The manufacturer of the scopes that spread a drug-resistant "superbug" to seven California patients had tweaked the scopes' design and was selling them without federal permission to do so, according to the Food and Drug Administration.
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Seven people have become infected with the drug-resistant "superbug" known as CRE at Ronald Reagan UCLA Medical Center after undergoing endoscopy procedures, and CRE may have played a role in two of those patients' deaths, hospital officials said in February, adding that 179 people were exposed to the germ at UCLA.
The scopes -- called duodenoscopes, which are inserted by mouth to access patients' small intestine, the pancreas and the liver -- were new and had only been in use since June, health officials said last month. Officials added that the scopes were cleaned in accordance with manufacturer guidelines. The hospital said it traced the bacteria back to two endoscopes manufactured by Olympus Corporation of the Americas.
According to the Food and Drug Administration, Olympus had tweaked the design of its duodenoscopes and sold them without seeking clearance from the FDA to do so. Manufacturers are supposed to notify the FDA of design changes 90 days before marketing an altered device, according to the FDA website.
It was not immediately clear what Olympus changed about the scopes' design or whether that change could have made the scopes more likely to harbor bacteria or more difficult to clean and sanitize -- and the FDA was not immediately able to clarify.
In March 2014, the FDA notified Olympus that it needed the additional clearance before selling the altered devices, but the manufacturer did not submit the request for clearance until October, the FDA told ABC News. The submission is still "pending" because the FDA asked for more data.
Olympus said in a statement that it was working with the FDA.
“Olympus modified our 510(k)-cleared duodenoscope in 2010 and determined that the resulting TJF-Q180V did not require a new 510(k) application according to the FDA policy,” the company said in its statement to ABC News. “The FDA subsequently requested a 510(k) notification with information regarding the modified device. Olympus submitted a 510(k) to the FDA and the company continues to cooperate with the agency.”
The FDA noted two other companies make duodenoscopes, and FDA spokeswoman Karen Riley told ABC News, "It's important to understand that we have received reports of infections associated with the duodenoscopes manufactured by all three device companies."
The Food and Drug Administration told ABC News last month that it has been aware of cleaning issues and bacterial transmissions associated with duodenoscopes for more than a year.
"The CDC first alerted the FDA to a potential association of multi-drug resistant bacteria and duodenoscopes in fall 2013," an agency spokesperson told ABC News. "The FDA has been actively working with federal partners, manufacturers and other stakeholders to better understand the issues that contribute to the infections and what can be done to mitigate them."
The FDA issued a safety communication about the duodenoscopes following the UCLA CRE cases, explaining that duodenoscopes are used in about 500,000 procedures a year, but meticulous cleaning and disinfecting "may not entirely eliminate" the risk of transmitting infection. From January 2012 through December 2014, the FDA received reports of 135 patients suspected of contracting germs from reprocessed duodenoscopes, the agency said.
According to the CDC, almost every state has had a confirmed case of CRE, but state health departments are not required to notify the CDC about CRE infections. Duodenoscope-related CRE outbreaks similar to the one at UCLA have occurred recently in Chicago, Pittsburgh and Seattle.