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Our systematic approach can help make switching from ethylene oxide sterilization to a V-PRO Sterilization System an easy process. During this process you must maintain sterilization needs, keep projects on time and prevent unexpected costs.

Here are the five major steps involved in converting from Ethylene Oxide (EO) Sterilizers to the V-PRO® Low Temperature Sterilization Systems.

Step 1: Determine Device Inventory and Compatibility

Document your inventory of devices currently processed through the ethylene oxide sterilizer, including the manufacturer, device description, and device model.

Figure 1 Example of a Device Inventory Log

The next step is to determine which sterilization cycles may be used to sterilize each device. This list should include both cycles for V-PRO® and steam sterilizers, if applicable. Figure 1 provides an example of a device inventory log.

To determine sterilization methods and cycles, use the manufacturer’s most recent instructions for use (IFU), STERIS’s Device Compatibility Matrix, and consider the device’s design for compatibility with V-PRO Sterilizers as detailed in the operator manual.

What if my Device IFU only lists EO?

Device instructions for use that list ethylene oxide sterilization as the only option do not automatically exclude the device from consideration for sterilization in a V-PRO System. Often, device manufacturers do not revalidate older device models, or may fail to update their instructions for use when new sterilization processes are developed.

Medical devices must meet two criteria for sterilization within a V-PRO® Sterilizer:

  1. Device Material Compatibility
  2. Device Design Compatibility

Device Material Compatibility: This can be determined using the device manufacturer’s IFUs. Devices processed by hydrogen peroxide or hydrogen peroxide gas plasma sterilization are compatible with V-PRO® Sterilizers. If the IFU does not include information on hydrogen peroxide or hydrogen peroxide gas plasma sterilization, determine if the materials of device construction that would be exposed to V-PRO Sterilization are compatible. Materials may be listed in the device’s technical information or may be obtained from the device manufacturer. A list of compatible and non-compatible materials can be found in the operator manual, as well as the Technical Data Monograph for your specific V-PRO® Sterilizer (Reference numbers 10023077C, 10037127D, 01248284B, or M4010EN_A).

Device Design Compatibility: The device’s design dictates which sterilization cycles of the V-PRO Sterilizer to use. This includes the lumen lengths, lumen diameters, and the type of device. Refer to the sterilizer’s indications for use statement for a detailed list.

STERIS provides additional instructions for determination of device suitability in the Sample Procedure “Determining Suitability of the V-PRO® Sterilizer for Low Temperature Sterilization of Device Inventory” (reference number M9536EN).

Step 2: Installation of the V-PRO® Sterilizer

Prior to installation, the location where the V-PRO Sterilizer will be installed must be identified. Placement near pass through windows, drying cabinets and dedicated prep and pack areas reduces  time wasted in transporting packs or devices across the department. V-PRO Sterilizers work within the current room requirements of 10 air exchanges per hour as dictated by ANSI/AAMI ST58 (2013).

V-PRO Sterilizers do not require water, drainage, house air or oxygen tanks. The only utility requirement is either a 208V or 120V electrical connection. Refer to the equipment drawings for exact electrical requirements for the unit. The installer must perform checks to ensure that the installation has been completed correctly and that the electrical supply meets the sterilizer requirements. These checks fall under Installation Qualification.

Qualification Testing

The facility must also perform Performance Qualification Tests to ensure the sterilizer is functioning properly. The required qualification testing is listed in Table 1 and varies by model. STERIS provides additional instructions in the sample procedures referenced in the table.

Table 1: List of Qualification testing to be completed upon installation of a V-PRO Sterilizer

Ethylene Oxide Sterilizer Decommissioning

Decommissioning of ethylene oxide sterilizers typically occurs after installation of the new low temperature sterilization systems. Work with the EO sterilizer manufacturer or other knowledgeable contractor to render the sterilizer inoperable, remove the sterilizer from planned maintenance schedules, and update hospital inventory lists. Remaining inventory of ethylene oxide sterilant, consumables and sterility assurance products must be disposed of as well and may require use of a hazardous chemical disposal company. Sterilization records and personnel monitoring records will need to be maintained for their required period of time.

Step 3: Create Policies and Procedures

During the installation process, update policies and procedures to include the V-PRO® Sterilizer. This includes a comprehensive review and update of all processes starting with cleaning of the devices and ending with storage of the devices. Many factors, from cleaning chemistries to load configurations can impact the sterilization process. It is necessary to review every step in the process and update all that require changes.

Here are some major areas to consider when updating policies and procedures:

1. Review the compatibility of cleaning chemistries, lubrication practices and any other treatments applied to instruments prior to sterilization in your V-PRO® sterilizer.

2. Confirm that packaging methods are compatible with V-PRO® Sterilization. Obtain appropriate sterilization pouches, wraps and containment devices. Review current packaging methods and procedures against the operator manual of the V-PRO® Sterilizer. Modify procedures appropriately.

3. Chemical indicators, biological indicators and other sterilization specific consumables will be different from those for ethylene oxide sterilization. Ensure that these are included in the operating procedures. Obtain wall charts for interpretation of all chemical and biological indicators to be used for V-PRO® Sterilization.

4. Compared to your old sterilizer, load configurations will be different. It may be necessary to segregate packs, based on contents, to ensure that they are processed in the correct cycle.

Step 4: Product Testing

After all procedures have been reviewed and updated it is time for product testing. Product testing is a type of Performance Qualification and verifies that the processes being used at the facility meet all instructions for use and provide sterile devices. Testing begins with identification of product families and representative sterilizer loads.  Biological and chemical indicators are placed within pouches, packs and container systems of the items within the load. Following completion of the sterilization cycle, all chemical indicators must demonstrate passing results and biological indicators must be negative for growth.

Step 5: Training

Training is the final and the most important part of implementation. Hydrogen peroxide sterilization will be different from ethylene oxide in many ways. Staff must understand these differences and be able to articulate those differences that if improperly performed, may interfere with sterilization of devices in the V-PRO Sterilizer.

Training must include all stakeholders including, but not limited to, decontamination and the operating room staff who will receive the devices after processing. Decontamination must understand any challenges in the cleaning or drying process that may affect the new sterilization process. Those who operate the new sterilizer must understand cycle restrictions, loading configurations and safety concerns. Finally, staff in the operating room will need training on packaging, chemical indicator strips and indicator tape used with V-PRO® Sterilizers.

Just remember – while this process may seem overwhelming, applying a systematic approach to your conversion will go a long way. STERIS offers resources to help you in this process such as the V-PRO® Device Compatibility Matrix, as well as online in-service tools to assist in your training process.

For even more help with converting from Ethylene Oxide Sterilization to V-PRO® Low Temperature Sterilization please reach out to a STERIS representative, visit STERIS.com or call 1-800-548-4873.

 

References

Association for the Advancement of Medical Instrumentation. (2013). ANSI/AAMI ST58: 2013.
M9536EN Sample Procedure: Determining suitability of the V-PRO® Sterilizer for Low Temperature Sterilization of Device Inventory.
M3815EN Sample Procedure: Microbial Verification Following Installation or Major Repair of the V-PRO®® 1, V-PRO®® 1 Plus, V-PRO® maX® and V-PRO® 60® Low Temperature Sterilization Systems.
Association for the Advancement of Medical Instrumentation. (2017). ANSI/AAMI ST90: 2017
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