The New EPA Regulations for EtO Emissions: What Do They Mean for Your Hospital?

On Dec. 28, 2007, the Environmental Protection Agency (EPA) issued a new rule designed to control air emissions from hospital sterilizers using ethylene oxide (40 CFR 63, subpart WWWWW). Given the lingering confusion over this rule (no, EtO is not going to be banned), this article will summarize the issues that hospital administrators must address, and to identify resources that will help make compliance easier.

First the good news. The EPA decided to regulate EtO emissions from hospitals by a focus on work practices and not on new equipment requirements. Simply stated, the new rule requires that hospitals should run their EtO sterilizers fully loaded. Exceptions to the rule include medically necessary circumstances and sterilizers with air pollution control devices (APCD).

This full load requirement is consistent with existing hospital practices, since a fully loaded sterilizer is more economical to operate. From the EPA’s perspective, by minimizing EtO use, the hospital also minimizes EtO emissions.

So, who is affected by the rule? If you run an inpatient hospital that performs diagnostic services or surgeries and operate an EtO sterilizer, you as an administrator should note the regulatory changes. Specifically excluded are doctor’s offices, clinics and other facilities whose primary purpose is to provide medical services on an outpatient basis.

As noted, if your EtO sterilizers already utilize air pollution control devices (APCD) you are already in compliance with the rule requirements, as long as the APCD is operating during all sterilization cycles. However, the EPA estimates that more than 600 hospitals in the United States do not have add-on APCDs, making it necessary to implement specific management practices.

Staff must sterilize full loads of items having a common aeration time. Partial loads may be run under medically necessary circumstances as determined by hospital central service (CS) staff, a hospital administrator or a physician, based upon generally accepted medical practices.

For each EtO sterilizer that does not use an APCD, hospital staff must maintain records of every sterilization cycle, including:

The date and time of the sterilization cycle

Whether or not the cycle contained a full load and if not,

A signed note from hospital staff that it was medically necessary

To determine your compliance date, you first must determine if your sterilizers are “existing” or “new.” If your ethylene oxide sterilizers were installed or rebuilt before Nov. 6, 2006, it is considered an existing source. Existing EtO sterilization facilities have until Dec. 29, 2008 to come into compliance with the new rule. Filing of an Initial Notification of Compliance Status (INOCS) is required 180 days after this date (May 2009).

If your sterilizer was installed or rebuilt after Nov. 6, 2006, but before Dec. 28, 2007, it is considered a new source. The compliance date for sterilizers that fit this category is Dec. 27, 2007. Hospitals with sterilizers in this new category have 180 days from Dec. 27, 2007, to file an INOCS with the EPA.

Finally, for EtO sterilizers installed after Dec. 28, 2007, the compliance date is start-up of the sterilizer. Your INOCS will be due 180 days after start-up.

Once your facility has filed an INOCS with the EPA you are required to keep copies of the INOCS and sterilization cycle records for each sterilizer. These records should be readily available for review if necessary.

Ethylene oxide is still the most popular method of sterilizing new medical devices, and it is an essential tool for hospitals' CS departments that count on its proven reliability. According to the EPA’s own analysis, the potential risk of EtO emissions to public health is minimal. This new rule, together with improved technology that use EtO more efficiently, will continue to reduce overall EtO emissions. 

A.E. Ted May is vice president and general manager of Andersen Products.

Resources

1. An EPA brochure explaining Final Rule 40 CFR 63, Subpart WWWWW, can be found at http://www.epa.gov/ttn/atw/area/sterilizers_3_7_08.pdf

2. The EPA has also provided an example of an Initial Notification of Compliance Status (INOCS) at http://www.epa.gov/ttn/atw/area/inocs_example.doc

3. Locate your regional EPA office at: http://www.epa.gov/epahome/locate2.htm

The Future of EtO Sterilization

EtO is unmatched in its ability to sterilize a wide range of delicate devices at low temperature. Combined with its compatibility with all conventional packaging materials, it is easy to understand why so many hospital CS directors are passionate about their EtO systems.

Ultra-efficient EtO sterilizers meet the spirit of the new EPA rule, and will ensure the popularity of EtO sterilization into the future. The Andersen EOGas™ system which uses 100 percent EtO gas cartridges and plastic sterilization bags. Items to be sterilized are prepared, wrapped and placed inside an individual sterilization bag along with a EtO cartridge. After the sterilization bag is sealed and loaded into the cabinet, the gas is released inside the sterilization bag by activating the cartridge through the bag wall.

Different bag and cartridge combinations are available, and EOGas cabinets are designed to process multiple sterilization bags simultaneously. Each sterilization cycle uses less than 11 grams of EtO. This technology allows operators to match their load to the appropriate bag/cartridge combination, and to fill the sterilization cabinet with as many bags as are required. This load flexibility is unique to the EOGas system, and results in greatly reduced overall gas consumption. With EOGas, the bag is the chamber, and with this system the chamber is always full. For more information on EOGas, go to www.anpro.com