FOR IMMEDIATE RELEASE
Indianapolis, Indiana (January 28, 2003)

Sterilization Cassette Systems, Inc.
To Announce "Sterilization Validation Guarantee"

Sterilization Cassette Systems, Inc. will announce a new program for OEM manufacturers at the AAOS in New Orleans. The new SCS "Sterilization Validation Guarantee" states that instrument sets designed by SCS can be processed in sterilization wrap in standard hospital sterilization cycles without requiring extended drying time.

The guarantee has important implications for orthopedic device manufacturers. There are more than 20,000 autoclaves in use at hospitals and surgery centers in the United States. Many of these autoclaves are old and almost all had sterilization cycles pre-set at the factory. This means that the hospital can choose a pre-set cycle but cannot change a cycle to accommodate non-standard steam times.

The standard cycles from STERIS/AMSCO and Getinge/Castle are:

The SCS guarantee means that sterilization instrument sets designed by SCS using SCS design guidelines are compatible with these standard cycles ensuring that the instrument set will be both sterile and dry at the end of a standard cycle.

Changing a steam cycle requires that the control panel of the sterilizer has to be removed, which takes about 45 minutes to complete. Once changed, AAMI standards recommend 3 test cycles to validate the new cycle before the sterilization of instruments or devices. Hospitals don't change cycles because of the time involved and the challenge of what cycle does the hospital choose when so many different cycles are suggested by different device manufacturers.

The greater problem is the loss of the autoclave manufacturer's warranty. STERIS states in its operating manual the following: "Any alteration of the sterilizer not authorized or performed by STERIS Engineering Service which could affect its operation will void the warranty, could adversely affect sterilization efficacy, and could violate federal, state, and local regulations and jeopardize your insurance coverage." So why would a hospital ever change a pre-set steam cycle?

The responsibilities of device manufacturers are clear. AAMI's ST33 Standard states the following on page 7: "Documentation of the manufacturer's test methodology and results should include information verifying that the sterilization efficacy of the container system has been qualified in standard hospital sterilization cycles and has passed standard AAMI challenge tests for each method of sterilization for which the container system was labeled." The SCS guarantee helps the device manufacturer meet these requirements.

Currently, there is a controversy over whether sterilization instrument sets should be in the Class I or Class II category. Only three of the ten major designer/manufacturers of sterilization instrument case/tray systems have a Class II Clearance from the FDA. The real challenge is not what Class these devices fall under—the real challenge is "are your sterilization instrument case/tray systems compatible with standard sterilization cycles?"

What business are you in? For most OEM manufacturers the answer is the orthopedic business…but they are not in the sterile processing business. These device manufacturers have to depend on their vendors to guarantee compatibility with the different sterilization processes.

So what business is your vendor in? Are they in the sterilization processing business or are they in the sheet metal or plastic box business? The answer makes a huge difference for the patient, surgeon and hospital and for the device manufacturer's reputation.

Sterilization Cassette Systems is in the "sterile processing business" so we can offer the new Sterilization Validation Guarantee for wrapped instrument sets in standard hospital cycles. We believe the orthopedic industry deserves nothing less from its vendors.

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