The USA TODAY article that everyone in the field is talking about:
“Deadly bacteria on medical scopes trigger infections” (By: Peter Eisler, 6:21 p.m. EST January 21, 2015)
Important quotes from this article:
- “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,” says Lawrence Muscarella, a biomedical engineer and independent consultant who advises hospitals on endoscope safety. “Patients have died, and the agency seems to be moving slowly.”
- “Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that’s got to change,” says Jeffrey Duchin, a physician who heads communicable disease control at the Seattle and King County (Wash.) Public Health Department.
- “There’s a likelihood that we’re just seeing a very small subset of the universe of infections from these types of scopes,” Duchin says.
- FDA: “(The FDA is) aware of and closely monitoring” the infection risks associated with the scopes. “Some parts of the scopes may be extremely difficult to access and clean thoroughly,” the agency adds, “and effective cleaning of all areas of the duodenoscope may not be possible.”
- “It (is) important for these devices to remain available.”
- CDC: “(Duodenoscopes) have a lot of intricate mechanisms and pieces that are very difficult to disinfect,” says Alex Kallen, an infectious-disease physician at the CDC who helped direct the investigation. “There definitely is a risk of (disease) transmission with these scopes.”
- APIC: “The cost of culturing is not that high,” (Marcia) Patrick says. “You can culture them once, see what’s there, and based on that, maybe do it once a month for surveillance.”
- ASGE: “This is a very important issue,” says Bret Petersen, a physician who serves as a counselor and board member at the American Society for Gastrointestinal Endoscopy.
- FDA: Ensuring duodenoscope safety “is on the agency’s priority list for guidance documents we intend to publish in 2015.”
- APIC: “The reported cases of CRE are “probably the tip of an iceberg” of infections transmitted by duodenoscopes, Patrick says. “But we don’t know how big that iceberg is.”
- ASGE: “We do expect the FDA and the manufacturers to provide additional public guidance.”