• Reference the full FAQ documentopens in a new tab or Solventum white paper Why should I use a process challenge device for monitoring vaporized hydrogen peroxide sterilization?
• The preassembled 1295PCD can save the time required to assemble a BI, CI, and peel pouch manually
• Preassembly of 1295PCD can help reduce potential for errors caused by manual assembly of BI and CI into a peel pouch
• 1295PCD can help streamline inventory management by reducing the need to order VH2O2 BIs, CIs, and peel pouches individually
• 1295PCD provides a higher level of quality assurance monitoring as compared to standalone BIs or BIs placed inside sterilization pouches
• The use of the 1295PCD provides a greater confidence in your sterilization assurance program as compared to the use of standalone BIs or BIs placed inside sterilization pouches
• By subjecting the sterilization process to a greater challenge during routine monitoring, healthcare facilities can better assess the effectiveness and reliability of their sterilization methods
• It enhances confidence that the sterilization process used is effective and reliable helping to support patient safety.
• Using the 1295PCD preassembled test pack allows customers to elevate their current VH2O2 sterilization load monitoring practice to a level that is on par with steam sterilization monitoring best practices/standards
• The preassembled 1295PCD is designed to more accurately simulate the environment inside of a surgical pack than using just a stand-alone BI (or a BI in a sterilization pouch) for VH2O2 load monitoring. It’s the same design principle used in preassembled steam BI test packs.
• 1295PCD is designed to represent the sterilization process challenge posed by instruments sterilized every day
• The 1295PCD is placed in a standardized location in the sterilization chamber; top rack towards the front of the chamber. This standardization reduces potential error in the placement of the BI as the ASP® systems and STERIS® systems have different locations for the placement of their BIs in these VH2O2 sterilizer systems.

Per ANSI/AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities 8.6.5.3 Frequency of use of biological indicators and process challenge devices: Biological indicators should be used within PCDs or an FDA-cleared BI-containing quality monitoring device for routine sterilizer efficacy monitoring for each cycle type every day the sterilizer is in use, but preferably in every load.

Standards and guidelines in your region of the world may differ. The benefits of using the 1295PCD vs. standalone BI or a standalone BI in sterilization pouch are multifaceted and extensive and are outlined in the beginning of the full FAQ documentopens in a new tab.

Yes, you can use the 1295PCD as a standard method of routine monitoring and performance qualification (operational and performance) and for process validation of vaporized hydrogen peroxide sterilization processes. In the U.S. if your VH2O2 sterilizer is listed in the indications for use for the 1295PCD, then the 1295PCD can be used a standard method of routine monitoring and performance qualification. The 1295PCD has a comprehensive list of indications for use. Please see the list of VH2O2 sterilizers and cycle types listed in the table below. Per ANSI/AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities 8.6.5.2 Using biological indicators and process challenge devices: BIs used in health care facilities are medical devices that require FDA clearance. Personnel should use BIs cleared by the FDA for use with that sterilization system.

The 1295PCD has been cleared by the U.S. FDA as safe and effective to monitor and qualify the VH2O2 sterilizers and cycles listed in the indications for use in the instructions for use (IFU). Solventum has completed extensive validation testing on the 1295PCD to meet the stringent requirements of both U.S. FDA and Solventum’s own quality system. There is no regulatory requirement for a sterilizer manufacturer to validate or endorse the compatibility of indicators designed to monitor the efficacy of a sterilization cycle in their sterilizers. It is misinformation or disinformation for anyone to express or suggest otherwise. The decision regarding the safety and efficacy of sterilization monitors is addressed by U.S. FDA’s review and clearance procedures. There are many examples of monitoring products from multiple manufacturers being used to monitor steam, ethylene oxide, and hydrogen peroxide sterilizers. Solventum strongly objects to statements that may cause confusion for users. Supporting documentation includes the 1295PCD IFU and the U.S. FDA 510(k) Summary for the 1295PCD.

Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the following systems:

• STERRAD 100S® Sterilization System
• STERRAD NX® Sterilization System (Standard and Advanced cycles)
• STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
• STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
• STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
• V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
• V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
• V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
• V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
• V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles)
• V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
• SteroScope® Sterilization System