Pentax Medical has received the US Food and Drug Administration (FDA) approval for its DEC Duodenoscope (ED34-i10T2s) compatibility with STERRAD 100NX Steriliser.
The STERRAD 100NX Steriliser with ALLClear Technology is a product of Advanced Sterilisation Products (ASP), a US-based provider of infection prevention solutions.
In partnership with Pentax, ASP has received the US FDA approval for its new ULTRA GI Cycle in its STERRAD 100NX Steriliser with ALLClear Technology.
ASP said its ULTRA GI Cycle is specifically designed to reprocess duodenoscopes using hydrogen peroxide gas plasma sterilisation and ensures a new standard of safety and efficacy.
The collaboration between ASP and Pentax Medical, focused on reducing the risk of cross-contamination, is said to address the ongoing challenges of duodenoscope reprocessing.
ASP president Chad Rohrer said: “We’re proud and excited to receive FDA clearance for our new ULTRA GI Cycle, developed in partnership with Pentax Medical.
“Both of our organisations are deeply committed to ensuring the safety of patients, and duodenoscopes have historically presented one of the greatest risks to patients in healthcare facilities.”
Pentax Medical chief product officer Harald Huber said: “The collaboration with ASP marks a pivotal step forward in our continued effort to enhance patient safety through innovative endoscope designs.”
According to ASP, duodenoscopes are often associated with relatively high contamination rates and indicate an urgent need for an effective sterilisation solution.
The partnership between ASP and Pentax Medical has resulted in an advanced method that provides healthcare professionals with a powerful tool to enhance patient safety.
Also, the FDA approval of its ULTRA GI Cycle would advance patient safety and address the challenges associated with current reprocessing methods for duodenoscopes, said ASP.
Pentax said that its DEC Duodenoscope is the world’s first GI endoscope compatible with hydrogen peroxide gas plasma sterilisation.
Tts DEC duodenoscope allows physicians to dispose of the elevator while maintaining image quality, performance, and handling easily and safely in each procedure.
Elevator is a component of the duodenoscope that is most vulnerable to contamination with enteric bacteria.
Pentax Medical chief medical officer and medical and scientific affairs global head Klaus Mergener said: “The low, but persistent risk of duodenoscope contamination post-reprocessing emphasises the need for a reliable sterilisation solution.
“The partnership between Pentax Medical and ASP has produced a method that also considers the workflow aspects that matter just as much as meeting sterilisation efficacy standards.”
ASP chief medical and scientific officer Ivan Salgo said: “The use of hydrogen peroxide gas plasma represents a significant shift in making it the gold standard of sterilisation for duodenoscopes, thereby improving safety for patients, technicians, and the environment.
“The ULTRA GI Cycle sets a new benchmark for the entire industry on sterilisation and environmental safety and will give healthcare professionals and their patients a heightened level of assurance that the duodenoscopes used are now being sterilised in a safe and effective way.”
