L.A. "superbug" patient in grave condition: lawyer
LOS ANGELES -- Among the seven people infected by a "superbug" outbreak tied to medical instruments at a Los Angeles hospital is an 18-year-old student who has spent nearly three months in the hospital and is in grave condition, one of his attorneys said.
The young man was struggling not to become the third of those infected at Ronald Reagan UCLA Medical Center to die, Kevin Boyle said Thursday.
At the same time, public health officials were stressing that the "superbug" is not a threat to the general public.
Also, the manufacturer of the device in focus disclosed previously that it is under federal investigation.
The patient had entered the hospital for a procedure that involved using an endoscope to examine his pancreas.
"They were scoping it out, trying to see what was the matter," Boyle said. "He had no life-threatening condition before like he does now."
At least seven people - two of whom died - were infected between October and January with a potentially lethal, antibiotic-resistant strain of bacteria known as carbapenem-resistant Enterobacteriaceae, or CRE, after undergoing similar endoscopic procedures. More than 170 other patients may also have been exposed, hospital officials said.
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Boyle declined to release the teenager's name or say where he attends school but said he spent 83 days in the hospital at one point and was released but recently relapsed and is currently hospitalized.
"After he had the procedure he was released. Then he came down with his illness, and when they studied him and noticed he had the CRE bacteria in him they quickly put two and two together," he said.
He said the family doesn't blame UCLA but is considering suing the endoscope's manufacturer, Olympus Corp. of the Americas, an arm of Japan's Olympus Corp.
Another attorney for the patient, Pete Kaufman, claims Olympus changed the device last year without changing its cleaning protocol.
"(It's) a change that you can market to doctors and say, 'Look what we've done, this is easier to use.' But they too often I think overlook the next step which is, 'We've insured that this change doesn't make the device dangerous,"' Kaufman said.
Hospital officials said the infections may have been transmitted through two contaminated endoscopes that were used to diagnose and treat pancreatic and bile-duct problems. The instruments were found to have "embedded" infections even though they had been cleaned according to manufacturer's instructions, said Dr. Robert Cherry, the hospital's chief medical and quality officer. Five other scopes were cleared.
Hospital officials said they immediately removed contaminated medical devices and adopted more stringent sterilization techniques.
At a news conference Thursday afternoon, health officials sought to reassure the public that there is no broad danger.
"This outbreak is not a threat to public health," said Dr. Benjamin Schwartz, deputy director of acute communicable disease control and prevention for the LA County Department of Public Health.
Olympus said in a statement that it emphasizes the importance of meticulous manual sterilization of its instruments. It says it is giving new supplemental instructions to users of the endoscopes and is working with the FDA on the infection problem.
The company is also being investigated for possible violations of false claims and anti-kickback laws. It disclosed Feb. 6 that it has been under federal investigation since 2011 for possible violations of laws that typically ban improper payments to doctors or other customers.
That statement said the company is talking with the Justice Department to "resolve the matters under investigation."
Infections of carbapenem-resistant Enterobacteriaceae, or CRE, have been reported at hospitals around the country, and some have been linked to the type of endoscope used at UCLA.
The duodenoscope is a thin, flexible fiber-optic tube that is inserted down the throat to enable a doctor to examine an organ. It typically has a light and a miniature camera.
Doctors first discovered the problem in mid-December when a patient underwent an endoscopic procedure and developed an infection that couldn't be treated with antibiotics.
An investigation was launched and doctors employed high-tech techniques to find other cases - a process that took several weeks, said Dr. Zachary Rubin, medical director of clinical epidemiology and infection prevention.
It was determined that CRE infections had been passed on from one "source case" patient between Oct. 3 and Jan. 28, Rubin said.
The hospital has notified potentially exposed patients through letters and phone calls and is offering free testing and treatment options.
Health inspectors visited UCLA after being notified and found "no breaks and no breaches" in its disinfection process, Schwartz said.
"You can very easily do everything right and still have some contamination," said Dr. Deverick Anderson, an infectious-disease expert at Duke University. "We're finding this is a problem, but it's probably one that we don't have a very good solution to right now."
The device requires a highly technical cleaning after each use, but with small movable parts and bendable tubing, it's not easy to sterilize, points out CBS News' Omar Villafranca.
"If any of these organisms are left, they can grow up in moisture that remains in the scope overnight, then become millions to billions of organisms by the next morning," infectious disease specialist Dr. Lance Peterson told CBS News.
The U.S. Food and Drug Administration on Thursday issued an advisory warning doctors that, even when a manufacturer's cleaning instructions are followed, germs may linger. The device's complex design and tiny parts make complete disinfection extremely difficult, the advisory said. Between January 2013 and December 2014, the FDA received 75 reports involving 135 patients in the U.S. who may have been infected by tainted scopes.
In a statement, the FDA said it is trying to determine what more can be done to reduce such infections. But it said that pulling the device from the market would deprive hundreds of thousands of patients of "this beneficial and often life-saving procedure."
"The FDA believes at this time that the continued availability of these devices is in the best interest of the public health," the agency said.