Scopes In CRE Outbreak Not FDA Approved

WESTWOOD—The manufacturer of the scopes that spread an antibiotic-resistant superbug to seven patients at UCLA’s Ronald Reagan Medical Center were selling the medical equipment without FDA approval.

The scopes, called duodenoscopes, are used to perform examinations of the pancreas and liver.

Per the FDA, the manufacturer of the scopes, Olympus Corporation of America, altered the design of the equipment and continued selling them to medical professionals without receiving federal permission to do so.

Oracle was required to inform the FDA of the changes 90 days before selling the manufactured product.

According to FDA regulations, a manufacturer must notify the FDA of design changes 90 days before actively selling an altered product.

The superbug, known as CRE is believed to have caused the deaths of two of the patients infected at UCLA. Per UCLA officials, the contaminated scopes that spread the infection had been cleaned in strict concordance with the instructions provided by Oracle.

At this juncture it is unknown whether the changes that Oracle made to the scopes had any effect on the superbug outbreak.

The bacteria, known as CRE is oftentimes deadly because of its resistance to antibiotics. The most recent outbreak at UCLA is one of several that have taken place nationwide, as the bacteria has spread through medical centers in Chicago, Pittsburgh, and Seattle.