The FDA is recommending the following to healthcare providers:

  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.
  • Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
  • Refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 consensus document for evidence-based recommendations for endoscope reprocessing.
  • Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
  • Consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.
  • Submit a report to the manufacturer and to the FDA via MedWatch, as described below, if you suspect that problems with reprocessing a duodenoscope have led to patient infections.
For more information visit FDA.gov