In the latest incidence of the outbreak of infections stemming from unclean endoscopes, 8 patients in Philadelphia were recently infected with bacteria resistant to carbapenem antibiotics, which kill up to half of those infected, the Philadelphia Inquirer reports.
Carbapenem-resistant--or CRE--bacteria have also been reported at hospitals in Seattle, Pittsburgh and Chicago. In all cases, the bug was found to stem from duodenoscopes, which are used to treat and diagnose problems of the small intestine. It is inserted down the throat and into patients' stomachs and the part of small intestine known as the duodenum.
Cleaning the device is tricky. The traditional method involves brushing, rinsing and treating the scope with chemicals. But some hospitals are now using gas sterilization, including Virginia Mason Medical Center in Seattle, according to USA Today.
Trade groups like the American Society for Gastrointestinal Endoscopy say they know of fewer than 100 recent cases of CRE stemming from duodenoscopes, but others say the problem is underreported, according to the Inquirer.
Critics say the FDA should have moved faster to fix the problem.
|Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia|
"It's fair to ask whether the FDA could have been doing more to regulate these devices and significantly reduce the risk of patient harm," Lawrence Muscarella, biomedical engineer and independent consultant, told USA Today. "Patients have died, and the agency seems to be moving slowly."
Meanwhile, the agency told the USA Today it is aware of the problem and working with the manufacturers, including Olympus, Fujifilm and Pentax, on design considerations and disinfection procedures.
The Inquirer explains that drug-resistant CRE spreads when antibiotics kill off other gut bacteria, allowing it to proliferate widely. It can then be spread to other parts of the body by contact with medical devices like duodenoscopes.