WESTWOOD (CBSLA.com) — A piece of medical equipment blamed for a so-called “superbug” outbreak at UCLA Medical Center was never approved for sale to hospitals by the Food and Drug Administration, according to reports.
KNX 1070’s Pete Demetriou reports an endoscope manufactured by the Olympus company had approval for a prior version, but made changes that were never even submitted for FDA approval.
The Japanese electronics giant reportedly started selling the endoscope in question in 2010, but the FDA didn’t notice it was on the market until at least 2013 and possibly through sometime in 2014, according to a CNN report.
The FDA has acknowledged that the devices – known as duodenoscopes – can be hard to clean but says pulling the devices off the market would prevent people from getting “life-saving” procedures.
Seven patients were infected with the carbapenem-resistant Enterobacteriaceae (CRE) bacteria between October and January, university officials said.
Two patients have died and about 180 more may have been exposed to potentially deadly bacteria on the scopes, the Los Angeles Times reported.
Lawrence Muscarella an independent expert on hospital safety and medical devices, said the lack of approval could be linked to funding or staffing cutbacks at the agency.
“It’s now time to look at whether more money is needed, and maybe more money is not needed,” Muscarella said. “Maybe more efficient and better regulation is needed.”
UCLA Health Sciences Department officials released a statement saying the issue is for the FDA to address and that the department “followed all the guidance provided by the manufacturer and the FDA in cleaning the equipment used in endoscopic procedures.”
Last month, Rep. Ted Lieu (D-Torrance) asked the House Committee on Oversight and Government Reform to hold a hearing to prevent additional superbug infections. The committee oversees the FDA.
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