FDA Issues Safety Warning on Endoscopes as News of Superbug Threat Hits UCLA Hospital
The Food and Drug Administration (FDA) has issued recommendations for healthcare professionals regarding endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) in response to adverse event reports of multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.
While the design of duodenoscopes can improve the efficiency and effectiveness of ERCP, it may also create challenges in cleaning and high-level disinfection; some parts of the duodenoscopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be feasible. Residual body fluids and organic debris may remain in these crevices following cleaning and disinfection, which may expose patients to serious infections if the fluids contain microbial contamination.
From January 2013 to December 2014, the FDA received 75 Medical Device Reports encompassing approximately 135 patients in the United States regarding possible microbial transmission from reprocessed duodenoscopes. In October 2014 an Illinois hospital reported an outbreak of Escherichia coli outbreak from endoscopes that had bacterial contamination despite being disinfected in the recommended way. At least 35 patients became ill and 11 died after becoming infected with carbapenem-resistant Enterobacteriaceae (CRE) as a result of contact with contaminated endoscopes at a hospital in Seattle, WA in January, despite cleaning of the devices that was performed in accordance with the manufacturer's instructions. The UCLA Health System has recently notified over 100 patients that they may have been infected by the same drug-resistant bacteria during complex endoscopic procedures that took place between October 2014 and January 2015. Infection in seven patients has been confirmed and may have been a contributing factor in two patient deaths. Both healthcare organizations are now utilizing a decontamination process that exceeds beyond manufacturer and national standards.
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.