FDA Looks at Endoscope Reprocessor Role in CRE Outbreaks

If you, your spouse or your parent contracted a CRE infection after a procedure using an endoscope, you may have claims against the makers of the endoscope and the device used to clean it between uses. This means you may have the right to sue both companies for compensation and to send a message that patient safety needs to come before profit.

CRE Bacteria

CRE infection outbreaks our lawyers are investigating:

The FDA investigation of outbreaks of hospital-acquired CRE infections around the country has focused on endoscopes used for endoscopic retrograde cholangiopancreatography (ERCP), called duodenoscopes. There is evidence that these devices were instruments of bacterial transmission, even though they had been cleaned and disinfected between uses with automated endoscope reprocessors, as recommended by ERCP endoscope manufacturers.

Now, the FDA has asked the makers of the automated endoscope reprocessor (AER) products for updated test data validating that the machines are disinfecting as required.

“If it turns out that hospitals are following manufacturers’ instructions and (the AER) doesn’t work, then shame on the manufacturers and shame on the FDA,” Mark Duro told USA Today.   Duro heads sterile processing operations at New England Baptist Hospital in Boston.

Any CRE infection cases our law firm handles will look at possible claims against both the maker of the ERCP endoscope and the automated endoscope reprocessor.

Even with the FDA and CDC investigating the CRE infection outbreaks, it is important that you hire lawyers who can conduct an independent investigation. Fred Pritzker is one of the few attorneys in the nation who focuses his practice on infection cases. You can click here now to contact Fred for a free consultation.

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Category: Product Liability
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