The Gold Standard in Low Temperature Sterilization: Ethylene Oxide

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1 The Gold Standard in Low Temperature Sterilization: Ethylene Oxide 08 March 2017 Dr. S.V. Ramesar (B.Med.Sc., B.Sc (hons), M.Med.Sc., PhD)

2 Disclosure I am the Scientific Affairs & Education Manager at 3M South Africa This presentation reflects the techniques, approaches and opinions of the individual presenter. Before using any medical device, review all relevant package inserts with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device(s). The third party trademarks used herein are trademarks of their respective owners. 2

3 Disinfection & Sterilization EH Spaulding believed that an object should be disinfected according to the object s intended use. CRITICAL - objects that enter normally sterile tissue or the vascular system or through which blood flows should be completely sterile. SEMI-CRITICAL - objects that touch mucous membranes or non intact skin require a highlevel disinfection (HLD) process. NON-CRITICAL - objects that touch only intact skin require low-level disinfection 3

4 Sterilization The complete destruction of microorganisms on an object 4

5 Effective Sterilization Swenson D. The science of sterilization. Springer

6 Sterilization Options High Temperature Low Temperature

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8 Steam Sterilization Four parameters for successful steam sterilization Saturated steam Temperature Time Pressure

9 Low Temperature Sterilization For the sterilization of Heat & Moisture Sensitive devices In South Africa we use 3 types: Ethylene Oxide Hydrogen Peroxide Formaldehyde

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11 Formaldehyde Formaldehyde is used as a disinfectant and sterilant in both its liquid and gaseous states. Formaldehyde inactivates microorganisms by alkylating the amino and sulfhydral groups of proteins and ring nitrogen atoms of purine bases.

12 Hydrogen Peroxide (Gas Plasma) Popular because of its short cycle times. Uses H 2 O 2 vapor and low temperature gas plasma for rapid inactivation of microorganisms.

13 Hydrogen Peroxide (Gas Plasma) There are some restrictions regarding the sterilization of lumens (diameter and length). Is not compatible with powders and strong absorbers like paper and linen made of cellulose.

14 Ethylene Oxide Used commonly in Hospitals since the 1950s Excellent Penetration Capabilities Kills microorganisms by alkylation

15 Alkylation The process of destroying microorganisms by making the cell unable to metabolize and/or reproduce.

16 Ethylene Oxide - chemistry French Chemist Charles Adolphe Wurtz 1940 used in sterilizing spices by Lloyd Hall in US 16

17 Where is Ethylene Oxide used? 17

18 Where is Ethylene Oxide Used? 18

19 Total Volume of Medical Products Sterilized in the U.S. by Manufacturers Other Radiation 41% 1% EO 56% Steam 2% CDC - Guideline for Disinfection and Sterilization in Healthcare Facilities, Rutala et al. (2008)

20 Why use Ethylene Oxide? Advantages Excellent penetrability (even devices with long lumens) Compatible with almost all the medical devices and packaging materials Most cost effective LTS method Long history of use

21 Ethylene Oxide One of the most exclusive aspects of EO is its ability to penetrate. No other chemical sterilant available today penetrates as efficiently as EO

22 Chamber Pressure The role of negative pressure in penetration Condition Exposure Exhaust Aerate Negative Pressure Time (Hours)

23 The importance of the Penetration of a Sterilant A chemical sterilant should be in contact with the microorganisms in order to inactivate them!

24 Dispelling the myths of Ethylene Oxide There are five myths with respect to sterilization with ethylene oxide in healthcare establishments

25 Myth No. 1 Ethylene Oxide has been banned or is about to be banned.

26 CFC Banned for use CFC was banned in 1987 because of its deleterious effects on the ozone layer. Previously ethylene oxide was used as a mixed gas in combination with chlorofluorocarbons (CFC). Alternatives to ETO-CFC ETO-CO2, ETO-HCFC, 100% ETO

27 Standards and guidelines supporting EO EN EO Sterilizers EN ISO Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices EN ISO EN ISO &2 CDC (Centers for Disease Control of the U.S.) OSHA (U.S. Occupational Safety and Health Administration) EOSA (Ethylene Oxide Sterilization Association) AORN (Association of Perioperative Registered Nurses) ANSI (American National Standards Institute) AAMI (Association for the Advancement of Medical Instrumentation)

28 Recommended by the WHO 28

29 Cleared for use by OSHA.. 29

30 Myth No. 2 EO poses risks to technicians in sterilization rooms and to patients who receive instruments sterilized with this gas.

31 EO Worker Exposure Regulations OSHA (Occupational Safety and Health Administration of the U.S.) Permissible Exposure Limits (PEL) 1 ppm (8 hours in Time- Weighted Average - TWA) Level of Action (LA) 0.5 ppm (8 hours in Time- Weighted Average - TWA) Exclusion Limit (EL) 5 ppm (Time- Weighted Average of 15 minutes)

32 NIOSH EO Study (National Institute for Occupational Safety and Health) : Study of the Mortality of 18,235 workers exposed to ethylene oxide

33 Results of NIOSH Study Mortality Indices Among Workers Exposed to EO Hematopoietic Cancers Brain Cancer Digestive System Cancers Respiratory Cancer Breast Cancer Urinary Cancer Heart Disease Benign Digestive Disease Benign Respiratory Disease Benign Genitourinary Disease Real number of deaths among the workers exposed to EtO Number of deaths expected in a similar segment of the general population

34 Results of the NIOSH EO Study Exposure to EO did NOT increase the incidence of mortality from any disease investigated.

35 Myth No. 3 The long aeration period for instruments sterilized with EO makes this sterilization method not cost effective.

36 Cost and Total Processing Time Despite the fact that the sterilization process with EO takes more time than other LTS methods REMEMBER gas sterilization is a specific process and must include a biological indicator result for the load to be released.

37 Myth No. 4 Ethylene oxide is the only sterilant that is toxic!

38 Toxicity of gas sterilants Currently, there are no chemical sterilants available that are not toxic

39 Comparative Toxicity of Ethylene Oxide, Hydrogen Peroxide, and Ozone Sterilant OSHA PEL (8 hour TWA) NIOSH IDLH Concentration Ethylene Oxide (EO) 1.0 ppm 800 ppm Hydrogen Peroxide (H 2 O 2) 1.0 ppm 75 ppm Formaldehyde 0.75ppm 30 ppm PEL Permissible Exposure Limit TWA = time weighted average NIOSH = National Institute for Occupational Safety and Health IDLH Immediately Dangerous to Life or Health Source: Hilliker, D.J., Employee Safety and gas sterilants, Infection Control Today, March of 1998

40 Myth No. 5 Ethylene Oxide is harmful to the environment

41 EO in the Environment The primary fate of EO in the environment is degradation by a process called hydrolysis. Ethylene oxide ethylene glycol Ethylene glycol is 100% biodegradable

42 EO in the Environment Air pollution control equipment installed when required by state or local regulations e.g. EO Abators convert exhausted ethylene oxide to carbon dioxide, water vapor and heat at 99.9% efficiency The solution to pollution is always dilution

43 Government bodies, Industry leaders and Health care associates agree: The sterility of medical items used in patient care is an integral component of an infection prevention strategy.

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46 Conclusions All of the sterilization technologies at low temperatures have advantages and limitations EO is the most efficient low temperature sterilant and most available to health care establishments The use of EO will continue to be the main method of sterilization at low temperature for many years to come

47 Why EO is the Gold Standard? EO has an exceptional ability to penetrate products and compatibility with large number of materials Being a very effective alkylating agent, it is a very good sterilant against a wide range of microorganisms It can be monitored by biological and chemical indicators at every cycle EO is regulated by global standards and guidelines

48 3M Infection Prevention Solutions/Standards of Excellence Our Patients This is why we have a passion about Safety in the OR This is the face of our patients the healthcare consumer They are innocent and frightened no matter their age They and their families entrust their lives in our care We have pledged to protect those who enter our doors 48

49 Thank you