FDA: tainted duodenoscopes report

Washington, D.C. – Officials from the U.S. Food and Drug Administration (FDA) recently disclosed more reports related to contaminated duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

According to the report, the agency received 146 medical device reports (MDRs) of ERCP devices linked to a patient infection, exposure, or device contamination from January 1997 to February 2015. Of the 146 reports, 142 came since 2010.

Coming up in the June issue of Today's Medical Developments magazine is an article by Douglas H. McConnell, M.D., F.A.C.S., medical director at OBP Medical, where he discusses how when it comes to reusable devices, sometimes cleaning just isn’t enough. He goes on to explain that there is a growing body of evidence that even when hospitals carefully follow instructions for cleaning and disinfection – as it appears UCLA did – the complexity of the instruments makes decontamination a challenge.

According to an article in the Los Angeles Times, about half that many MDRs (75) on contaminated duodenoscopes were received during 2013 and 2014, FDA officials also revealed receipt of 152 MDRs associated with automated endoscope reprocessors (AERs), which are devices used to wash, clean, and disinfect heat sensitive endoscopes.

Read the FDA report here.

Source: FDA