Pentax Medical Pushes People, Product And Process Amid New US FDA Guidance

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

Duodenoscopes are used in more than half a million endoscopic retrograde cholangiopancreatography (ERCP) procedures annually, but the prevention of cross-contamination in these medical devices continues to be a major challenge in clinical practice.

Due to the complex design of duodenoscopes, they require thorough processes to properly clean and disinfect, which if not performed correctly can lead to contamination. Failure to properly clean has led to several significant adverse events with these products, leading the US Food & Drug Administration (FDA) to issue a new safety communication in August 2019 urging hospitals and providers to transition from using fixed endcap duodenoscopes to those where the cap can be switched out

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