About Hospital Safety Center  
Career Center  
Contact Us
       Free Resources
Hospital Safety Insider

Mac's Safety Space  
        News & Analysis
Healthcare Safety Leader  
Environment of Care Leader  
Forms and Checklists Library  




Upcoming EtO sterilizer rule takes effect in December


December 1, 2008

Upcoming EtO sterilizer rule takes effect in December

You should pay attention to an important upcoming deadline, as a rule mandating that hospitals run full loads in their ethylene oxide (EtO) sterilizers is effective December 29.

The rule is expected to affect up to 1,600 of the nation’s 5,800 hospitals, according to the Environmental Protection Agency (EPA).

We first reported the EPA regulation in the March Briefings on Hospital Safety.

No changes have been made to the rule since its Federal Register entry in 2007, says David Markwordt, project lead environmental engineer of the coatings and chemicals group at the EPA.

The agency recently uploaded a sample form hospitals can use as a template for required initial notification to environmental regulators that they have a sterilizer falling under the rule, Markwordt says. (See the box at right for more details).

The form is a sample and not mandatory, the EPA states. The rule requires only that initial notification be provided to your EPA regional office or state environmental regulator, depending on which state you’re in, so other forms of submission are allowed.

The agency uploaded the form due to hospitals’ frequent requests for a sample template. “A lot of people called up and said, ‘Gee, do you have a form we can fill out?’ ” Markwordt says. “But it’s not an official form; it’s just an example that would satisfy the requirement.”

The EPA recommends hospitals check with their state or regional offices to confirm the form is acceptable.

Quick review of the EPA rule

As a way to further protect the air from EtO pollution, the regulation requires hospitals to:

  • Run full loads in EtO sterilizers
  • Run partial sterilizer loads, if medically necessary
  • Document every sterilizer load and, when loads aren’t full, note the medical reasons and their authorizers

Hospitals with existing EtO sterilizers have until December 29 to comply with the rule. Those constructing new facilities with EtO sterilizers must comply upon initial startup of the sterilizer. The EPA mandates initial notification of compliance status for existing sterilizers by June 27, 2009. For new sterilizers that hospitals begin utilizing after December 29, the EPA requires initial notification within 180 days after they go into use.

Logs necessary to track loads

As noted, the rule mandates that hospitals generally run full loads in their sterilizers.

A central services staff member, hospital administrator, or physician may authorize a partial load for medical necessity, according to the EPA. The definition of medical necessity in this case is left to individual hospitals.

Initially, regulators were planning to only let doctors authorize partial loads, Markwordt says.

During the proposed rule’s comment period in 2007, hospitals made it clear that that wasn’t always practical and asked that others in the facility be given that authority too.

“We tried to broaden it so it wasn’t onerous,” says Markwordt. “The people who were actually operating the equipment should be able to sign [off].”

The rule not only requires reporting to the EPA that you have a sterilizer falling under the regulation, but that you keep load records in a log for five years—including at least two years’ worth on-site—for quick review, according to the EPA.

The rule also requires hospitals to implement management practices to ensure compliance with the rule.

Hospitals contribute to EtO pollution

Only EtO sterilizers in hospitals fall under this rule; it does not apply to physicians’ offices, clinics, and other facilities whose primary purpose is to provide outpatient services.

No single hospital is a major EtO polluter, according to the EPA. However, the agency found that, taken together, EtO sterilizers account for a significant source of pollution. This finding was the catalyst for the new rule.

The EPA isn’t the only national regulator interested in EtO. OSHA governs employee exposure to the substance as a gas or colorless liquid. EtO presents risks to workers who touch or inhale the substance.

To read the EPA’s full regulation, go to www.epa.gov and search for the term “FRL-8512-1.”

Subscribe Now!
Sign up for our free e-newsletter
About Us | Terms of Use | Privacy Statement | Contact Us
Copyright © 2020. Hospital Safety Center.