LOW-TEMPERATURE OXIDATIVE STERILIZATION METHODS FOR STERILIZING MEDICAL DEVICES

Revision Date: 11/01
Process Code: Navy/Marines: MD-01-01; Air Force: MD01; Army: N/A
Usage: Navy: Medium; Marines: Medium;
Army: Medium; Air Force: Medium
Compliance Impact: Low
Alternative for: Ethylene Oxide Sterilization
Applicable EPCRA Targeted Constituents: Ethylene Oxide (CAS: 75-21-8)

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.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."
2 Stewart.
3 Michael H. Scholla and Mary E. Wells, "Tracking Trends in Industrial Sterilization," Medical Device & Diagnostic Industry, September 1997.


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:
  • Consumes less power than traditional EtO sterilization units;
  • Requires no water, drainage, or venting;
  • Has shorter cycle times than traditional EtO sterilization units (74 minutes vs. 12 hours);
  • Eliminates the use of EtO, a carcinogen/mutagen and highly explosive chemical;
  • Has significantly lower annual operating costs than traditional EtO sterilization units;
  • Eliminates the use of CFC-12, an ODS; and
  • Avoids costs and regulatory paperwork associated with the emissions

 

Disadvantages: Hydrogen peroxide plasma sterilization units:
  • Are not compatible with cellulose products, cotton, paper, towels, certain packaging materials, dressings, and wadding;
  • Are more expensive than EtO sterilization units ($100,000 vs. $40,000 for an EtO sterilization unit with the same sterilization volume); and
  • Are unable to handle large-volume requirements (i.e., hydrogen peroxide sterilization units can handle the sterilization of items up to about 18 inches; however, larger hydrogen peroxide sterilization units that will be able to meet industrial sterilization requirements are beginning to enter the market).


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:

  • Sterilization unit: STERRADTM 100 Sterilizer
  • Sterilization volume: 14,976 cubic ft.
  • Supplies: Pouches and wrap, biological indicators, chemical indicators, and tape
  • Utilities: EtO sterilization (electricity, steam, and water), hydrogen peroxide plasma sterilization (electricity)
  • EtO tanks: 104 tanks required per year
  • Hydrogen peroxide cassettes: $7.95 per cycle and 4680 cycles per year
  • Maintenance and service: Maintenance and service for the hydrogen peroxide plasma units for the first year are included in the capital and installation costs and will be $17,280 every year thereafter
  • Risk management cost: Includes insurance premium, potential employee lawsuits, environmental lawsuits

Cost Comparison for Ethylene Oxide Sterilization vs. Hydrogen Peroxide Plasma Sterilization

 

EtO Sterilization

Hydrogen Peroxide Plasma Sterilization

Capital and Installation Costs:    
Sterilization unit cost, including installation and initial supplies. This cost also includes the 1st year maintenance contract for the STERRADTMunit only: $40,000 $100,000
Operational Costs (1st year):    
Supplies: $28,521 $28,040
Utilities: $6,627 $468
EtO tanks: $63,440 $0
Hydrogen peroxide cassettes: $0 $37,206
Maintenance, service: $16,000 $0
Training, protective attire: $2,000 $0
EtO recovery cost: $10,000 $0
Risk management cost: $5,000 $0
Total Costs: (not including capital and installation costs) $131,588 $65,714
Total Income: $0 $0
Annual Benefit: -$131,588 -$65,714

Economic Analysis Summary

    Annual savings for hydrogen peroxide plasma sterilization: $65,874
    Capital Cost for Equipment/Process: $100,000
    Payback Period for Investment in Equipment/Process: 1.5 years

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.


NSN/MSDS:
Product NSN Unit Size Cost MSDS*
STERRAD sterilizer None identified N/A $N/A  
PLAZLYTE sterilizer None identified N/A $N/A  


*There are multiple MSDSs for most NSNs.
The MSDS (if shown above) is only meant to serve as an example.

 

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

 

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

 

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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