Pioneering Advances in Sterilization: The Future of Infection Control

Sterile Processing Perspectives With Marjorie Wall, EDBA, MLOS, CRCST, CIS, CHL, CSSBB

As health care continues to evolve, so do the methods we use to ensure the highest level of sterilization for medical instruments. New technologies are pushing the boundaries of what is possible, and recent advancements are providing more efficient, reliable, and innovative solutions to meet the increasing demands of sterile processing departments (SPDs). This article explores some of the most groundbreaking technologies driving these changes and examines how they transform SPD operations, workflow, and infection control outcomes. We begin with an innovative approach to high-level disinfection (HLD), setting the stage for a journey through novel sterilization solutions that address the complex challenges that SPDs face today.

Germitec UV-C Light Disinfection for Ultrasound Probes and Scopes

Among the latest advancements in high-level disinfection is Germitec’s UV-C–based disinfection system, which was developed in France and is now available in the US. Specifically designed for nonlumen ultrasound probes, this device introduces a fast and efficient alternative for environments where chemical-based sterilization may not be ideal.¹ Notably, the device has received a de novo clearance from the FDA, highlighting its novelty and setting it apart in the medical device market.^1,2

Figure 1. STERIS enspire 3000 CLCSPS

Courtesy: STERIS 2024. All rights reserved.

The Germitec system employs UV-C radiation, which penetrates the cell walls of microorganisms, causing irreversible damage to their DNA and rendering them unable to reproduce.¹ This photolytic mechanism enables rapid disinfection within 90 seconds without relying on chemicals or disposable components, thus offering an environmentally friendly approach, according to Richard Salzar, Germitec’s vice president of US market development.^1,2 With its short cycle time, the Germitec system is particularly suited to high-turnover settings, such as ambulatory care and emergency departments, where delays in reprocessing could impact patient throughput.¹ By reducing touchpoints, the system also minimizes the risk of cross-contamination, which is a vital benefit in infection control.²

Designed to integrate seamlessly with major ultrasound equipment brands, the Germitec system enhances accessibility across diverse health care facilities.² The automation and electronic traceability within the device further streamline the HLD process, providing auditable records that can be incorporated into patient records and reducing the risk of human error.¹ Importantly, this system has been validated against resilient pathogens, including human
papillomavirus (HPV), which poses a significant risk in gynecological and other medical procedures.³ Germitec’s effectiveness against HPV underscores its reliability in high-stakes clinical environments where safety is paramount.^2,3

This UV-C disinfection device aligns with FDA and Therapeutic Goods Administration standards, ensuring it meets stringent health care requirements through microbiological potency and simulated use tests.^1,2 Eliminating the need for disposable items reduces operational costs and environmental impact, whereas its efficiency-driven design offers high-value improvements in facilities with tightly scheduled procedures. The system’s rapid processing times and reduced touchpoints also lower the risk of cross-contamination, adding to a safer, more streamlined environment for patients and health care workers.

Liquid Chemical Sterilization: STERIS’ Enspire 3000 Series

As the need for sterilization solutions that address more complex devices (eg, flexible endoscopes grows), STERIS’ enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) represents a significant leap in reprocessing technology. Developed with input from health care professionals, the enspire 3000 replaces traditional HLD with advanced liquid chemical sterilization, offering a validated liquid chemical sterilization claim. This robust solution is ideal for reprocessing complex scopes, such as duodenoscopes, that require meticulous sterilization to prevent contamination. Katilin Slaper-Hawranko, MBA, senior product manager at STERIS highlights that the system’s interface minimizes touchpoints and reduces cross-contamination risks, making it highly user-friendly for new or rotating staff members.⁴

The enspire 3000 utilizes STERIS’ S40 Sterilant Concentrate, a peracetic acid–based solution that can eliminate all viable microbial life, including spores, in a 6-minute cycle.⁵

Figure 2. ASP Sterrad Ultra GI Cycle

Courtesy: ASP

Its unique Maxflow Connectors enhance sterilization by delivering the sterilant to all channels within the device, minimizing the risk of bacteria or biofilm. This approach aligns with the Association of periOperative Registered Nurses’ (AORN’s) Guidelines for Perioperative Practice, emphasizing validated sterilization processes for reusable endoscopes.6 Furthermore, enspire 3000 CLCSPS design reflects updates in The
2021 American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ST91 standards, which prioritize sterilization for flexible endoscopes due to microbial contamination risks.7 STERIS’ FDA clearance further affirms that this system complies with regulatory guidelines, allowing even high-risk scopes to achieve a safe reprocessing cycle.5

An advantage of the enspire 3000 CLCSPS is its adaptability to high-throughput environments. Its 38-minute cycle time accommodates rapid instrument turnaround, making it ideal for facilities that need to efficiently scale sterilization processes. This feature meets AORN’s guidelines that allow SPDs to manage high procedural volumes without compromising reprocessing quality.⁶ By automating key steps, the enspire 3000 CLCSPS reduces manual cleaning requirements and minimizes human error, enabling SPDs to achieve consistent, reliable decontamination outcomes and better address the needs of complex instruments.⁴

ASP’s FDA Approval for New PENTAX Medical Scope Sterilization

Adding to the arsenal of advanced sterilization solutions, Advanced Sterilization Products’ (ASP’s) Sterrad system received FDA clearance to sterilize PENTAX Medical’s new duodenoscopes, a crucial development for SPDs handling complex instruments. Ivan S. Salgo, MD, MS, MBA, vice president and chief medical and scientific officer of ASP, emphasizes in an interview with Infection Control Today (ICT) that the Ultra GI Cycle leverages hydrogen peroxide gas plasma technology to sterilize the duodenoscope used in procedures such as endoscopic retrograde cholangiopancreatography. According to Salgo, by
utilizing Sterrad as a predicate device, ASP achieved FDA approval through a 510(k) pathway, establishing the safety and efficacy of hydrogen peroxide
sterilization for intricate scopes.⁸

The Ultra GI Cycle addresses a pressing need for more reliable sterilization options for duodenoscopes, which carry significant infection risk. Salgo points out that hydrogen peroxide sterilization offers notable advantages over ethylene oxide (ETO), particularly in reduced processing times and addressing carcinogenic concerns. By allowing facilities to complete sterilization more rapidly, Salgo said that the Ultra GI Cycle is compatible with existing Sterrad systems, providing a streamlined cost and environmentally-friendly solution for SPDs aiming to improve turnaround times. As industry standards increasingly favor full sterilization over HLD for semicritical devices, the Ultra GI Cycle provides SPDs with a proactive approach to infection control that aligns with guidelines from the Healthcare Sterile Processing Association and Canada’s National Standard Z314:23.⁹

Figure 3. ASP Sterrad 100NX

Courtesy: ASP

The sterilization processing time vs ETO and compatibility with existing systems make the Ultra GI Cycle particularly beneficial for SPDs managing high volumes of endoscopic procedures. It shortens sterilization wait times, ensuring that duodenoscopes are ready when needed and improving overall safety by adhering to a consistent, reliable reprocessing standard.

Sterilizing 3D-Printed Medical Devices: STERIS’ V-Pro System and FDA Clearance

As the use of 3D-printed devices grows in health care, the demand for specialized sterilization methods has surged. STERIS’s V-Pro Low Temperature Sterilization System, which recently earned FDA 510(k) clearance for specific resins and anatomical models, addresses this need by providing a validated option for processing these delicate, heat-sensitive materials, according to Randal Eveland, PhD, senior principal scientist, science and technology, at STERIS. He explains that the V-Pro system was developed to safely sterilize 3D-printed medical devices that could be damaged by traditional steam sterilization due to their low heat tolerance.^10,11

The transition for hospitals into 3D printing has created new challenges, as they must meet manufacturing and quality standards previously limited to large-scale medical device manufacturers. STERIS worked with the FDA to validate the V-Pro system for specific 3D-printed resins and incorporated ASTM International standards to ensure material durability and biocompatibility. According to Eveland, this validation allows health care facilities to sterilize 3D-printed devices without incurring additional testing costs. Vaporized hydrogen peroxide technology within the V-Pro system offers a low-temperature alternative that prevents the deformation of thermoplastic materials, such as polylactic acid and acrylonitrile butadiene styrene, enabling SPDs to integrate 3D-printed tools more readily into clinical use.^10,11

For SPDs, the V-Pro maX 2 Sterilizer simplifies the reprocessing of
anatomical models and custom surgical guides by eliminating the risk of deformation during sterilization. This cost-effective and biohazard-conscious approach makes the V-PRO Sterilizer an attractive option for SPDs striving to meet the needs of a technologically advanced operating environment.

Electromagnetic Seals:The Zuno Smart Container

Figure 4. STERIS V-PRO maX 2

Courtesy STERIS 2024. All rights reserved.

Zuno Medical’s Zuno Smart Container introduces an innovative approach to sterilization containers with its electromagnetic sealing mechanism. Unlike traditional containers that require disposable filters, Zuno’s system uses electromechanical vents to create a vacuum seal within the autoclave. According to Allan McNichol, CEO of Zuno, and Aerienne Cunningham, vice president of marketing at Zuno, this design maintains the integrity of the sterile barrier and provides visual confirmation of the seal’s status through an external indicator light. This indicator is accessible anytime, from when the container exits the sterilizer until it reaches the operating room, ensuring consistent, objective sterility checks.¹²

One of the driving factors behind Zuno’s design is the elimination of single-use components, which helps to reduce SPD waste and preparation errors. McNichol explains that traditional filters and retention plates often lead to missing or misaligned filters, compromising sterile barriers. The Zuno system’s “ready” indicator light effectively mitigates this risk, signaling to staff when the container is fully prepped and ready for transport. This feature aligns with industry standards, emphasizing ease of use and reliability as essential elements of successful sterilization processes.¹²

The electromechanical seals used in Zuno containers are particularly advantageous in high-volume, high-turnover environments where sterilization speed and reliability are crucial. The vacuum seal mechanism allows sterilized trays to be handled immediately after sterilization, even while still warm, without risking contamination of the sterile barrier. This innovation is especially valuable in SPDs, where traditional porous barriers typically require cooling periods, which can delay workflow, according to the ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4, Section 10.3.1. Furthermore, the system’s electromagnetic seal monitors the subatmospheric pressure and provides continuous sterile barrier verification without locks, aligning with AAMI standards for sterilization security and simplifying SPD operations.¹²

Figure 5. Zuno Smart Container System

Courtesy: Zuno

Rigorous FDA testing confirmed that the electronic components in Zuno’s Smart Container can withstand the high temperatures and pressure cycles of autoclave sterilization. This innovation represents a breakthrough in sterilization container design, meeting the needs of modern health care environments by providing a sustainable, efficient, and user-friendly solution that enhances SPD operations.

The Zuno Smart Container significantly improves workflow efficiency in SPDs by offering immediate, visual confirmation of sterile preparation status with its “ready” indicator light. Eliminating disposable filters and integrating a vacuum seal system reduces environmental impact and operational waste. For high-volume facilities, this system’s immediate handling capability minimizes wait times and boosts productivity, enabling staff to maintain fast and effective turnover in sterilized equipment while upholding stringent infection control standards.

The Future of Sterilization

Together, these advancements mark a paradigm shift in sterile processing, pushing the field beyond traditional, labor-intensive practices toward streamlined, automated processes. Each technology optimizes SPD efficiency and strengthens infection control, offering health care facilities critical tools to enhance patient safety. As SPDs face growing demands to operate with limited resources, these innovations provide solutions that promise a more effective and resilient future in infection control. With each new device and system, health care facilities gain access to enhanced workflows, reduced contamination risks, and the ability to meet high standards of sterilization for an expanding variety of medical devices.

References

1. New UV-C disinfection technology for ultrasound probes earns FDA clearance. Infection Control Today. September 4, 2024. Accessed October 31, 2024.
2. Wall M. Every-load monitoring in low-temperature sterilization: a solution to device complexity and failure risks. Infection Control Today. Accessed October 24, 2024. https://www.infectioncontroltoday.com/view/every-load-monitoring-low-temperature-sterilization-solution-device-complexity-failure-risks
3. Meyers C, Milici J, Robison R. UVC radiation as an effective disinfectant method to inactivate human papillomaviruses. PLoS One. 2017;12(10)e0187377. doi:10.1371/journal.pone.0187377
4. Slaper-Hawranko Wall M. Every-load monitoring in low-temperature sterilization: a solution to device complexity and failure risks. Infection Control Today. September 26, 2024. October 31, 2024. https://www.infectioncontroltoday.com/view/every-load-monitoring-low-temperature-sterilization-solution-device-complexity-failure-risks
5. 510(k) premarket notification. FDA. Updated October 28, 2024. Accessed October 31, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230930
6. Association of periOperative Registered Nurses. AORN’s Guidelines for Perioperative Practice. AORN; 2021.
7. American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021. AAMI; 2021.
8. Advanced Sterilization Products announces FDA clearance for revolutionary sterilization cycle for duodenoscopes in partnership with PENTAX Medical. Press release. Advanced Sterilization Products; August 5, 2024. Accessed October 31, 2024. https://www.asp.com/en-us/media/Advanced-Sterilization-Products-Announces-FDA-Clearance-Revolutionary-Sterilization-Cycle-Duodenoscopes
9. Healthcare Sterile Processing Association. Endoscope Reprocessing Manual, 2nd Edition. HSPA; 2023.
10. Wiseman J, Rawther T, Langbart M, Kernohan M, Ngo Q. Sterilization of bedside 3D-printed devices for use in the operating room. Ann 3D Print Med. 2022;5:100045. doi:10.1016/j.stlm.2022.100045
11. Shea GK, Wu KL, Li IW, et al. A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively. 3D Print Med. 2020;6(1):7. doi:10.1186/s41205-020-00061-w
12. Conventus Flower Orthopedics. Smart sterilization container technology: the evolution of orthopaedic experience and innovation. Conventus Flower Orthopedics; 2024.