WASHINGTON -- The FDA on Friday cleared a after a single use, which -- if gastroenterologists can afford it -- will eliminate problems associated with device sterility once and for all.
Boston Scientific's is the first such device to be cleared for marketing, the FDA said. The question now is whether clinicians will find it economical to buy the new scopes instead of conventional ones that can be reused many times, albeit with costs for reprocessing and the now infamous risks of infection.
It's the latest step in the FDA's push to improve safety of so-called endoscopic retrograde cholangiopancreatography or ERCP procedures. These require duodenoscopes with elevator mechanisms at the tip, which inevitably have hinges and crevices where pathogens can hide. Obtaining complete sterility in reprocessing 100% of the time has thus far proved impossible. Yet traditional devices were considered too expensive to throw away after one use.
The post-reprocessing sterility problem drew major attention in 2015 when an outbreak of abdominal "superbug" infections was traced to contaminated duodenoscopes. Manufacturers beefed up instructions on proper procedures and the FDA issued multiple notices urging users to follow them. Yet in a December 2018 report, the agency said it was still finding "up to 3% of properly collected samples testing positive for high concern organisms."
When it became clear that protocols alone wouldn't solve the problem, the FDA asked manufacturers to develop devices with single-use parts. In 2017, it approved a Pentax device with a disposable end cap, followed later by others; then last month it approved another Pentax product with a throwaway elevator mechanism.
In Boston Scientific's own announcement of the Friday clearance, the company said it ran clinical tests to confirm that the single-use device performed for ERCP as well as standard duodenoscopes. It also promised a "limited market release" early in 2020.
However, the statement said nothing about how the EXALT Model D compares to multiple-use duodenoscopes in terms of cost. In response to an inquiry from ľֱ, a Boston Scientific spokesperson said, “At the moment, pricing and purchasing programs are still being developed and will be finalized prior to full commercial launch; we intend to price the single-use device to appropriately reflect the value it brings to physicians and the healthcare system.”