ETO vs H2O2 Supplementary Doc

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8.

17. Thank You!

1. Supplementary Education Document

9. • ASP published article: “Comparison Study of Environmental Hydrogen Peroxide Levels” • CHL Self - Study Lesson Plan sponsored by Steris: “Safety in Central Service: Management Responsibility” • Tokyo Healthcare University Postgraduate School: “Problems on Hydrogen Peroxide Sterilisation - New Proposal for Safety and Effective Use”

15. • Cost Effective • Designed to provide TWA • Accuracy +/ - 25% • Results in 1 - 2 weeks • Accepted Method but NOT the SOLUTION

14. • Use chemical splash - type goggles and a face shield • Approved gloves made of nitrile, PVC, or neoprene • Impervious clothing such as an approved splash protective suit • Approved boots made of NBR, PVC, Polyurethane, or neoprene • If concentrations in excess of 10 ppm are expected, use NIOSH/DHHS approved self - contained breathing apparatus • Avoid breathing vapors, mist or gas.

2. • Ethylene Oxide Overview • Hydrogen Peroxide Overview • Similarities between Ethylene Oxide ( EtO ) and Hydrogen Peroxide (H2O2) • Best Practices for Hydrogen Peroxide Sterilization • ChemDAQ Hydrogen Peroxide Gas D etection System

3. • S terilant used widely in hospitals and sterilization facilities • Colorless, odorless and flammable • Human carcinogen, mutagenic, reproductive and neurological hazards • OSHA PEL: 1.0 ppm 8 - hour TWA STEL: 5.0 ppm 15 - min TWA • NIOSH IDLH: 800 ppm

13. • Follow device and sterilizer manufacturers’ written IFUs • SDSs - learn about chemical hazards, labels, training • Laws • OSH Act 1970 • Air contaminants Std. 1910.1000 (& Tbl . Z - 1) • Hazcom Std. 1910.1200

5. • Sterilant used widely in hospitals • Up to 90% Concentration - NOT comparable to the H2O2 you get at the grocery store • Colorless, odorless and unstable • Severe Primary Irritant • Animal Carcinogen (ACGIH) • Mutagen • OSHA PEL: 1.0 ppm 8 - hour TWA

16. • Real - time measurement in PPM • Displays 15 - min and 8 - hour TWAs • Built in low - level and high - level alarm • Data reporting and archiving • Ability to connect to control system

10. • Event Description: The facility reported an employee experienced a burn while handling items that were processed in a v - pro max 2 sterilizer • A service technician found the unit to be operating according to specification; no repairs were required, and the unit was returned to service • Facility personnel confirmed that the employee was not wearing proper PPE, specifically gloves, while operating the sterilizer • The sterilizer operator manual states, "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide • User facility personnel should ensure all instruments are properly dry prior to placement in the v - pro max 2 sterilizer • Residual H2O2 may remain at cycle completion and/or a cycle abort occurs

11. • Event Description: A customer reported an odorless vapor/smoke emitting from the sterrad ® 100nx sterilizer and one healthcare worker experienced irritation, burning, and itchiness in the eye • The hcw took contacts off to rinse and flush eyes, the reaction lasted 4 hours • The hcw also had a light headache which lasted one hour • The hcw did not receive medical attention/treatment for his symptoms • The customer was advised to clear the facility and shut down the unit until serviced • A field service engineer was dispatched and replaced the adapter converter, catalytic converter, oil mist filter and vacuum pump oil to resolve the smoke/haze issue

12. • Elimination - Physically remove the hazard • Substitution - Replace the hazard • Education and Training - Develop best work practices • Engineering Controls - Isolate people from the hazard • Personal Protective Equipment - Protect the worker • Sterilizer and Re - processor Maintenance - Keep your equipment in top shape • Continuous Monitoring Solution - Understand your environment

7. 1818 Discovered by Alexander von Humboldt 1920s - 1940s Used as a medical treatment for various ailments 1950s ACGIH TLV set to 1.0 ppm 8hr TWA 1970 OSHA adopts ACGIH TLVs from 1968 1.0 ppm 8hr TWA 1977 EPA registers H2O2 as a pesticide 1983 Hazard Communication Standard Implemented Late 1980s - Early 1990s AMSCO VHP Sterilizers are first released 1999 Animal Carcinogen (International Agency for Research on Cancer) 2013 AAMI ST58: The Chemical Sterilizer Standard

6. https://www.hpnonline.com/continuing - education/article/21129765/keys - to - success - with - vaporized - hydrogen - peroxide - sterilization H2O2 Concentration Products and Applications < 8% (Non - Hazardous) Contact lens sterilant (2%) Over the counter pharmaceutical grade (3%) Liquid detergent bleach (5%) Hair bleach (6 - 12%) 8% - 28% Pool shock (27%) 28.1% - 52% Industrial strength – pulp and paper bleaching (20 – 52%) 125 - 280 Solution – STERIZONE VP4 (50%) 52.1 – 91% STERRAD Cassettes for STERRAD Sterilizers (58%) VAPROX HC Sterilant for STERIS AMSCO V - PRO Sterilizers (59%) Specialty applications and uses (52 – 91%) >91% Rocket propellant

4. 1859 Discovered by Charles - Adolphe Wurst 1928 Reported as a powerful insecticide 1930s & 1940s Used to sterilize spices and other food preservatives 1950s Becomes a common sterilant of medical instruments 1970 OSHA PEL established - 50 ppm 8 - hour TWA 1981 ACGIH establishes PEL of 10 ppm 8 - hour TWA. Suspects EtO of being a human carcinogen 1984 OSHA determines EtO presents a carcinogenic, mutagenic, hazard 1987 The IARC classsifies EtO as probably carcinogenic to humans 1988 OSHA establishes an excursion limit (STEL) of 5 ppm 15 - min TWA and a (PEL) 1.0 ppm 8 - hour TWA 1990 The NTP classifies EtO as “reasonably anticipated to be a human carcinogen” 1994 The IARC concluded “ EtO is carcinogenic to humans” 2000 The NTP upgraded its classification from Reasonably Anticipated to Human Carcinogen 2003 - 2004 NIOSH reports that EtO causes breast cancer and lymphomas 2009 California adds EtO to its list of toxic substances 2016 The EPA publishes updated assessment of cancer risks 9 years after being advised by independent researchers Present Day OSHA - Occupational Safety and Health Administration ACGIH - American Conference of Governmental Industrial Hygienists NIOSH - National Institute for Occupational Safety and Health IARC - International Agency for Research on Cancer NTP - National Toxicology Program

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