Some medical experts question whether this design change goes far enough to protect patients.
This article first appeared September 22, 2017 on Kaiser Health News.
By Chad Terhune
Seeking to prevent superbug outbreaks, federal health officials said they have approved the first gastrointestinal medical scope with a disposable cap for use in the U.S.
The Food and Drug Administration said that the design of the new duodenoscope by Japanese device maker Pentax should make it easier to remove dangerous bacteria that can become trapped inside these reusable instruments.
“We believe the new disposable distal cap represents a major step toward lowering the risk of future infections associated with these devices,” said Dr. William Maisel, the acting director of the FDA’s Office of Device Evaluation, in a statement Wednesday. “We encourage companies to continue to pursue innovations that will help reduce the risk to patients.”
But some medical experts questioned whether this design change goes far enough to protect patients.
“This new scope will probably reduce the infection risk, but I’m not sure by how much,” said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa.
In addition, he and other experts said, this is just one scope, and its modest redesign will not address the shortcomings that plague many different medical scopes on the market and continue to put patients at risk of antibiotic-resistant infections.
Pentax didn’t provide any details Thursday about when the new duodenoscope will be available or what it may cost. In general, duodenoscopes can cost up to $40,000 apiece, and they can represent a major expense for hospitals that handle a large volume of procedures.
In a statement, the company said “the disposable distal cap design represents a significant advancement in infection control.”
One advantage of a removable cap is that it would allow hospital cleaning staff better access to tiny crevices and small parts at the tip of the scope. Some areas are hard to reach with brushes and washing machines, increasing the risk of bacteria being passed from one patient to another.
While the scope tip has proven troublesome, experts say harmful bacteria also have been found in other areas, such as biopsy ports and instrument channels.
“I think it may be a step in the right direction to have single-use components whenever possible. But we still have gaps here,” said Cori Ofstead, a researcher and epidemiologist in St. Paul, Minn.
She and other infection-control experts are urging manufacturers and regulators to move toward sterilization for all medical scopes, which would involve gas or chemicals and be a step above the current federal requirement for high-level disinfection. That change would likely require further design changes to enable complex scopes to withstand the process.
Other device manufacturers have gone in a different direction, developing scopes that are fully disposable, rather than just enabling the cap to be thrown away. The FDA recently approved two colonoscopes that are designed to be used just once. Other companies are promoting similar devices for use in the lungs and kidneys.
Doctors put duodenoscopes down a patient's throat to diagnose and treat problems in the digestive tract, such as gallstones, cancers and blockages in the bile duct. There are about 700,000 of these ERCP procedures done annually in the U.S.
Since 2015, U.S. prosecutors, lawmakers and government regulators have been investigating dozens of infections and deaths tied to duodenoscopes.
KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.