FDA Committee Recommends Sterilization of Duodenoscopes

The transmission of infection by poorly cleaned endoscopes, especially duodenoscopes has been national news in newspapers such as the Wall Street Journal for several months. The problem lies in the complexity of these scopes that makes cleaning somewhere between very difficult and impossible even when following the manufacturer’s instructions.

At least a half-dozen U.S. outbreaks of carbapenem-resistant Escherichia coli (CRE) and related superbugs since 2012 that were linked to contaminated duodenoscopes. In the latest outbreak, duodenoscopes spread antibiotic-resistant bacteria to seven patients at a University of California at Los Angeles (UCLA) hospital, contributing to two deaths. Both UCLA and the University of Pittsburgh Medical Center (UPMC) have switched to ethylene oxide to sterilize their duodenoscopes instead of the normal high level disinfection methods.

The FDA’s Gastroenterology-Urology Devices Panel met and recommended more intensified cleaning of medical scopes linked to deadly outbreaks of “superbugs” at several U.S. hospitals, including two in Los Angeles.  The panel had the following recommendations after its May 14 -15, 2015 meeting,  [Bold emphasis added]:

The panel was asked to consider six FDA discussion questions and the panel provided the following recommendations:

1. Based on the methodology and criteria for acceptance of cleaning, high-level disinfection, and sterilization validation testing for both manual and automated processes, the panel concluded that duodenoscopes and AERs do not provide a reasonable assurance of safety and effectiveness. The panel believes that manual cleaning is a critical component in the process, thus needs to continue. Majority of the panel also believes it is necessary to reclassify duodenoscopes based on the Spaulding Classification from semi-critical to critical and support the move from high level disinfection towards sterilization. Although, some panelists maintained that high level disinfection is adequate, if done properly.

The panel unanimously agreed that ERCP* is an important procedure and the use of duodenoscopes during this procedure is safe and should continue from a public health perspective. The benefits of the procedure for the population outweigh the potential risks associated with the use of duodenoscopes.

2. The panel discussed the role of pre-market human factors testing in reprocessing instructions and concluded human factors testing is important and therefore, should be a part of the pre-market assessment. The panel supported a guide of best practices and competency assessments for ensuring user adherence with manufacturer’s reprocessing instructions.

3. The panel discussed cleaning agents and brushes differing from the duodenoscope manufacturer’s instructions and concluded that brushes or other cleaning agents should meet the manufacturer’s specifications. The panel also agreed it is necessary to receive data from the manufacturer on the efficacy of brushes or other cleaning agents as well as the need for development and validation of cleaning verification assays

4. The panel discussed CDC’s interim guidance for surveillance for bacterial contamination of duodenoscopes after reprocessing and concluded the guidance is not sufficient in the current form to be implemented by healthcare facilities as a best practice. The panel believes more data and validation testing is needed before a surveillance program should be implemented by healthcare facilities. Despite its limitations, the panel agreed the guidance provides a well documented outline for healthcare facilities.

5. The panel’s recommended approach for ensuring patient safety for ERCP is to discuss the informed consent with patients and to provide information on the risk of infection from the procedure and to disclose if the health facility has had an issue with infections. Patient selection is also critical for ensuring patient safety. Patients should also be informed of the effects of foregoing the procedure and provided alternatives to the procedure.

6. The panel discussed temporizing measures the FDA should consider when the FDA has a medical device concern but not enough information to determine the most appropriate action towards a resolution. The panel urged the FDA to provide early communication of the facts to the public. The panel also stated the FDA should work with professional societies in an effort to disseminate a consistent message to healthcare providers.

* ERCP = Endoscopic retrograde cholangiopancreatography