Following a series of deadly outbreaks in hospitals around the country, the Food and Drug Administration on Friday approved the first fully disposable version of the medical device implicated in the infections.
Reusable versions of the device — a long, snakelike tube with a fiber-optic camera at one end, called a duodenoscope — are inserted in one patient after another to diagnose and treat diseases of the pancreas and bile duct, like tumors and gallstones.
Duodenoscopes are used in 700,000 medical procedures each year. Yet tests showed that the devices could not be properly decontaminated between procedures because they cannot be sterilized by the usual methods.
After the outbreaks caused by duodenoscopes came to light, the FDA had urged hospitals to use models with disposable parts and had called on manufacturers to produce fully disposable models.
The new device, called Exalt and made by Boston Scientific, is designed to be used only once before being discarded or recycled. The device should eliminate “the risk of potential infection due to ineffective reprocessing,” the arduous cleaning process, said Dr. Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health.
The disposable duodenoscope was designated a “breakthrough” device, indicating it provides for more effective treatment or diagnosis of life-threatening conditions. Its review at the FDA was expedited in order to get it to market as soon as possible.
Since 2012, contaminated duodenoscopes have been implicated in dozens of infectious outbreaks affecting hundreds of hospital patients in the United States and Europe. Many were infected with bacteria resistant to powerful antibiotics.
More than 30 patients in Seattle were infected with resistant bacteria following duodenoscope procedures between 2012 and 2014. Eleven of them died. In 2015, two patients in Los Angeles died and five were sickened by contaminated duodenoscopes.
The devices are used to perform a procedure, called endoscopic retrograde cholangiopancreatography, needed to diagnose and treat diseases of the pancreas, bile duct and gallbladder, such as life threatening jaundice, tumors, blocked bile ducts and stones.
The long tube, with a camera at the tip, is inserted through the patient’s mouth and stomach, and then into the first part of the small intestine, called the duodenum.
Many different reusable scopes are used in medicine, but duodenoscopes — which have a movable mechanism at the tip — are particularly difficult to clean. Though they are disinfected with chemicals, they have tiny nooks where bodily fluids and bacteria can lodge.
Cleaning, also called reprocessing, between patients involves nearly 100 steps, including both hand-scrubbing the device and inspecting it visually to check for biological debris clinging to the scopes.
Recent tests performed by manufacturers at the FDA’s request found that even after the proper cleaning procedures were followed, 1 in 20 duodenoscopes retained disease-causing microbes like E. coli.
Whether the new disposable duodenoscope will be widely adopted remains to be seen. The Exalt is expected to carry a price tag of approximately $3,000, and insurance coverage is still uncertain.
Health care systems already have a full inventory of durable, reusable duodenoscopes, which cost between $35,000 and $45,000. Some of the durable devices already have disposable parts.
The disposable models will also have an environmental impact, creating a new stream of medical waste if they cannot be recycled. A spokesman for Boston Scientific said the company planned to offer a recycling program and was “currently finalizing plans with a medical waste recycle company to facilitate this process.”
Art Butcher, senior vice president of Boston Scientific Corp., said the new device would represent a “unique solution to a complex problem.”
Six experts who used the disposable scope in a clinical trial of 60 patients gave it satisfactory scores. Ninety percent said the disposable scope was as good as the reusable scope, and 2% said it was preferable. Eight percent said it was inferior to the reusable scope.