HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 63 Protection from Surgical Smoke
SPONSOR(S): Woodson and others
TIED BILLS: IDEN./SIM. BILLS: SB 410
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Select Committee on Health Innovation 14 Y, 0 N Guzzo Calamas
2) Health Care Appropriations Subcommittee 14 Y, 0 N Smith Clark
3) Health & Human Services Committee 20 Y, 0 N Guzzo Calamas
SUMMARY ANALYSIS
Surgical smoke is the gaseous by-product produced when tissue is dissected or cauterized by heat generating
devices such as lasers, electrosurgical units, ultrasonic devices, and high-speed burrs, drills and saws.
Surgical smoke contains chemicals, blood and tissue particles, bacteria, and viruses, and has been proven to
exhibit potential risks for surgeons, nurses, anesthesiologists, and technicians in the operating room due to
long term exposure.
The bill requires hospitals and ambulatory surgical centers to adopt and implement policies by January 1,
2025, that require the use of a smoke evacuation system during any surgical procedure that is likely to
generate surgical smoke. Smoke evacuation systems must effectively capture, filter, and eliminate surgical
smoke at the site of origin before the smoke makes contact with the eyes or respiratory tract of occupants in
the room.
The bill has no fiscal impact on state or local government.
The bill provides an effective date of July 1, 2024.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
STORAGE NAME: h0063e.HHS
DATE: 2/8/2024
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Surgical Smoke
Surgical smoke is the gaseous by-product produced when tissue is dissected or cauterized by heat
generating devices such as lasers, electrosurgical units, ultrasonic devices, and high-speed burrs, drills
and saws.1 During a surgical procedure, the heat generated from one of these devices causes the
target cell membranes to rupture, and subsequently generates and releases a plume of smoke into the
operating room.2 Surgical smoke contains chemicals, blood and tissue particles, bacteria, and viruses,
and has been proven to exhibit potential risks for surgeons, nurses, anesthesiologists, and technicians
in the operating room due to long term exposure.3
Potential known health effects from the exposure to surgical smoke include eye, nose, and throat
irritation; headache; cough; nasal congestion; and asthma and asthma-like symptoms, but little is
known about the health effects from chronic exposure to surgical smoke. 4 Other risks include the
transmission of viruses through surgical smoke; for example, transmission of Human Papillomavirus
(HPV) through surgical smoke from lasers has been documented, 5 and some researchers have
suggested that surgical smoke may act as a vector for cancerous cells that may be inhaled.6
Surgical Smoke Evacuation Systems
Smoke evacuators are devices which contain a suction unit (i.e. a vacuum), filter, hose, and inlet
nozzle. They are designed, as recommended by the Center for Disease Control, to capture air from
where the nozzle is targeted and filter the air through a HEPA filter. 7 These systems may be stationary,
with permanent construction requirements, or handheld portable systems with disposable filters, hand
pieces, and hoses. While costs for these products range greatly, with installation of a stationary system
costing as much as $120,000,8 the more common handheld systems have recurring costs associated
with disposable parts of roughly $19 per surgery, and total recurring costs including filter replacement
between $8,000 and $10,000 annually depending on frequency of use. 9
1
Liu Y, Song Y, Hu X, Yan L, Zhu X. Aw areness of surgical smoke hazards and enhancement of surgical smoke prevention among the gynecologists.
Journal of Cancer (June 2, 2019) available at https://www.jcancer.org/v10p2788.htm (last visited January 21, 2024).
2
Id.
3
Id.
4
Steege AL, Boiano JM, Sw eeney MH. NIOSH health and safety practices survey of healthcare workers: training and aw areness of e mployer safety
procedures, American Journal of Industrial Medicine (February 18, 2014) available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504242/ (last
visited January 21, 2024).
5
Id.
6
United States Department of Labor, Occupational Safety and Health Administration, Surgical Suite >> Smoke Plume, available at
https://www.osha.gov/etools/hospitals/surgical-suite/smoke-plume, (last visited January 21, 2024).
7
Centers for Disease Control, Control of Smoke from Laser/Electrical Surgical Procedures, available at
https://www.cdc.gov/niosh/docs/hazardcontrol/hc11.html (last visited January 21, 2024).
8
Relias Media, Consider Overall Cost, Ease when Choosing Evacuators, available at https://www.reliasmedia.com/articles/61664-consider-overall-cost-
ease-when-choosing-evacuators (last visited January 21, 2024).
9
See Relias Media, OR Teams Often Exposed to Toxic Chemicals in Surgical Smoke, Mar. 1, 2021, available at
https://www.reliasmedia.com/articles/147530-or-teams-often-exposed-to-toxic-chemicals-in-surgical-
smoke#:~:text=The%20estimated%20cost%20of%20using,for%20the%20standard%20electrosurgical%20pencil. (last visited January 21, 2024), Ohio
Legislative Service Commission, SB 161 Fiscal Note & Local Impact Statement, available at
https://www.legislature.ohio.gov/download?key=17773&format=pdf (last visited January 21, 2024); Kreuger, Steven, et al., The Effect of a Surgical
Smoke Evacuation System on Surgical Site Infections of the Spine, available at https://www.oatext.com/pdf/CMID-3-132.pdf (last visited January 21,
2024).
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DATE: 2/8/2024
Surgical Smoke Regulation
Hospitals and ambulatory surgical centers (ASCs) must comply with the 2021 National Fire Protection
Association (NFPA) 101 Life Safety Code.10 The 2021 version does not require the use of surgical
smoke evacuation systems, but the 2024 version does. However, in Florida, the 2021 version will be
enforceable until 2027, when the State Fire Marshal adopts the 2024 version. 11 The 2024 version
requires facilities to capture surgical smoke using either a dedicated exhaust system (may share an
established system for waste gas removal), a connection and return or exhaust duct after air cleaning
through high efficiency particulate air (HEPA) and gas phase filtration, or a point of use smoke
evacuator for air cleaning and return to the space. As a result, Florida will have no regulatory
requirement to use surgical smoke evacuation systems in hospitals and ASCs until 2027.
The Occupational Safety and Health Administration (OSHA) recognizes potential risk factors and
remedial measures, but it has not adopted regulations on protection from surgical smoke. OSHA’s
recognized controls and work practices for surgical smoke include: 12
Using portable local smoke evacuators and room suction systems with in-line filters.
Keeping the smoke evacuator or room suction hose nozzle inlet within two inches of the surgical
site to effectively capture airborne contaminants.
Having a smoke evacuator available for every operating room where plume is generated.
Evacuating all smoke, no matter how much is generated.
Keeping the smoke evacuator "ON" (activated) at all times when airborne particles are
produced during all surgical or other procedures.
Considering all tubing, filters, and absorbers as infectious waste and dispose of them
appropriately.
Using new tubing before each procedure and replace the smoke evacuator filter as
recommended by the manufacturer.
Inspecting smoke evacuator systems regularly to ensure proper functioning.
Additionally, the Joint Commission, an accrediting organization for hospitals and ASCs, recommends
the following actions to protect patients and staff from the dangers of surgical smoke:
Implement standard procedures for the removal of surgical smoke and plume through the use of
engineering controls, such as smoke evacuators and high filtration masks.
Use specific insufflators for patients undergoing laparoscopic procedures.
During laser procedures, use standard precautions to prevent exposure to the aerosolized
blood, blood by-products and pathogens contained in surgical smoke plumes.
Establish, review, and make available policies and procedures for surgical smoke safety and
control.
Provide surgical team members with initial and ongoing education and competency verification
on surgical smoke safety, including the organization’s policies and procedures.
Conduct periodic training exercises to assess surgical smoke precautions and consistent
evacuation for the surgical suite or procedural area.” 13
As of August 2023, 11 states have adopted legislation to require the use of surgical smoke evacuation
systems in certain health care facilities. Of those 11 states, 8 states require surgical smoke evacuation
systems to be used in hospitals and ASCs for procedures that generate surgical smoke, and 3 states
require them to be used in all health care facilities for procedures that produce surgical smoke. 14
10
Rule 69A-3.012, F.A.C., and s. 633.206(1)(b), F.S.
11
S. 633.202(1), F.S., requires the State Fire Marshal to adopt a new version of the fire prevention code every third year. The 2021 version becomes
effective December 31, 2024, so the 2024 version w ill not become effective until December 31, 2027.
12
Id.
13
The Joint Commission, Quick Safety Issue 56: Alleviating the Dangers of Surgical Smoke, available at
https://www.jointcommission.org/resources/news-and-multimedia/new sletters/newsletters/quick-safety/quick-safety-issue-56/quick-safety-issue-56/ (last
visited January 21, 2024).
14
Staff of the Select Committee on Health Innovation conducted a 50-state analysis on law s relating to surgical smoke evacuation.
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DATE: 2/8/2024
Effect of the Bill
The bill requires hospitals and ASCs to adopt and implement policies by January 1, 2025, that require
the use of a smoke evacuation system during any surgical procedure that is likely to generate surgical
smoke. Smoke evacuation systems must effectively capture, filter, and eliminate surgical smoke at the
site of origin before the smoke makes contact with the eyes or respiratory tract of occupants in the
room.
The bill provides an effective date of July 1, 2024.
B. SECTION DIRECTORY:
Section 1: Creates s. 395.1013, F.S., relating to smoke evacuation systems required.
Section 2: Provides an effective date of July 1, 2024.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
None.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
The bill will have a negative fiscal impact on hospitals and ASCs who do not currently use surgical
smoke evacuation systems during procedures that generate surgical smoke. Such hospitals and ASCs
could incur costs of up to $10,000 per surgical suite annually.
D. FISCAL COMMENTS:
None.
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
None. The bill does not appear to affect local or municipal governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
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DATE: 2/8/2024
The bill does not necessitate rule-making for implementation.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
None.
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DATE: 2/8/2024