The U.S. Food and Drug Administration is offering hospitals advice on how to avoid spreading drug-resistant superbugs with reusable medical scopes that have proven difficult to clean.
The instructions aren't mandatory, and some hospitals may not even be equipped to follow them. But the advice may help avert future infections from contaminated scopes, known as duodenoscopes, that have been linked to at least 13 deaths and dozens of infections at several U.S. hospitals, including UCLA Medical Center and Seattle's Virginia Mason Medical Center. The instruments are used in more than 600,000 procedures each year to diagnose and treat disorders of the bile ducts in the small intestine.
In May, a panel convened by the FDA unanimously concluded that the devices aren't reliably safe. But the agency has declined to pull them, citing a medical need that would leave patients without access to life-saving procedures.
The new safety protocols the FDA recommends would be in addition to meticulously following manufacturers' reprocessing instructions, which can run more than 100 pages. The FDA says hospitals should consider culturing—testing the scopes for contamination—between uses. Some hospitals have already adopted that practice. The agency also suggests additional measures to try to decontaminate the scopes, including liquid chemical solutions or a gas called ethylene oxide. These approaches may kill more microbes than the existing protocol, which usually involves scrubbing dirty scopes by hand and putting them in a sort of medical-instrument dishwasher known as an automated endoscope reprocessor.
The recommendations are "a good step" but incomplete, says Lawrence Muscarella, a hospital safety consultant who has written extensively about the problems of cleaning endoscopes and other medical devices. For one, the FDA's safety notice fails to warn about the risks of other devices, such as bronchoscopes, which have also been linked to superbug infections. And he warns that culturing the scopes can lead to a false sense of security. The devices have intricate internal parts that may harbor bacteria, and a swab may not reach the infected area. If that happens, a test could indicate that the scope is clean when it's actually still carrying dangerous microbes.
The FDA is working with manufacturers on ways to reengineer the scopes to make them easier to clean, spokeswoman Jennifer Dooren says. The agency's own warning acknowledges that no cleaning procedure can make the instruments completely safe: "While there will always be a risk of infection transmission with devices used internally, it is important to take all possible steps to minimize that risk so that patients may realize the benefits of these devices."