Best Practices for the Safe Use of Glutaraldehyde in Health Care U.S. Department of Labor Occupational Safety and Health Administration OSHA 3258-08N 2006
This best practices booklet is not a standard or regulation,
and it creates no new legal obligations. The document is advisory
in nature, informational in content, and is intended to assist
employers in providing a safe and healthful workplace. The Occupational
Safety and Health Act (OSH Act) requires employers to
comply with hazard-specific safety and health standards. In
addition, pursuant to Section 5(a)(1), the General Duty Clause
of the Act, employers must provide their employees with a workplace
free from recognized hazards likely to cause death or serious
physical harm. Employers can be cited for violating the General
Duty Clause if there is a recognized hazard and they do not
take reasonable steps to prevent or abate the hazard. However,
failure to implement these recommendations is not, in itself,
a violation of the General Duty Clause. Citations can only
be based on standards, regulations, and the General Duty Clause.
OSHA standards that may apply in exposure
scenarios similar to those described in this publication include
Hazard Communication (29 CFR 1910.1200) and Personal Protective
Equipment, General Requirements (29 CFR 1910.132); Eye and
Face Protection (29 CFR 1910.133); Respiratory Protection (29
CFR 1910.134.); and Hazardous Waste Operations and Emergency
Response (29 CFR 1910.120(q)). Scenarios where these OSHA standards
may apply are identified in the text of this document.
Mention of any company or product is for informational purposes
only and does not constitute an endorsement by OSHA.
Introduction This document describes best practices for the safe use of
glutaraldehyde in health care facilities. Glutaraldehyde is
used widely as a cold sterilant to disinfect a variety of heat-sensitive
instruments, such as endoscopes, bronchoscopes, and dialysis
equipment (NIOSH, 2001). In addition, health care employees
may be exposed to glutaraldehyde in its uses as a hardener
in x-ray developing and as a tissue fixative in histology and
pathology labs.
Glutaraldehyde’s properties as a chemical sterilant
were initially recognized in the early 1960s as the health
care industry searched for a safer alternative to formaldehyde,
which is regulated by OSHA as a carcinogen (29 CFR 1910.1048).
In the years since its introduction as a disinfectant/sterilant,
glutaraldehyde has been linked with a variety of health effects – ranging
from mild to severe – including asthma, breathing difficulties,
respiratory irritation, and skin rashes (Pryor, 1984; Crandall,
1987).
The purpose of this document is to provide information that
can be used by health care employers and employees to understand
and control exposures to glutaraldehyde. This document describes
engineering controls, work practices, and facility design considerations
that will help reduce employee exposure to glutaraldehyde.
This document also includes recommendations for personal protective
equipment, employee training, exposure monitoring, disposal
practices, and spill and cleanup procedures. The use of alternatives
to glutaraldehyde is also addressed.
Note: The term “health care facilities” is intended
to encompass the broad range of health care facility types
and sizes, including hospitals, clinics, freestanding surgical
centers, physician offices, and dental clinics, as well as
nursing homes and other residential health care facilities.
Summary of Health Effects The most serious adverse health effect documented among employees
exposed to glutaraldehyde vapor is occupational asthma, a chronic
condition characterized by bronchial hyperresponsiveness. Reactions
can be either immediate or delayed, with a latent period ranging
from a few weeks to several years from the onset of exposure.
Human studies on the effects of glutaraldehyde exposure consist
of many case reports in the published literature, some identified
by both American and British health surveillance systems, and
symptom surveys of American health care employees, all of which
document an association between exposure to glutaraldehyde
and the development of asthma. (Gannon et al., 1995; Rosenman
et al., 1997; Keynes et al., 1996; Di Stefano et al., 1999).
In addition, a few cross-sectional studies also show that
an increased prevalence of irritant symptoms, including itching
of the eyes with increased lacrimation (tearing), and rhinitis,
is reported by health care employees who are exposed to short-term
(15minute) concentrations well below 0.2 parts-per-million
(ppm) in air, predominantly in the range of about 0.005 to
0.050 ppm (Norback, 1988; Pisaniello et al., 1995).
In addition to causing respiratory effects, glutaraldehyde
acts as a contact allergen, giving rise to contact dermatitis,
usually on the hands but occasionally on the face. Skin sensitization
from contact with glutaraldehyde has been documented in endoscopy
nurses, dental assistants, x-ray technicians, hospital maintenance
and cleaning staff, and funeral service employees (Marzulli
and Maibach, 1974; Fowler, 1989; Nethercott et al., 1988; Maibach
and Prystowsky, 1977; Nethercott and Holness, 1988; Ballantyne
and Berman, 1984; Waters et al., 2003). Individuals who have
become sensitized to glutaraldehyde can develop dermatitis
after contacting solutions containing as little as 0.1 percent
glutaraldehyde. In contrast, simple skin irritation typically
occurs on contact with solutions containing more than 2 percent
glutaraldehyde (HSE, 1997). In one study of health care employees
who had developed allergic contact dermatitis from glutaraldehyde,
ten employees who were followed for six months after initial
diagnosis continued to have persistent hand eczema, although
five of these employees had left their jobs because of this
health problem (Nethercott et al., 1988).
Occupational Exposure Limits for Glutaraldehyde The Federal Occupational Safety and Health Administration
(OSHA) does not have a Permissible Exposure Limit for glutaraldehyde.
The National Institute for Occupational Safety and Health (NIOSH)
established a Recommended Exposure Limit (REL) of 0.2 ppm in
1989 (http://www.cdc.gov/niosh/npg/npgd0301.html). Other organizations
that have occupational exposure limits include the American
Conference of Governmental Industrial Hygienists (ACGIH), which
currently recommends a Threshold Limit Value (TLV) of 0.05
ppm in air, measured as a ceiling concentration, and the United
Kingdom Health and Safety Executive which also has established
a 0.05 ppm Workplace Exposure Limit (WEL) averaged over both
8 hours and 15 minutes.
The occupational exposure limits discussed above were current
at the time this document was published. However, it is essential
that health care personnel keep informed of current Federal,
state, and local regulations applicable to glutaraldehyde,
as well as with professional guidelines.
Glutaraldehyde-based agents are used to disinfect medical
equipment that cannot be subjected to steam sterilization,
specifically heat-sensitive, lensed devices typically requiring
high-level disinfection between patient uses (ANSI/AAMI, 1996).
Glutaraldehyde-based products may be used in a variety of locations
within a facility, such as surgery, endoscopy, and respiratory
therapy. Trade names of glutaraldehyde-based products include,
but are not limited to, Cidex®, Sonacide®, Sporicidin®,
Hospex®, and Omnicide® (NIOSH, 2001).
Definitions:
Sterilant : Physical or chemical agent(s)
or process which completely eliminates or destroys all forms
of life, particularly microorganisms.
Disinfectant : An agent that destroys pathogens
by physical or chemical means. Disinfection processes do not
ensure the same margin of safety associated with sterilization
processes and can vary in their extent of microorganism elimination.
This variation leads to subcategories, the first of which is
high-level disinfection.
High-Level Disinfection : A process utilizing
a sterilant under less than sterilizing conditions. The process
kills all forms of microbial life except for large numbers
of bacterial spores.
Disinfection activities range from simple soaking of small
instruments to automated processing of complex lensed instruments,
such as endoscopes. Exposure to glutaraldehyde as a high-level
disinfectant occurs primarily during the following activities:
activating
and pouring glutaraldehyde solution into or out of a cleaning
container system (e.g., soaking basin in manual disinfecting
operations and reservoir in automated processors);
opening the cleaning container system to immerse
instruments to be disinfected;
agitating glutaraldehyde solution;
handling of soaked instruments;
removing instruments from the container system;
rinsing the channels of instruments containing residual
glutaraldehyde solution;
flushing out instrument parts with a syringe;
drying instrument interiors with compressed air;
disposing of “spent” glutaraldehyde solutions
to the sanitary sewer;
performing maintenance procedures, such as filter
or hose changes on automated processors that have not been
pre-rinsed with water.
Measurements of health care employee exposure to glutaraldehyde
vapor during high-level disinfection have been reported to
range from none detected to 0.20 ppm or greater (Naidu et al.,
1995; Pisaniello et al., 1997). NIOSH has documented levels
as high as 0.5 ppm (NIOSH, 1985); 0.48 ppm (NIOSH, 1987); and
0.08 ppm (NIOSH, 1991) during disinfection procedures at health
care facilities. A recent study (Waters et al., 2003) documented
exposures of up to 0.15 ppm in endoscopy disinfection. Exposure
levels will vary depending on a number of factors such as the
concentration of the glutaraldehyde solution, type of process
(manual versus automatic), ventilation conditions, site-specific
factors, as well as the duration of the sampling period (e.g.,
peak, 15-minute short-term, or full task duration).
Manual operations with inadequate or ineffective controls
result in higher exposures. Pisaniello et al. (1997) reported
on exposures in operating theaters and endoscopy areas with
and without local exhaust ventilation (LEV). In endoscopy units,
the mean geometric exposure of 14 samples without LEV was 0.093
ppm, and 0.022 ppm with LEV. Figure 1 presents some exposure
data for specific operations with and without exposure controls.
Sources: NIOSH, 1991; NJDOHSS, 1998; Naidu et al., 1995. All exposures are personal breathing zone samples.
Recommended Exposure Controls
A variety of engineering controls, facility design considerations,
and work practices are available to minimize exposure to glutaraldehyde
during its use as a disinfectant and sterilant. In good industrial
hygiene practice such methods are to be used to control employee
exposure, and if they prove to be insufficient to protect employees,
respirators and other personal protective equipment are to
be used. Employees required by their employer to wear respirators
must receive training and a medical evaluation to determine
their fitness to use the equipment. Fit testing of the respirator
is also required. For details on fit testing and other requirements
for employee use of respirators see OSHA’s Respiratory
Protection standard (29 CFR 1910.134). Employees whose employers
do not require them to wear respirators but who choose to do
so must obtain certain information concerning the safe use
of respirators (Appendix D to Part 1910.134). Respirators protect
only the user, and others in the area may be overexposed to
glutaraldehyde vapor if it is not adequately controlled at
the source of the release.
Other forms of personal protective equipment (PPE), such
as gloves, safety eyewear, and isolation gowns, lab coats,
or aprons (plus sleeve protectors) should be worn and may be
required whenever there is the potential for skin or eye contact
with glutaraldehyde. See the following OSHA standards: Personal
Protective Equipment, General Requirements (29 CFR 1910.132);
Eye and Face Protection (29 CFR 1910.133); Respiratory Protection
(29 CFR 1910.134) and Hand Protection (29 CFR 1910.138), and
ANSI/AAMI, 1996. Such PPE should always be used in combination with
effective engineering controls.
Studies have documented the effectiveness of controls in
reducing exposure to glutaraldehyde in disinfecting. Butt
et al. (1999) documented exposures during sterilization and
mixing over a 5-month period, while changes to ventilation,
equipment and work practices were made. During this time, exposures
to glutaraldehyde during mixing decreased from a high of 0.96
ppm down to 0.04 ppm. The authors indicated that the changes
that appeared to have the most impact on reducing mixing exposures
were the addition of a waste pump and new filters in the hood.
This section describes recommended engineering controls and
work practices to reduce glutaraldehyde exposures to safe levels
during disinfection activities. This section also summarizes
the most recent information concerning possible substitutes
for glutaraldehyde. Employers should consider whether for a
particular use of glutaraldehyde there is an effective substitute
that has reduced risks to employees.
See General Recommendations section of this publication
at page 23 for additional information on the selection and
use of personal protective equipment, employee information
and training, exposure monitoring, disposal of glutaraldehyde
solutions, and spill and cleanup procedures applicable to the
use of glutaraldehyde as a high-level disinfectant.
Engineering Controls The goal of engineering controls is to keep glutaraldehyde
vapor from entering the workroom and the employee’s breathing
zone by containing and removing it at the source of release.
As described above, the primary sources of employee exposure
to glutaraldehyde during disinfection/sterilant activities
include pouring glutaraldehyde solutions into container systems,
opening soaking basins or reservoirs, and handling instruments
containing residual glutaraldehyde. Engineering controls tailored
for these exposure sources include ventilation, both general
exhaust ventilation and local exhaust systems (such as laboratory
chemical hoods), process automation, and isolation (e.g., basins
with tight-fitting covers, dedicated centralized storage and
use areas).
General Room Ventilation
The American National Standards Institute, Inc., in collaboration
with the Association for the Advancement of Medical Instrumentation,
recommends that rooms where glutaraldehyde disinfection/ sterilization
is performed be large enough to ensure adequate dilution of
vapor and have a minimum air exchange rate of 10 air exchanges
per hour (ANSI/AAMI, 1996). Some agencies recommend even
higher air exchange rates, e.g., 15 air exchanges per hour,
to ensure dilution of vapor. There are no national standards
that apply specifically to glutaraldehyde usage areas; however,
local codes may apply. The air exchange rate recommended by
ANSI/ AAMI is consistent with the American Institute of Architects’ guidelines
for health care facilities (ANSI/AAMI, 1996).
Local Exhaust Ventilation
ANSI/AAMI ST58 recommends that local exhaust ventilation
also be installed at the point of release of glutaraldehyde
vapors. The health care facility must ensure that the ventilation
system is operating properly and is not obstructed or disturbed
by drafts from sources such as fans, supply air diffusers,
open windows and doors, and heavily traveled aisles.
Local exhaust ventilation located at the level of vapor discharge
is the preferred method of reducing glutaraldehyde vapor concentrations
because it captures and removes vapor at the source before
it can escape into the general work environment. Local exhaust
ventilation systems for glutaraldehyde-based activities may
include a local exhaust hood (such as a laboratory fume hood)
and the associated ductwork and fan; or, a self-contained,
freestanding, recirculating exhaust ventilation system (i.e.,
ductless fume hood).
Local Exhaust Hood
The purpose of a local exhaust hood is to capture glutaraldehyde
vapor during processing and conduct it into the exhaust system
(via the hood). The capture and control of glutaraldehyde vapor
is achieved by the inward airflow created by the exhaust hood.
The minimum hood-induced air velocity necessary to capture
and convey glutaraldehyde vapor into the hood is called the “capture
velocity.” Pryor (1984) recommends a minimum capture
velocity of at least 100 feet per minute to prevent exposure
to glutaraldehyde vapor.
The average velocity of the air drawn through the face (opening)
of the hood is called the “face velocity.” The
face velocity of a hood greatly influences the containment
efficiency of the hood (i.e., the hood’s ability to contain
hazardous air contaminants) (National Research Council, 1995).
The American Industrial Hygiene Association recommends an average
face velocity of 80 to 120 feet per minute for laboratory exhaust
hoods (AIHA, 1992 in ANSI/AAMI, 1996).
Once glutaraldehyde vapor is collected inside a suitable
exhaust hood, it is transported through a duct system and then
discharged to the outside via a fan.
Ductless Fume Hoods
Ductless fume hoods are ventilated enclosures that have their
own exhaust fan that draws air out of the hood, passes it through
an air cleaning filter and then discharges the cleaned exhaust
air back into the workplace. Ductless fume hoods are “recirculating” exhaust
systems used for contaminant control and use a variety of filters
for air cleaning purposes, depending on the air contaminant(s).
For glutaraldehyde, a filter containing activated charcoal
or other suitable sorbent material must be used to effectively
capture vapors. Because the collection efficiency of these
filters decreases over time, a preventive maintenance program
in accordance with the manufacturer’s recommendations
must be implemented to ensure optimum performance of the system
and effective employee protection.
Ductless fume hoods may also come equipped with a variety
of features as specified in the American National Standards
for Recirculation of Air from Industrial Process Exhaust Systems
(ANSI/AIHA, 1998). These safety features are designed to prevent
inadvertent exposure in the workplace and include continuous
monitoring devices equipped with alarms to alert operators
to potential filter break through, and backup air cleaning
devices.
Transfer Procedures
Reducing the release of glutaraldehyde vapor during transfer
operations can be accomplished by the use of automated and
enclosed equipment. For example, the transfer of glutaraldehyde
from drums into process containers can be automated using pumps
and closed transfer lines. Such automated equipment can help
employees avoid glutaraldehyde exposure (OSHA “Hospital
e-Tool;” http://www.osha.gov/SLTC/etools/hospital/index.html);
(AFSCME, 2001).
The use of a “safety nozzle” for pouring reduces
the potential for splashing and “glugging” during
initial pouring of glutaraldehyde solutions. When using a “safety
nozzle, ” be aware that droplets may remain inside the
nozzle and take care to avoid spraying droplets into the atmosphere
when removing (unscrewing) it from one container and screwing
it onto another container.
Automated Disinfection
The use of automated processing equipment to disinfect instruments
can significantly reduce the glutaraldehyde exposures of employees
performing disinfection procedures, as well as of other employees
and non-employees in the vicinity. However, exposure is still
possible, especially when poor work practices are used or the
equipment is poorly designed or improperly installed. The ANSI/
AAMI ST58 standard contains detailed guidelines (Figure 2,
below) for the purchase and installation of automated equipment
which is now widely used in health care facilities that perform
high-volume disinfection.
Mobile Disinfecting Stations
Mobile disinfecting soaking stations designed specifically
for manual high-level disinfecting provide an enclosed area
for sterilizing trays, protecting employees from splashes and
spills, and controlling exposure to vapor from glutaraldehyde
and other disinfectants. Mobile disinfecting stations utilize
ductless fume hoods for vapor control and may have different
types of filters available depending on the disinfectant to
be used.
Facility Design
The health care facility should designate central areas for
disinfection and sterilization using glutaraldehyde so that
specific controls can be utilized (ANSI/AAMI, 1996). Specific
engineering controls are more difficult to implement in facilities
that permit the widespread use of glutaraldehyde throughout
the site. The centralized location should be large enough to
permit freedom of movement (a crowded work space creates the
potential for spills), and have limited access. Posting warning
signs at the entrance to the centralized location and limiting
access to only trained personnel designated to perform operations
involving the use of glutaraldehyde will contribute to reducing
exposure at the facility.
Recommended Work Practices
Poor work practices can contribute significantly to an employee’s
glutaraldehyde exposure. The health care facility should evaluate
each glutaraldehyde-using operation and observe employees’ work
practices to determine all potential sources of exposure. Developing
procedures for safe work practices may be useful for training
and communication purposes. These procedures should emphasize
prevention of employee contact with glutaraldehyde solution
or vapors. Only trained, designated personnel should be responsible
for handling glutaraldehyde. The following sections provide
general recommendations for safe work practices addressing
the transportation, storage, use, spill control, cleanup, and
disposal of glutaraldehyde. Individual facilities should tailor
their work practices to the specific glutaraldehyde operations
in place at their work sites.
Transportation and Storage of Glutaraldehyde
Transport glutaraldehyde solution only in closed
containers with tight-fitting lids to minimize the potential
for spills (NICNAS, 1994).
Designate centralized locations for using glutaraldehyde
to reduce the potential for spills during transport.
Store unused glutaraldehyde solutions in tightly
covered containers in a cool, secured, and properly labeled
area (NICNAS, 1994; ANSI/AAMI, 1996).
■ Dispose of outdated solutions properly.
Use and Handling Procedures
When transferring glutaraldehyde to soaking basins
and reservoirs, pour the liquid carefully and minimize splashing.
Minimize splashing and agitation of glutaraldehyde solutions
by careful placement and removal of instruments (NSW Health
Department, 1993).
When transferring and pouring glutaraldehyde solutions,
use safety nozzles designed with a flexible spout and shut-off
valve, when available (http://www.kemmed.com).
Keep covers on soaking basins closed as much as possible
and use appropriately-sized, tight-fitting lids for containers.
Use appropriately-sized soaking basins designed to
minimize surface area (e.g., narrow, deep container) (ANSI/AAMI,
1996).
Keep automatic washer doors closed at all times except
when necessary for loading or unloading of instruments to be
disinfected.
Rinse soaked instruments under gently running water
as close as possible to the soaking tray or washer to contain
solution and minimize dripping on other surfaces (NSW Health
Department, 1993).
Use adequate ventilation if using compressed air
to dry instruments rinsed with ethyl or isopropyl alcohol rinses.
See discussion on Engineering Controls at page 10 in this section.
Use glutaraldehyde only in designated areas where
traffic and ventilation can be controlled.
Ensure that the ventilation system is operating prior
to handling glutaraldehyde solutions. (Consult your facilities
department for help on how to check the operation of your ventilation
system.) NOTE: The odor threshold of glutaraldehyde has been
reported to be 0.04 parts per million (ppm), and odor detection
is a potential indicator that the engineering controls are
inadequate. However, you cannot always rely on odor detection
because some formulations may contain a perfume to mask the
odor of glutaraldehyde (ANSI/AAMI, 1996). Additionally, individuals
vary in their ability to detect odors; thus, the lack of an
odor does not necessarily mean that exposures are adequately
controlled.
Follow recommended ACGIH procedures for proper use
of laboratory hoods (see Figure 3 at page 19).
Close workroom doors to ensure the effectiveness
of any available general dilution ventilation (NJDOHSS, 1998).
Do not store food, eat, drink, smoke, or apply cosmetics
in any area where glutaraldehyde is stored or used.
Clean up small glutaraldehyde spills and releases
immediately. In the case of large spills or delayed response,
employees should be encouraged to close doors, alert others
and activate the HazMat spill response team.
Alternatives to Glutaraldehyde for High-Level Disinfection When an alternative to glutaraldehyde is available which
is at least as effective as an FDA-approved high-level disinfectant,
consideration should be given to whether the alternative is
safer for employees. Prior to selecting a specific glutaraldehyde
alternative, in addition to process and product considerations,
consideration should be given to the following: the toxicity
of the glutaraldehyde alternative (e.g., there may be limited
knowledge regarding the potential health effects of the alternative);
disposal, ventilation, personal protective equipment (PPE)
and air monitoring requirements.
Health care facilities that would like to eliminate or reduce
their dependence on glutaraldehyde as a high-level disinfectant
have two options: (1) use a different (drop-in) liquid chemical
disinfectant (e.g., Cidex OPA, Compliance, Sporox II, and Sterilox);
or (2) invest in new enclosed equipment technologies that do
not utilize glutaraldehyde (e.g., Sterrad and Steris) (Sustainable
Hospitals, 2001). Current alternatives to glutaraldehyde for
high-level disinfection and/or sterilization can be found on
the Food and Drug Administration’s (FDA) website at www.fda.gov/cdrh/ode/germlab.html. Material Safety Data Sheets (MSDSs) for each product
can be obtained directly from the manufacturer.
Selection and Use of Personal Protective Equipment
See the General Recommendations section of this
publication at page 23 for additional information on the selection
and use of personal protective equipment to control employee
exposures to glutaraldehyde. General information on employee
training, exposure monitoring, disposal of glutaraldehyde solutions,
and spill and cleanup procedures applicable to the use of glutaraldehyde
as a high-level disinfectant is also included.
Glutaraldehyde is used in some health care facilities as
a fixative in electron and light microscopy and as a tissue
preservative. Laboratory personnel may be exposed to solutions
containing up to 50% glutaraldehyde during the preparation
of fixative solutions for use in microscopy and histology,
and to very small quantities of working strength solutions
(3-6%) during tissue fixation. If the use is regular and exposure
controls are lacking or ineffective, adverse health effects
may occur. Eye, skin, and respiratory irritation have been
reported for laboratory personnel engaged in tissue fixing
(NICNAS, 1994, NIOSH, 1986). The more serious effects, such
as skin/respiratory tract sensitization and asthma, may occur
in some exposed individuals.
NIOSH has measured and reported air concentrations of glutaraldehyde
as high as 1.5 mg/m 3 (0.36 ppm) during tissue fixing operations
evaluated during maintenance procedures (NIOSH, 1984). The
following activities are the primary sources of glutaraldehyde
exposure during its use as a tissue fixative:
preparing glutaraldehyde solution from concentrate
to fill enclosed fixing basin;
draining and cleaning of fixing basin;
removing and adding materials (e.g., tissue sample)
to the fixing basin;
handling materials fixed in the basin;
handling tissue samples for refrigeration;
rinsing tissue samples in a buffer;
slicing tissue samples onto slides (NIOSH, 1986).
Recommended Exposure Controls
The use of a properly operating laboratory hood is the recommended
method of controlling the exposures of laboratory employees
who use glutaraldehyde to prepare slides of tissue samples.
As discussed above, for employees who perform instrument disinfection
using glutaraldehyde, respirators should not be the primary
means of controlling exposure during these laboratory operations.
Appropriate PPE, such as gloves and safety eyewear, should
always be used in combination with the laboratory hood. Guidelines
for the proper use of laboratory hoods are presented in Figure
3, below. These guidelines were developed by the American Conference
of Governmental Industrial Hygienists (ACGIH).
Selection and Use of Personal Protective Equipment
See the General Recommendations section of this
publication at page 23 for additional information on the selection
and use of personal protective equipment to control exposures
to glutaraldehyde. General information on employee training,
exposure monitoring, disposal of glutaraldehyde solutions and
spill and cleanup procedures applicable to the use of glutaraldehyde
as a tissue fixative is also included.
Health care facilities employees who develop x-rays may be
exposed to glutaraldehyde during such operations. Glutaraldehyde
is used in developing solutions as a hardening agent to shorten
the drying cycle in film processing. X-ray developers are typically
supplied as a concentrate containing 30-50% weight-to-weight
ratio glutaraldehyde and are diluted to working strength solutions
containing less than 1-2% glutaraldehyde. Automatic mixers
are generally used to mix and dispense developing solutions;
however, smaller radiology units may still use manual methods.
The primary sources of glutaraldehyde exposure during x-ray
processing are as follows:
mixing glutaraldehyde developer solutions;
adding solutions to tanks and processors;
processing x-rays;
removing incompletely dried processed x-rays;
cleaning rollers and tanks on x-ray machines;
emptying tanks and processors;
fugitive emissions from open tanks and leaky hoses
and equipment; and
automatic processor exhaust.
(Source: NICNAS, 1994.)
Measurements of health care employee exposure to glutaraldehyde
during x-ray film processing generally show glutaraldehyde
levels below recommended exposure standards, especially with
automatic mixing and processing operations. Efforts to minimize
or eliminate occupational exposure are recommended because
glutaraldehyde is a potential sensitizer, health effects may
occur at levels lower than current standards, and the effects
of simultaneous exposure to multiple chemicals used in developer
and fixer solutions are not clearly understood (NICNAS, 1994;
Teschke et al., 2002).
Recommended Exposure Controls
As described for previous operations, the primary method
of exposure control is enclosing the operation and installing
local exhaust ventilation. The following sections describe
methods of exposure control during x-ray processing.
Alternative Processes
A good method of glutaraldehyde exposure control is substitution
with a safer process that does not require the use of glutaraldehyde.
There are commercially available processes that do not require
glutaraldehyde as a hardener (Thunthy et al., 1994). Digital
x-ray processors are also a viable substitute.
Engineering Controls
Where alternative processes cannot be implemented, engineering
controls should be implemented to minimize glutaraldehyde exposure
during film processing operations. Examples of engineering
controls include:
installing automatic mixers and processors equipped with
local exhaust ventilation that is discharged to outdoors;
conducting manual mixing and processing within laboratory
fume hoods;
using sealed containers and dispensing units for automatic
transfer of glutaraldehyde solutions to processors;
maintaining glutaraldehyde work areas under slight negative pressure to prevent glutaraldehyde emissions from escaping into surrounding areas;
keeping darkroom and processing temperatures as low as possible to minimize glutaraldehyde evaporation.
(Source: NICNAS, 1994.)
Recommended Work Practices
Safe work practices for the use and handling of glutaraldehyde
in x-ray film processing include the following:
regular inspection and maintenance of auto mixers
and processors to prevent vapor releases due to leaks and overheating;
placement and use of mixing tanks and glutaraldehyde
solutions in laboratory fume hoods or other enclosed, well
ventilated areas;
careful mixing and handling procedures to minimize
vapor release, splashing, spillage, and skin contact;
use of tight-fitting lids on mixing tanks;
use of adequately-sized and properly located washing
receptacles for cleaning processor equipment and tanks;
limited handling of wet films; and
immediate cleanup of small glutaraldehyde spills
and releases. See the paragraph on large spills in the General
Recommendations section of this document at page 31.
(Source: NICNAS, 1994.)
Selection and Use of Personal Protective Equipment
See the General Recommendations section of this
publication, below, for additional information on the selection
and use of personal protective equipment. General information
on employee training, exposure monitoring, disposal of glutaraldehyde
solutions and spill and cleanup procedures applicable to the
use of glutaraldehyde in x-ray processing is also included.
selection and use of personal protective equipment;
employee information and training;
exposure monitoring;
disposal of glutaraldehyde solutions; and
spill control and cleanup procedures.
Selection and Use of Personal Protective Equipment
Employees must wear personal protective equipment (PPE) designed
to protect skin and eyes from contact with glutaraldehyde solutions
(29 CFR 1910.132 and 1910.133). Contact with clothing should
also be prevented. The health care facility should develop
and implement a written program outlining the facility’s
policies and procedures for PPE selection and use, including
a hazard assessment and written certification that the hazard
assessment has been performed (pursuant to the requirements
of 29 CFR 1910.132) to determine the nature of the hazards
requiring PPE.
Skin Protection
Employers must select and require employees to use appropriate
hand protection when employees' hands are exposed to potential
skin absorption of substances such as glutaraldehyde (29 CFR
1910.138). Gloves impervious to glutaraldehyde are required
to be worn to prevent contact with glutaraldehyde solutions.
Elbow-length gloves or protective sleeves made of glutaraldehyde-impervious
material should be worn to protect the hands and forearms (ANSI/AAMI,
1996). The gloves used will depend on the type of work to be
done, the duration of contact, and the concentration of glutaraldehyde.
Among the chemical-protective materials, butyl rubber , nitrile and Viton ® are
the most impervious to 50% glutaraldehyde solutions and have
been shown to provide full shift protection against glutaraldehyde
permeation (Jordan et al., 1996; Forsberg and Keith, 1999).
For shorter exposures, gloves made of polyethylene and styrene-butadiene/styrene-isoprene
copolymers (i.e., Allergard Synthetic Surgical Gloves) provide
protection for several hours with dilute (2% to 3.4%) glutaraldehyde
solutions (Jordan et al., 1996; Ansell Health Care, 2003).
Latex examination gloves may not provide adequate skin protection
against glutaraldehyde. Although one author reports a breakthrough
time of 45 minutes with latex examination gloves and standard
2% to 3.4% glutaraldehyde solutions, other materials are available
that provide a greater margin of safety. Therefore, latex gloves
are not recommended for use with glutaraldehyde.
Polyvinyl chloride (PVC) and neoprene gloves do not provide
adequate protection and should not be used with glutaraldehyde
solutions because they may retain or absorb glutaraldehyde
(Jordan et al., 1996).
If the required hazard assessment (29 CFR 1910.132) indicates
a need for additional protection for skin and clothing, it
can be provided through the use of isolation gowns, lab coats,
or aprons (plus sleeve protectors) that are made of glutaraldehyde-impervious
material such as polyethylene-coated, spun-bond polypropylene.
Protective clothing that has become saturated should be removed
quickly and laundered prior to reuse. If skin contact with
glutaraldehyde occurs, the skin should be washed thoroughly
with soap and water for at least 15 minutes (ANSI/AAMI, 1996).
Eye Protection
Splashproof goggles or safety glasses with full face shields
must be worn wherever there is potential for glutaraldehyde
solution to contact the eyes (29 CFR 1910.133). Suitable emergency
eyewash equipment must be immediately available for quick drenching
or flushing of the eyes (for at least 15 minutes) in all glutaraldehyde
usage locations. It is recommended that emergency eyewash units
be accessible and located within a 10 second travel time of
all affected areas. For additional details, consult American
National Standard Z358.1-1998, Emergency Eyewash and Shower
Equipment.
If an eyewash and a shower are required, a combination unit
should be considered.
Respiratory Protection
Respirators should not be used as a substitute for installing
effective engineering controls. When effective engineering
controls are not feasible, or while they are being implemented,
appropriate respirators may be used to control employee exposure
to glutaraldehyde vapor (29 CFR 1910.134(a)(1)).
All personnel who may be required to wear a respirator for
routine or emergency use must be included in a written respiratory
protection program that meets the requirements of OSHA’s
Respiratory Protection standard (29 CFR 1910.134). Such a program
must have written site-specific procedures for selecting, using,
and maintaining respirators; medical evaluations; fit testing;
employee training; and routine program evaluation.
Employers must select appropriate respirators based on an
exposure assessment or a reasonable estimate of employee exposures
to glutaraldehyde vapor during routine and/or emergency work
procedures. For protection against exposures to glutaraldehyde
vapor during routine procedures, employers may provide air-purifying
respirators (i.e., a half-face or full-face air-purifying respirator
with organic vapor cartridges), or air-supplying respirators.
If air-purifying respirators are provided, employers must
implement a change-out schedule for air-purifying canisters
and cartridges to ensure that they are changed before the end
of their service life. Change-out schedules must be developed
by consulting the respirator manufacturer cartridge or canister
test data and evaluating workplace conditions such as estimated
glutaraldehyde concentrations, temperature, relative humidity,
and employee breathing rate. Cartridge or canister service
life calculation formulas are also available on the OSHA website,
www.osha.gov.
Air-supplied respirators should be used when exposures may
be reasonably anticipated to be higher and for unknown exposures,
such as emergency spill situations.
All respirators used must be certified by the National Institute
for Occupational Safety and Health (NIOSH) and must be appropriate
for use with glutaraldehyde (29 CFR 1910.134(d)(1)(i) and (ii)).
The disposable air-purifying particulate respirators (filtering
facepieces) are not effective against organic vapors, and must
not be used for glutaraldehyde protection.
Employees who voluntarily choose to wear respirators, but
who are not required by their employers or OSHA to wear a respirator,
must still receive the information in Appendix D to 29 CFR
1910.134. See OSHA’s Respiratory Protection standard,
29 CFR 1910.134, for further details regarding the requirements
for employee use of respirators.
Employee Information and Training
All employers with glutaraldehyde solutions or other hazardous
chemicals in their workplaces must develop and implement a
written hazard communication program that meets the requirements
of OSHA’s Hazard Communication standard, 29 CFR 1910.1200.
Such a program must include provisions for employee access
to material safety data sheets (MSDSs), container labeling,
and training for all potentially exposed individuals.
Employees who use, handle, or may have potential exposure
(e.g., accidental or possible) to glutaraldehyde solutions
must be provided information and training prior to their initial
work assignment. Employees must be provided information regarding
the requirements of the Hazard Communication standard; operations
in their work area where glutaraldehyde solutions (and other
hazardous chemicals) are present; and the location and availability
of the written hazard communication program and material safety
data sheets (MSDSs).
Employee training must include, at a minimum, the following
elements (29 CFR 1910.1200):
methods and observations that may be used to detect
the presence or release of glutaraldehyde in the workplace;
the physical and health hazards of glutaraldehyde;
the measures employees can take to protect themselves,
including specific procedures the employer has implemented
to protect employees from exposure to glutaraldehyde, such
as appropriate work practices, emergency procedures, and personal
protective equipment; and
an explanation of the material safety data sheet,
the employer’s labeling system, and how employees can
obtain and use the appropriate hazard information.
Exposure Monitoring
Workplace exposure monitoring should be conducted to ensure
a safe work environment and to compare monitoring results with
recommended occupational exposure limits for glutaraldehyde.
Monitoring should be conducted after initiating use of glutaraldehyde
solutions; whenever there is a significant change in protocol,
work practices, caseload, or workplace ventilation systems;
and after major equipment (e.g., endoscope washers or other
automated equipment) repairs (ANSI/AAMI, 1996). Exposure monitoring
should also be conducted if employees have complaints or symptoms
of glutaraldehyde exposure.
Monitoring should be conducted in all glutaraldehyde use
areas as well as in the breathing zone of each employee using
or handling glutaraldehyde solutions. Special attention should
be given to short-term tasks that may have elevated exposures
such as pouring, mixing or otherwise agitating glutaraldehyde
solutions.
Several air sampling methods are available for monitoring
glutaraldehyde exposures. These methods include active and
passive sampling techniques as well as the use of a direct-reading
instrument. Active air sampling uses battery-powered personal
sampling pumps and treated filters or sorbent tubes for sample
collection. Passive sampling uses small, lightweight, easy-to-use
badge assemblies that rely on natural air movement rather than
pumps for sample collection. After sampling, the filters or
sorbent tubes and passive monitors should be sent to a laboratory
for analysis. Accredited laboratories have demonstrated their
ability to meet performance standards and are preferred. The OSHA website at www.osha.gov/dts/sltc/methods/organic/org064/org064.html and NIOSH at www.cdc.gov/niosh/nmam/pdfs/2532.pdf [Get free Adobe Reader] may be consulted for additional information regarding validated
sampling and analytical methods for glutaraldehyde. In addition,
the American Industrial Hygiene Association (www.aiha.org)
may be consulted for a listing of consultants and accredited
industrial hygiene laboratories.
A direct-reading, handheld, easy-to-use, portable instrument
called the “Glutaraldemeter” may also be used to
compare monitoring results with recommended glutaraldehyde
exposure limits as well as to determine concentrations resulting
from spills and other emergencies.
Active air sampling methods require sampling expertise and
special sampling supplies and should be performed by an industrial
hygienist or other qualified professional trained in industrial
hygiene air sampling strategies and techniques. Passive monitors
and the Glutaraldemeter do not necessarily require sampling
expertise and can be used by health care personnel to evaluate
workplace exposures. Proper use of passive monitors may be
determined by consulting the manufacturer’s instructions
and/or the laboratory that will conduct the analyses. Proper
use and maintenance of the Glutaraldemeter may be determined
by consulting the equipment manufacturer (e.g., MSA or PPM
Technology).
Active sampling methods are more sensitive and reliable than
passive monitors/badges and the Glutaraldemeter. Quantitative
limits of detection (LOD) for the active methods are in the
range of 0.44 ppb (parts per billion), while the reliable LOD
for passive methods and the Glutaraldemeter are in the range
of 20-100 ppb.
Disposal of Glutaraldehyde Solutions
Dispose of glutaraldehyde solutions in accordance with local,
state, and Federal regulations. Check with your local Publicly
Owned Treatment Works (POTW) to determine if glutaraldehyde
solutions can be disposed of in the sanitary sewer system.
Some POTWs may prohibit the disposal of glutaraldehyde solutions
in the sanitary sewer system or may require neutralization
prior to disposal. If there are no disposal restrictions, glutaraldehyde
solutions may be disposed of, along with copious amounts of
cold water, into a drain connected to the sanitary sewer system.
Do not discard glutaraldehyde solutions (including neutralized
solutions) into septic systems. Unlike municipal sewage treatment
systems, septic systems are not diluted by other waste streams.
Consequently, glutaraldehyde concentrations entering the system
may be higher and have an adverse effect on the microorganisms
that are necessary for proper functioning of the septic system.
Dispose of empty glutaraldehyde containers according to product
label instructions.
Spill Control and Cleanup Procedures
All glutaraldehyde spills have the potential to create vapor
concentrations that exceed recommended exposure limits. Vayas
et al. (2000) measured airborne concentrations during two spills
that occurred during their study. The TWA exposures to glutaraldehyde
were 0.27 mg/m 3 (0.06 ppm) for a spill of about one liter
in an unventilated room, and 0.439 mg/m 3 (0.11 ppm) for a
spill greater than 5 liters in a positive pressure theater.
Niven et al. (1997) also reported on glutaraldehyde monitoring
results (as high as 1.4 ppm) from various spill scenarios. Consequently, a suitable
plan of action with procedures for handling glutaraldehyde
spills should be developed and implemented by knowledgeable
and responsible individuals at the facility. In the development
of this plan, consideration should be given to the physical
characteristics of the area(s) where glutaraldehyde solutions
are used (e.g., type and effectiveness of ventilation, room
size and temperature) as well as the quantity and concentration(s)
of the solution(s). The spill control plan should incorporate
the following key elements (ANSI/AAMI, 1996):
designation of individuals responsible for managing
spill cleanup;
evacuation procedures for nonessential personnel,
if necessary;
medical treatment procedures for exposed individuals;
site-specific reporting requirements (e.g., site
safety and health personnel);
cleanup procedures, the location of spill control
supplies, and required personal protective equipment;
location and availability of material safety data
sheets (MSDSs) for glutaraldehyde-based sterilants/disinfectants
and manufacturer recommendations for emergency response;
employee training requirements;
air exchange rate(s) within the areas of use and
procedures to prevent the dispersal of glutaraldehyde vapor
to other areas of the facility through the general ventilation
system; and
respiratory protection program requirements pertaining
to glutaraldehyde.
General Procedures
All spills should be cleaned up immediately, regardless of
size. All necessary spill cleanup equipment (e.g., sponges,
towels, absorbent mats/wipes, spill pillows, mop and bucket,
plastic dustpan and trash bags) and personal protective equipment
(i.e., eye, hand, body and respiratory protection) should be
readily available. Whether or not a spill can be cleaned up
safely without the use of neutralizing chemicals and/or a respirator
will depend on a number of factors such as the glutaraldehyde
concentration and the amount spilled, the temperature of the
room and the solution, and the effectiveness of the ventilation
in the spill area. (ANSI/AAMI, 1996). Any spill larger than
a drip or a splash may need to be neutralized; and, when vapor
concentrations are unknown, air-supplied or atmosphere-supplying
respirators are appropriate.
Neutralizing Chemicals
Before using any type of glutaraldehyde-based product, review
the manufacturer’s recommendations for spill cleanup.
Several chemicals can be used to lower the glutaraldehyde concentration
in solutions and/or the ambient vapor level during a spill.
Examples include household ammonia, ammonium carbonate powder,
dibasic ammonium phosphate, and sodium bisulfite. Glycine is
also used as a neutralizer, and may be less hazardous than
others. There are also commercially available products for
this purpose (ANSI/AAMI, 1996), including powders, solutions,
and salts.
Drips and Splashes
A reusable or disposable sponge, towel, or mop may be used
to quickly clean up small spills. Glutaraldehyde solutions
can also be neutralized with an appropriate chemical agent
before wiping up with a sponge, towel, or mop. Cleanup supplies
should be thoroughly rinsed with large amounts of water prior
to reuse. Rinse water and disposable cleanup supplies should
be discarded according to applicable regulations as well as
the procedures outlined in the facility spill control plan
(ANSI/AAMI, 1996).
Drips and splashes may also be cleaned up with commercially
available spill control kits that contain mats/wipes to absorb
and neutralize small spills. The absorbed medium should be
disposed of according to local, state and Federal regulations.
Large Spills
Any glutaraldehyde spill larger than small drips or splashes
should be cleaned up by properly trained and equipped spill
response personnel. Certain larger spills of glutaraldehyde
are covered by the requirements of OSHA’s Hazardous Waste
Operations and Emergency Response standard (29 CFR 1910.120(q)).
Pre-planning for spills is a critical piece of the facility
exposure control plan. Personnel should understand the necessity
to evacuate until the spill is cleaned up and the worksite
is safe for reentry of employees. Appropriate spill-response
equipment placed outside the affected area for access after
the area is evacuated will facilitate compliance with the emergency
spill response plan. Supplied air respirators are an important
component of a spill-response kit. Appropriate training on
the use of the respirators is an important piece of the pre-spill
planning, so that spill responders are adequately equipped
and trained.
Large spills should be contained and neutralized or contained
and collected for disposal. Once contained, spills may be neutralized
with an appropriate chemical agent such as sodium bisulfite
(2-3 parts (by weight) per part of glutaraldehyde solution)
with a contact time of 5 minutes at room temperature, using
a mop or other tool to thoroughly blend in the deactivation
compound. A less hazardous neutralizer, glycine, can be used
in a ratio of 25 grams per gallon of 2.4% glutaraldehyde solution
to neutralize in 5 minutes. Depending on the size of the spill
and site conditions, heat and vapor may be liberated by the
reaction with the neutralizing chemicals (ANSI/AAMI, 1996).
Commercially available spill pillows and booms may also be
used to easily contain, absorb, and/or neutralize large glutaraldehyde
spills.
After the glutaraldehyde solution is removed, the spill area
and the cleanup supplies/tools should be thoroughly rinsed
with large amounts of cold water. Rinse water, disposable cleanup
supplies and absorbent medium (if used) should be disposed
of according to applicable regulations and the procedures outlined
in the facility spill control plan (ANSI/AAMI, 1996).
National Institute for Occupational Safety and Health (NIOSH).
2001. Glutaraldehyde: occupational hazards in hospitals. Online
at http://cdc.gov/niosh/2001-115.html
References
ACGIH, 2001. Industrial Ventilation – A Manual of Recommended
Practice. American Conference of Governmental Industrial Hygienists.
24th Edition. Cincinnati, OH. ACGIH.
ACGIH, 2004. Documentation of the Threshold Limit Values
and Biological Exposure Indices. American Conference of Governmental
Industrial Hygienists. 7th Edition. 2004 Supplement, ACGIH.
AFSCME Health and Safety Program 2001. Fact Sheet, Glutaraldehyde.
1625 L Street, N.W., Washington, DC 20036, and online.
Ansell Health Care. 2003. Allergard® II Sterile Synthetic
Copolymer Surgical Gloves. [Technical Data Sheet]. Red Bank,
NJ: Ansell Health Care.
ANSI/AAMI. 1996. ST58. American National Standard for the
Safe use and handling of glutaraldehyde-based products in health
care facilities. Arlington, VA: Association for the Advancement
of Medical Instrumentation.
ANSI/AIHA (Z9.7) 1998. American National Standard for Recirculation
of Air from Industrial Process Exhaust Systems. Fairfax, VA:
American Industrial Hygiene Association.
APIC Guideline. 1994. APIC Guideline for Infection Prevention
and Control in Flexible Endoscopy. Association for Professionals
in Infection Control and Epidemiology. APIC, Inc. 1994.
Ballantyne, B. and B. Berman. 1984. Dermal sensitizing potential
of glutaraldehyde: a review and recent observations. J
Toxicol Cutaneous Ocul Toxicol 3(3):251-262.
Butt, G., Greenley, P., Herrick, R., and L. DiBerardinis.
1999. Exposure to glutaraldehyde vapors during endoscopic sterilization
processes in a large research and teaching institution. Journal
of Healthcare Safety, Compliance & Infection Control 3(4):
172179.
Crandall, M.S. 1987. Montgomery Hospital, Norristown, PA.,
NIOSH Health Hazard Evaluation Report No. 86-226-1769. NIOSH.
Di Stefano, F., Siriruttanapruk, S., McCoach, J. and P. Sherwood
Burge. 1999. Glutaraldehyde: an occupational hazard in the
hospital setting. Allergy 54:1105-1109.
FDA. 2003. FDA-Cleared Sterilants and High Level Disinfectants
with General Claims for Processing Reusable Medical and Dental
Devices. U.S. Department of Health and Human Services, Food
and Drug Administration, Center for Devices and Radiological
Health. Online at http://www.fda.gov/cdrh/ode/germlab.html
Forsberg, K., and L.H. Keith. 1997. Chemical Protective Clothing
Performance Index. 2nd Edition. New York: John Wiley & Sons,
Inc., pp. 326-327.
Fowler J.F., Jr. 1989. Allergic contact dermatitis from glutaraldehyde
exposure. J Occup Environ Med , 31(10):852-853.
Gannon, P.F.G., Bright, P., Campbell, M., O’Hickey,
S.P., and P.S. Burge. 1995. Occupational asthma due to glutaraldehyde
and formaldehyde in endoscopy and x-ray departments. Thorax ,
50:156-159.
Health & Safety Executive, UK. 1997. Glutaraldehyde criteria
document for an occupational exposure, ISBN 07176 1443 3.
Jordan , S.L.P., Stowers, M.F., Trawick, E.G., and A.B. Theis.
1996. Glutaraldehyde permeation: choosing the proper glove. Am
J Infect Control , 24(2):67-69.
Keynes, H.L., Ross, D.J. and J.C. McDonald. 1996. SWORD ’95:
Surveillance of work-related and occupational respiratory disease
in the U.K. Occup Med 46(5):379-381.
Marzulli, F.N. and H.I. Maibach. 1974. The use of graded
concentrations in studying skin sensitizers: experimental contact
sensitization in man. Food Cosmet Toxicol , 12: 219-227.
Naidu, V., S. Lam, and G. O’Donnell. 1995. Typical
glutaraldehyde vapour levels in endoscope disinfection units
in New South Wales hospitals. J Occup Health and Safety -
Austral NZ 11(1): 43-57.
National Research Council. 1995. Prudent Practices in the
Laboratory – Handling and Disposal of Chemicals. Washington,
D.C.: National Academy Press. Nethercott, J.R., and D.L. Holness.
1988. Contact dermatitis in funeral service workers. Contact
Dermatitis , 18:263-267.
Nethercott J.R., Holness D.L., and E. Page. 1988. Occupational
contact dermatitis due to glutaraldehyde in health care workers. Contact
Dermatitis , 18:193-196.
National Industrial Chemicals Notification and Assessment
Scheme, Australian Government Publishing Service, Canberra.
NIOSH. 1984. Health Hazard Evaluation Report No. HETA 83-074-1525.
National Jewish Hospital, Denver, Colorado. U.S. Department
of Health and Human Services, Public Health Service, Centers
for Disease Control, National Institute for Occupational Safety
and Health, Cincinnati, OH.
NIOSH. 1986. Health Hazard Evaluation Report No. HETA 84-535-1690.
National Jewish Hospital, Denver, Colorado. U.S. Department
of Health and Human Services, Public Health Service, Centers
for Disease Control, National Institute for Occupational Safety
and Health, Cincinnati, OH.
NIOSH. 1987. Health Hazard Evaluation Report No. HETA85-257-1791.
Mercy Medical Center, Denver, Colorado. U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control, National Institute for Occupational Safety
and Health, Cincinnati, OH.
NIOSH. 1991. Health Hazard Evaluation Report No. HETA-90296-2149.
Monongalia General Hospital, Morgantown, West Virginia. U.S.
Department of Health and Human Services, Public Health Service,
Centers for Disease Control, National Institute for Occupational
Safety and Health, Cincinnati, OH.
NIOSH. 2001. Glutaraldehyde: Occupational Hazards in Hospitals.
DHHS (NIOSH) Publication No. 2001-115. U.S. Department of Health
and Human Services, Centers for Disease Control and Prevention,
National Institute for Occupational Safety and Health, Cincinnati,
OH.
Niven, K.J.M., Cherrie, J.W. and J. Spencer. 1997. Estimation
of exposure from spilled glutaraldehyde solutions in a hospital
setting. Ann Occup Hyg , 41(6):691-698.
NJDOHSS. 1998. Glutaraldehyde survey. New Jersey Department
of Health and Senior Services, Occupational Disease and Injury
Services, Trenton, NJ.
Norbäck, D. 1988. Skin and respiratory symptoms from
exposure to alkaline glutaraldehyde in medical services. Scand
J Work Environ Health , 14:366-371.
Nova Scotia Department of Environment and Labour, 2000. Glutaraldehyde
Hazard Alert. Occupational Health and Safety Division. Hazard
Alerts.
Occupational Safety and Health Administration, online at:
http://www.osha.gov
Pryor, P.D., 1984. National Jewish Hospital, Denver, Colorado.
NIOSH Health Hazard Evaluation Report No. 83-074-1525.
Pisaniello, D.L., Gun, R.T., Tkaczuk, M.N., Nitshcke, M.
and J. Crea. 1997. Glutaraldehyde exposures and symptoms among
endoscopy nurses in South Australia. Appl Occup Environ
Hyg , 12(3):171-177.
Rosenman, K.D., Reilly, M.J. and D.J. Kalinowski. 1997. A
state-based surveillance system for work-related asthma. J
Occup Environ Med , 39(5):415-425.
Stern, M.L., et al. Contact hypersensitivity response to
glutaraldehyde in guinea pigs and mice. Toxicol Ind Health ,
5(1):3143, 1989.
Teschke, K., Chow, Y., Brauer, M., Chessor, E., Hirtle, B.,
Kennedy, S.M., Yeung, M.C. and H.D. Ward. 2002. Exposures and
their determinants in radiographic film processing. Am
Ind Hyg Assoc J , 63:11-21.
Thunthy, K.H., Yeadon, W.R. and R. Winberg. 1994. Sensitometric
and archival evaluation of Kodak RA films in dental automatic
processing. Oral Surg Oral Med Oral Pathol , 77(4):
427-430.
Vyas, A., Pickering, C.A., Oldham, L.A., Francis, H.C., Fletcher,
A.M., Merrett, T., and R. M. Niven. 2000. Survey of symptoms,
respiratory function, and immunology and their relation to
glutaraldehyde and other occupational exposures among endoscopy
nursing staff. Occup Environ Med , 57:752-759.
Waters, A., Beach, J., and M. Abramson. 2003. Symptoms and
lung function in health care personnel exposed to glutaraldehyde. Am
J Ind Med , 43:196-203.
OSHA Assistance OSHA can provide extensive help through a variety of programs,
including technical assistance about effective safety and health
programs, state plans, workplace consultations, voluntary protection
programs, strategic partnerships, training and education, and
more. An overall commitment to workplace safety and health
can add value to your business, to your workplace and to your
life.
Safety and Health Program Management Guidelines
Effective management of employee safety and health protection
is a decisive factor in reducing the extent and severity of
work-related injuries and illnesses and their related costs.
In fact, an effective safety and health program forms the basis
of good employee protection and can save time and money (about
$4 for every dollar spent) and increase productivity and reduce
employee injuries, illnesses and related workers’ compensation
costs.
To assist employers and employees in developing effective
safety and health programs, OSHA published recommended Safety
and Health Program Management Guidelines (54 Federal
Register (16): 3904-3916, January 26, 1989). These voluntary
guidelines apply to all places of employment covered by OSHA.
The guidelines identify four general elements critical to
the development of a successful safety and health management
program:
Management leadership and employee involvement.
Work analysis.
Hazard prevention and control.
Safety and health training. The guidelines recommend specific
actions, under each of these general elements, to achieve
an effective safety and health
program. The Federal Register notice is available
online at www.osha.gov
State Programs
The Occupational Safety and Health Act of 1970 (OSH
Act) encourages states to develop and operate their own job
safety and health plans. OSHA approves and monitors these plans.
Twenty-four states, Puerto Rico and the Virgin Islands currently
operate approved state plans: 22 cover both private and public
(state and local government) employment; Connecticut, New Jersey,
New York and the Virgin Islands cover the public sector only.
States and territories with their own OSHA-approved occupational
safety and health plans must adopt standards identical to,
or at least as effective as, the Federal standards.
Consultation Services
Consultation assistance is available on request to employers
who want help in establishing and maintaining a safe and healthful
workplace. Largely funded by OSHA, the service is provided
at no cost to the employer. Primarily developed for smaller
employers with more hazardous operations, the consultation
service is delivered by state governments employing professional
safety and health consultants. Comprehensive assistance includes
an appraisal of all mechanical systems, work practices and
occupational safety and health hazards of the workplace and
all aspects of the employer’s present job safety and
health program. In addition, the service offers assistance
to employers in developing and implementing an effective safety
and health program. No penalties are proposed or citations
issued for hazards identified by the consultant. OSHA provides
consultation assistance to the employer with the assurance
that his or her name and firm and any information about the
workplace will not be routinely reported to OSHA enforcement
staff.
Under the consultation program, certain exemplary employers
may request participation in OSHA’s Safety and Health
Achievement Recognition Program (SHARP). Eligibility for participation
in SHARP includes receiving a comprehensive consultation visit,
demonstrating exemplary achievements in workplace safety and
health by abating all identified hazards and developing an
excellent safety and health program.
Employers accepted into SHARP may receive an exemption from
programmed inspections (not complaint or accident investigation
inspections) for a period of one year. For more information
concerning consultation assistance, see the OSHA website at
www.osha.gov
Voluntary Protection Programs (VPP)
Voluntary Protection Programs and on-site consultation services,
when coupled with an effective enforcement program, expand
employee protection to help meet the goals of the OSH Act.
The three levels of VPP are Star, Merit, and Star Demonstration
designed to recognize outstanding achievements by companies
that have successfully incorporated comprehensive safety and
health programs into their total management system. The VPPs
motivate others to achieve excellent safety and health results
in the same outstanding way as they establish a cooperative
relationship between employers, employees and OSHA.
For additional information on VPP and how to apply, contact
the OSHA regional offices listed at the end of this publication.
Strategic Partnership Program
OSHA’s Strategic Partnership Program, the newest member
of OSHA’s cooperative programs, helps encourage, assist
and recognize the efforts of partners to eliminate serious
workplace hazards and achieve a high level of employee safety
and health. Whereas OSHA’s Consultation Program and VPP
entail one-on-one relationships between OSHA and individual
worksites, most strategic partnerships seek to have a broader
impact by building cooperative relationships with groups of
employers and employees. These partnerships are voluntary,
cooperative relationships between OSHA, employers, employee
representatives and others (e.g., labor unions, trade and professional
associations, universities and other government agencies).
For more information on this and other cooperative programs,
contact your nearest OSHA office, or visit OSHA’s website
at www.osha.gov
Alliance Programs
The Alliance Program enables organizations committed to workplace
safety and health to collaborate with OSHA to prevent injuries
and illnesses in the workplace. OSHA and the Alliance participants
work together to reach out to, educate and lead the nation’s
employers and their employees in improving and advancing workplace
safety and health. Groups that can form an Alliance with OSHA
include employers, labor unions, trade or professional groups,
educational institutions and government agencies. In some cases,
organizations may be building on existing relationships with
OSHA that were developed through other cooperative programs.
There are few formal program requirements for Alliances and
the agreements do not include an enforcement component. However,
OSHA and the participating organizations must define, implement
and meet a set of short- and long-term goals that fall into
three categories: training and education; outreach and communication;
and promoting the national dialogue on workplace safety and
health.
OSHA Training and Education
OSHA area offices offer a variety of information services,
such as compliance assistance, technical advice, publications,
audiovisual aids and speakers for special engagements. OSHA’s
Training Institute in Arlington Heights, IL, provides basic
and advanced courses in safety and health for Federal and state
compliance officers, state consultants, Federal agency personnel,
and private sector employers, employees and their representatives.
The OSHA Training Institute also has established OSHA Training
Institute Education Centers to address the increased demand
for its courses from the private sector and from other Federal
agencies. These centers are nonprofit colleges, universities
and other organizations that have been selected after a competition
for participation in the program.
OSHA also provides funds to nonprofit organizations, through
grants, to conduct workplace training and education in subjects
where OSHA believes there is a lack of workplace training.
Grants are awarded annually. Grant recipients are expected
to contribute 20 percent of the total grant cost.
For more information on grants, training and education, contact
the OSHA Training Institute, Office of Training and Education,
2020 South Arlington Heights Road, Arlington Heights, IL 60005,
(847) 297-4810 or see “Training” on OSHA’s
website at www.osha.gov. For further information on any OSHA
program, contact your nearest OSHA area or regional office
listed at the end of this publication.
Information Available Electronically
OSHA has a variety of materials and tools available on its
website at http://www.osha.gov. These include eTools such as Expert Advisors, Electronic Compliance Assistance Tools
(e-cats), Technical Links ; regulations, directives and
publications; videos and other information for employers and
employees. OSHA’s software programs and compliance assistance
tools walk you through challenging safety and health issues
and common problems to find the best solutions for your workplace.
A wide variety of OSHA materials, including standards, interpretations,
directives, and more, can be purchased on CD-ROM from the U.S.
Government Printing Office, Superintendent of Documents, phone
toll-free (866) 512-1800.
OSHA Publications
OSHA has an extensive publications program. For a listing
of free or sales items, visit OSHA’s website at www.osha.gov
or contact the OSHA Publications Office, U.S. Department of
Labor, 200 Constitution Avenue, NW, N-3101, Washington, DC
20210. Telephone (202) 693-1888 or fax to (202) 693-2498.
Contacting OSHA
To report an emergency, file a complaint or seek OSHA advice,
assistance or products, call (800) 321-OSHA or contact your
nearest OSHA regional or area office listed at the end of this
publication. The teletypewriter (TTY) number is (877) 889-5627.
Written correspondence can be mailed to the nearest OSHA
Regional or Area Office listed at the end of this publication
or to OSHA’s national office at: U.S. Department of Labor,
Occupational Safety and Health Administration, 200 Constitution
Avenue, N.W., Washington, DC 20201.
By visiting OSHA’s website at www.osha.gov, you can
also:
file a complaint online,
submit general inquiries about workplace safety and
health electronically, and
find more information about OSHA and occupational
safety and health.
(IA,* KS, MO, NE) City Center Square 1100 Main Street, Suite 800 Kansas City, MO 64105 (816) 426-5861
Region VIII
(CO, MT, ND, SD, UT,* WY*) 1999 Broadway, Suite 1690 PO Box 46550 Denver, CO 80202-5716 (720) 264-6550
Region IX
(American Samoa, AZ,* CA,* HI,* NV,* Northern Mariana Islands) 71 Stevenson Street, Room 420 San Francisco, CA 94105 (415) 975-4310
Region X
(AK,* ID, OR,* WA*) 1111 Third Avenue, Suite 715 Seattle, WA 98101-3212 (206) 553-5930
* These states and territories operate their own OSHA-approved job safety and health programs (Connecticut, New Jersey, New York and the Virgin Islands plans cover public employees only.) States with approved programs must have standards that are identical to, or at least as effective as, the Federal standards.
Note: To get contact information for OSHA
Area Offices, OSHA-approved State Plans and OSHA Consultation
Projects, please visit us online at www.osha.gov or call us
at 1-800-321-OSHA.
This is one in a series of informational fact sheets highlighting OSHA programs, policies or
standards. It does not impose any new compliance requirements. For a comprehensive list of
compliance requirements of OSHA standards or regulations, refer to Title 29 of the Code of Federal
Regulations. This information will be made available to sensory impaired individuals upon request.
The voice phone is (202) 693-1999; teletypewriter (TTY) number: (877) 889-5627.
For more complete information:
Occupational
Safety and Health
Administration
U.S. Department of Labor www.osha.gov (800) 321-OSHA