Medical scopes suspected of spreading deadly bacteria are under scrutiny since an outbreak at UCLA Medical Center emerged this month. But problems with the devices were recorded years ago: The same type of scopes was implicated in a previously unreported outbreak of antibiotic- resistant superbugs six years ago in Florida that affected 70 patients, including 15 who died.
The Florida outbreak is one of a handful now coming to light that states haven’t previously made public. The cases were linked to the same kind of specialized medical scopes, known as duodenoscopes, that was involved in the UCLA outbreak. They affected patients at two hospitals in Highlands County in central Florida in 2008 and 2009, according to G. Steve Huard, a spokesman for the Florida Department of Health. The outbreak was reported to the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the device manufacturers, Huard said.
He said he couldn’t identify the hospitals involved, citing Florida law that makes the information confidential.
The FDA warned in a safety alert on Feb. 19 that the complex design of the scopes means it “may not be possible” to effectively clean them. That was the day after the Los Angeles Timesreported that 179 patients at UCLA might have been exposed to potentially life-threatening bacteria, known as CRE, that resist last-resort antibiotics. Seven UCLA patients have been confirmed infected, including two who died, according to the hospital.
Patients who contract CRE are generally being treated for other serious medical problems, and deaths in any outbreak may be attributable to other causes. Bloomberg learned about the Florida outbreak after asking state health officials about records of CRE infections.
The FDA apparently has no record of the earlier Florida cases in Highlands County. “We are aware, via a search of medical literature, of cases of CRE at two hospitals in the Tampa area during that time,” FDA spokeswoman Leslie Wooldridge said in an email. Tampa is in Hillsborough County, about 100 miles from Highlands County.
A paper on the Tampa cases, published in 2012, describes seven cases in two hospitals. Based on the medical literature, the Tampa outbreaks “were due to inadequate cleaning procedures,” Wooldridge said, and the FDA has no record of problems with the devices being reported at the time.
In the newly revealed Highlands County outbreak, the number of patients affected and the number of deaths appear to be greater than in other outbreaks that have come to light. “It’s catastrophic. I’m stunned to hear it,” said Lawrence Muscarella, a patient safety consultant who has been tracking endoscope- related outbreaks. He said hospitals have a responsibility to tell patients when they may have been exposed, though they’re not required by law to do so.
Duodenoscopes are used in about 500,000 procedures a year in the United States, according to the FDA. The risk that endoscopes can transmit bacteria between patients, even after cleaning, has been known in the medical community for decades. But the devices are in the spotlight now because outbreaks in Los Angeles and Seattle involve drug-resistant superbugs. The Seattle outbreak at Virginia Mason Medical Center began in 2012 and didn’t become widely public until late January, with reports in USA Today and the Seattle Times. Thirty-two patients were affected, including 11 who died.
States have a haphazard approach to tracking the infections. Only about half of the 44 state health departments that responded to questions from Bloomberg said they require hospitals and labs to report individual cases of CRE. More states require reporting if doctors detect an outbreak or cluster of cases, but the rules for this are inconsistent across states as well.
Wisconsin hospitals have to report CRE cases to the state. Authorities have identified two clusters since 2012, including one tied to a contaminated duodenoscope that passed the infection to four patients, according to Jennifer Miller, a spokeswoman for the Wisconsin Department of Health Services. That outbreak has not previously been publicized.
In Pennsylvania, where the University of Pittsburgh Medical Center investigated superbug infections transmitted by duodenoscopes in 2012, the state doesn’t track CRE infections or transmissions by endoscopes, according to Wes Culp, a spokesman for the state Department of Health. Another outbreak linked to the scopes at an unidentified Philadelphia hospital was reported this month by the Philadelphia Inquirer.
Illinois has required reporting of CRE since November 2013. That year the state had one of the most widely documented outbreaks tied to the scopes: Investigators from the Centers for Disease Control and Illinois health authorities identified 39 cases of a rare variety of the bug known as NDM, with 35 due to exposure to duodenoscopes. The team published its findings last fall in JAMA: The Journal of the American Medical Association, noting that no mistakes in cleaning had been identified: “It appears that these devices have the potential to remain contaminated with pathogenic bacteria even after recommended reprocessing is performed.”
A second set of cases in Illinois got less attention: Two scopes transmitted CRE to two patients in April 2014, according to Melaney Arnold, a spokeswoman for the state Department of Public Health. The state started a registry to track patients who may have been exposed to CRE, and a task force devoted to the superbug will begin to meet in May, she said.
Duodenoscopes are threaded through the mouth and the gastrointestinal tract, allowing doctors to reach tiny ducts in organs such as the pancreas or gallbladder without cutting patients open. They’re mainly manufactured by Olympus, Pentax, and Fujifilm. Olympus, the maker of the scopes used at UCLA, was named in a lawsuit this week by one of the patients infected. Olympus didn’t respond to requests for comment.
Hospitals are evaluating their infection control processes in light of the recent outbreaks. Some, including UCLA and Virginia Mason, have changed the way they clean the scopes. The CDC is expected to issue new guidelines to prevent transmissions. Sen. Patty Murray, a Washington Democrat, urged the FDA to update its guidelines. Rep. Ted Lieu, a California Democrat, called for hearings to investigate “multiple sterilization failures” of the scopes. The full extent of those failures, and how many lives they may have cost, is still unknown.
