Contaminated duodenoscopes sickened at least 250 people worldwide between 2012 and Spring 2015, and the Senate’s Health, Education, Labor, and Pensions Committee deemed the illnesses and resulting deaths preventable tragedies. The Committee’s investigation into the outbreaks revealed wrongdoing and/or errors committed by device manufacturers, hospitals, and the FDA that led to a lengthy investigative process, during which additional patients were infected (see Olympus pressed for information about response to superbug outbreaks, Health Law Daily, June 11, 2015). In a January 13, 2016 report, the Committee, led by Ranking Minority Member Patty Murray (D-Wash), made several recommendations for preventing infections related to medical devices, including the implementation of a robust medical device safety surveillance system similar to the existing Sentinel system that monitors drugs.
In September 2013, the Centers for Disease Control and Prevention (CDC) notified the FDA of an outbreak of infections at a Chicago-area hospital linked to a duodenoscope manufactured by Hoya Corporation PENTAX Life Care Division (Pentax). Around the same time, a Seattle hospital linked infections to a duodenoscope manufactured by Olympus Medical Systems (Olympus). The hospitals at issue had cleaned the duodenoscopes pursuant to manufacturer instructions. Although the FDA began investigating closed channel duodenoscopes, devices used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at that time, the Committee noted that the FDA did not issue a safety alert to hospitals for at least 17 months. Further,the agency did not provide hospitals with additional measures to supplement reprocessing of duodenoscopes for reuse for nearly two years, during which at least 68 patients were infected in the U.S.
The Committee determined that Olympus failed to issue safety alerts, despite knowledge of potential infection for years; that, Olympus and Fujifilm Medical Systems (Fujifilm) never applied for FDA clearance for their new device designs before selling them in the U.S.; and that Olympus, Fujifilm, and PENTAX attested that their cleaning instructions worked reliably, without sufficient data (see Cracking down: FDA sends warning letters to duodenoscope manufacturers, Health Law Daily, August 18, 2015). It concluded that the duodenoscope manufacturers, along with Custom Ultrasonics, the manufacturer of an automated cleaning machine used on duodenoscopes, “failed at every level to meet basic expectations of transparency and openness.” It further found that 16 U.S. hospitals affected were slow to report infections to various entities and did not follow all steps to report adverse events resulting from the devices to manufacturers and the FDA.
The Committee was most concerned about the length of the FDA’s investigation and its failure to take notice of existing studies from Europe that determined that the duodenoscopes could cause infections, even after adherence to cleaning instructions provided by the manufacturers. As a result, it recommended the creation and implementation of a robust medical device safety surveillance system, similar to the Sentinel system that allows the FDA to monitor drugs. Such a system would allow the FDA to access real-time information on adverse events, such as that included in insurance claims, without relying on manufacturers and hospitals to report them. It would also provide a larger pool of data so that the agency could analyze adverse events in the context of total patients treated.
The Committee specifically recommended that the FDA evaluate the design of closed-channel duodenoscopes and implement a phased recall; update guidance to specify when manufacturers should request 510(k) clearance after devices are modified; and implement new draft guidance to quickly provide providers with information when it becomes aware that a medical device might compromise patient safety. It recommended that Congress require that unique device identifiers (UDIs) be used in insurance claims, electronic health records, and device registries and clarify the FDA’s authority to consider 510(k) applications incomplete due to lack of sufficient data regarding whether a device can be safely cleaned and reused. Finally, it recommended that hospital compliance with adverse event reporting be made a condition of participation in Medicare.