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Update on Tainted Medical Scopes: Unflagging Spotlight on the FDA

Update on Tainted Medical Scopes: Unflagging Spotlight on the FDA

When we stated in a recent blog entry that we would keep our readers in Texas and elsewhere updated on a major story regarding contaminated medical scopes, we meant just that.

And, indeed, we feel compelled to do so, adding a material update today to matters that we first addressed in a March 3rd blog post focused upon the health crisis prompted by contaminated duodenoscopes used to diagnose and treat digestive-tract ailments.

Many of our readers have likely heard much about that dire health concern, which stems from the fact that some scopes -- which are used on multiple patients -- have proven resistant to standard cleaning techniques. The result has been the spread of an especially nasty bacterial agent that goes by the acronym of CRE. It is often deadly, and has proven to be so at multiple hospitals in the United States.

In our earlier post, we questioned whether doctors using the scopes act negligently "by placing their patients at known risk for contracting a scope-related infection."

An ancillary inquiry has centered on the United States Food and Drug Administration, which has been subjected to much criticism for its perceived laxity in responding to the CRE outbreak.

A recent media investigation into the scope-related transmission of the CRE superbug has followed up on that criticism, with research into the FDA's public database compiling so-called Medical Device Reports chronicling health issues relating to medical tools and appliances -- such as the scopes -- pointing to troubling systemic flaws.

Put another way: There is some evidence indicating that medical device makers are not reporting problematic issues in some instances, and that the FDA has been slow in identifying problems and taking necessary enforcement actions to alleviate them.

Critics of the so-called MDR process say it needs to be tightened up. That would certainly seem to be true with FDA's slow response to the CRE outbreak.

Duodenoscopes were reportedly linked to CRE transmission in at least eight American hospitals between 2012 and 2014. Consultation service from the Maloney lawyers is free. Contact us today to get started.


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