5 Reasons Why Duodenoscope Problems Matter

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Duodenoscopes are long tubes that are threaded down a patient’s throat to treat gallstones, cancers, and other disorders of the digestive system. Half a million duodenoscope procedures are performed a year in the U.S. and only recently have scope safety problems surfaced publicly.


Here are 5 reasons why you should pay attention:

1) Duodenoscopes have been linked to deadly superbug infections.

In January, Virginia Mason Hospital in Seattle said that from 2012 and 2014, 32 patients had been infected with the deadly superbug carbapenem-resistant Enterobacteriaceae (CRE) by duodenoscopes and that it possibly contributed to 11 deaths. In February, UCLA Medical Center said that 179 patients were exposed to CRE through contaminated endoscopes, 7 patients were infected and 2 patients died. The CDC had notified the FDA about the potential link between antibiotic resistant infections and duodenoscopes in 2013, and FDA pointed out that it was working on the scope cleaning issue even before CDC notified them of the infections. According to a CDC infectious-disease physician Alex Kallen, “There definitely is a risk of (disease) transmission with these scopes.”

2) Safety issues weren’t addressed early on.

Paul Levy at Not Running a Hospital raises some excellent questions: “How can the device have been allowed on the market by the FDA without a thorough review of this issue?  After all, it is well known that the scope is going to travel through the stomach and beyond each time it is used.  Why wouldn’t the agency insist that the manufacturer’s recommendation about sterilization at the time the product entered the market be sufficient?” Despite knowing about potential safety problems for two years, “FDA didn’t do its job,” said Diana Zuckerman, president of National Center for Health Research in a LA Times interview.

3) Hospitals and FDA shouldn’t keep secrets from patients.

The hospital infection outbreaks in Seattle and Los Angeles show how long it took for hospitals to talk about their infection problems. We believe patients have a right to know about infection dangers in the hospital while they are happening. In Seattle, hospital officials and the health department didn’t tell patients or family members about the outbreak. In Los Angeles, it took months before hospital officials notified patients that they may be infected with CRE. What are they hiding?

FDA’s Chief Scientist, Dr. Stephen Ostroff told Reuters that the FDA will convene a public advisory committee meeting to discuss drug and device safety issues, including the cleaning issue. No date has been set as of yet. So far, the manufacturers have submitted only flawed data on the reliability of their cleaning methods. FDA keeps working with industry. According to our Safe Patient Project director, Lisa McGiffert, “It is outrageous that the FDA is giving them a third try to prove these devices can be cleaned properly and the public didn’t know about it till today.”

4) Patients and providers need safety guidance.

In January, the FDA said in a written statement to USA Today  that it was “aware of and closely monitoring” the infection risks associated with the scopes and added that “some parts of the scopes may be extremely difficult to access and clean thoroughly…and effectively cleaning of all areas of the duodenoscope may not be possible.” The agency added that it was working with manufacturers on cleaning protocols, and that the device benefits outweighs its infection risks. The FDA issued a safety guidance to state that the duodenoscope’s complex design make it challenging to clean, while encouraging providers to meticulously clean to reduce the risk of spreading infection. More recently, the FDA acknowledged that it had never reviewed data from manufacturers on how to disinfect the devices, and asked manufacturers to provide evidence that their cleaning methods work, but their methods have failed, twice. The duodenoscope is a very difficult device to clean, and right now there is no consensus on how they should be cleaned. Meanwhile, patients are still getting these procedures and have nothing to assure them that this device has been 100% disinfected.

5) If we do nothing to stop the superbugs, the consequences are dire.

CRE is a reminder of a much bigger threat facing us all: antibiotic-resistance. Antibiotic-resistance is driven by the overuse of antibiotics and lack of disinfection in hospitals. CRE is a rare but deadly infection that is difficult to treat because it is resistant to last-resort antibiotics. While healthy people usually don’t get CRE infections, these infections have up to a 50% mortality rate, according to the CDC.

Learn How to Protect Yourself from Medical Scope Harm

  • Read and share Consumer Reports’ Consumer Health Choices Guide: Upper Endoscopy for GERD.
  • Check out APIC’s advice for how to stay safe if you need an ERCP scope procedure.


From FDA:

  • Discuss the benefits and risks of procedures using duodenoscopes with your physician. For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed.
  • Ask your doctor what to expect following the procedure and when to seek medical attention. Following ERCP, many patients may experience mild symptoms such as a sore throat or mild abdominal discomfort. Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools).

Why is the public often the last to know about medical safety problems? Is the FDA dropping the ball on notifying patients and keeping us safe?