FDA on Wednesday approved the first duodenoscope with a disposable distal cap designed to lower the risk of infections associated with such devices.
William Maisel, the acting director of FDA's Office of Device Evaluation, said the approval "represents a major step" toward reducing the risk of infections tied to the spread of bacteria often trapped inside a standard duodenoscope after it is cleaned and reused.
A Senate report in 2016 found at least 25 incidents of antibiotic-resistant infections linked to specialized duodenoscopes from 2012 to spring of 2015, which sickened at least 250 individuals worldwide. However, according to the report, that figure likely underestimates the number of infection incidents tied to the scopes, because most hospitals do not monitor patients for the infections.
In January, FDA issued a safety alert involving Pentax, the device maker behind the new medical scope. FDA in the alert notified health care providers of a design issue with an earlier version of Pentax's duodenoscope, the ED-3490TK. According to the alert, the device had the potential for cracks and gaps in the adhesive sealing the duodenoscope's distal cap onto the scope—which could allow fluids and tissue to leak into the device.
However, device manufacturers recently have moved toward correcting design flaws, Kaiser Health News reports. For example, FDA recently approved two fully disposable colonoscopes, and other device makers are promoting similar devices for kidneys and lungs.
According to FDA, the new duodenoscope—Pentax ED34-i10T—features:
- A disposable and detachable one-time use cap;
- A simpler user interface;
- Improved ergonomics;
- Improved image quality; and
- Reduced overall length.
FDA said the device's removable cap and other design features will make it easier to access and clean the crevices and small parts on the tip of duodenoscope.
Pentax on Thursday did not provide details on when the scope would be available or how much it would cost. However, duodenoscopes in general represent a major expense for hospitals, costing up to $40,000 apiece, KHN reports.
Lawrence Muscarella, a hospital-safety consultant, expressed measured praise for the new medical scope, saying while it "will probably reduce the infection risk, ... [he's] not sure by how much."
Muscarella and other experts said the new duodenoscope provides a modest redesign that fails to address the flaws that put patients at risk of acquiring antibiotic-resistant infections. For example, some experts say duodenoscopes carry harmful bacteria in other areas beside the tip, such as the biopsy ports and instrument channels.
Cori Ofstead, a researcher and epidemiologist, said the new scope "may be a step in the right direction to have single-use components whenever possible," but there are "still ... gaps here." Ofstead and other experts on infection control are urging regulators to raise standards for sterilizing medical scopes to involve gas or chemicals instead of simply requiring a high-level disinfection. Such a shift likely would require manufacturers to redesign the scope to withstand the sterilization process, KHN reports (Terhune, Kaiser Health News, 9/22).
The current state of hospital antibiotic stewardship
Antibiotic resistance has emerged as a major imperative for the U.S., linked to an estimated two million infections annually. In response to such concerns—as well as pressure from federal agencies—many hospitals are stepping up their efforts to better manage antibiotic use.
Yet hospitals often lack the resources to implement every stewardship strategy recommended by experts. This survey explores trends in hospital-based antibiotic stewardship programs (ASPs) and identifies what stewardship challenges still remain.