Update, March 24: On Monday, Rep. Ted Lieu sent a letter to device maker Olympus, asking if the company plans to redesign or recall the duodenoscopes linked to several deaths from antibiotic-resistant superbugs spread through dirty scopes.
LOS ANGELES – A medical device called a duodenoscope that's been linked to recent deadly superbug infections across the country was also connected to a 2013 outbreak at a Wisconsin medical facility that infected five people, America Tonight has learned.
Health officials at the Wisconsin Department of Health Services confirmed the five patients were sickened with NDM1 – a subgroup of an antibiotic-resistant "superbug" known as carbapenem-resistant Enterobacteriaceae, or CRE, that's responsible for two deaths at UCLA’s Ronald Reagan Medical Center in Los Angeles since October and dozens of serious infections around the country in recent years.
Meanwhile, Cedars-Sinai Medical Center, another Los Angeles hospital, announced Wednesday that four patients there were infected with the deadly superbug due to a dirty duodenoscope and that 64 more patients may have been exposed since August.
The Wisconsin patients were infected after undergoing a relatively common scoping procedure called endoscopic retrograde cholangiopancreatography, or ERCP, using an Olympus Medical Systems scope. Medical workers run the flexible scope with a light through the mouth and stomach into the top of the small intestine to drain fluids from ducts in the small intestine that may be blocked by gallstones or tumors.
The medical facility followed the manufacturer’s cleaning protocols for the scopes, according to Gwen Borlaug with Wisconsin’s Department of Health Services:
DPH worked with the facility to help determine the source of a CRE infection in a hospital inpatient who had no risk factors for a subgroup of CRE called NDM-1 (New Delhi-metallo-beta-lactamase-1). Medical records review by the facility showed the only epidemiologic link between the source patient (Patient 1) and the second patient (Patient 2) was that each had had an endoscopic procedure( called ERCP) with the same duodenoscope. Molecular testing of CRE isolates obtained from Patient 1 and Patient 2 indicated the CRE organisms from the two patients were related, and combined with the epidemiologic link, it was determined that Patient 1 was the likely source of Patient 2’s CRE infection, and that the duodenoscope was the likely means by which CRE was transmitted. The facility tested additional patients who had procedures with the same duodenoscope, and in total, 4 patients with NDM-1 CRE were identified in addition to the source patient (Patient 1).
Actions taken by the facility included removing the scope from service, culturing the scope for bacteria, and evaluating their endoscope reprocessing methods. The facility also had a third party infection prevention expert conduct a site visit to review their endoscope reprocessing methods, and neither review resulted in identification of any breaches in reprocessing procedures. All scopes were processed according to currently established professional guidelines. All cultures of the endoscope were negative.
Similar to other outbreaks of CRE organisms, this incident demonstrates that the complex design of duodenoscopes makes them difficult to clean and disinfect, and current reprocessing methods may not be adequate to prevent patient-to-patient transmission of bacteria. CDC, the FDA and professional societies are working with the scope manufacturers to develop more effective cleaning and disinfection processes.
Some patients who had scoping procedures in the Wisconsin facility were not infected.
Jennifer Miller, a communications specialist with Wisconsin's state health department, said the state notified the Centers for Disease Control and Prevention about the outbreak and that the health facility notified the FDA.*
Rep. Ted Lieu, a newly elected Democratic congressman who represents part of Los Angeles, said Wednesday he's considering legislation that would require states to report superbug outbreaks and medical device failures to certain federal agencies.
“It stunned me that our federal agencies didn’t know sometimes what was going on because it’s state-by-state reporting,” Lieu told America Tonight.
"There is no national uniform reporting to the CDC," said Lieu, who added the FDA does have a reporting database, MAUDE, to track device failures and when a device causes death or serious injury. But that means anything less than a death or serious injury doesn’t get reported, according to Lieu.
"It’s possible a device just causes an infection but no serious injury," Lieu said.
Transparency and uniform reporting standards were on Lieu's mind Wednesday when he met with Dr. Stephen Ostroff, the FDA's chief scientist who has been tapped to serve as acting commissioner when the current commissioner, Dr. Margaret A. Hamburg, steps down later this month.
During an hour-long meeting on Capitol Hill, Ostroff told Lieu the agency is planning new procedures for approving endoscopes.
“That’s one of their short- and middle-term things they are looking at,” said Lieu, who wasn’t told of the details of the new procedures.
It stunned me that our federal agencies didn’t know sometimes what was going on because it’s state-by-state reporting
Rep. Ted Lieu
Requests for comment from the FDA on the new protocols have not been answered.
Lieu and nine other members of Congress just sent Hamburg a four-page letter asking, among other things, what the agency did to warn hospitals, doctors and patients about superbug infections prior to media reports about outbreaks at UCLA. They also want to know if the FDA is working with manufacturers to make the devices safer.
The FDA is also being questioned about how and why Olympus was allowed to sell an unapproved duodenoscope.
Olympus, which produced the scopes linked to outbreaks in Los Angeles, Seattle and Wisconsin, issued a statement Wednesday admitting that the company did not get FDA clearance in 2010 when it modified it an already FDA-cleared duodenoscope.
The device maker "determined that the resulting TJF-Q180V did not require a new 510(K) application according to FDA policy," wrote Mark Miller, the company's executive director of. A 510(K) is a fast-track approval process offered by the FDA when modest changes are made to a device already approved for sale.
Miller also noted that endoscopes are used in about 500,000 ERCP procedures each year and that the reported incidence of infections is extremely low.
Requests to Olympus for comment on the Wisconsin outbreak have not been answered.
* Clarification added March 5: In an earlier version of this article, Miller said the state of Wisconsin did not notify the FDA or the CDC about the outbreak or that the scopes appeared to be the source of those infections because it isn't required to do so. On Thursday, she clarified that the state had, in fact, notified the CDC and that the health facility notified the FDA.