Alleged Manufacturing and Reporting Problems Lead to Sending of Warning Letters to Duodenoscope Companies

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The FDA has sent warning letters to three manufacturers of duodenoscopes because of the link between these products and ‘superbug’ outbreaks.  The manufacturers who received these letters include Fujifilm, Pentax and Olympus.  The reasons for these warning letters being sent were that the FDA believes that these companies failed to take action to either prevent these outbreaks or to warn the government about them.  While these warning letters do not carry any type of penalty for these companies, they most certainly have put them on notice that this problem is one that the government is watching carefully.

Duodenoscopes and Superbug Outbreaks – The Alleged Connection

According to several studies and investigations, the use of duodenoscopes in medical procedures has possibly led to the outbreak of superbugs.  A duodenoscope is used in procedures known as an endoscopic retrograde cholangiopancreatography, or ERCP.  These devices are used in approximately 500,000 ERCP procedures across the country every year.  An ERCP is done to drain fluids from pancreatic and biliary ducts that are blocked by tumors, according to the FDA.

Specifically, duodenoscopes are flexible, lighted tubular devices that are inserted through the mouth and threaded into the top of the small intestine.  Once in place, the duodenoscope can insert a contrasting dye or provide for the insertion of smaller instruments through its hollow shaft that allow medical professionals to remove tissue samples for biopsies or for other possible reasons.  They were seen as an advance compared to the use of endoscopes because they simply allowed for more options once inserted.

Unfortunately, the complex nature of the design of duodenoscopes can make them very difficult to clean, and given their exposure to the stomach, throat and small intestines, these devices often come into contact with potentially harmful bacteria.  Several infamous cases of outbreaks of what are known as superbugs have occurred that have been allegedly linked to duodenoscopes that were not properly cleaned.  Some of these instances involved duodenoscopes that were cleaned according to the manufacturers’ instructions, but bacteria remained on them.

What Is a Superbug?

A superbug is a term that can be used for several different forms of bacteria.  Basically, these bacteria have become resistant to antibiotic medications that are often used to treat infections.  As such, people who contract a superbug often face a very difficult medical challenge and some are unable to recover from their presence in their bodies.  Outbreaks of superbugs where duodenoscopes may have been involved have occurred at the UCLA Medical Center, the Cedars-Sinai Medical Center, both in Los Angeles, and a hospital in Connecticut.

Duodenoscope Superbug Exposure and Your Legal Rights

In addition to the warnings letters sent by the FDA, these three companies are also currently being investigated by the Department of Justice.  If you or someone you love has been made ill after having a duodenoscope inserted into your body, you need to contact the duodenoscope lawyers at Parilman & Associates as soon as possible to schedule a free initial consultation.  You can either email the firm or call 800-800-DRUG.