eg, operating rooms, dental clinics, morgues during autopsy and laboratories). Per the ruling, these facilities were to minimize or eliminate the risks of surgical smoke by conduct risk assessments in consultation with employees, implement controls identified through the risk assessments and review the controls at a frequency relative to the level of risk to ensure their ongoing effectiveness. Control measures must be put in place by all facilities and include:80

1. Adequate plume evacuation at the source (ie, use plume evacuation systems).2. Effective room air filtration systems that are 0.1 micron at 99.999% efficiency.3. Safe work procedures including standard precautions against exposure to

bloodborne pathogens when entering or working in an area where infectious material from a plume could be present in the air or on surfaces.

4. Maintenance of the plume evacuation system (eg, replacing filters in accordance with the manufacturer’s instructions).

5. Waste disposal in accordance with state health policy.

OPERATING ROOM NURSES ASSOCIATION OF CANADA (ORNAC) ORNAC is the organization representing perioperative nurses throughout Canada. In addition to referencing standards from the Canadian Standards Association, ORNAC publishes recommended practices to assist perioperative nurses in Canada with smoke evacuation practices. ORNAC advocates smoke free theatres (ORs) which is reflected in the website they promote at www.becomenasti.com (with “nasti” standing for “nurses advocating smoke free theatres immediately”). Information about this website can be found at http://www.ornac.ca/safety-nurses.phtml.

IMPLEMENTING A SMOKE EvACUATION PROGRAMThe first step in developing a smoke evacuation program is for each facility to make a commitment that it is a priority to protect staff and patients from the potentially harmful effects of surgical smoke. The commitment should be made with representatives from each of the professional groups providing care in the operating room: surgeons, anesthesia providers, perioperative staff and administration. Consensus among the entire surgical team before the program begins is important and will help insure success.

Once an agreement has been reached, a plan should be developed to introduce the program through education. Educating staff members about the hazards of surgical

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smoke is another key to success. Take advantage of all available resources to create an educational program that will increase awareness.

A smoke evacuation system must be selected. Again, a multidisciplinary group that investigates available technology will provide a comprehensive list of what is needed. Some points to consider in choosing among the available systems are:

• Portability• Effectiveness (filtering capability, suction power)• Noise production• Ease of use• Foot pedal activation versus automatic activation• Filter monitoring (indicator for filter changing)• Filter and canister design• Cost and operating expenses

Once a system is selected and the equipment and supplies are available, in-services on the equipment must be conducted. Representatives from the manufacturer of the equipment usually facilitate this training as they know the equipment best. Policies and procedures should be developed based on the type of equipment being used – not all systems are the same. Both inline suction filters and portable smoke evacuators will likely be necessary.

The smoke evacuation policy should include a delineation of which smoke evacuation system (inline, or individual smoke evacuation system) is recommended for which surgical procedures (Appendix B).

Policies should include competencies based on selecting and using accessories and smoke evacuation equipment. Some of the competency checklist activities can include:

• Ability to identify which smoke evacuation method is appropriate depending on the amount of plume generated.

• Sets up smoke evacuation supplies, devices, and/or equipment appropriately.• Changes and disposed of filter correctly and appropriately.• Uses smoke evacuation devices and equipment properly throughout

procedure.• Documents use of smoke evacuation devices/equipment.

As with any new practice, compliance needs to be monitored. Research demonstrates that smoke evacuation practices are very inconsistent. The most popular method of smoke evacuation is using a suction device for fluid evacuation without an inline filter.

81, 82 Other research by Edwards & Reiman notes that smoke evacuation practices in

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2010 as compared to those in 2007 continue to be inconsistent with no change for most procedures and a higher use of the wall suction for smoke evacuation for other procedures.75

When surveying AORN members about smoke evacuation practices, Ball’s research notes that the key indicators of compliance or reasons that surgical smoke recommendations are being followed include: 81, 82

• Education (if the nurse has attended a lecture or read an article about surgical smoke hazards and smoke evacuation practices, then compliance is greater)

• Leadership (if there is strong departmental leadership in support of smoke evacuation, then compliance is greater)

• Easy to follow smoke evacuation policy (then compliance will be greater)• Greater internal collaboration (if the doctors and nurses have a good working

relationship, then there will be greater compliance)• Large facilities with multi-discipline services (are more apt to comply with

smoke evacuation recommendations)

The barriers to compliance with smoke evacuation recommendations include: 81, 82, 83

• Smoke evacuation devices and supplies aren’t readily available• Surgeons state that smoke evacuation is not necessary for their procedures• The smoke evacuation equipment is too noisy• The staff has a complacent attitude about the need to evacuate surgical smoke

(they don’t fully understand the negative consequences of inhaling surgical smoke)

When a smoke evacuation program for a facility is planned and implemented, the reasons that nurses comply with smoke evacuation practices must be reviewed and discussed. The barriers to compliance must also be identified so they can be minimized. Sometimes leadership has discovered that setting a date for full compliance gives a goal that everyone who is involved can anticipate. Before the predetermined smoke-free date is reached, a smoke evacuation policy must be created along with a competency checklist, smoke evacuation supplies and devices must be evaluated, ordered, and made readily available, physician procedure cards need updated, and (most importantly) education must be provided so that the entire staff fully understands the negative consequences of inhaling surgical smoke and how to use the smoke evacuation equipment and supplies. Champions who support smoke evacuation need to be identified so they can help encourage others to employ proper smoke evacuation practices.

Once a smoke evacuation program is implemented, monitoring is part of evaluation and needs assessment. If compliance with using smoke evacuation continues to be low, the need for additional education may be necessary. Teamwork and peer review are essential components of a successful and effective monitoring program. Setting up

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a smoke evacuation program requires work and dedication but a successful outcome, however, is very beneficial to the health of the surgical team members. Hospitals that can advertise a smoke-free work environment in the operating room just might have an edge in recruiting and retaining top perioperative staff.

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