Detoxing Sterilization and High Level Disinfection Alternatives to Ethylene Oxide and Glutaraldehyde

1. Detoxing Sterilization and High Level DisinfectionAlternatives to Ethylene Oxide and Glutaraldehyde Janet Brown Director of Facility Engagement Practice Greenhealth * Resource: Erika Stewart, Kaiser Permanente

2. 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

3. 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?

4. 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

5. Green Team Development • Administration • Nursing/Clinical Staff • Engineering • Facility Management • Environmental Services • Infection Control • Materials Management • Risk Management • Safety • Industrial Hygiene

6. 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.

7. 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.

8. Sterilization & High Level Disinfection • Medical devices • Gas or liquid • Instruments that can’t handle heat • Devices difficult to thoroughly clean • Long lumens

9. 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.

10. 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.

11. Ethylene Oxide Glutaraldehyde © 2006 Kaiser Permanente Health Plan, Inc.

12. 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.

13. 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.

14. 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.)

15. EtO Alternatives Summary © 2006 Kaiser Permanente Health Plan, Inc.

16. 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.

17. High level disinfection

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

24. Best Management • Training • Documentation • Separation of clean from dirty • Standardization • Air Testing • Spill Response • Reporting

25. 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

26. 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.

27. 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

28. 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

29. 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

30. Credits • Replace the sterilant ethylene oxide with safer alternatives for a minimum of 90% of the equipment requiring sterilization.

31. 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.

32. 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.

33. Thank you! Janet Brown – 413/253-0254 jbrown@practicegreenhealth.org www.practicegreenhealth.org