LOW-TEMPERATURE OXIDATIVE STERILIZATION METHODS FOR STERILIZING MEDICAL DEVICES
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Overview: | Low-temperature oxidative
sterilization for medical devices and surgical instruments is a safe
alternative to ethylene oxide (EtO) sterilization. Two of these
low-temperature oxidative methods include hydrogen peroxide plasma
sterilization, developed by Advanced Sterilization Products (ASP) and
marketed under the trade name STERRAD™, and peracetic acid gas/plasma
technology, developed by AbTox, Inc. and marketed under the trade name
PLAZLYTE™. Abtox, Inc. has not received FDA approval for its technology
and is not sold in the U.S.
Hydrogen peroxide plasma sterilization uses 1.8 milliliters of 58 percent hydrogen peroxide that is vaporized in a sterilization chamber. The vapor is converted into a plasma through the use of radio frequency (RF) energy.1 The plasma consists of highly charged particles and free radicals to sterilize instruments in about one hour without producing toxic residues or emissions. The only byproducts of this method are water vapor and oxygen. Peracetic acid gas/plasma technology provides a continuous infusion of peracetic acid gas into the sterilization chamber, where the gas is subjected to RF energy and converted to a plasma state.2 Peracetic acid plasma technology requires a cycle time of about three hours.Hydrogen peroxide plasma sterilization and peracetic acid gas/plasma sterilization will have the greatest impact in the smaller volume areas, such as in-hospital sterilization. According to one study,3 both methods are emerging technologies and are unable to handle large-volume requirements; therefore, they will not greatly affect the industrial sterilization market in the next few years. 1CDR T.C. Stewart, Head, Sterile
Processing, National Naval Medical Center, Bethesda, Maryland, 20889-5000,
"Sterilization Alternatives to Ethylene Oxide." | |||||||||||||||||||||||||||||||||||||||||||||
Compliance Benefit: | Switching to hydrogen
peroxide plasma sterilization should decrease the amount of power consumed
during the sterilization process. This will help facilities meet the
requirements under Executive Order 13123, Greening Government
through Efficient Energy management. In addition, switching to an
alternative sterilization techniques (which does not use CFC-12) will help
a facility meet the requirements under 40 CFR 82, Subpart D and EO
12843 requiring Federal agencies to maximize the use of safe
alternatives to class I and class II ozone depleting substances, to the
maximum extent practicable. Low-temperature oxidative sterilization
methods are currently not subject to the regulatory reporting associated
with an emission standard. The United States Environmental Protective
Agency has a NESHAP under 40 CFR 63, Subpart O for ethylene oxide
emissions from sterilizers that use 1 ton or more of EtO per year but it
does not apply to hospitals or medical facilities.
The compliance benefits listed here are only meant to be used as a general guideline and are not meant to be strictly interpreted. Actual compliance benefits will vary depending on the factors involved, e.g., the amount of workload involved. | |||||||||||||||||||||||||||||||||||||||||||||
Materials Compatibility: | Certain materials (e.g., cellulose products, cotton, paper, towels, certain packaging materials, muslin, dressings, organic materials, water and wadding) are not compatible with hydrogen peroxide plasma units. For example, cellulosic materials will absorb the sterilant, often leading to incomplete sterilization of the device4. Materials incompatibility issues for peracetic acid plasma sterilization are unknown. 4Scholla and Wells. | |||||||||||||||||||||||||||||||||||||||||||||
Safety and Health: | In hydrogen peroxide
plasma sterilization, the hydrogen peroxide used in the process is
contained in cassettes or cartridges. At no time does the operator come in
contact with the chemical. Also, the process does not produce any toxic
residues or emissions. The only byproducts are water vapor and
oxygen.
These new technologies minimize the use of the EtO sterilization process. EtO is highly explosive in nature, a known carcinogen/mutagen, and in the sterilization process, must be mixed with a carrier agent such as chlorofluorocarbon (CFC)-12 (Freon®), which is an ozone-depleting substance (ODS). Note** Not all instruments are F.D.A certified for plasma sterilization. Consult your local industrial health specialist, your local health and safety personnel, and the appropriate material safety data sheet (MSDS) prior to implementing these technologies. | |||||||||||||||||||||||||||||||||||||||||||||
Benefits: | A hydrogen peroxide plasma
sterilization unit:
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Disadvantages: | Hydrogen peroxide plasma
sterilization units:
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Economic Analysis: | The following cost
elements compare the hydrogen peroxide plasma unit to the EtO
sterilization unit.
Wilford Hall Medical Center in San Antonio, Texas, switched their EtO sterilization unit to a hydrogen peroxide plasma unit in January 1998. A cost analysis was performed in November 1995 by ASP, the vendor of the STERRADTM unit, and is summarized below. Assumptions:
Cost Comparison for Ethylene Oxide Sterilization vs. Hydrogen Peroxide Plasma Sterilization
Economic Analysis Summary Annual savings for hydrogen peroxide plasma
sterilization: $65,874 Click Here to view an Active Spreadsheet for this Economic Analysis and Enter Your Own Values. To return from the Active Spreadsheet, click the reverse arrow in the Tool Bar. | |||||||||||||||||||||||||||||||||||||||||||||
Approving Authority: | Approval is controlled
locally and should be implemented only after engineering approval has been
granted. Major claimant approval is not required.
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NSN/MSDS: |
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Points of Contact: | Air Force: John Jura Wilford Hall Medical Center MCOS, 2200 Berquist Drive, Suite 1 Lackland Air Force Base San Antonio, TX 78236-5300 Phone: (210) 292-5300 or (210) 292-4621 FAX: (210) 292-6781 |
Navy: Mr. Bill Rogers BUMED Environmental Program Manager Navy Environmental Health Center 2510 Walmer Avenue Norfolk, VA 23513-2617 Phone: (757) 462-5546 DSN: 253-5546 FAX: (757) 444-7261 Email: rogersw@nehc.med.navy.mil
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Vendors: | Advanced Sterilization
Products A Division of Johnson & Johnson Medical, Inc. 33 Technology Drive Irvine, CA 92618 Phone: (800) 595-0200 or (949) 450-6800 Fax: (949) 450-6800 Email: aspcomment@aspus.jnj.com Sales & Technical: Phone: (888) 783-7723 or (949) 453-6400 |
AbTox. Inc. 104 Terrace Drive Mundelein, IL 60060-3826 Phone: (800) 228-6950 or (847) 949-0552 Note: **PlazLyte is not currently sold in the US
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Sources: | Sgt. Ernest Nichols, Wilford
Hall Medical Center, December 1999. Conversation with Mr. Bill Rogers, BUMED Environmental Program Manager, Navy Environmental Health Center, March 6, 1998. Conversation with Captain DeDecker, Wilford Hall Medical Center, March 5, 1998. Sterilization Alternatives to Ethylene Oxide, CDR T.C. Stewart, Head, Sterile Processing, National Naval Medical Center, Bethesda, Maryland. Tracking Trends in Industrial Sterilization, Michael H. Scholla and Mary E. Wells, Medical Device & Diagnostic Industry, September 1997. Vendor information from Advanced Sterilization Products (ASP), a division of Johnson & Johnson and AbTox, Inc. |
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