Duodenoscope devices have drawn the public's ire this past year, with the FDA and patients pushing back against the products in light of superbug outbreaks and mounting safety concerns. Now, healthcare experts are cautioning against a variety of scopes, saying similar devices could lead to potentially deadly infections.
As The Los Angeles Times reports, during the past three years, patients have been exposed to bacteria in scopes used to examine the lungs, colon, bladder and stomach, adding to mounting concerns over the devices. In May, some members of an FDA expert panel for duodenoscope products said they were alarmed about the broader range of danger from other scopes.
"Let's not just pretend it's only happening with one set of complex scopes because it's not," said panel member Phyllis Della-Latta, a clinical pathology professor at Columbia University, as quoted by the LA Times.
The reports of bacterial infections from other devices began surfacing last year. In November, a nurse manager reported that 7 patients were infected with C. difficile bacteria for a device used in colonoscopies. The following month, a doctor said a medical scope used to examine patients' lungs infected 14 people with a superbug known for killing half its victims. And another scope used to probe the bladder made three patients sick in March, according to the LA Times story.
Part of the problem could be a lack of regulation. After the superbug outbreak at UCLA in February, the FDA began requiring manufacturers to provide studies showing new scopes could be disinfected. But the new rules don't apply to devices already on the market, the LA Times article points out, allowing hospitals to continue using current scopes. The agency had already proposed rules to crack down on scope safety four years ago, but did not approve them until the UCLA outbreak.
Still, the FDA is standing by is policy on the scopes. The risk of acquiring an infection from an inadequately cleaned medical device is "relatively low" given the number of devices in use, FDA spokeswoman Jennifer Dooren told the LA Times. And the agency is continuing to look at reports of scope-related infections to see if it should take more action, she added. Altogether, the scopes are used tens of millions of times each year.
But medical professionals are still cautioning against the devices, with infection experts pointing to troubling data that shows the scopes still remain dirty after cleaning. Last year, Minneapolis epidemiologist and consultant Cori Ofstead told a national group of infection control professionals that she and her colleagues were still finding scopes that were contaminated after they were disinfected according to guidelines, the LA Times reports.
"This is deeply disturbing to us," Ofstead said at the time.
- read the LA Times story