FDA: Medical Scope Design Changes May Be Responsible for Superbug Outbreaks

A recent, multi-state outbreak of an antibiotic-resistant superbug has been linked to a medical scope commonly used to assess symptoms of liver, bile duct or pancreatic disease. A personal injury lawyer in Chicago knows that the superbug, known as Carbapanem-resistant Enterobacteriaceae, has killed at least two people in California, and is suspected in the deaths of patients in Philadelphia, Seattle and Illinois, according to The FDA recently announced that a change of design in the scope may have contributed to the problem, making it impossible to completely eliminate the presence of bacteria during the cleaning process.

The scopes, which are used on hundreds of thousands of patients each year, have been connected to at least 135 patients’ contraction of infections over the last two years. According to ABC News, the design change on the scope had not been reported to the FDA which means that hospitals purchased the equipment, unaware that the new design did not have FDA approval.

Design defects

In response to the superbug infections, wrongful death lawsuits have been filed against the scope’s manufacturer. According to the Cornell University School of Law, the laws of product liability dictate that a design defect can only be established when there is proof that a safer, equally effective and economical alternative design exists. Furthermore, the primary purpose of the original design must not be altered when the changes in design are made.

In the case of the duodenoscope, CNN reports that the manufacturer sealed part of the device known as the elevator channel in hopes of minimizing the risk of infection. FDA regulations dictate that the manufacturer must have a design reapproved if it “could significantly affect the safety or effectiveness of the device.” Further complicating matters, according to Fierce Healthcare, is the FDA’s assertion that Olympus Corp. first learned of the product’s defective design and CRE risk back in 2012. The manufacturer then failed to inform medical providers of how to properly use and clean the duodenoscope.

New cleaning guidelines

The FDA recently established new guidelines that require patients to be informed of all risks associated with the duodenoscope, and also that medical facilities consider limiting or prohibiting its use entirely. Providers are also encouraged to immediately contact the FDA, as well as the product manufacturer, if they believe a patient was infected due to its use. While these new regulations are a step in the right direction, medical professionals and a personal injury lawyer in Chicago acknowledge that these new guidelines only do so much.

The FDA plans to hold its next public meeting regarding the deadly superbug outbreak this May. In the meantime, if people have been given a procedure with this device, they may find it helpful to speak with an attorney.