The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Community Affairs
BILL: SB 380
INTRODUCER: Senator Garcia and others
SUBJECT: Protection from Surgical Smoke
DATE: March 14, 2023
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Looke Brown HP Favorable
2. Hackett Ryon CA Pre-meeting
3. RC
I. Summary:
SB 380 requires hospitals and ambulatory surgical centers to, by January 1, 2024, adopt and
implement policies that require the use of a smoke evacuation system during any surgical
procedure that is likely to generate surgical smoke.
The bill provides an effective date of July 1, 2023.
II. Present Situation:
Surgical Smoke
Surgical smoke is produced by the thermal destruction of tissue by use of lasers or
electrosurgical devices.
1
Surgical smoke has been shown to contain toxic gases, vapors and
particulates, viable and non-viable cellular material, viruses, and bacteria.
2
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.
3
Other risks include the
transmission of viruses through surgical smoke, for example the transmission of Human
Papillomavirus (HPV) through surgical smoke from lasers has been documented,
4
and some
1
The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Health
and Safety Practices Survey of Healthcare Workers, last updated March 30, 2017, available at
https://www.cdc.gov/niosh/topics/healthcarehsps/smoke.html (last visited March 2, 2023).
2
Id.
3
Id.
4
Id.
REVISED: BILL: SB 380 Page 2
researchers have suggested that surgical smoke may act as a vector for cancerous cells that may
be inhaled.
5
According to the Occupational Safety and Health Administration (OSHA), recognized controls
and work practices for surgical smoke include:
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.
6
While OSHA recognizes potential risk factors and remedial measures, it has not as of yet
adopted regulations specific to surgical smoke.
7
Additionally, the Joint Commission, a major accrediting non-profit organization for hospitals and
ambulatory surgical centers, 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.”
8
5
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 March 9, 2023).
6
Id.
7
United States Department of Labor, Occupational Safety and Health Administration, Laser/Electrosurgery Plume, available
at https://www.osha.gov/laser-electrosurgery-plume/standards (last visited Mar. 9, 2023).
8
The Joint Commission, Quick Safety Issue 56: Alleviating the Dangers of Surgical Smoke, available at
https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-
56/quick-safety-issue-56/ (last visited March 9, 2023). BILL: SB 380 Page 3
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 High Efficiency Particulate Air
(HEPA) filter.
9
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 far more costly than more
common handheld systems, recurring costs associated with disposable parts for handheld
systems are frequently cited at roughly $19 per surgery, and total recurring costs including filter
replacement between $8,000 and $10,000 annually depending on frequency of use.
10
As of 2021, 21 states had considered legislation requiring smoke evacuator usage during
surgery.
11
At least 10 states
12
have passed laws requiring that operating rooms are made free of
surgical smoke.
13
III. Effect of Proposed Changes:
SB 380 creates s. 395.1013, F.S., to require that hospitals and ambulatory surgical centers
(ASC)
14
adopt and implement policies that require the use of a smoke evacuation system during
any surgical procedures that is likely to generate surgical smoke.
The bill defines:
“Smoke evacuation system” to mean equipment that effectively captures, filters, and
eliminates surgical smoke at the site of origin before the smoke makes contact with the eyes
or respiratory tract of occupants in the room; and
“Surgical smoke” to mean the gaseous byproduct produced by energy-generating devices
such as lasers and electrosurgical devices. The term includes, but is not limited to, surgical
9
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 Mar. 9, 2023).
10
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 Mar. 10, 2023), 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 Mar. 10, 2023); Kreuger, Steven, et al., The
Effect of a Surgical Smoke Evacuation System on Surgical Site Infrections of the Spine, available at
https://www.oatext.com/pdf/CMID-3-132.pdf (last visited Mar. 10, 2023); Utah State Legislature, S.B. 105 Surgical Smoke
Evacuation System Requirements Fiscal Note, available at https://le.utah.gov/~2020/bills/static/SB0105.html (last visited
Mar. 10, 2023).
11
The Joint Commission, Surgical Smoke Legislation Gaining Traction Across the Country, Jun. 9, 2021, available at
https://www.jointcommission.org/resources/news-and-multimedia/blogs/leading-hospital-improvement/2021/06/surgical-
smoke-legislation-gaining-traction-across-the-country/ (last visited Mar. 9, 2023).
12
Arizona, Colorado, Connecticut, Georgia, Illinois, Kentucky, New York, Oregon, Rhode Island, and Washington.
13
AORN, Surgical Smoke-Free OR, available at https://www.aorn.org/get-involved/government-affairs/policy-
agenda/surgical-smoke-free-or (Mar. 9, 2023).
14
The bill uses the term “licensed facilities,” which is defined as hospitals or ambulatory surgical centers (ASCs) licensed
under ch. 315, F.S. An ASC is further defined as a facility separate from a hospital, the primary purpose of which is to
provide elective surgical care with less than 24 hours’ inpatient time, not including facilities which perform abortions or
dentistry. Section 395.002(3), F.S. BILL: SB 380 Page 4
plume, smoke plume, bio-aerosols, laser-generated airborne contaminants, and lung-
damaging dust.
The bill requires hospitals and ASCs to adopt and implement the required policies by January 1,
2024.
The bill provides an effective date of July 1, 2023.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None identified.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
SB 380 may have a negative fiscal impact on hospitals and ASCs if the hospital or ASC
is required to purchase and maintain equipment in order to meet the requirements of the
bill.
C. Government Sector Impact:
To the extent that hospitals and ASCs are funded or operated by governmental entities,
this bill may similarly have a negative government sector impact. BILL: SB 380 Page 5
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill creates section 395.1013 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.