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Regulation of surgical smoke plume

Regulation of surgical smoke plume

Candace L. Romig

AORN and the AORN Foundation sponsored the second surgical smoke conference at AORN Headquarters on Feb 7, 1997. This meeting of health care industry representatives, government regulatory officials, and industry leaders discussed the safe use of electrosurgical units (ESUs) and resulting surgical smoke in settings where surgical and invasive procedures are performed.

Electrosurgery is used routinely to cut and coagulate body tissue with high radiofrequency electrical current. When individual cells are disrupted, vaporized, and released as aerosolized blood and bloodborne contaminants, they are forcibly ejected and transmitted in vaporized intracellular water, which is seen as surgical smoke.

The AORN meetings on surgical smoke have been convened because of the growing controversy about surgical smoke. Anecdotal evidence describes burning eyes, scratchy throats, allergic reactions, and respiratory problems attributed to the inhalation of surgical smoke. Research has been performed on laboratory animals and with sophisticated models of OR situations to determine the kind and quantity of particles possibly transmitted in surgical smoke to OR nurses, attending physicians, surgical technologists, and even patients. The validity and reliability of most of the research have been questioned, however.

The February meeting concluded with a call for more research to investigate the following issues.

* Does surgical smoke cause significant work absences of OR personnel?

* Does the lack of smoke evacuation units cause significant injuries?

* Is equipment currently available to alleviate an identified problem?

* What is the cost of potential regulations of electrosurgical smoke?

This article focuses on proposed regulations of surgical smoke, current mechanisms that may be used to control electrosurgical smoke, and options for perioperative nurses.

PROPOSED REGULATION OF SURGICAL SMOKE

The Coalition for the Protection of Operating Room Personnel, Washington, DC, has worked to include guidelines for the use of electrosurgical units in the proposed revision of the Occupational Safety and Health Administration’s (OSHA’s) “Guidelines for Laser Safety and Hazard Assessment.”(1) On Feb 3, 1997, Congressman Carlos Romero-Barcelo (D-PR) wrote to OSHA Acting Assistant Secretary Gregory Watchman and encouraged him to amend these guidelines and protect OR personnel from the dangers of surgical smoke. The following members of Congress supported the recommendation.

* Eliot Engel (D-NY),

* Ron Dellums (D-Calif),

* Marcy Kaptur (D-Ohio),

* Sheila Jackson Lee (D-Tex),

* Joseph Kennedy (D-Mass),

* David Skaggs (D-Colo),

* Danny Davis (D-Ill),

* Jose Serrano (D-NY), and

* Louise Slaughter (D-NY).

Many AORN members supported this letter by calling their representatives in Congress.

CURRENT MECHANISMS FOR CONTROLLING SURGICAL SMOKE

Surgical smoke has been a controversial issue throughout this decade. Although there is still no consensus about whether surgical smoke actually is hazardous, evidence suggests that smoke associated with vaporized or aerosolized tissue contains biohazards (ie, carbon, toxic gases, viral particulates, bacteria, DNA, blood, bloodborne pathogens). The following documents provide health care professionals with guidance in controlling the hazardous effects of surgical smoke–with the caveat that there is no legal or regulatory mandate specific to surgical smoke at this time.

AORN Recommended Practices. AORN recommended practices are intended to be used as guidelines and are adaptable to traditional ORs, ambulatory surgery units, physicians’ offices, cardiac catheterization suites, endoscopy rooms, radiology departments, emergency departments, and all areas where surgery may be performed.(2) Patients and perioperative personnel should be protected from inhaling the smoke generated during electrosurgery. Policies and procedures for electrosurgery should be developed, reviewed annually, revised as necessary, and available within the practice setting.

AORN does not endorse any smoke evacuation product. Biomedical services in all practice settings should develop detailed, routine safety and preventive maintenance inspections with well-documented records. Purchase of smoke evacuator equipment should be undertaken only after a thorough investigation of the various product lines and current use in similar practice settings.

American Society for Laser Medicine and Surgery (ASLMS) position statement. The ASLMS is a multidisciplinary, professional organization concerned with laser technology in clinical use and research. An ad hoc subcommittee of ASLMS’ safety committee issued a one-page report in 1995 that restated the official position of the organization and outlined three areas of guidance, including a policy statement, a mandate to use evacuation, and suggestions for personal protective equipment. The current policy, which is being revised, states,

All medical personnel should

consider the plume to be

potentially hazardous both in

terms of the particulate

matter and infectivity….

Evacuator suction systems

should be used at all times to

collect the plume.”(3)

This policy was developed in response to the presence of hazards existing for people exposed to surgical smoke. Input from OSHA, the National Institute for Occupational Safety and Health (NIOSH), the Centers for Disease Control and Prevention (CDC), AORN, and the American National Standards Institute (ANSI) will be considered during ASLMS’ revision process, as will other recent studies and publications.

American National Standards Institute Z136.3. The ANSI provides a mechanism for the development of voluntary standards that have obtained the general agreement of manufacturers, vendors, researchers, and clinician groups. It does not mandate adherence to ANSI standards, however. The ANSI standard for safe use of lasers has been adopted widely by OSHA, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), state regulatory agencies, professional organizations’ recommended practices, and the medical-legal community as the benchmark for safe practice in health care facilities, including ORs, outpatient centers, mobile laser services, and private medical and dental clinics. Facilities are expected to comply with ANSI standards to ensure a nationally acceptable level of practice and a uniform quality of care to patients.

No similar national standard exists for ESUs and their production of smoke plume in surgery; however, ANSI has made definitive statements about the need for smoke evacuation of hazardous particulates resulting from laser surgery, with a special note of discussion related to electrosurgery:

Electrosurgical devices and

instrumentation often are

used both separately and

simultaneously with health

care laser systems. These

devices have been found to

produce the same type of

airborne contaminants as

produced by laser-tissue

interaction, and these

contaminants should be

evacuated from the surgical

site.(4)

Section 7.3 of ANSI’s Z136.3 states:

In operations that use Class

4 lasers, the vaporization of

target tissue produces laser

generated airborne

contaminants (LGAC)….

Analysis of the LGAC has

shown the presence of

gaseous toxic compounds,

bioaerosols, dead and live

cellular matter, and

viruses.(5)

ANSI recommends that laser users be aware of potential LGACs during surgical procedures and encourages them to “utilize control measures such as universal (standard) precautions that are covered by the bloodborne pathogen standard.”(6)

Room ventilation and local smoke evacuation systems are considered the primary means for protection from airborne contaminants and must be located as close as possible to the point of smoke production to be effective (ie, generally not more than 2 inches). Smoke must not be recirculated and must be vented in an environmentally sound manner, with all filters and other disposable components handled in the same manner as biohazardous materials. Wall suction should be protected by an appropriate filter that also is disposed of properly.

The National Institute for Occupational Safety and Health/Centers for Disease Control and Prevention hazard alert. In July 1996, NIOSH and the CDC issued a two-page alert to all health care employers and health care workers in their 10,000 health facility network.(7) The alert strongly supports research findings of toxins, carcinogens, viruses, and other contaminants in electrosurgical smoke.

There are two basic types of monitoring gauges available currently on smoke evacuation systems–pressure drop monitors and time-based monitors. Pressure monitors measure the pressure drop across the filter and can indicate accurately when a filter is full and needs replacement. A time-based monitor indicates only how long the filter has been used. With this type of indicator, it is possible for the user either to change the filter too soon–increasing operational cost per procedure or not soon enough, which exposes staff members to potential health hazards.

The NIOSH and CDC recommend controlling the airborne contaminants through proper ventilation and work practices:

General room ventilation is

not sufficient by itself to

capture contaminants

generated at the source (ie,

the surgical site). The two

major local exhaust

ventilation approaches used

to reduce surgical smoke

levels for health care

personnel are portable

smoke evacuators and room

suction systems.(8)

At the 1997 AORN smoke conference, NIOSH representatives reiterated that smoke evacuator systems should pull approximately 50 cu ft per minute (ie, air flow for suction) and should have a capture velocity of 100 ft to 150 ft per minute at the inlet nozzle. Central wall room suction

* is designed to capture liquids (ie, not particulates),

* has a much lower suction rate, and

* should not be used for eliminating smoke without appropriate filters.

All filters should be cleaned, monitored and replaced regularly, and disposed of properly because of possible biohazardous waste. All ESUs include manufacturers’ recommendations for changing filters within specified time frames, but most do not include disposal instructions. The NIOSH/CDC alert recommends that the evacuation suction nozzle be about 2 in from the surgical site; therefore, all collection devices and instrumentation (eg, speculums, laryngoscopes, wands, electrosurgical loops, pens) should incorporate suction ports that extend as close as possible to the end of the instrument and to the tissue. Most laser and electrosurgical companies provide sheaths and adapters for this purpose.

The alert emphasizes also the need to treat all disposable components of the smoke evacuation system as biohazardous material after the procedure is completed. For this reason, the facility’s infection control supervisor should be involved with developing management policy.

Occupational Safety and Health Administration’s Universal and standard precautions for bloodborne pathogens. According to the universal precautions developed by the CDC for infection control, all human blood and certain human body fluids are treated as if they were known to contain HIV, the hepatitis B virus, or other bloodborne pathogens. Advanced scientific knowledge, combined with an increasingly mobile society, means that harmful tissue particulates can spread much more rapidly than ever before. Health care professionals cannot screen patients for all conditions that may be present; therefore, they must comply with these precautions as the primary method of prevention in health care facilities.

Recognizing these universal precautions, OSHA published its 1991 “Occupational exposure to bloodborne pathogens: Final rule,” in which the Assistant Secretary of Labor Gerald Scannell asserted:

Providing full legal force to

universal precautions–employers

and employees

must treat blood and certain

body fluids as if infectious.

Meeting these requirements

is not optional. It’s essential

to prevent illness, chronic

infection, and even death.(9)

Surgical instrument setting controls, engineering controls (ie, physical devices for reducing hazards), and work practice controls (ie, handwashing practices, appropriate handling of sharps) are to be implemented before the use of personal protective equipment. This equipment includes anything designed to protect against a hazard (eg, gloves, gowns, laboratory coats, face masks, eye protection, ventilation devices). Personal protection equipment should prevent

blood or other potentially

infectious material to pass

through to or reach

employees’ skin, eyes,

mouths, or other mucous

membranes.(10)

Standards recommended by OSHA also preclude wearing protective gear (ie, head covers, masks, shoe covers) outside the OR. Contaminated gear must be removed as quickly as feasible and washed, decontaminated, or disposed of appropriately. Studies have confirmed that, when used, universal precautions effectively protect against contaminants that may be in blood and other body fluids.(11)

In 1996, the development of “standard” precautions superseded the universal precautions with the release of the revised “CDC Guideline for Isolation Precautions in Hospitals.”(12) This guideline provides a uniform historical analysis and review of isolation practices in hospitals, as well as recommendations for isolation practices in primarily acute care hospitals and some subacute care facilities. The intent of the revisions was to

* be scientifically sound;

* recognize the importance of all body fluids, secretions, and excretions in the transmission of nosocomial pathogens;

* provide precautions for infections transmitted by the airborne, droplet, and contact routes of transmission;

* be as simple as possible; and

* use new terms to avoid confusion with previous precaution practices.(13)

Two types of precautions were identified: standard precautions to be used in the care of all patients to contain nosocomial infection and transmission-based precautions to be used with patients known to be infected with dangerous pathogens that could be transmitted by air or skin contact. Standard precautions combine provisions of the previous “universal” precautions, which were designed to reduce the risk of transmitting bloodborne pathogens that are both recognized and unrecognized, with the precautions used to reduce the risk of disease transmission from moist body substances.

The standard precautions are categorized as follows.

* Category IA (ie, strongly recommended for all hospitals and strongly supported by well-designed experimental or epidemiologic studies, such as surgical asepsis).

* IB (ie, strongly recommended for all hospitals and reviewed as effective by experts in the field and a consensus based on strong rationale and suggestive evidence, such as handwashing, gloves, eye protection, and patient care equipment).

* II (ie, suggested for implementation in many hospitals. Recommendations may be supported by suggestive clinical or epidemiologic studies, a strong theoretical rationale, or definitive studies applicable to some,but not all, hospitals, such as smoke evacuators).

* “No recommendation/unresolved issue,” based on scientific or suggestive evidence and the institutions in question.(14)

Surgical masks and respirators. At the 1997 AORN smoke meeting, presenters discussed wearing surgical masks or respirators as a protection from contaminants in the absence of smoke evacuators. AORN states that “protective eyewear, masks, or face shields must be worn whenever activities could place one at risk for a splash or spraying.”(15)

AORN’s “Recommended practices on electrosurgery” state that patients and perioperative personnel should be protected from inhaling the smoke generated during electrosurgery and that the ESUs should be used according to manufacturers’ written instructions.(16)

Research findings suggest that there is little difference between the smoke generated from ESU devices and from lasers (ie, there is an undefined potential for bacterial and viral contamination of smoke). Toxicity and mutagenicity of the gaseous by-products exist. High-filtration surgical masks may be worn by perioperative personnel during procedures that generate surgical smoke to minimize noxious odors and/or potential toxic effects of smoke.(17)

Masks must be fitted, worn properly, and changed frequently because of filtration problems that develop as the masks become moist from breathing. In addition, the demands of a surgical procedure may prevent wearers from changing surgical masks as frequently as recommended or desired to maintain full protection from surgical smoke.

Some health care personnel resist wearing respirators because they believe they may constrict breathing, impair communication, and frighten patients. Studies pertaining to the use of masks and respirators with tuberculosis, however, have shown that most respirators protect personnel from airborne pathogens with significantly greater efficiency than surgical masks.(18) A particulate respirator provides added protection through a tighter fit and more effective filtration capacity. Only OSHA has certified and approved for use high-efficiency particulate air respirators with filtration efficiency for particles as small as I micron.(19)

OPTIONS FOR THE PERIOPERATIVE NURSE

Although controversial, many studies have been perfommed on the subject of surgical smoke. Administrators and nurse managers debating the necessity of purchasing and using smoke evacuators for all laser and electrosurgical procedures should become familiar with the latest data. As health care professionals, we must all become active participants in this effort rather than wait for new laws to be passed or new regulations to be established. Education is the most effective instrument for change, increased awareness, and communication.

The perioperative nurse can be instrumental in documenting the effects of surgical smoke in the work environment by asking the following questions.

* How many sick days do perioperative personnel take as a result of surgical smoke inhalation?

* How much does smoke evacuation actually cost?

* What are the comparative costs of purchasing the equipment and reducing the number of nurse sick days?

When the data are gathered and the literature review is complete, the information should be shared with other nurses, physicians, technologists, biomedical engineers, purchasing agents, risk managers, and hospital administrators.

Investigating scientists and government regulatory bodies agree that there are insufficient data to support the mandatory use of smoke evacuator systems. AORN supports further studies perfommed by objective, independent researchers. Continued discussion of these issues within professional organizations and with government officials will help generate the support necessary to fund these studies and to accomplish crucial regulation of the hazard of surgical smoke in all perioperative settings.

NOTES

(1.) Occupation Safety and Health Administration, Guidelines for Laser Safety and Hazard Assessment, publ no 8-1.7 (Washington, DC: US Government Printing Office, 1991).

(2.) “Recommended practices for electrosurgery,” in AORN Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1997) 163-168.

(3.) P J Smalley, “Update on regulation of surgical smoke and its management,” Surgical Services Management 3 (March 1997) 31-35.

(4.) American National Standards Institute, Inc, “American National Standard for Safe Use of Lasers in Health Care Facilities,” (Orlando, Fla: Laser Institute of America, 1996) 15-16.

(5.) Ibid, 1.

(6.) Ibid.

(7.) National Institute for Occupational Safety and Health, Control of Smoke from Laser/Electric Surgical Procedures, publ no 96-128 (Cincinnati: OSHA [NIOSH] September 1996) 1-2.

(8.) Ibid.

(9.) US Department of Labor, “Occupational Safety and Health Administration, USDL: 91-618,” US Department of Labor News, Dec 2, 1991, 1.

(10.) Ibid, 449.

(11.) L L Ronk, N J Girard, “Risk perception, universal precautions compliance,” AORN Journal 59 (January 1994) pages.

(12.) “Guideline for isolation precautions in hospitals,” Infection Control and Hospital Epidemiology 17 no 1, US Department of Health and Human Services, January 1996.

(13.) Ibid, 54-55.

(14.) Ibid, 68.

(15.) “Recommended practices for surgical attire,” in AORN Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1997) 146.

(16.) “Recommended practices for surgical attire,” 146.

(17.) Ibid, 167.

(18.) S K Chen et al, “Evaluation of single-use masks and respirators for protection of health care workers against mycobacterial aerosols,” American Journal of Infection Control 22 (April 1994) 65-74.

(19.) M M Jackson, “The particulate respirator controversy,” Today’s OR Nurse 16 (September/October 1994) 13-19.

CANDACE L. ROMIG Health Policy Analyst/ Legislative Program Coordinator

PENNY J. SMALLEY RN Technology Concepts International, Inc Chicago

COPYRIGHT 1997 Association of Operating Room Nurses, Inc.

COPYRIGHT 2004 Gale Group