Solventum Launches Preassembled, See-through VH2O2 Test Pack for Low-temp Medical Instrument Sterilization

The Attest™ Super Rapid VH2O2 Clear Challenge Pack integrates biological and chemical performance indicators in a ready-to-use design to support every load monitoring¹

U.S. hospital infections affect 1 in 31 patients;² new all-in-one solution is aimed at making expert-recommended safety practices in steam sterilization³ feasible for VH2O2 low-temperature method

Test pack is U.S. FDA-cleared for routine monitoring across multiple sterilizer brands, models and cycle types, and is designed to streamline workflow and simplify inventory management for sterile processing teams

, /PRNewswire/ -- Solventum, a global MedTech leader at the forefront of infection prevention innovation, today announced the launch of its Attest™ Super Rapid Vaporized Hydrogen Peroxide (VH2O2) Clear Challenge Pack. The ready-to-use test integrates two previously FDA-cleared indicators – a biological indicator (BI) for confirming microbial neutralization and a chemical indicator (CI) for verifying proper sterilizer function – into a single-use test pack with a transparent container.

Medical instrument sterility is a critical component in the fight against hospital-associated infections, which impact one in every 31 hospital patients in the U.S.⁴ The practice of every load monitoring – using dual indicators (both BIs and CIs) to verify the efficacy of every sterilization cycle for each batch of instruments – is recommended by industry guidelines and expert consensus to help minimize patient safety risks.

This unique combination makes the Attest™ Super Rapid VH2O2 Clear Challenge Pack the first and only preassembled VH2O2 test pack that is U.S. FDA-cleared for routine monitoring across multiple sterilizer brands, models and cycle types*, offering:

• Convenience: preassembled, ready-to-use pack eliminates the step of assembling testing pouches with separate indicators, saving time and mitigating the risk of errors inherent to manual preparation, like incorrect indicator placement or omission of an indicator.
• Accuracy: engineered to more accurately simulate the environment within a wrapped set of surgical instruments during a VH2O2 cycle.⁵ This helps to provide a realistic challenge to the sterilizer's ability to neutralize potentially harmful microorganisms, providing greater assurance that a "pass" result reflects effective sterilant penetration and conditions within the load.
• Simplification: integrated, all-in-one design helps streamline inventory management by reducing the need to order BIs, CIs and peel pouches individually.

"Innovations that make every load monitoring easier to adopt, more reliable, and faster across sterilization modalities empower healthcare facilities to consistently uphold the highest patient safety standards while supporting the increasing productivity demand of modern sterile processing departments," said Sharon Greene-Golden, past president of the Healthcare Sterile Processing Association (HSPA).⁶ "Many of today's advanced surgical instruments simply cannot tolerate high-temperature steam so, the availability of validated low-temperature sterilization processes like VH2O2, coupled with rigorous monitoring, is part of what enables these sophisticated instruments to be used safely."

The pack's transparent design allows sterile processing professionals to immediately inspect both the CI and BI's process indicator located on its cap post-cycle without breaching the pack's seal. In addition to the instant CI-result, this enables the BI's physical integrity to be confirmed visually before incubation. Confidence that the BI is undamaged and correctly processed at this early stage of the process can contribute to streamlined workflows and timely instrument load release decisions.

"In the high-stakes environment of sterile processing where patients' lives are at stake, both speed and accuracy are non-negotiable," said Doug Bartlett, senior vice president of the company's Infection Prevention & Surgical Solutions business. "Solventum innovations equip dedicated professionals with intuitive, cutting-edge resources that help them to safeguard patient health, reflecting our drive to continually support elevated standards of care in critical settings."

The Attest™ Super Rapid VH2O2 Clear Challenge Pack is available immediately in the U.S. through authorized Solventum distribution partners. It is slated for a global rollout throughout 2025,⁷ underscoring Solventum's unwavering commitment to advancing sterile processing practices worldwide.

About Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com. 

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) ; the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (6) reduction in customers' research budgets or government funding; (7) the timing and market acceptance of Solventum's new product and service offerings; (8) ongoing working relationships with certain key healthcare professionals; (9) changes in reimbursement practices of governments or private payers or other cost containment measures; (10) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions and disruptive factors; (11) risks related to the highly regulated environment in which Solventum operates; (12) Solventum's failure to obtain, maintain, protect or effectively enforce its intellectual property ("IP") rights.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

¹ Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST58:2024; Chemical sterilization and high-level disinfection in health care facilities. Page 84. Updated April 20, 2024. Accessed May 27, 2025. https://array.aami.org/doi/epdf/10.2345/9781570208799.ch1 Copyright year: 2024
² Centers for Disease Control and Prevention. About HAIs. Updated April 15, 2024. Accessed May 27, 2025. https://www.cdc.gov/healthcare-associated-infections/about/index.html
³ Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST58:2024; Chemical sterilization and high-level disinfection in health care facilities. Page 84. Updated April 20, 2024. Accessed May 27, 2025. https://array.aami.org/doi/epdf/10.2345/9781570208799.ch1 Copyright year: 2024
⁴ Centers for Disease Control and Prevention. About HAIs. Updated April 15, 2024. Accessed May 27, 2025. https://www.cdc.gov/healthcare-associated-infections/about/index.html
* Based on U.S. FDA cycle clearances as of 01/17/2025
⁵ Compared to a standalone BI.
⁶ Dr. Sharon Greene-Golden is a paid consultant to Solventum and was compensated for her time.
⁷ Some countries may be delayed due to additional local regulatory requirements.

SOURCE Solventum