Duodenoscope Voluntary recall
(FDA) has issued a Safety Communication regarding a voluntary recall of the Pentax Medical Duodenoscope Model ED-3490TK
The United States Food and Drug Administration (FDA) has issued a Safety Communication regarding a voluntary recall of the Pentax Medical Duodenoscope Model ED-3490TK. The recall has been issued in order to replace a number of defective parts within the device and to make updates to the product’s Operation Manual, including a new recommendation for annual maintenance. Healthcare professionals at facilities utilizing this device are advised to identify affected products immediately.
The Safety Communication and voluntary recall follow earlier FDA releases highlighting concerns over infections associated with reprocessed duodenoscopes. The FDA describes duodenoscopes as “flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).” The devices are used regularly in a procedure known as endoscopic retrograde cholangiopancreatography (ERCP), which is performed to identify problems with and provide treatment to the pancreas and bile ducts. According to the FDA, in the U.S. alone, over 500,000 ERCP procedures are performed each year using duodenoscopes.
The present issues arise from concerns over the efficacy of duodenoscope reprocessing, or, in other words, the ways in which duodenoscopes are cleaned and disinfected between uses in different patients. According to the FDA itself, the agency has been aware of this problem going back until at least 2013:
“In fall 2013, the Centers for Disease Control and Prevention (CDC) alerted the FDA to a potential association between multi-drug resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that the users were following the proper manufacturer cleaning and disinfection or sterilization instructions.”
The FDA states that it is partnering in a number of ongoing investigations seeking to better understand how bacterial infections are spread via reused duodenoscopes and how the problem can be mitigated.
Stay tuned to TheLawFirm.com for the latest medical device recall news. If you underwent one of the over half-a-million ERCP procedures performed each year using a duodenoscope and subsequently suffered a serious bacterial infection as a result, contact the expert attorneys at TheLawFirm.com for a free consultation.