Regulations and Industry Resources
ChemDAQ is happy to provide easy references to summarize complex regulations documents. Most are available as pdf downloads. As you browse this page you will also find links to educational industry articles on a range of topics. If you don't find what you're looking for please contact us at:

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Summary Charts: Toxicity, Regulations & Health Hazards
In the United States occupational safety is regulated by the Occupational Safety and Health Administration (OSHA), interlaced with states laws, a summary of which are provided below:
      Summary of Regulations & Health Risks for EtO, H2O2 and O3
      Ethylene Oxide General Regulations, Record Keeping & Health Risks
      Ethylene Oxide Tank Changing Regulations
      Hydrogen Peroxide General Regulations, Record Keeping & Health Risks
      Ozone General Regulations, Record Keeping & Health Risks
      Complete Chart of Gases, Associated Health Issues & Regulations
      Canadian EtO General Regs, Storage & Record Keeping
      Peracetic Acid Chart of Health Risks

Reporting adverse events involving medical devices
The FDA Med Watch/MAUDE database stores voluntary reports of adverse events involving medical devices.   Users are encouraged to submit such incidents to the FDA.

To submit an adverse incident report on form 3500 to MedWatch database:
       https://www.accessdata.fda.gov/scripts/medwatch/
To search the Manufacturer and User Facility Device Experience (MAUDE) database
       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

National Emissions Standards for Ethylene Oxide Sterilizers
Under Section 112 of the Clean Air Act, the EPA developed National Emission Standards to regulate both major sources and area source’s use of ethylene oxide.

For hospitals, the final rule, dated December 28, 2007, 2007, involves registration, use of abators, running full loads, record keeping.
      EPA information sheet
      Example of Initial Notice of Compliance Status
For sterilization facilities, depending on amount of ethylene oxide used, there are additional requirements for abators and/or monitoring emissions into the atmosphere
      Ethylene Oxide Commercial Sterilization and Fumigation Operations Implementation Document

Educational Opportunities & Articles Related to Workplace Safety

February, 2009	Personnel working in Central Sterile work around harsh and sometimes dangerous chemicals. Richard Warburton. This article discusses long-term health effects from exposure to most common chemicals, and explains what you can do to protect your staff;
March 21, 2009	2009 Sterilization Technology Showcases Steri-Trac Monitoring System, Daisy Mcarty Managing Infection Control article about protecting employees from exposure to chemicals such as Ethylene Oxide, Hydrogen Peroxide and Ozone.
October 2008	“The Importance of Monitoring all Sterilant Gases for Employee Safety”; Richard Warburton This article provides important safety information to protect workers from exposure to gases used in low temperature sterilization.
October 2008	Download webinar “Protecting Yourself from Toxic Sterilants”; David Hilliker and Richard Warburton Take the test and receive 1 credit hour.
September 2008	“Indoor Air Quality Affects Patient Care Quality”; Jeannie Ackridge, Richard Warburton Healthcare Purchasing News Article "Monitoring for airborne toxins, such as gases used in sterile processing, is an integral part of ensuring safe air quality in hospitals"
July 2008	** Approved for (1) contact hour ** The Essentials of Sterilant Gas Monitoring; Occupational safety in the use of sterilant gases: Richard Warburton This 10-page full color Gas Safety Education and Training document published by Managing Infection Control is available for free download.
May 2008	“The Myths of Sterilant Gas Safety Exposed”, Richard Warburton, New low temperature sterilization technologies offer greater throughput and greater safety over Ethylene Oxide. This article dispels common myths regarding the safety of Hydrogen Peroxide, Gas Plasma and Ozone sterilants. Download free Full Color PDF copy
September 2007	“How Sterile Processing Plays Central Role in Success”; Susan Klacik, Central service / sterile processing professionals are vital to hospital performance and patient care quality but their valuable contributions can be overlooked or not taken seriously. Read the full article with contributions from 15 Sterile Processing Professionals <click here>
September 2006	“VHP Safety Basics”; The Safety Guys, Vince McLeod and Glenn Ketcham Over exposure to hydrogen peroxide vapors can present serious health effects should a worker enter a room during decontamination or if a self-contained sterilizer experiences a leak.. <click here>

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