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 – 413/253-0254Shafir.wendi@epa.govjbrown@practicegreenhealth.org

www.practicegreenhealth.org