The U.S. Food and Drug Administration recently released a report revealing that it received 142 reports of patient infection or device contamination associated with duodenoscopes since 2010. There were also four additional reports dating back to 1997.
Of the 146 total reports related to duodenoscopes, 13 involved patient deaths and 121 involved injuries.
The FDA noted that its current system for monitoring these adverse events "has limitations." The reports are submitted to the FDA by device manufacturers and device user facilities, which could lead to "the potential submission of incomplete, inaccurate, untimely, unverified, or biased data," the FDA report states. Also, there is a potential for underreporting of such events.
"These reports can come in 18 months to two years later," Lawrence Muscarella, a consultant, told the LA Times, which means that the new numbers from the FDA "could significantly underestimate the risk."
Duodenoscopes have been in the news this year, since two patients at Ronald Reagan UCLA Medical Center in Los Angeles died after contracting carbapenem-resistant Enterobacteriaceae infections from improperly cleaned scopes. Other facilities, like Los Angeles-based Cedars-Sinai Medical Center, have dealt with infections tied to the hard-to-clean scopes recently.
Of nine hospitals that reported infections associated with the use of the scopes, six used scopes made by Olympus, two used Pentax-made scopes, and one used scopes from Fujifilm, according to the FDA.