Duodenoscope Processing Procedures Outlined by FDA

Today, the FDA issued a Safety Communication regarding supplemental measures to enhance duodenoscope reprocessing (cleaning before reuse). These measures were approved after the FDA was informed of instances of persistent bacterial contamination after use of a duodenoscope, even following strict adherence to manufacturer reprocessing instructions.

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These infections, called Carbapenum-Resistant Enterobacteriaceae (CRE) infections, involved Escherichia coli (E. coli) and other antibiotic-resistant strains of deadly pathogens. There is a 40% mortality rate, meaning about 40% of the people with CRE infections die. The hospitals involved in three outbreaks include:

An Olympus duodenoscope (endoscope) has been linked to at least some of these CRE infections. These medical devices are used for endoscopic retrograde cholangiopancreatography (ERCP). They are sometimes referred to as ERCP endoscopes.

The outbreaks and the hospitals’ insistence that manufacturer reprocessing instructions were followed prompted the FDA to recommend use of the supplemental measures for reprocessing and the establishment and strict adherence to quality control programs:

Facilities and staff that reprocess ERCP duodenoscopes [should] establish and implement a comprehensive quality control program for reprocessing duodenoscopes (FDA).

According to the FDA, hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of the following additional steps to further reduce the risk of infection and increase the safety of the duodenoscopes:

  • Microbiological Culturing – Sampling duodenoscope channels and the distal end of the scope and culturing those samples to identify any bacterial contamination that may be present on the scope after reprocessing.
  • Ethylene Oxide Sterilization – Use of a non-portable device that uses ethylene oxide gas to sterilize.
  • Use of a Liquid Chemical Sterilant Processing System – A device that uses a chemical solution (liquid chemical sterilant) to destroy all viable forms of microbial life.
  • Repeat High-Level Disinfection – This involves immersing the device with a disinfectant that is expected to inactivate all microorganisms except for large numbers of bacterial endospores, and it can be done manually or with a Automated Endoscope Reprocessor (AER), a cleaning device that washes and provides a high-level disinfection of endoscopes and scope accessories to decontaminate them between uses.

The risk of infection transmission cannot be completely eliminated, according to the FDA, but the agency has determined that “the benefits of these devices continue to outweigh the risks in appropriately selected patients.”

What Can Patients Do?

  • 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).

The Audiences for This FDA Safety Communication

  • Gastroenterologists
  • Gastrointestinal surgeons
  • Endoscopy nurses
  • Staff working in endoscopy reprocessing units in health care facilities
  • Infection control practitioners
  • Personnel conducting endoscope culturing (e.g. clinical diagnostic and laboratory staff)
  • Patients considering Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures



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Category: Medical Products And Procedures
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