FDA issues list of supplemental cleaning procedures for duodenoscopes

Safety Communication comes after dozens of patients exposed to antibiotic resistant bacteria

The Food and Drug Administration (FDA) recently issued a Safety Communication to healthcare providers concerning the reprocessing of duodenoscopes, which are medical devices inserted into a patient's mouth used to visually examine the small intestine. The FDA issued the Safety Communication after dozens of patients contracted severe bacterial infections between 2013 and 2015 after undergoing gastrointestinal procedures using duodenoscopes.

Patients at hospitals in Los Angeles, Seattle, Chicago, and Pittsburgh were exposed to carbapenem-resistant enterobacteriaceae, a strain of drug resistant bacteria found inside the intestinal tract. At least two people died at the UCLA Medical Center in 2015 after contracting infections of the drug-resistant bacteria.

Reprocessing (cleaning) duodenoscopes after use is a difficult yet important step to prevent severe bacterial infections. In February 2015, the FDA issued a Safety Communication warning health care providers the physical design of the endoscope makes reprocessing a difficult task. The flexible head of the duodenoscope can be difficult to clean, allowing bacteria to propagate and possibly infect other patients.

The FDA’s latest Safety Communication recommends health care providers using duodenoscopes strictly follow the manufacturer's reprocessing protocols and to take supplemental steps to ensure proper sterilization. These supplemental cleaning measures include:

• microbiological culturing,
• ethylene oxide sterilization using liquid chemical sterilant processing system, and
• repetition of high-level disinfection.

Duodenoscopes are a type of side viewing endoscope used in a procedure known as endoscopic retrograde cholangiopancreatography (ERCP). During an ERCP, the patient is sedated and the endoscope is inserted through the throat, down into the stomach and into the duodenum. With the duodenoscope in the intestinal tract, doctors can treat a variety of medical conditions like removing gallstones, inserting stents into the pancreas, and drain the bile ducts.

Patients undergoing an ERCP may be at risk of contracting severe bacterial infections, developing pancreatitis, and suffering intestinal perforation. Sometimes, these conditions are the result of medical malpractice or a defective product.