By Sherrie Chen
Where can one find the source of the highly lethal superbug whichmakes 10 gastroenterology patients come down with the exact same type of rare bacterial infection?
The answer is surprising–a device called a duodenoscope used to check out intestinal tract located just in Dr. John Allen’s office.
The pseudomonas bacteria had evaded the standard cleaning process causing infection on one patient after another.
This case isn’t the first of its kind. Back to 1987, duodenoscopes caused patients in Minnesota being infected and some of them were dead.
In 2010, safety expert Lawrence Muscarella published an article in the journal Endoscopy calling for special attention to the elevator wire. In 2011, a consortium of medical societies warned that automatic cleaning processes didn’t always effectively disinfect duodenoscopes and so manual cleaning should be performed.
Over the years, the FDA also received dozens of reports about infections from duodenoscopes as well as a million adverse event reports on various devices each year.
The biggest problem being led is: How can we deal with the missed points in medical devices?
People are eager to figure out the solution.But there was significant concern before 2013 that duodenoscopes were difficult if not impossible to clean thoroughly outside the FDA.
Allen, the president of the American Gastroenterological Association said :”This problem has been known since at least 1987,it certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.”
For the first time, the FDA issued advice to hospitals paying attention to the manufacturer’s cleaning instructions on Thursday Feb.19th. But Rep. Ted Lieu, D-California, questioned the reason “why the FDA didn’t issue this advice until now.”
Though there are many different resources and opinion up till now, but the path of the future is quite clear. Dr. John Greene, an infectious disease expert at the Moffitt Cancer Center who published an article in 2013 on a duodenoscope outbreak in Tampa said. “This is clearly a matter that needs addressing, we really should have done this sooner.”
