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New EPA Rule Requires Many Hospitals to Monitor Device Sterilization

Scott Wallask, for HealthLeaders Media, May 7, 2009

A new Environmental Protection Agency (EPA) rule—which has an important notification deadline coming up—will affect about 1,600 of the nation's 5,800 hospitals.

The regulation deals with ethylene oxide, commonly abbreviated as EtO. While EtO may not be part of your everyday language, the gas is used often in hospitals as a sterilizer for medical instruments.

If CEOs and hospital managers aren't aware of the new rule, they should make themselves familiar with it, says Janet Brown, director of sustainable operations at Practice Greenhealth, a national group that promotes environmentally friendly practices in healthcare.

The rule generally mandates that hospitals run full loads in their EtO sterilizers, unless a physician, administrator, or central services representative determines it is medically necessary to run a partial load. The definition of medical necessity in this case is left to individual hospitals.

For example, the EPA states the medical necessity clause could be invoked to sterilize medical devices that are under research and development and thus may not have established sterilization cycles. In such cases, keeping them separate from regular medical instruments would be prudent.

If your hospital uses an EtO sterilizer that existed before November 6, 2006, you have until June 26, 2009, to file an initial notification with the agency letting it know what your compliance status is with the rule.

Newly constructed sterilizers must send in initial notification within 180 days of start-up.

Michael D. Shaw, vice president of Interscan Corp., in Chatsworth, CA, says that hospitals must indicate one of the following two notification provisions to the EPA:

  • The facility will run fully loaded ethylene oxide sterilizers unless it is deemed medically necessary to run a partial load
  • As an alternative, the facility will install an EtO emission control device and operate it in accordance with state or local regulations, as well as the  manufacturer's recommended procedures
  • Interscan manufactures gas monitors and detectors. Based on his work, Shaw says he hasn't seen many major problems for hospital central processing departments to comply with the new EtO notification.

    As part of the regulation, hospitals must document every sterilizer load and, when loads aren't full, note the medical reasons and their authorizers.

    The reasoning behind the EPA rule is that EtO exhaust creates pollution. No single hospital is a major EtO polluter, according to the EPA. However, the agency found that, taken together, EtO sterilizers in medical centers account for a significant source of pollution.

    Beyond environmental concerns, EtO can also be dangerous to workers and others who touch or inhale the substance.

    Since 2005, at least four hospitals in Alabama, California, New Hampshire, and Rhode Island have had to call emergency authorities to respond to alarms for EtO leaks within the facilities.


    Scott Wallask is senior managing editor for the Hospital Safety Center. He can be reached at swallask@hcpro.com.

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