In an attempt to stop patients from being infected by lethal superbugs, federal regulators have approved the first fully disposable duodenoscope, a commonly used medical device.
For years, patients have been subjected to reusable duodenoscopes, which hospitals have found extremely difficult to clean.
Since 2013, at least 35 deaths in the U.S. have been tied to bacteria remaining on duodenscopes after cleaning. Three who died were patients at Ronald Reagan UCLA Medical Center. Infections were also reported at Cedars-Sinai Medical Center in Los Angeles and Pasadena’s Huntington Hospital.
A series of Times stories reported that scope manufacturer Olympus knew of the potential flaws in the scope as early as the spring of 2012, following an infection outbreak in the Netherlands, but failed to alert American hospitals or regulators until after the UCLA outbreak in February 2015.
Boston Scientific, the manufacturer of the Exalt Model D scope, said sales would begin early next year. It did not say how much the disposable device would cost. The reusable scopes are priced at about $40,000.
An estimated 1.5 million procedures are performed worldwide with the duodenoscopes each year. The device is a long, snake-like tube with a tiny camera on the tip that is inserted through a patient’s mouth and throat to treat cancers and other problems in the upper gastrointestinal tract.
The FDA has also recently approved other duodenscope models that allow certain difficult-to-clean parts to be replaced between patients.
After a series of outbreaks were linked to the scopes in 2015, the FDA ordered manufacturers to strengthen their guidelines for cleaning the reusable devices. Yet a year ago regulators announced they were still finding some devices contaminated after cleaning. And in August, the agency urged hospitals to stop using the reusable duodenscopes that don’t have disposable parts.
Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa., said he worried that a high price for the new disposable scopes would discourage hospitals from using them or even tempt them to try to reuse them.
Hospitals will ask, “Should we just throw this $3,000 piece of equipment out?” Muscarella said.
A Boston Scientific spokeswoman said executives had not yet finalized pricing for the scopes.
“We intend to price the single-use device to appropriately reflect the value it brings to physicians and the healthcare system,” she said.
Studies have also tied infections to other types of reusable medical scopes, including those used in colonoscopies and to examine lungs. However, more outbreaks have so far been linked to the duodenoscopes, which contain many intricate parts and crevices where blood and other fluids can become trapped.