Who’s responsible for infecting patients with a “superbug” at UCLA?
Friday, February 20, 2015
Two patients have died, seven have been infected and nearly 200 others have been exposed to a “superbug” bacteria at Ronald Reagan UCLA Medical Center in Los Angeles. The drug-resistant bacteria was spread by tainted medical scopes used in examinations, leading to fever, chills and in some cases severe sepsis.
The outbreak was not announced to the public until Feb. 18, but hospital officials say doctors had confirmed the scopes’ role in spreading the infection on Jan. 28, after an investigation that began when the first infected patient was identified in mid-December. But attorney Pete Kaufman wonders if the problem could have been identified even earlier. Kaufman represents the family of an 18-year-old man who was diagnosed with the infection in October after one of the scopes was used in an examination of his pancreas at UCLA. The teen spent nearly three months in the hospital, then was reinfected and readmitted after being examined with another scope.
From the Los Angeles Times:
Kaufman said the patient’s family blames the medical device manufacturer, not UCLA, for the infection.“We don’t think that UCLA did anything wrong,” he said. “Based on the early investigation we think it is the fault of the manufacturer for not determining an effective cleaning protocol” for the medical scope used.
UCLA officials say they were sterilizing their scopes “according to the standards stipulated by the manufacturer” but are “now utilizing a decontamination process that goes above and beyond manufacturer and national standards.” The Times reported:
UCLA said it hasn’t had any further infections since it changed its decontamination procedures for the endoscopes involved. After the outbreak, UCLA switched to gas sterilization of its duodenoscopes. Some other hospitals have turned to that technique in the wake of similar outbreaks at other hospitals across the country since 2012.
But the gas sterilization technique is reportedly expensive and can take up to 12 hours, meaning hospitals need to buy more scopes to have enough available for use at any given time. One health care consultant told Reuters that can lead to an additional $1 million expenditure by the hospital.
The Associated Press pointed out widespread infection issues related to the scopes:
The U.S. Food and Drug Administration issued an advisory [Feb. 19] 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.”
Meanwhile, Reuters reports knowledge of the problem goes back even further:
U.S. health regulators have known since at least 2009 that the medical devices at the center of the “superbug” outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said….
In 2009, soon after 16 patients in France were infected with a pathogen after undergoing the procedure, the FDA issued its first notice about the devices, warning the medical community they could transmit dangerous germs from one patient to another.
Infectious disease specialist Judy Stone, writing at Forbes.com, asked who should be held responsible for the outbreak:
Is it the FDA, everyone’s favorite scapegoat, for not insisting on more stringent design and cleaning recommendations?
Is the hospital to blame, for cutting corners in cleaning scopes? I’ve certainly seen that happen, when a temperamental surgeon or gastroenterologist doesn’t want to wait longer for scopes to be soaked for the recommended amount of time in disinfectant.
None of the three major manufacturers of duodenoscopes, Pentax Medical, Olympus, and Fujifilm Medical Systems, are planning to redesign the problematic part of the scope, the “elevator wire channel,” according to Modern Healthcare. Perhaps the FDA can help change their minds. After all, the FDA notes that with the current design “effective cleaning of all areas of the duodenoscope may not be possible.”
One interesting aside, reported by the Los Angeles Times, is that the Olympus Corp. has been under investigation since 2011 for possible violations of federal anti-kickback laws and the False Claims Act in regards to their promotion of their product.
Kaiser Health News reporter Jordan Rau writes the problem goes beyond the design and cleaning of the scopes:
The bacterial outbreak at a Los Angeles hospital highlights shortcomings in the federal government’s efforts to avert the most lethal hospital infections, which are becoming increasingly impervious to treatment.
Government efforts are hobbled, infection control experts say, by gaps in monitoring the prevalence of these germs both within hospitals and beyond. The continued overuse of antibiotics — due to over-prescription by doctors, patients’ insistence and the widespread use in animals and crops — has helped these bacteria evolve into more dangerous forms and flourish….
The federal government has been trying for years to get doctors and hospitals to shrink their use of antibiotics, since their proliferation has helped create these new resistant bacteria strains. The CDC has encouraged hospitals to create antibiotic stewardship programs, in which experts systematically try to insure that the bacteria-fighting drugs are the best resource and that there is evidence that they actually work on the specific infection the patient has….
California last year mandated hospitals create stewardship programs, but the federal government considers them voluntary. Even the Infectious Diseases Society of America was unable to determine how many hospitals have such a program, said John Billington, the society’s director of health policy.
Some patients say UCLA officials waited too long to act on the situation. Sheila Adamczyk, whose 16-year-old daughter was examined with a scope for cancer screening in October and again in December, told the Los Angeles Times: “I want to know what the hell is going on and I want to know right now. They had two deaths. They knew this had taken place.”