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Detoxing Sterilization and High Level Disinfection
Alternatives to Ethylene Oxide and Glutaraldehyde
Wendi ShafirUSEPA R9June 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?
Safety Liability Community Relations Cost Savings Indoor Air Quality Environmental
Impact Regulatory
Compliance Mission Statement Healing Environment Commitment to
Health2
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
Administration Nursing/Clinical Staff Engineering Facility Management Environmental Services Infection Control Materials Management Risk Management Safety Industrial Hygiene
© 2006 Kaiser Permanente Health Plan, Inc.
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
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
© 2006 Kaiser Permanente Health Plan, Inc.
Ethylene Oxide
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
© 2006 Kaiser Permanente Health Plan, Inc.
*Reprinted with permission from: Muscarella LF, “Automatic Flexible Endoscope Reprocessors,” Gastrointestinal Endoscopy Clinic of North America, 2000 April;10(2):245-257
Reprocessing Algorithm*
Reusable?
Discard after initial
use
Thoroughly cleaned?
Heat sensitive?
Pressurized Steam or Dry Heat Sterilization
Low Temp Gas, Plasma or Vapor Sterilization
Long, thin lumens?
Just-In-Time Liquid Sterilant or Cold Liquid Sterilant
NoNoNoNo
Yes Yes
Yes
Yes Yes
Alternatives to EtO 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
Cycle Time
Cost per Load
Cost per Machine
3M 5XL EtO (with abator)
17 hr $34 $25K
ASP Sterrad NX / 100
30-40 min
$19-$37 $45K / $120K
Steris P6000 30 min $6 $20K
TSO3 4 hr $1 $150K
© 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
© 2006 Kaiser Permanente Health Plan, Inc.
Clinical Processes and Medical Equipment Flexible Endoscopy• Gastroenterology• Gynecology• Head & Neck Surgery• Urology• ENT
Rigid Endoscopy• Operating Room
Ultrasound Transducers• Obstetrics• Radiology• Cardiology• Urology
Miscellaneous• Cryo probe tips• Diaphragms
Cold Liquid Disinfection Methods
Glutaraldehyde• 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%)
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%)
© 2006 Kaiser Permanente Health Plan, Inc.
Disadvantages of Glutaraldehyde Severe irritant - may cause asthma and respiratory
sensitization (although not cancer or reproductive harm)
Skin sensitizer
Low exposure limits• 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 shift5 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
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
© 2006 Kaiser Permanente Health Plan, Inc.
The Built Environment Isolation
• Cleaning and disinfection process isolated from clinical procedure areas
• Infectious Patients from others, staff
Separation • Clean and dirty areas• Airflow from clean to dirty• Positive and negative pressure
Process flow • From dirty to clean, with no
cross-over encouraged between the two
Engineering controls • Vapor-generating activities and
equipment• Cough-inducing procedures
Safety equipment• Eyewash • Shower• Spill containment• Emergency shut off switches and
valves
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.
http://www.cdc.gov/ncidod/dhqp/sterile.html
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
operationssection
1 – Integrated Operations2 – Sustainable Sites Management3 – Transportation Operations4 – Facilities Management5 – Chemical Management6 – Waste Management7 – Environmental Services8 – Food Service9 – Environmentally Preferable Purchasing10 – Innovation in Operation
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 415-972-3422Janet Brown – 413/[email protected]@practicegreenhealth.org
www.practicegreenhealth.org