THE SAFETY OF FLEXIBLE ENDOSCOPE’S REPROCESSING
Patient safety is the shared responsibility of the treating physician and their team, ensuring the patient benefits from their expertise, experience, and the latest technology.
Flexible endoscopes are among the most critical medical devices (MDs) as defined by the Spaulding classification, due to their intricate design and complex structure. Their lumens, working channels, and multiple joints make them highly susceptible to contamination, posing a significant risk if not thoroughly cleaned, disinfected, or sterilized. For procedures involving blood contact or sterile body cavities, terminal sterilization has been recommended as a necessary measure since at least 2012 (KRINKO 2001/2012).
The evidence of infections—some with fatal outcomes—necessitates a reassessment of risks by healthcare operators. The critical question remains: What additional steps are essential to enhance the reprocessing of these thermolabile, reusable medical devices and ensure greater safety?
The goal of any sterilization measure is to prevent the growth of residual, potentially pathogenic microorganisms, including spore-formers like Clostridioides difficile. Sterile barrier packaging and guaranteed drying at the end of the sterilization process essentially end the discussion about storage or drying cabinets, as these are no longer needed for sterilized and packaged medical devices. Thermolabile flexible duodenoscopes or bronchoscopes are packaged and ready for internal or external transport and application.
This has been made possible by the proven LTSF (Low Temperature Steam with Formaldehyde) sterilization technology, for over 40 years. In contrast to the potentially hazardous 100% ethylene oxide gas sterilization—where insufficient outgassing poses risks—LTSF requires only a 2% formaldehyde aqueous solution, evaporated during the process, to achieve successful sterilization. The WEBECO FA95, a successor to the Matachana 130LF®, and the latest High-Speed version, has enabled Leopoldina Hospital in Schweinfurt to deliver standard-compliant, safe, and simple sterilization for many years.
By complying with the current process-specific criteria (VSK) outlined in Plant 5 of TRGS 513, the control measures mandated by MPBetreibV under the Hazardous Substances Ordinance for obtaining an operating permit are no longer required for this process in a RUMED. Unlike other sterilization methods, the LTSF process stands out for its exceptional material compatibility, and its ability to penetrate narrow, long ducts—ranging from 0.5 mm inner diameter to up to 4 m in length—at operating temperatures of 60°C and 78°C. These attributes provide an additional layer of safety when sterilizing long-lumen flexible endoscopes with narrow multichannel structures, helping to significantly reduce the risk of infections caused by microbial growth.
Sterilization does not replace cleaning; instead, it acts as a complementary protective measure, addressing the limitations of inspecting intricate internal surfaces. While complete cleaning could theoretically render sterilization superfluous, recent risk assessments and documented incidents over the past year indicate at least 1% of microbial colonization persists even after thorough cleaning. This finding, supported by multiple publications (available upon request), highlights sterilization as an important step in ensuring patient safety and mitigating contamination risks.
Clinical investigations are currently being conducted on flexible endoscopes of varying lengths, from bronchoscopes to duodenoscopes, to obtain validatable results. Simultaneously, standard simulation tests with various test specimens are being performed to ensure maximum certainty regarding sterilization outcomes and identify limits.
The unrivalled high loading capacity of the LTSF sterilizer in clinical use is critically evaluated, focusing on cleverly optimized placement to accommodate various packaging, and loading options for efficient handling. Drying results, both inside and outside the sterilized items, are a key focus of evaluation as they directly impact safe transport and storage. The most qualitative and economically viable alternative to EO sterilization must operate reliably, particularly with the optimized 60 °C High-Speed program, which shortens the sterilization time in the new 130LF High Speed unit to approximately 90 minutes, depending on the load.
Example of packaging: PENTAX Gastro-Duodenoscope double wrapped in paper/foil. Photo shows test package for microbiological examination. Channels closed with spore carrier (Geobacillus stearothermophilus).
The LTSF batch times are thus comparable to the steam and H2O2 processes: One to two colonoscopes, two to three duodenoscopes or three bronchoscopes/ureterenoscopes could be available, packaged after less than 2 hours of sterilization.
This additional patient safety measure, achieved through final sterilization, is particularly crucial for returnable endoscopes, especially at high-frequency endoscopy settings. Even established specialists, such as gastroenterologists, urologists, and pulmonologists, can benefit from this service offered by regional hospitals under contractually regulated agreements, allowing them to focus more on patient care. The sterility of the flexible endoscope is guaranteed by the manufacturer's validated procedures.
For more details on testing procedures and results, visit www.matachana.com
Test load (full load).
Lower loading basket: R. WOLF Ureterorenoscope (with test spore carrier), double wrapped in paper/foil. Including 12 double-packed recipe pellets of different inner diameters/lengths with spores of Geobacillus stearothermophilus.
Upper loading basket: PENTAX Gastroduodenoscope, double wrapped in paper/foil.
View original blog: Matachana Blog
