My name is Dr. Anna Mazzucco, and I thank you for the opportunity to speak today on behalf of the National Center for Health Research. After completing my Ph.D. at Harvard Medical School, I conducted research at the National Institutes of Health. Those are the perspectives I bring today.
Our nonprofit organization conducts research, analyzes data from the research literature, compares the risks and benefits of medical products, and also explains the evidence so that it is understandable to patients and providers. Our organization does not accept funding from medical device companies, and therefore I have no conflicts of interest.
The FDA received 146 adverse event reports for duodenoscopes between 1997 and 2015, including 13 deaths. As infections are not always traced to the source, and the MAUDE system is voluntary and known to be under-utilized, these numbers are very likely underestimates of the true number of infections spread via these devices.
More than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed every year in the U.S. These patients assume that the devices used during their procedure are clean and safe. As duodenoscopes allow physicians to perform potentially life-saving procedures quickly and less invasively, adequate safety measures must be used for patients to continue to benefit from these devices without fear of receiving a potentially deadly infection.
The CDC released interim guidance in March to address duodenoscope contamination. We urge the panel to recommend that these guidelines be implemented in all healthcare facilities. Among these recommendations, staff training and annual competency re-verification with direct observation should be top priorities. That’s needed because studies have shown that lack of compliance with decontamination protocols is widespread.
Decontaminating and sterilizing these devices is challenging for many reasons, including because of their design. Therefore, we strongly advocate for ongoing monitoring of these devices through the CDC-recommended surveillance program, even in the absence of a known outbreak. This should include routine culturing, which is already the standard procedure in Australia and parts of Europe, and holding duodenoscopes out of use until results are complete. Even when decontamination protocols are strictly followed, these additional safeguards are still needed, so that outbreaks would be identified and contained as quickly as possible.
We enthusiastically support increased transparency with patients during the informed consent process about the risks of infection transmission during the ERCP procedure. Patients are entitled to full disclosure of the potential risks of any procedure or treatment they receive.
In addition, patient notification measures should be in place at all healthcare facilities that perform ERCP procedures. Rapid response to potential outbreaks relies on the ability of healthcare facilities to track their duodenoscopes and inform the relevant patients at the first sign of danger.
Lastly, the FDA report highlighted past deviation from manufacturer’s instructions and use of cleaning accessories, which are not cleared by the FDA for this purpose. These deviations were not reviewed by the FDA as factors which may contribute to contamination. Since these deviations seemed to be quite common, they deserve further investigation. We ask that the panel consider requiring that warning labels should be placed on duodenoscope packaging AND in areas where they are cleaned. These warnings would remind decontamination staff that duodenoscopes should be re-processed according to the manufacturer’s instructions.
Thank you for the opportunity to speak today.