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

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. 3 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

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

6. � 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 Erica Now that we�ve looked at the medical devices used in these areas, let�s look a little closer at the infection control issues in these areas. First, we need to define what we mean when say what is sterile and what is disinfected. The following definitions of the terms sterilization and disinfection present their respective meanings from an infection control standpoint: 1) STERILIZATION IS� 2) DISINFECTION INVOLVES THE�Erica Now that we�ve looked at the medical devices used in these areas, let�s look a little closer at the infection control issues in these areas. First, we need to define what we mean when say what is sterile and what is disinfected. The following definitions of the terms sterilization and disinfection present their respective meanings from an infection control standpoint: 1) STERILIZATION IS� 2) DISINFECTION INVOLVES THE�

7. � 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)

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. � 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 Remember to separate clean from dirty and to learn going into it if this department will require high level disinfection of reusable medical equipment � emergency department, cardiology, ENT, Endoscopy, Operating Room, Women�s Health, Radiology, Urology, Pulmonary, to name a few areas. Air exchanges, separation of clean from dirty, counter space, two sinks�..better to have one good place than lots of marginal locations. While on subject of air quality, biggest compliant from patients and staff alike is the floor care. Remember to separate clean from dirty and to learn going into it if this department will require high level disinfection of reusable medical equipment � emergency department, cardiology, ENT, Endoscopy, Operating Room, Women�s Health, Radiology, Urology, Pulmonary, to name a few areas. Air exchanges, separation of clean from dirty, counter space, two sinks�..better to have one good place than lots of marginal locations. While on subject of air quality, biggest compliant from patients and staff alike is the floor care.

11. Glutaraldehyde Asthma and asthma symptoms, burning eyes and conjunctivitis, rashes and dermatitis, headaches and nausea, and hives 0.2 ppm NIOSH REL 0.05 ppm ACGIH TLV 0.05 ppm 8-Hr TWA in CA 0.05 ppm Ceiling Limit in CA Asthma and asthma symptoms, burning eyes and conjunctivitis, rashes and dermatitis, headaches and nausea, and hives 0.2 ppm NIOSH REL 0.05 ppm ACGIH TLV 0.05 ppm 8-Hr TWA in CA 0.05 ppm Ceiling Limit in CA

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. � 2006 Kaiser Permanente Health Plan, Inc. Reprocessing Algorithm*

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

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

17. High level disinfection

18. � 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

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 Asthma and asthma symptoms, burning eyes and conjunctivitis, rashes and dermatitis, headaches and nausea, and hives Asthma and asthma symptoms, burning eyes and conjunctivitis, rashes and dermatitis, headaches and nausea, and hives

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%)

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

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

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

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. � 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

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.

28. The section names in the Operations section are not based on LEED, but many of the credits in this section were modeled on LEED for Existing Buildings. In addition, the Operations section includes many pollution prevention, waste management, and environmentally preferable purchasing strategies taken from health-care specific environmental non-profits such as Hospitals for a Healthy Environment and Health Care Without Harm. There are a total of 72 credits in the Operations section. The total number of credits in both the Construction and Operations sections are 166 credits and 21 Prerequisites.The section names in the Operations section are not based on LEED, but many of the credits in this section were modeled on LEED for Existing Buildings. In addition, the Operations section includes many pollution prevention, waste management, and environmentally preferable purchasing strategies taken from health-care specific environmental non-profits such as Hospitals for a Healthy Environment and Health Care Without Harm. There are a total of 72 credits in the Operations section. The total number of credits in both the Construction and Operations sections are 166 credits and 21 Prerequisites.

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