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Detoxing Sterilization and High Level Disinfection Alternatives to Ethylene Oxide and Glutaraldehyde. Janet Brown Director of Facility Engagement Practice Greenhealth. * Resource: Erika Stewart, Kaiser Permanente. Why a Focus on EtO and Glutaraldehyde?. Safety Liability Community Relations

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Detoxing Sterilization and High Level DisinfectionAlternatives to Ethylene Oxide and Glutaraldehyde

Janet Brown

Director of Facility Engagement

Practice Greenhealth

* Resource: Erika Stewart, Kaiser Permanente

why a focus on eto and glutaraldehyde
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 Health
other toxicity issues
Ethylene Oxide, Glutaraldehyde

Disinfectants

Cleaning Chemicals

Pesticides

Herbicides

Hazardous Pharmaceuticals

Laboratory Chemicals, solvents

Brominated fire retardants

Exhaust from vehicles

DEHP in medical devices

Electronics waste

Materials and finishes

Safer Building Materials

Other Toxicity issues

What story

Do they have

To tell?

learning objectives
Learning Objectives
  • Understand the options for sterilization and high level disinfection in health care environment
  • Recognize value of standardization, training and education
  • Identify resources for communicating others about alternatives to Ethylene Oxide and Glutaraldehyde
green team development
Green Team Development
  • Administration
  • Nursing/Clinical Staff
  • Engineering
  • Facility Management
  • Environmental Services
  • Infection Control
  • Materials Management
  • Risk Management
  • Safety
  • Industrial Hygiene
infection control definintions 1
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
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
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
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
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

Glutaraldehyde

© 2006 Kaiser Permanente Health Plan, Inc.

ethylene oxide
Ethylene Oxide
  • Commonly used biocide
  • Under EPA Clean AirAct as a sterilizer
  • National Toxicology Program as a 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.
reprocessing algorithm
Reprocessing Algorithm*

Yes

Heat sensitive?

Yes

Yes

Yes

Yes

Thoroughly cleaned?

Long, thin lumens?

Reusable?

No

No

No

No

Discard after initial use

Pressurized Steam or Dry Heat Sterilization

Low Temp Gas, Plasma or Vapor Sterilization

Just-In-Time Liquid Sterilant or Cold Liquid Sterilant

*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.

alternatives to eto
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
EtO Alternatives Summary

© 2006 Kaiser Permanente Health Plan, Inc.

costs benefits not quantified
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.

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

Clinical Processes and Medical Equipment

© 2006 Kaiser Permanente Health Plan, Inc.

disadvantages of glutaraldehyde
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.

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%)

Cold Liquid Disinfection Methods

© 2006 Kaiser Permanente Health Plan, Inc.

opa considerations
OPA 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
  • 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
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
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
Best Management
  • Training
  • Documentation
  • Separation of clean

from dirty

  • Standardization
  • Air Testing
  • Spill Response
  • Reporting
transition over time
Transition over time…
  • Inventory/Assess current practices
  • Pilot alternatives
  • Evaluate financial ROI, worker safety, environmental 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

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

The Built Environment

© 2006 Kaiser Permanente Health Plan, Inc.

keep learning
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

slide28

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

green guide for health care www gghc org
Green Guide for Health Care – www.gghc.org
  • Chemical Management – CM
    • CM Credit 1.2-1.4 Indoor Chemical Contaminant Reduction:
    • Hand Hygiene Products, Sterilization and High Level Disinfection
    • Intent – Reduce and eliminate the use and improper disposal of chemical hazards and toxic materials within the health care facility to safeguard the health of building occupants.
    • CM Credit 1.2: Hand Hygiene
    • CM Credit 1.3 – Sterilization – 1 point
credits
Credits
  • Replace the sterilant ethylene oxide with safer alternatives for a minimum of 90% of the equipment requiring sterilization.
reference standards iaq
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
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
Thank you!

Janet Brown – 413/253-0254

jbrown@practicegreenhealth.org

www.practicegreenhealth.org