Objectives
1. To state how to control exposure to glutaraldehyde through
appropriate engineering controls and work practices.
2. To identify how to choose and use the correct personal protective clothing
when working with glutaraldehydes.
3. To establish a personnel monitoring program to determine if engineering
controls and work practices are eliminating personnel exposure to glutaraldehydes.
4. To list how to clean, soak, rinse and store medical devices properly,
so they are safe to use on the patient.
Glutaraldehydes
are used in healthcare settings to disinfect or sterilize semi-critical
and critical medical devices. It is important to know how to use glutaraldehyde
solutions effectively to ensure items are correctly disinfected or sterilized
and safe to use on the patient. In addition, it is as equally important
to know how to use glutaraldehydes safely to prevent personnel and patient
exposure to the solution and vapors because glutaraldehyde is a skin,
eye, and respiratory irritant.1
Presently,
there are no OSHA standards for airborne glutaraldehyde, but they can
and will enforce the American Conferences of Governmental Industrial
Hygienists (ACGIH) established and accepted ceiling Threshold Limit
Value (TLV-C). The TLV-C value is 0.05 parts per million (ppm) for either
activated or unactivated solutions.2,3
This is the limit above which a person should not be exposed even momentarily.
The TLV-C is based on the irritation threshold in humans. Short term
overexposure symptoms include: eye and throat irritation, tightness
of the chest, and asthma-like symptoms. Long term respiratory irritation
and skin sensitization can also occur.1
Management
and employees must develop policies and procedures for effectively and
safely working with glutaraldehydes. The Joint Commission on the Accreditation
of Health Care Facilities (JCAHO) states that these policies and procedures
should be based on the most stringent laws and regulations, recommended
practices, and current scientific knowledge. Policies and procedures
should be standardized throughout the facility and reviewed annually.
The Association
for the Advancement of Medical Instrumentation (AAMI) standard on Safe
use and handling of glutaraldehyde-based products in health care facilities,
1996 is an excellent reference in addition to the Material Safety Data
Sheet (MSDS) and use instructions supplied by the manufacturer of the
glutaraldehyde solution.1 The
following information should be included in your policies and procedures.
Training
OSHA's
Hazard Communication Standard requires each facility to develop an education
and training program for all personnel who work with hazardous chemicals.1,4,11
This training should discuss applicable OSHA regulations, signs, symptoms
of overexposure, safe work practices, personal protective equipment,
steps taken by the employer to minimize exposure levels, how to recognize
an exposure, clean up of spills, and the data included in the MSDS.
Adult education
techniques should be used to ensure learning. Training and education
should be presented in the language and at the level of understanding
appropriate for the individuals being trained. Evaluations of training
effectiveness should be used to revise the educational programs.
Engineering
Controls
Engineering
controls are technology used to isolate or remove hazards from the workplace
and are the preferred method of controlling hazards. For glutaraldehyde
solutions, this is done by isolation of the work area and ventilation.
The space in which glutaraldehyde solutions are used for disinfection
or sterilization of medical devices should be separate from cleaning/decontamination,
patient procedure areas, and personnel support areas. This minimizes
employee and patient exposure to glutaraldehyde by ensuring proper engineering
controls and employee work practices.
The room
in which the glutaraldehyde is used should be large enough to ensure
adequate dilution of vapor and should have a minimum of 10 air exchanges
per hour. The preferred method of reducing glutaraldehyde vapors is
local exhaust ventilation at the level of the point of discharge of
the glutaraldehyde vapor. If this is not achievable, a self-contained,
free-standing system, ductless fume or local exhaust hood should be
installed to contain the glutaraldehyde vapors.1,4
This local exhaust should be operating continuously to capture glutaraldehyde
vapor from the top of the container to eliminate personnel exposure.
Major personnel exposures occur when the glutaraldehyde solution is
poured into or out of the bottle and immersion tray, when the immersion
tray is open for use, the solution is agitated during use, and medical
devices are removed and rinsed. Vapor monitoring must be done to ensure
that the ventilation is capturing the vapor and reducing personnel exposure.
If the vapors are irritating the nose or eyes during these procedures,
the TLV is probably being exceeded and additional venting is needed.5
Automated reprocessing equipment for high-level disinfection also reduces
vapors. Follow the equipment manufacturer's recommendations for proper
installation and ventilation of the equipment to ensure that it is containing
and/or removing the vapor and reducing personnel exposure.
Personal
Protective Equipment
The appropriate
personal protective equipment (PPE) should be used to protect skin,
eyes, and clothing from splashes when using glutaraldehyde solutions.
There should be a written program on the proper use of PPE that complies
with OSHA standards. Employers must provide specific training to each
employee and written certification that they know how to select, use,
and maintain the PPE.
Eye Protection
(OSHA: 29 CFR 1910.133 and 29 CFR 1910.151). In addition to the engineering
and work practice controls used to keep the vapor levels below the TLV-C,
always wear splashproof goggles or a full face shield to protect the
eyes from contact with the chemical and to prevent eye irritation. Suitable
eyewash units must be available in all glutaraldehyde locations.1
If contact does occur, flush eyes immediately with water for at least
15 minutes and see a physician.
Skin Protection
(OSHA: 29 CFR 1910.132 and 29 CFR 1910.138). Wear gloves impervious
to glutaraldehyde such as those made of nitrile and butyl rubber any
time there is a possibility of contact with the solution. If the gloves
do not cover the forearms, wear a protective sleeve made of glutaraldehyde
impervious material. Do not wear latex gloves; they will not protect
your skin.1,6 Wear protective
clothing such as isolation gowns, lab coats, or aprons plus sleeve protectors
that are impervious to glutaraldehyde to protect the skin and clothing.
Review the manufacturer's protective clothing's permeation data before
making a purchase.1 This clothing
should be removed immediately if it becomes saturated and laundered
before reuse. Any skin that contacts the glutaraldehyde should be washed
thoroughly with soap and water and flushed with water for 15 minutes.
Respiratory
Protection (OSHA: 29 CFR 1910.134 and 29 CFR 1910.1200). Respirators
are not required for regular use but only for temporary overexposure
to chemical vapors or in the interim until engineering and work practice
controls are in place to reduce operator exposure to the chemical.1
To determine the appropriate respirator to use, measure the exposure
levels with a direct reading meter. For exposures greater than 0.05
ppm but less than 2.5 ppm or 50 times the ceiling limit, a National
Institute for Occupational Safety and Health (NIOSH) approved full facepiece
air purifying respirator equipped with organic vapor cartridges is required.
A vapor cartridge change schedule must be established. A self-contained
breathing apparatus is required where concentrations are unknown. A
written Respiratory Protection Program that meets OSHA's Respiratory
Protection Standard (29 CFR 1910.134) and includes employee training
must be in place.1
Work
Practices
Work practices
are a preferred method of controlling and reducing the likelihood of
exposure to occupational hazards by altering the manner in which a task
is performed. Policies and procedures should address work practices
that prevent personnel contact with glutaraldehyde solutions and reduce
exposure to the vapors.
Using
Solutions. Prepare, activate, and use glutaraldehyde solutions
according to the manufacturer's instructions. Minimize splashing, spilling,
and exposure. Record the date of the solution's activation and the expiration
date on the solution's container to ensure it is not used beyond its
effective use life. Use a safety nozzle that vacuums vapor back into
the container while pouring the solution into the immersion tray to
prevent employee contact with the solution and reduce exposure to the
vapor.7 To reduce the surface
area of the solution and minimize exposure to vapors, use an immersion
tray that is as small as possible, narrow, and deep rather than large,
long, and shallow. The tray should allow for complete submersion of
the medical devices and have a tight fitting lid to contain vapors and
prevent spills. Neutralizing absorbent mats are available to absorb
and neutralize harmful glutaraldehyde spills while using the immersion
trays.
Reduce
the risk of spills by avoiding transportation of the glutaraldehyde
solutions in immersion or secondary trays or buckets. Store glutaraldehyde
solutions in a closed container in a well ventilated area. Always keep
immersion trays closed and labeled. Only remove the lid when the medical
devices are placed into and removed from the solution.
After activating
the solution, test the solution with a chemical monitor developed for
the specific disinfectant solution being used to ensure that it was
prepared effectively, activated, and ready for use. In addition, during
the solution's use life, test the solution prior to placing the medical
devices in the solution to ensure that the chemical solution is still
at or above its minimum effective concentration (MEC).10 The MEC of
the solution will be affected by the amount of water, bioburden, protein,
and soap added to the solution each time a medical device is immersed
and removed, and by elevated temperatures, pH changes, and time. Do
not use a glutaraldehyde solution that is below its MEC. Immediately
discard the chemical solution. It is also recommended that a thermometer
and timer be used during the soaking procedure to ensure correct temperature
and time and the pH of the activated solution be checked periodically.10
Cleaning,
Soaking, Rinsing, and Storing Medical Devices. Develop or obtain
validated cleaning methods to ensure that each medical device is properly
cleaned. The time and concentration of glutaraldehyde needed to achieve
high-level disinfection or sterilization will depend on the type and
number of microorganisms left on the medical device and the amount of
organic soil. Meticulously clean and rinse the external surfaces and
internal channels to reduce the bioburden, protein load, and detergent
residue that can inactivate or interfere with the effectiveness of the
disinfection/sterilization process. Dry the medical device externally
and internally by flushing with air prior to immersing in the chemical
solution to eliminate water. Remove the lid from the immersion tray,
and gently place dry medical devices in the activated glutaraldehyde
solution to minimize agitation of the solution's surface, which is a
major source of vapor exposure. When using a syringe to irrigate or
flush channels or lumens, protect yourself from splashes by slowly pushing
the solution into the channels. Wash gloved hands before replacing the
lid on the immersion tray to avoid contaminating the lid. Then soak
the instruments for the time required by the manufacturer to achieve
disinfection or sterilization.
After soaking
and while the medical device is immersed, remove the solution from the
channels or lumens by flushing with a syringe filled with air.1 Gently
remove all medical devices from the solution, transfer, and immerse
in the rinse tray. Wash gloved hands and replace the cover on the immersion
tray. While the medical devices are immersed, thoroughly rinse externally
with clean, potable water or sterile water if the medical device is
to be used in a sterile field, on known or potentially immunocompromised
patients, or when practicable, bronchoscopes.1,10
When practicable, a sterile water rinse is recommended.10 Continue
to flush the internal channels with clean, potable water or sterile
water and air, followed by 70% alcohol and another air wash.1,9
Dry exterior surfaces with a soft cloth and store medical devices in
a well ventilated, dust free cabinet.
Disposal
and Spills of Solutions. Store unused solutions in tightly closed,
labeled containers. Dispose of solutions in accordance with manufacturer's
recommendations and federal, state, and local ordinances. Neutralize
the solutions before disposal to reduce worker exposure to vapors and
meet the requirements of some local sewage treatment facilities.3
Follow
the glutaraldehyde solution manufacturer's recommendations for disposing
of empty solution containers. In the case of a spill, the objective
is to clean up the glutaraldehyde solution quickly to control vapor
and prevent contact with skin or eyes. A written spill containment plan
should be prepared by an emergency response team.1,3
This plan covers cleanup equipment, placement of cleanup equipment,
plan for alerting personnel, recommendations for avoiding contact with
the glutaraldehyde solution, and evacuation of nonessential personnel.
Wear the
appropriate personal protective equipment: splashproof goggles or full
face shield, nitrile or butyl rubber gloves, protective clothing that
is impervious to glutaraldehyde, and a self-contained breathing apparatus
if the concentration of glutaraldehyde vapor is not known.
Use a neutralizing
agent to convert the chemical to a harmless solution for spill cleanup
and disposal. Drips and splashes can be wiped up quickly with a sponge,
towel, or mop or neutralized first and then rinsed. Reusable sponges,
towels, or mop heads should be laundered before reuse and disposable
items disposed of accordingly.
Personnel
who contact the glutaraldehyde solution should immediately remove contaminated
clothing and shoes and rinse skin with flowing water. Eyes should be
flushed for at least 15 minutes. Contact lenses should be removed, and
exposed personnel seen by a physician. Contaminated clothing should
be washed or tossed. Rubber goods should be rinsed thoroughly.
Vapor
Monitoring
Several
air sampling and monitoring techniques are available to ensure a safe
work environment and to establish compliance with recommended and voluntary
guidelines on occupational exposure to glutaraldehydes.1
Because this technology is evolving, it is important to keep up-to-date
on the latest developments.
The monitoring
method chosen will depend on the frequency of glutaraldehyde use, the
level of monitoring needed, the availability of sampling and analytical
instrumentation, and whether the testing is done internally or by an
outside service. It is suggested that an industrial hygienist or other
qualified professional be involved in designing a monitoring program.
The manufacturer of the monitoring equipment is the best source of information
about the performance of their equipment. Annex B of the AAMI document
discusses a method to select airborne glutaraldehyde monitoring equipment
or services.1
Personnel
are monitored to determine the concentration of airborne glutaraldehyde
in the breathing zone. Since the exposure limit for glutaraldehyde is
a ceiling limit of 0.05 ppm that cannot be exceeded any time during
the day, three 5-minute sampling times taken during the day will be
more accurate at determining overexposure than one sampling of 15 minutes.
4 A 15-minute sampling will understate exposure levels
as they relate to a ceiling limit.
Monitoring
should be done in the chemical sterilant monitoring area and the breathing
zone of each employee directly involved with the disinfection process.
Monitoring should be conducted during normal usage when maximum exposure
is expected: medical devices are placed into the immersion tray, taken
out and rinsed off; solutions are poured into/from immersion trays;
disposing of spent solutions down the drain; the solution is being agitated;
and the solution is activated. When using the automated processing equipment,
monitor when the solution is activated, the reservoir is filled or if
the equipment is opened in mid-cycle, and during malfunction.
Monitoring
should also be done at the initiation of a new glutaraldehyde solution;
whenever there is a major change in protocol, workplace ventilation
systems, or case load; after major repairs to endoscope washers or other
automated equipment; and after changes in work practices.1
The frequency of monitoring will depend on the amount of glutaraldehyde
solution used, how often it is used, and the recommendations of an industrial
hygienist.
Personnel
monitoring must be documented and maintained for the duration of employment
plus 30 years.1 Employees must
be notified of the results within 15 days of receipt of the results.
If personnel breathing zone monitoring shows that glutaraldehyde concentrations
exceeded the recognized ceiling limit, corrective actions must be taken.
References
1. Safe Use and Handling of Glutaraldehyde-Based
Products in Health Care Facilities. Association for the Advancement
of Medical Instrumentation. ANSI/AAMI ST58, 1996.
2. OSHA Chemical Sampling Information, Glutaraldehydes. www.osha-slc.gov/ChemSamp_data/CH_243400.html
01/11/99.
3. Working Safely With Glutaraldehydes: American Conference of Governmental
Industrial Hygienists Recommended Exposure Limit. www.cchs.ca.
Do a search using the term "glutaraldehydes".
4. Norarianni GL. Glutaraldehyde: A Seven-Step Safety Program. Infect
Control Sterilization Technol. November 1996: 19-26.
5. Ventilation, Routine. Material Safety Data Sheets for Cidex Disinfecting
Solutions. Advanced Sterilization Products.
6. Use of Latex Surgical Exam Gloves for Protection From Glutaraldehyde.
www.osha-slc.gov/OshDoc/Interp_data/I19971003.html
10/03/97.
7. Norarianni GL. Controlling Glutaraldehyde Exposure: Part 1. Infect
Control Sterilization Technol. March 1995:20-26.
8. Norarianni GL. Controlling Glutaraldehyde Exposure: Part 2. Infect
Control Sterilization Technol. April 1995:16-26.
9. Standards for Infection Control and Reprocessing of Flexible Gastrointestinal
Endoscopes. Society of Gastroenterology Nurses and Associates, Inc.
1997.
10. Indicators for Use: Cidex Disinfecting Solutions. Advanced Sterilization
Products.
11. Occupational Safety and Health Administration. Hazard Communication
Standard. Code of Federal Regulations. Title 29, Part 1910.1200.
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