New EPA Regulations for EtO Emissions:
What do they mean for your hospital?
Control Today Article Re: EPA 40 CFR 63, subpart
National Emission Standards for Hospital Ethylene Oxide
Submitted by: A.E. Ted May, Vice President
28, 2007, the Environmental Protection Agency released 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 aims to summarize the issues
that hospital administrators must address, and to identify resources
that will help make compliance easier.
good news. EPA decided to regulate EtO emissions from hospitals
by a focus on work practices, and not 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).
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.
is covered by the new rule?
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
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 over 600 hospitals in the United
Statesdo not have add-on APCDs, making it necessary
to implement specific management practices.
Specific Management Practices?
sterilize full loads of items having a common aeration time.
Partial loads may be run under medically necessary circumstances
as determined by hospital 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,
or not the cycle contained a full load and if not,
- a signed
note from hospital staff that it was medically necessary
for Compliance; new versus existing sources
your compliance date, you first must determine if your sterilizers
are “existing” or “new.”
If your ethylene
oxide sterilizers were installed or rebuilt before November
6, 2006, it is considered an existing source. Existing EtO sterilization
facilities have until December 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 November 6, 2006, but before December
28, 2007, it is considered a new source. The compliance date
for sterilizers that fit this category is December 27, 2007.
Hospitals with sterilizers in this new category have 180 days
from December 27, 2007, to file an INOCS with the EPA.
EtO sterilizers installed after December 28, 2007, the compliance
date is start up of the sterilizer. Your INOCS will be due 180
days after start up.
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.
is still the most popular method of sterilizing new medical devices,
and it is an essential tool for hospitals CS Departments who
count on its proven reliability.
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.
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
EtO sterilizers meet the spirit of the new EPA rule, and will
ensure the popularity of EtO sterilization into the future.
The most gas-efficient
system on the market today is the Andersen EOGas™ system.
EOGas uses 100% 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.
bag & 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.
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.
NOTICE: This article is intended for informational
purposes only, and should not be construed as legal or compliance
advice. Hospitals and other healthcare facilities should
consult with their Regional EPA Office for more information
for more research:
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 .
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
Questions? You can locate your EPA Regional Office
a leading manufacturer of gas detection equipment (including
EtO), has created a site with other useful links on this subject: http://www.gasdetection.com/kb/index.php?article=48