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FDA issues Warnings to Duodenoscope Makers

Timely Insights on Laws, Issues and New Developements

olympusOn August 12, 2015, the FDA issued warnings to several duodenoscope makers: Olympus Corporation of the Americas, Fujifilm Medical Systems and Hoya (Pentax) Corporation.

Olympus Corp., the U.S. subsidiary of the Japanese scope maker, said in February 2015 that the Justice Department had been investigating its medical business since November 2011.

UCLA reported that the CRE superbug possibly infected nearly 200 UCLA patients. Olympus manufactured the scopes that medical officials believe infected seven patients at UCLA’s Medical Center with a drug-resistant bacteria. Two of those people died.

FDA warned hospitals and physicians in February 2015 that the commonly used medical scopes may have spawned the superbug outbreak at UCLA.

500,000 Duodenoscope Procedures Yearly

Duodenoscopes are complex instruments of many small working parts. Failure to thoroughly clean and disinfect them can pass tissue or fluid from one patient to another.

Duodenoscopes – flexible, lighted tubes threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) – are used during endoscopic retrograde cholangiopancreatography (ERCP). This procedure is used to diagnose and treat problems in the pancreas and bile ducts. Duodenoscopes are used in more than 500,000 ERCP procedures in the U.S. yearly.

FDA Alert

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 proper manufacturer cleaning and disinfection or sterilization instructions.  – FDA Web site

FDA’s Ongoing Investigation

FDA says that even though the large majority of procedures with these devices are carried out safely and effectively, the agency takes the risk of infection very seriously and is working intensively to address it.


  • Warning Letter – Fujifilm Medical Systems U.S.A., Inc. 8/12/15
  • Warning Letter – Hoya (Pentax) Corporation 8/12/15
  • Warning Letter – Olympus Corporation of the Americas 8/12/15
  • FDA:  Infections Associated with Reprocessed Duodenoscopes
  • Duodenoscope Lawsuit

by Matthews & Associates

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