Four major gastroenterological societies denounced an article on duodenoscope sterilization published in The New York Times, stating that the article understates the value of the devices to patients and that they can't be removed from the marketplace as a result.
Presidents of the American Society for Gastrointestinal Endoscopy, American College of Gastroenterology, American Gastroenterological Association and the Society of Gastroenterology Nurses and Associates signed off on a letter to the editor sent to The New York Times:
"We agree that identifying safe and effective solutions that eliminate risk of infection transmission is a top priority. This cannot happen overnight: We cannot adopt a new technology such as disposable scopes without first understanding the new risks we may be introducing to our patients. Our medical societies have been working closely with the FDA and industry to identify and properly vet potential solutions."
Duodenoscopes are used to diagnose pancreatic and bile duct diseases. The devices have components like moveable cameras that create small crevices that are difficult to clean, and the devices can't be sterilized by high temperatures because of the damage it could cause.
The New York Times cited examples of patients acquiring life-threatening infections stemming from duodenoscope use, including 30 patients in Seattle who were infected with carbapenem-resistant Enterobacteriaceae after duodenoscope use. Eleven of those patients later died.
The New York Times included a statement in the article from William Rutala, the University of North Carolina's statewide director of infection control and epidemiology saying that the "need is urgent" for manufacturers to develop scopes that can be properly sterilized. Either that, or all duodenoscopes should be removed from the market.
However, the article also points out that the risk of infection from duodenoscope use is low. The article quotes epidemiologist Alexander Kallen, MD, of the Centers for Disease Control and Prevention, who said the infection risk associated with duodenoscope use is more of a public health concern than a risk to individual patients, but that patients should be aware of the
infection risks duodenoscopes present.
Read The New York Times article here.
Read the letter from the GI societies here.