Detoxing Sterilization and High Level Disinfection
Alternatives to Ethylene Oxide and Glutaraldehyde
Wendi Shafir
USEPA R9
June 2010
Adapted from presentation by Janet Brown, Director of Facility Engagement, Practice Greenhealth
* Resource: Erika Stewart, Kaiser Permanente
Why a Focus on EtO and Glutaraldehyde?
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Safety
Liability
Community Relations
Cost Savings
Indoor Air Quality
Environmental Impact
Regulatory
Compliance
 Mission Statement
 Healing Environment
 Commitment to
Health
2
Learning Objectives
 Understand options for sterilization and high level
disinfection
 Recognize value of standardization, training and
education
 Identify resources for communicating about alternatives
to Ethylene Oxide and Glutaraldehyde
Green Team Development
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Administration
Nursing/Clinical Staff
Engineering
Facility Management
Environmental Services
Infection Control
Materials Management
Risk Management
Safety
Industrial Hygiene
Infection Control Definintions1
 Sterilization
• Validated process used to render a product free of all
forms of viable microorganisms
 Disinfection
• Destruction of pathogenic and other kinds of
microorganisms by thermal or chemical means.
Destroys most recognized pathogenic microorganisms,
but not necessarily all microbial forms, such as
bacterial spores
1 Rutala, W.A., “Draft Guidelines for Disinfection and Sterilization in Healthcare Facilities,” HICPAC 2b, CDC 02/20/2002
© 2006 Kaiser Permanente Health Plan,
Inc.
Categories of Medical Devices*
 Critical
• Enters sterile tissue or vascular system (e.g., surgical
instruments, cardiac and urinary catheters, implants)
 Semi-Critical
• Contacts mucous membranes or non-intact skin (e.g.,
endoscopes, respiratory therapy and anesthesia
equipment, diaphram rings)
 Non-Critical
• Contacts intact skin (e.g., bedpans, blood pressure cuffs,
crutches)
*Spaudling scheme
© 2006 Kaiser Permanente Health Plan, Inc.
Sterilization & High Level Disinfection
 Medical devices
 Gas or liquid
 Instruments that can’t handle heat
 Devices difficult to thoroughly clean
 Long lumens
Goals of Effective Sterilization &
Disinfection Program
 Balance sporicidal, viricidal, and bactericidal
effectiveness vs. human health effects and
environmental toxicity of wastes
 Check material compatibility with delicate
medical devices and equipment repair costs
 Design areas and processes to promote
success
 Strive to assure patient and worker safety
© 2006 Kaiser Permanente Health Plan, Inc.
So What’s the Problem?
Many health care institutions
concerned about:
Safety of liquid chemical sterilants
(LCS).
Risk of adverse health effects to
workers who use them or patients
who may be exposed.
Impact on the environment from
waste generation and disposal
© 2006 Kaiser Permanente Health Plan, Inc.
Glutaraldehyde
Ethylene Oxide
Severe respiratory
sensitizer
Known carcinogen
Asthmagen
Probable teratogen
Skin sensitizer
Neurotoxin
Low exposure
limits
May damage central
nervous system
Water pollutant
Air pollutant
© 2006 Kaiser Permanente Health Plan, Inc.
Ethylene Oxide - EtO
 Commonly used biocide
 Under EPA Clean Air Act as a sterilizer
 National Toxicology Program: known human
carcinogen and other acute and chronic health
effects.
 Extremely reactive and flammable, with risk of
chemical accident that could harm hospital
workers and patients.
Hospital Sterilizers now under new EPA Rule
 New EPA Air regulations govern emissions from sterilizers using
ethylene oxide.
 Must run full loads in EtO sterilizers unless physician or
administrator determines medical necessity to run partial load.
 EtO exhaust creates pollution. While no single hospital is a
major EtO polluter, EPA has found that, taken together, EtO
sterilizers in medical centers account for a significant source of
pollution.
 Additionally, EtO can be dangerous to workers and others who
touch or inhale the substance.
 For more info: http://www.epa.gov/ttn/atw/area/fr28de07b.pdf
Reprocessing Algorithm*
Yes
Reusable?Yes
No
Discard
after initial
use
Thoroughly
cleaned?
Yes
No
Pressurized
Steam or
Dry Heat
Sterilization
*Reprinted with permission from: Muscarella LF, “Automatic
Flexible Endoscope Reprocessors,” Gastrointestinal Endoscopy
Clinic of North America, 2000 April;10(2):245-257
© 2006 Kaiser Permanente Health Plan, Inc.
Heat
sensitive?
Yes
Long, thin
lumens?
No
No
Low Temp
Gas, Plasma
or Vapor
Sterilization
Just-In-Time Liquid Sterilant
or Cold Liquid Sterilant
Yes
Alternatives to EtO
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Sporox – 7.5% Hydrogen Peroxide, Sultan Chemists
Sterrad – J&J, hydrogen peroxide plasma
Steris 20, Steris Corporation .2% peracetic acid
EndoSpor Plus Sterilizing and Disinfecting Solution – Cottrell Limited,
7.35% hydrogen peroxide, .23% peracetic acid
Peract 20 Liquid Sterilant/Disinfectant, Minntech Corp, 1.0%
hydrogen peroxide, .08% peracetic acid.
Sterilox Liquid High Level Disinfectant System, Sterilox, Technologies,
In.c, hypochlorite and hypochlorous acid.
Cidex OPA concentrate, Advanced Sterilization Products 5.75% ortho
phthalaldehyde
Cidex OPA Solution, Advanced Sterilization Products, .55%
orthophthalaldehyde
EO Gas System, Anderson Products (100% EtO gas cartridges and
plastic sterilization bags.)
EtO Alternatives Summary
Sterilization
Process
3M 5XL EtO (with
Cycle
Time
17 hr
Cost per
Load
$34
Cost per
Machine
$25K
30-40
min
30 min
$19-$37
$6
$45K /
$120K
$20K
4 hr
$1
$150K
abator)
ASP Sterrad NX /
100
Steris P6000
TSO3
© 2006 Kaiser Permanente Health Plan, Inc.
Costs / Benefits Not Quantified
 Transaction cost of hazardous materials
substitution or reduction effort
 Value of quicker turnaround time
 Increased availability of instruments
 Instrument upgrade / replacement costs
 Elimination of contact with EtO
© 2006 Kaiser Permanente Health Plan, Inc.
Disinfection Levels
 High-level
• Capable of killing bacterial spores, and is
therefore expected to kill all other
microorganisms
 Intermediate-level
 Destroys all vegetative bacteria, including tubercle bacilli,
viruses, and fungus spores
 Low-level
 Destroys all vegetative bacteria (except tubercle bacilli),
some viruses and fungi
High level disinfection
Clinical Processes and Medical Equipment
 Flexible Endoscopy
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Gastroenterology
Gynecology
Head & Neck Surgery
Urology
ENT
 Ultrasound
Transducers
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Obstetrics
Radiology
Cardiology
Urology
 Rigid Endoscopy
 Miscellaneous
• Operating Room
• Cryo probe tips
• Diaphragms
© 2006 Kaiser Permanente Health Plan, Inc.
Cold Liquid Disinfection Methods
 Glutaraldehyde
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Cetylcide-G (3.2%)
Cidex (2.4, 2.5, 3.4%)
MedSci (3%)
Metricide (2.5, 2.6, 3.4%)
Omnicide (2.4, 3.4%)
Procide (2.4%)
Rapidcide (2.5%)
Sporicidin (1.12/1.93%
glut/phenol)
• Wavicide-01 (2.5%)
© 2006 Kaiser Permanente Health Plan, Inc.
 Hydrogen Peroxide
• Sporox (7.5%)
 Hydrogen Peroxide/
Peroxyacetic Acid
• EndoSpor Plus (7.5/0.23%)
• Peract 20 (1.0/0.08%)
 ortho-Phthalaldehyde
• Cidex OPA (0.55%)
 Peroxyacetic Acid
• Steris S-20 (35%)
Disadvantages of Glutaraldehyde
 Severe irritant - may cause asthma and respiratory
sensitization
(although not cancer or reproductive harm)
 Skin sensitizer
 Low exposure limits
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0.2 ppm NIOSH REL
0.05 ppm ACGIH TLV
0.05 ppm 8-Hr TWA in CA 7/8/2006
0.05 ppm Ceiling Limit in CA 7/8/2008
© 2006 Kaiser Permanente Health Plan, Inc.
OPA (ortho-Phthalaldehyde) Considerations
Cons
 Unknown long term health effects or cross-sensitivity to other
aldehydes
 Potent skin sensitizer - systemic reactions in patients resulting in
anaphylaxis (Urology)
 No regulatory or recommended exposure limits
 No validated air sampling method
 Precautionary principle requires same engineering controls as
glutaraldehyde
 CA requires treatment as a hazardous waste
© 2006 Kaiser Permanente Health Plan, Inc.
OPA (ortho-Phthalaldehyde) Considerations
Cons
 Local sewer district may not allow drain disposal even with
treatment
 4 times the cost of glutaraldehyde
 OPA must be treated with glycine prior to disposal (state to state)
 Treatment in external tanks only
 New reports of adverse respiratory effects
© 2006 Kaiser Permanente Health Plan, Inc.
Time Out: Comparing Cycle Times
 Glutaraldehyde ($5 per bottle)
20 minutes per cycle = 24 cycles per 8-hour shift
 Cidex OPA ($25 per bottle)
12 minutes per cycle (manual) = 40 cycles per 8-hour shift
5 minutes per cycle (automated) = 96 cycles per 8-hour shift
© 2006 Kaiser Permanente Health Plan, Inc.
Benefits of Quicker Process Time
 Increased availability of instruments and medical
devices
 Decreased inventory needed on hand
 Increased personnel availability to care for
patients
© 2006 Kaiser Permanente Health Plan, Inc.
Best Management
 Training
 Documentation
 Separation of clean
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from dirty
Standardization
Air Testing
Spill Response
Reporting
Transition over time…
 Inventory/Assess current practices
 Pilot alternatives
 Evaluate financial ROI, worker safety, env. Safety
 Develop and Implement Plan
 Educate, track, report, monitor regularly
The Built Environment
 Isolation
• Cleaning and disinfection process
isolated from clinical procedure
areas
• Infectious Patients from others,
staff
 Engineering controls
• Vapor-generating activities and
equipment
• Cough-inducing procedures
 Safety equipment
 Separation
• Clean and dirty areas
• Airflow from clean to dirty
• Positive and negative pressure
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Eyewash
Shower
Spill containment
Emergency shut off switches and
valves
 Process flow
• From dirty to clean, with no
cross-over encouraged between
the two
© 2006 Kaiser Permanente Health Plan, Inc.
Local Exhaust Ventilation
Keep Learning
 Discuss sterilization and high level disinfection
when purchasing equipment.
 Continuously assess new technologies through
supply chain and organizations such as AORN and
APIC.
Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008
http://www.cdc.gov/ncidod/dhqp/sterile.html
1 – Integrated Operations
2 – Sustainable Sites Management
3 – Transportation Operations
4 – Facilities Management
5 – Chemical Management
6 – Waste Management
7 – Environmental Services
8 – Food Service
9 – Environmentally Preferable Purchasing
10 – Innovation in Operation
operations
section
Reference Standards - IAQ
 Where EtO must be used due to incompatibility or
regulatory recommendations, ensure that reprocessing
units are enclosed under negative pressurization and
utilize local exhaust ventilation in accordance with OSHA
Standard 29 CFR 1910.1047 and Niosh Current Intelligence
Bulletin 52; ETO Sterilizers in Health Care Facilities and the
CDC/HICPAC Disinfection and Sterilization Guidelines,
2008. Monitor exposure to ensure that the threshold
limit value (TLV 15 min STEL) to the American Conference
of Government Industrial Hygienists (ACGIH) and the
OSHA Permissible Exposure Limit (PEL) of 1 ppm for an 9
hour time weighted average with a 5 ppm excursion level
is never exceeded. In addition, meet state permitting
requirements for use of ETO Sterilizer reprocessing units.
Best Management when In Use
 Sterilize with full loads only.
 Maintain sterilization records, date and time of
each cycle, whether full or not, and if not full,
note from staffers of why.
 Assess all equipment requiring sterilization to
identify compatibility issues and potential for
alternative methods.
Thank you!
Wendi Shafir 415-972-3422
Janet Brown – 413/253-0254
Shafir.wendi@epa.gov
jbrown@practicegreenhealth.org