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.
You may also be interested in...
After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.
Federal law requiring agencies to weigh and document potential environmental impacts of major regulatory actions does not dictate what happens next. Neither does it provide federal agencies with authorities beyond their statutory purviews, FDA/CDER leadership says.
The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.