Duodenoscopes are among the most challenging medical devices to reprocess in a hospital, and Central Sterile Services Departments (CSSDs) know this better than anyone. Medical Innovations and Technologies (MIOT) is the official representative of Matachana in Ukraine, and we are sharing a new study by our partner demonstrating how LTSF sterilization addresses this challenge.
Why Duodenoscopes Are So Difficult to Reprocess
A duodenoscope is a flexible endoscope used to examine and treat the bile and pancreatic ducts through the duodenum.
These endoscopes cannot withstand steam sterilization due to their heat-sensitive materials. In addition, their long, narrow channels and the movable elevator at the distal tip can retain protein residues and biological fluids even after cleaning. This is why the industry is looking for additional safety measures.
How the Study Was Conducted
In the second part of its White Paper series, Matachana tested LTSF (low-temperature steam and formaldehyde) technology using the 130LF® sterilizer.
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3 duodenoscopes: Olympus EVIS EXERA III TJF-Q190V, each with 2 channels;
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1 million spores of Geobacillus stearothermophilus introduced into the channels;
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Protein contamination in the biopsy channel 72.8 times higher than the threshold specified in ISO 15883-5;
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3 independent cycles at 60°C for 30 minutes each.
Results
After each cycle, the channels were tested using culture methods, followed by a seven-day incubation period. No microbial growth was detected in any of the 18 cases, indicating that the results met the sterility assurance level (SAL) of 10⁻⁶ — a probability of no more than one in a million of a viable microorganism surviving the sterilization process.
What Does This Mean in Practice?
The results apply to compatible devices and validated cycles. Sterilization does not replace cleaning and disinfection; it provides an additional layer of safety. This is a manufacturer-led laboratory study, so its findings should be considered alongside the requirements of each healthcare facility and the endoscope manufacturer's instructions before implementation.
The authors plan to investigate the effectiveness of LTSF against biofilms, which remain one of the major challenges in endoscope reprocessing. We will follow the publication of these findings.
Conclusion
For MIOT, as the official representative of Matachana in Ukraine, this study is an important example of how modern sterilization technologies can address the practical challenges faced by CSSDs. The results of testing on duodenoscopes are particularly noteworthy, as these devices are among the most difficult to reprocess.
We will continue to follow new research and technologies from Matachana to help Ukrainian CSSD professionals stay informed about the latest solutions and global experience in sterilization and infection prevention.
Read the full study here.
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