Some of the lighted, camera-carrying tubes used to treat cancerous tumors could spread deadly bacteria even if they are cleaned properly after being used, the federal government warned Thursday.
The Food and Drug Administration said patients should ask their doctors about the risks surrounding certain procedures performed with a particular type of endoscope — a small tube inserted into a person’s body that has a camera at one end, allowing doctors to look for signs of diseases and cancer.
The medical instruments appear to be responsible for spreading drug-resistant “superbug” bacteria that killed two people and infected five others at a California hospital. They have also been linked to similar deadly outbreaks.
Doctors also use a different type of endoscope called a duodenoscope for a complex medical procedure to examine bile ducts in the pancreas. Instead of just taking pictures, that scope can take tissue samples for a biopsy, administer drug treatments, or drain fluids from gallstones or cancerous tumors. More than 500,000 such procedures are performed in the U.S. each year, the agency said.
The main problem is that the scopes are extremely hard to clean, and the FDA found that even using the manufacturer’s instructions doesn’t get everything.
For instance, the scope has tiny, microscopic crevices that can hold body fluids and organic debris that could easily be missed during cleaning. Those fluids could infect patients down the road, the agency said.
The agency cautioned that duodenoscope procedures are necessary and often treat life-threatening conditions. However, patients should discuss with their doctor the benefits and risks, what to expect following the procedure and when to seek medical attention.
Fevers, chills, chest pains, or nausea and vomiting could be signs of complications, the agency said.
The warning comes after reports of a severe outbreak at the University of California-Los Angeles Medical Center last month. The hospital reported that two scopes sterilized properly could have transmitted deadly bacteria to seven patients.
The scopes involved in the infections were immediately removed, and UCLA is using a decontamination process for duodenoscopes from now on, the hospital system said Thursday.
UCLA notified more than 100 patients who had the complex endoscopic procedures between October 2014 and last month that they should get tested for the infection.
The UCLA case isn’t the first outbreak linked to complex scopes.
The agency received reports of approximately 135 patients getting contaminated from cleaned duoendoscopes between January 2013 and December 2014.
Last October, researchers from the University of North Carolina-Chapel Hill linked supposedly clean scopes to E. coli infections in Illinois.
The American Gastroenterological Association said earlier this year that the infection complication rate for the complex pancreatic procedure is about one percent.
The Food and Drug Administration said it is working with scope manufacturers and the Centers for Disease Control and Prevention to develop ways to keep scope patients safe.
