Background: Each year, the FDA receives more than a million reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical device reports (MDRs) are submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers. The FDA uses MDRs to monitor device performance, including monitoring reports of infection or device contamination to detect potential device-related safety issues and to share this information in public communications. In this analysis, the FDA presents MDRs for duodenoscopes, which are a type of flexible endoscope that have been associated with infections in patients. Methods: For this analysis, we searched the MDR database for duodenoscope reports submitted between January 2015 and July 1, 2019. MDRs were classified into clinical risk categories based on the MDR’s text narratives as patient infection (indicated the presence of infection in patients potentially transmitted by the device), patient exposure (indicated a contaminated device has been used in a patient, but the MDR lacks clear mention of patient infection), or device contamination (indicated that the device was contaminated, but no mention of device use in patients or patient infection). Results: Overall, 1,115 duodenoscope reports related to a patient infection, patient exposure, or device contamination for devices marketed inside and outside the United States were received from January 2015 to mid-2019. Among them, 79 MDRs were received for deaths in patient infection, patient exposure, or device contamination reports. The number of reported infections decreased from 247 MDRs in 2015 to 55 MDRs in the first half of 2019. Furthermore, the number of reported deaths decreased from 25 MDRs in 2015 to 2 MDRs reported in the first half of 2019. Conclusions: The MDR data indicate a decrease in the number of reported infections. The decrease in infections suggests that efforts to reduce the risk of infection from duodenoscopes have yielded improvements; however, additional improvements are necessary to further decrease the risk of infection.Funding: NoneDisclosures: None
Formal Verification of Medical Device User Interfaces Using PVS