BILL ANALYSIS Ó
AB 2272
Page A
Date of Hearing: April 20, 2016
ASSEMBLY COMMITTEE ON LABOR AND EMPLOYMENT
Roger Hernández, Chair
AB 2272
(Thurmond) - As Introduced February 18, 2016
SUBJECT: Occupational safety and health standards: plume
SUMMARY: Requires the Occupational Safety and Health Standards
Board (Board) to adopt standards to protect healthcare personnel
and patients from noxious airborne contaminants "plume"
generated during specified medical procedures. Specifically,
this bill:
1)Requires the Board by June 1, 2018 to adopt standards
requiring a health facility to evacuate or remove plume in all
settings that employ techniques which create plume.
2)Directs the Board to consider and use as benchmarks standards
established by the International Organization for
Standardization (ISO) and the Canadian Standards Association
(CSA) unless federal Occupational Safety and Health
Administration (OSHA) or the National Institute for
Occupational Safety and Health (NIOSH) recommendations are
more effective in the evacuation of plume and would be more
protective of occupational health.
3)Defines "plume" as noxious airborne contaminants generated as
AB 2272
Page B
byproducts of the use of energy-based devices, electrosurgical
devices, electrocautery devices or mechanical tools during
surgical, diagnostic or therapeutic procedures.
4)Defines "plume scavenging system" as smoke evacuators, laser
plume evacuators, plume scavengers, and local exhaust
ventilators that capture and neutralize at least 95 percent of
plume before plume can make contact with eyes or contact with
the respiratory tract of healthcare personnel or patients.
5)States the use of surgical masks or respirators do not satisfy
the requirements under this bill.
EXISTING LAW: Establishes the Board within the Department of
Industrial Relations (DIR) which promulgates and enforces
occupational safety and health standards for the state including
standards dealing with toxic materials and harmful physical
agents.
FISCAL EFFECT: Unknown
COMMENTS: According to the sponsors, the California Nurses
Association/National Nurses United, a Nurses' Health Study found
that operating room nurses, "were at significantly higher risk
of severe persistent asthma" as a result of occupational
exposure to the dangerous and infectious materials that can be
found in surgical plume smoke.<1> By adopting standards to
remove these infectious airborne contaminants before they are
dispersed into the surgical suite and surrounding areas,
---------------------------
<1> Nurses' Health Studies are among the largest ongoing
investigations of factors that influence nurses' health.
Started in 1976 and expanded in 1989, the information provided
by 238,000 dedicated nurse participants has led to insights on
health and disease.
AB 2272
Page C
California could be a leader in the reduction of hazardous
exposure to surgical plume which could prove beneficial both to
health care providers and their patients.
Federal OSHA can cite hospitals for not making an effort to
control smoke emission in laser or electrosurgical procedures
through a clause that covers all hazardous conditions. In
Section 5(a)(1) of the Occupational Safety and Health Act,
OSHA's General Duty Clause states:
Each employer shall furnish to each of his [sic] employees
employment and a place of employment which are free from
recognized hazards that are causing or are likely to cause
death or serious physical harm to his [sic] employees.
However OSHA's limited ability to enforce elimination of unsafe
practices involving such surgical procedures has led many to
stress the need for a more concentrated campaign. "In many
ways, this is an education issue rather than an enforcement
issue," says Vangie Dennis, R.N., C.N.O.R., C.M.L.S.O., advanced
technology manager, Surgical Services Support, at Gwinnett
Medical Center near Atlanta. Ms. Dennis, says "there are still
operating room personnel who are unaware of the issue, who do
not realize that they are breathing human body parts. There are
surgeons using smoke evacuators for laser procedures but not
electrosurgery, which is actually more dangerous because this
procedure emits more particulates." In her role at Gwinnett, Ms
Dennis, helped transform the way surgical smoke is dealt with at
Gwinnett. "In the past, there was inconsistent use of smoke
evacuators and no real understanding of the hazards of
electrosurgical smoke," she says. "We now use smoke evacuators
with any procedure that emits smoke. Getting to that point
AB 2272
Page D
involved a proactive strategy to optimize workplace safety."<2>
ISO Standard on Systems for Evacuation of Plume Generated by
Medical Devices
ISO is an independent, non-governmental international
organization with a membership of 161 national standards bodies.
According to their website international standards make things
work. They give world-class specifications for products,
services and systems, to ensure quality, safety and efficiency.
ISO has published more than 19000 International Standards and
related documents, covering almost every industry, from
technology, to food safety, to agriculture and healthcare. ISO
International Standards impact everyone, everywhere.
ISO Standard 16571:2014 specifies requirements and guidelines
for the design, manufacture, installation, function,
performance, maintenance, servicing, documentation, testing, and
commissioning of equipment for evacuation of plume generated by
medical devices.
NIOSH Recommendations
As part of the Centers for Disease Control (CDC), NIOSH is
responsible for conducting research and making recommendations
for the prevention of work-related illnesses and injuries.
---------------------------
<2> Environment of Care News, September 2007, Volume 10, Issue
9- Joint Commission on Accreditation of Healthcare Organizations
AB 2272
Page E
According to information published on their website, during
surgical procedures using a laser or electrosurgical unit, the
thermal destruction of tissue creates a smoke byproduct.
Research studies have confirmed that this smoke plume can
contain toxic gases and vapors such as benzene, hydrogen
cyanide, and formaldehyde, bio-aerosols, dead and live cellular
material (including blood fragments), and viruses. At high
concentrations the smoke causes ocular and upper respiratory
tract irritation in health care personnel, and creates visual
problems for the surgeon. The smoke has unpleasant odors and
has been shown to have mutagenic potential.
NIOSH research has shown airborne contaminants generated by
these surgical devices can be effectively controlled. Two
methods of control are recommended by NIOSH:
Ventilation
Recommended ventilation techniques include a combination of
general room and local exhaust ventilation (LEV). General
room ventilation is not by itself sufficient to capture
contaminants generated at the source. The two major LEV
approaches used to reduce surgical smoke levels for health
care personnel are portable smoke evacuators and room suction
systems.
Smoke evacuators contain a suction unit (vacuum pump), filter,
hose, and an inlet nozzle. The smoke evacuator should have
high efficiency in airborne particle reduction and should be
used in accordance with the manufacturer's recommendations to
achieve maximum efficiency. A capture velocity of about 100
to 150 feet per minute at the inlet nozzle is generally
recommended. It is also important to choose a filter that is
effective in collecting the contaminants. A High Efficiency
AB 2272
Page F
Particulate Air (HEPA) filter or equivalent is recommended for
trapping particulates. Various filtering and cleaning
processes also exist which remove or inactivate airborne gases
and vapors. The various filters and absorbers used in smoke
evacuators require monitoring and replacement on a regular
basis and are considered a possible biohazard requiring proper
disposal.
Room suction systems can pull at a much lower rate and were
designed primarily to capture liquids rather than particulate
or gases. If these systems are used to capture generated
smoke, users must install appropriate filters in the line
ensure that the line is cleared, and that filters are disposed
of properly. Generally speaking, the use of smoke evacuators
is more effective than room suction systems to control the
generated smoke from non-endoscopic laser/electric surgical
procedures.
Work Practices
The smoke evacuator or room suction hose nozzle inlet must be
kept within two inches of the surgical site to effectively
capture airborne contaminants generated by these surgical
devices. The smoke evacuator should be ON (activated) at all
times when airborne particles are produced during all surgical
or other procedures. At the completion of the procedure all
tubing, filters, and absorbers must be considered infectious
waste and be disposed appropriately. New filters and tubing
should be installed on the smoke evacuator for each procedure.
While there are many commercially available smoke evacuator
systems to select from, all of these LEV systems must be
regularly inspected and maintained to prevent possible leaks.
Users shall also utilize control measures such as "universal
precautions," as required by the OSHA Blood-Borne Pathogen
standard.
AB 2272
Page G
Federal OSHA Recommendations
During surgical procedures that use a laser or electrosurgical
unit, the thermal destruction of tissue creates a smoke
byproduct. Each year, an estimated 500,000 workers, including
surgeons, nurses, anesthesiologists, and surgical technologists,
are exposed to laser or electrosurgical smoke. Surgical plumes
have contents similar to other smoke plumes, including carbon
monoxide, polyaromatic hydrocarbons, and a variety of trace
toxic gases. As such, they can produce upper respiratory
irritation, and have in-vitro mutagenic potential. Although
there has been no documented transmission of infectious disease
through surgical smoke, the potential for generating infectious
viral fragments, particularly following treatment of venereal
warts, exists. Local smoke evacuation systems have been
recommended by consensus organizations, and may improve the
quality of the operating field. Employers should be aware of
this emerging problem and advise employees of the hazards of
laser smoke.
There are currently no specific OSHA standards for
laser/electrosurgery plume hazards however they make the
following recommendations:
§ Use portable smoke evacuators and room suction systems
with inline filters.
§ Keep the smoke evacuator or room suction hose nozzle
AB 2272
Page H
inlet within two inches of the surgical site to effectively
capture airborne contaminants.
§ Have a smoke evacuator available for every operating
room where plume is generated.
§ Evacuate all smoke, no matter how much is generated.
§ Keep smoke evacuator "ON" (activated) at all times when
airborne particles are produced during all surgical or
other procedures.
§ Consider all tubing, filters, and absorbers as
infectious waste and dispose of them appropriately. Use
Universal Precautions as required by the OSHA Bloodborne
Pathogens Standard when contaminated with blood or OPIM [29
CFR 1910.1030(d)(1)].
§ Use new tubing before each procedure and replace the
smoke evacuator filter as recommended by the manufacturer.
§ Inspect smoke evacuator systems regularly to ensure
proper functioning.
Arguments in Support
The sponsors argue that the Joint Commission on Accreditation of
Healthcare Organizations and NIOSH has called for a reduction of
plume exposure to healthcare workers and yet a federal
legislative mandate has not been forthcoming. California is one
of many states that as an OSHA approved state plan that allows
for the adoption of occupational standards without having to
resort to the onerous federal process. Our state should take
the lead on this important issue as it has in areas like
occupational exposure to blood borne pathogens, Ebola virus,
safe patient handling, and workplace violence standards.
AB 2272
Page I
Arguments in Opposition
The California Hospital Association, are opposed to this bill
unless amended, stating "the equipment at issue in this bill
directly implicates patient care decisions. The hospital
together with physicians, select devices that may generate plume
as well as devices that could minimize exposure to plume because
of the patient care considerations. Once in the operating room,
the physician is in charge. Because most hospitals do not
employ their physicians (and most private hospitals are
prohibited from doing so) the hospital's ability to impact
decisions made by physicians in the operating room may be
limited and as noted above, could interfere with patient care."
They argue that directing the Board to utilize specific guidance
is too prescriptive particularly where the guidance referenced
is from a non-traditional source. Guidance can change over
time, new guidance could be published before the Board begins
its process and/or there may be more appropriate guidance
available currently. Lastly, they state it is not operationally
feasible to take guidance documents reflecting numerous options
and convert those options into mandates.
REGISTERED SUPPORT / OPPOSITION:
Support
California Nurses Association/National Nurses United (sponsor)
Opposition (Unless Amended)
AB 2272
Page J
California Hospital Association
Analysis Prepared by:Lorie Alvarez / L. & E. / (916) 319-2091