The Future of Infection Control: Advances in Sterilization
As healthcare continues to evolve, so do the methods we use to ensure the highest level of sterilization of medical instruments. New technologies are pushing the boundaries of what is possible, and recent advances are providing more efficient, reliable and innovative solutions to meet the growing demands of sterile processing departments (SPDs). This article examines some of the most innovative technologies driving these changes and explores how they are changing SPD operations, workflow, and infection control outcomes. We begin with an innovative approach to high-level disinfection (HLD), setting the stage for a journey to new sterilization solutions that address the complex challenges facing SPDs today.
Germitec UV-C light disinfection for ultrasonic probes and sights
Among the latest advances in high-level disinfection is Germitec's UV-C disinfection system, which was developed in France and is now available in the US. Specifically designed for non-lumen ultrasound probes, this device represents a fast and efficient alternative for environments where chemical sterilization may not be ideal. Notably, the device received de novo clearance from the FDA, which highlights its novelty and sets it apart in the medical device market.
The Germitec system uses ultraviolet radiation that penetrates the cell walls of microorganisms, causing irreversible damage to their DNA and losing their ability to reproduce. According to Richard Zalzar, Germitec's vice president of US market development, this photolytic mechanism provides rapid disinfection within 90 seconds without relying on chemicals or single-use components, thus offering an environmentally friendly approach. Thanks to its short cycle time, the Germitec system is particularly suitable for facilities with high staff turnover, such as ambulatory care and emergency departments, where delays in reprocessing can affect patient throughput. By reducing touch points, the system also minimizes the risk of cross-contamination, a vital advantage for infection control.
Designed for seamless integration with major brands of ultrasound equipment, the Germitec system improves accessibility in a variety of healthcare settings. Automation and electronic traceability within the device further simplifies the HLD process, providing verifiable records that can be incorporated into patient records and reducing the risk of human error. It is important to note that this system is tested against resistant pathogens, including
human papillomavirus (HPV), which poses a significant risk during gynecological and other medical procedures. Germitec's effectiveness against HPV underscores its reliability in challenging clinical environments where safety is paramount. This UV-C disinfection device is FDA and Therapeutic Goods Administration compliant, ensuring that it meets stringent health care requirements through microbiological performance and simulated use tests. 1,2 Eliminating the need for single-use items reduces operating costs and environmental impact, while its efficient design enables high-cost improvements in facilities with tightly scheduled procedures. The system's fast turnaround time and reduced touch points also reduce the risk of cross-contamination, helping to create a safer and more convenient environment for patients and healthcare professionals.
Liquid chemical sterilization: STERIS Enspire 3000 series
As the need for sterilization solutions for more complex devices (such as flexible endoscopes) increases, the STERIS enspire 3000 Series Chemical Liquid Sterilizer Cleaning and Processing System (CLCSPS) represents a significant leap in reprocessing technology. Developed with input from healthcare professionals, the inspire 3000 replaces traditional HLD with advanced liquid chemical sterilization, offering a proven requirement for liquid chemical sterilization. This reliable solution is ideal for reprocessing complex areas such as duodenoscopes that require thorough sterilization to prevent contamination. Katilin Sleeper-Gavranko, MBA, senior product manager at STERIS, emphasizes that the system's interface minimizes touch points and reduces cross-contamination risks, making it very convenient for new or transitioning employees. 
The enspire 3000 uses STERIS S40 sterilizing concentrate, a peracetic acid-based solution that can kill all viable microorganisms, including spores, in a 6-minute cycle.
Its unique Maxflow connectors improve sterilization by delivering sterilant to all channels within the device, minimizing the risk of bacteria or biofilm. This approach is consistent with the Association of Postoperative Registered Nurses (AORN) Perioperative Practice Guidelines, emphasizing validated sterilization processes for reusable endoscopes. In addition, the design of the inspire 3000 CLCSPS reflects the upgrade in the
2021 American National Standards Institute (ANSI)/Association. Advances in Medical Instrumentation (AAMI) ST91 standards favoring sterilization for flexible endoscopes due to risks of microbial contamination. STERIS FDA approval also confirms that this system meets regulatory requirements, enabling a safe reprocessing cycle even in high-risk areas.
The advantage of the enspire 3000 CLCSPS is its adaptability to high-throughput environments. Its 38-minute cycle time ensures rapid instrument turnover, making it ideal for facilities that need to efficiently scale sterilization processes. This feature meets AORN guidelines to allow SPDs to manage high procedural volumes without compromising the quality of reprocessing. By automating key steps, the enspire 3000 CLCSPS reduces the need for manual cleaning and minimizes human error, enabling SPD to achieve consistent, reliable decontamination results and better meet the needs of complex instruments.
ASP FDA Approval for New Sterilization PENTAX Medical Scope
The Sterrad system from Advanced Sterilization Products (ASP) has added to its arsenal of advanced sterilization solutions and received FDA approval to sterilize PENTAX Medical's new duodenoscopes, an important development for SPD handling complex instruments. Ivan S. Salgo, MD, MS, MBA, vice president and chief medical and scientific officer of ASP, points out in an interview with Infection Control Today ( ICT ) that the Ultra GI Cycle uses hydrogen peroxide plasma technology to sterilize the duodenoscope used in the following procedures: as endoscopic retrograde cholangiopancreatography. Using Sterrad as the primary device, ASP received FDA approval through the 510(k) pathway, establishing the safety and efficacy of hydrogen peroxide sterilization for challenging areas, according to Salgo.
The Ultra GI cycle meets the urgent need for more reliable sterilization options for duodenoscopes that carry a significant risk of infection. Salgo notes that hydrogen peroxide sterilization has significant advantages over ethylene oxide (ETO), particularly in reducing processing time and addressing carcinogenic concerns. Allowing businesses to complete sterilization faster, Salgo said the Ultra GI Cycle is compatible with existing Sterrad systems, providing a cost-optimized and environmentally friendly solution for SPDs aimed at reducing turnaround times. As industry standards increasingly favor full sterilization over HLD for semi-critical devices, the Ultra GI Cycle provides SPD with a proactive approach to infection control that aligns with the Association for Sterile Healthcare Processing guidelines and Canadian National Standard Z314:23.
Sterilization processing times compared to ETO and compatibility with existing systems make the Ultra GI Cycle particularly useful for SPDs performing high volume endoscopic procedures. This reduces waiting times for sterilization, ensuring duodenoscopes are ready when needed and improves overall safety by maintaining a consistent, reliable reprocessing standard.
Sterilization of 3D-printed medical devices: STERIS's V-Pro system and FDA clearance
As the use of 3D-printed devices grows in healthcare, the demand for specialized sterilization methods has skyrocketed. The STERIS V-Pro Low-Temperature Sterilization System, which recently received FDA 510(k) clearance for specific resins and anatomical models, addresses this need by providing a proven treatment option for these delicate, heat-sensitive materials, according to Randall Eveland, Ph.D., senior scientist at the of science and technology STERIS. He explains that the V-Pro system was designed to safely sterilize 3D-printed medical devices that can be damaged by traditional steam sterilization due to their low heat resistance.
Hospitals' transition to 3D printing has created new challenges as they must meet production and quality standards that were previously restricted to large medical equipment manufacturers. STERIS worked with the FDA to validate the V-Pro system for specific 3D printed resins and incorporated international ASTM standards to ensure material durability and biocompatibility. According to Eveland, this validation allows healthcare facilities to sterilize 3D-printed devices without additional testing costs. The hydrogen peroxide vaporization technology in the V-Pro system offers a low-temperature alternative that prevents the deformation of thermoplastic materials such as polylactic acid and acrylonitrile butadiene styrene, allowing SPD to more easily integrate 3D printed tools into clinical use.
For SPD, the V-Pro maX 2 sterilizer simplifies reprocessing
anatomical models and non-standard surgical guides, eliminating the risk of deformation during sterilization. This cost-effective biohazard approach makes the V-PRO Sterilizer an attractive option for SPDs seeking to meet the needs of a technologically advanced work environment.
Electromagnetic Seals: The Zuno Smart Container
Zuno Smart Container від Zuno Medical представляє інноваційний підхід до стерилізаційних контейнерів завдяки електромагнітному механізму запечатування. На відміну від традиційних контейнерів, для яких потрібні одноразові фільтри, система Zuno використовує електромеханічні вентиляційні отвори для створення вакуумного ущільнення в автоклаві. За словами Аллана МакНікола, генерального директора Zuno, та Еріенн Каннінгем, віце-президента з маркетингу Zuno, ця конструкція підтримує цілісність стерильного бар’єру та забезпечує візуальне підтвердження статусу пломби через зовнішній світловий індикатор. Цей індикатор доступний у будь-який час, починаючи з моменту виходу ємності зі стерилізатора й до досягнення операційної, що забезпечує послідовні об’єктивні перевірки стерильності.
One of the driving factors behind Zuno's design is the elimination of disposable components, which helps reduce SPD waste and make-up errors. McNicol explains that traditional filters and retention plates often result in missing or misaligned filters, which compromise sterile barriers. The Zuno system's "ready" indicator effectively reduces this risk by signaling personnel when the container is fully prepared and ready for transport. This feature meets industry standards, emphasizing ease of use and reliability as important elements of successful sterilization processes.
The electromechanical seals used in Zuno containers are particularly beneficial in high-volume, high-turnover environments where speed and reliability of sterilization are critical. The vacuum sealing mechanism allows you to work with sterilized trays immediately after sterilization, even if they are still warm, without the risk of contaminating the sterile barrier. This innovation is particularly valuable for SPDs, where traditional porous barriers typically require cool-down periods that can delay the work process, as per Amendments A1, A2, A3, A4, Section 10.3.1 of ANSI/AAMI ST79:2017 & 2020. Additionally , the system's electromagnetic seal controls subatmospheric pressure and provides continuous, lock-free sterile barrier testing that meets AAMI standards regarding the safety of sterilization and the simplification of SPD operations
Rigorous FDA testing has confirmed that the electronic components in Zuno's Smart Container can withstand the high temperatures and pressure cycles of sterilization in an autoclave. This innovation is a breakthrough in sterilization container design, meeting the needs of today's healthcare environment by providing a sustainable, efficient and convenient solution that improves SPD performance.
The Zuno Smart Container significantly improves workflow efficiency in SPD by offering immediate visual confirmation of the sterility status of the preparation with a “ready” light indicator. The rejection of disposable filters and the integration of a vacuum sealing system reduce the impact on the environment and operational waste. For high-volume facilities, the system's immediate processing capability minimizes wait times and increases productivity, allowing staff to maintain a fast and efficient turnover of sterilized equipment while maintaining strict infection control standards.
The future of sterilization
Together, these advances mark a paradigm shift in sterile processing, moving beyond traditional, labor-intensive practices to simplified, automated processes. Each technology optimizes SPD performance and enhances infection control, offering healthcare facilities important tools to improve patient safety. As SPDs face increasing demands to work with limited resources, these innovations offer solutions that promise a more effective and sustainable future in infection control. With each new device and system, healthcare facilities gain access to enhanced workflows, reduced contamination risks, and the ability to meet high sterilization standards for a variety of medical devices.
