1. 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

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 2

3. 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

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

5. © 2006 Kaiser Permanente Health Plan, Inc. Infection Control Definintions 1  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

6. © 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

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

8. 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.

9. 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.

10. Glutaraldehyde © 2006 Kaiser Permanente Health Plan, Inc. Ethylene Oxide Severe respiratory sensitizer AsthmagenSkin sensitizer Low exposure limits Water pollutant Known carcinogenProbable teratogenNeurotoxin May damage central nervous system Air pollutant

11. 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.

12. 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.pdfhttp://www.epa.gov/ttn/atw/area/fr28de07b.pdf

13. © 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 No Yes

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 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 P600030 min$6$20K TSO34 hr$1$150K © 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. Disinfection Levels  High-level Capable of killing bacterial spores, and is therefore expected to kill all other microorganisms  Intermediate-level T Destroys all vegetative bacteria, including tubercle bacilli, viruses, and fungus spores  Low-level TDestroys all vegetative bacteria (except tubercle bacilli), some viruses and fungi

18. High level disinfection

19. © 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

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

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

27. 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

28. © 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

29. Local Exhaust Ventilation

30. 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

31. operations section 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

32. 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.

33. 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.

34. Thank you! Wendi Shafir 415-972-3422 Janet Brown – 413/253-0254 Shafir.wendi@epa.gov jbrown@practicegreenhealth.org www.practicegreenhealth.or g