U.S. Rep. Ted Lieu (D-Calif.) has written letters to the Olympus Corporation of the Americas (Center Valley, PA) and to Pentax Medical (Montvale, NJ) asking a number of questions in the wake of what’s become a growing national public health concern.
Congressman Lieu’s letters reflect his growing concerns and focused effort to improve public health and to stop the transmission of deadly “superbugs” during certain types of gastrointestinal (GI) endoscopic procedures known as “ERCP.”
The congressman’s letter to Olympus, dated March 23, 2015, may be read by clicking here and his letter to Pentax, dated March 27, 2015, may be read by clicking here.
Adoption by hospitals of the ‘test-and-hold’ surveillance policy proposed by the CDC (click here to read more about it) would likely, if not also ironically, increase sales of a manufacturer’s duodenoscope. Waiting for the microbiological culturing results sidelines the instrument for two days, so a hospital would likely have to purchase additional endoscopes to meet demand for the procedures. — Lawrence F Muscarella PhD
A call for congressional hearings, federal legislation
Congressman Lieu recently called for congressional hearings to investigate the factors that contributed to this recent spate of superbug outbreaks linked to contaminated duodenoscopes, which are a physically complex type of GI endoscope used to perform ERCP.
The congressman says he also plans to introduce federal legislation that would require U.S. hospitals to report infections of carbapenem-resistant Enterobacteriaceae, or CRE, to the Centers for Disease Control and Prevention (CDC), adding:
I don’t see how we can combat superbugs if the CDC doesn’t even know the full scope of the problem. … We should have uniform national reporting for all hospitals. — Rep. Ted Lieu (From The Los Angeles Times March 6, 2015, article “Superbug outbreaks prompt calls for mandatory reporting“)
Currently there are no national reporting requirements for CRE. Fewer than half of the states have passed legislation governing the reporting of these superbugs, and California is not among them.
‘Superbug’ outbreaks linked to GI endoscopes began in 2008
Documented instances of these deadly types of infections, which are primarily caused by the superbug known as “CRE”, first surfaced in 2008, in Florida.
Since then, these infections have increased in frequency, being most prevalent between 2012 and 2014 and occurring in Washington (Seattle), Illinois (Park Ridge), California (Los Angeles), and Pennsylvania (Pittsburgh and Philadelphia), among other cities, too.
Each of these CRE outbreaks was linked by hospital or public health officials to a design limitation that hinders the thorough cleaning and disinfection of the duodenoscope. For more details, the reader is referred to the FDA’s safety communication: “Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning,” which was updated March 4, 2015.
Update: On March 4, 2015, Rep. a bipartisan group of 10 lawmakers including Rep. Ted Lieu (D-CA) wrote a letter to the FDA voicing their concerns about the contribution of the design of regulated duodenoscopes to deadly outbreaks of CRE, including one at UCLA’s Ronald Reagan Medical Center in early 2015.
Dated May 6, 2015, the FDA wrote an 11-page letter to Rep. Lieu, in response. For a continued discussion of this letter, read the Los Angeles Times article, dated May 8, 2015: “U.S. lawmaker slams FDA response to superbug outbreaks.”
Impact of outbreaks
Dozens of patients have been adversely affected by these outbreaks, with the deaths of more than two dozen patients being linked to them. In an ironic twist, many of the infected patients impacted by these several CRE outbreaks across the U.S. since 2008 were never told that a potentially defective GI endoscope model was the cause of their morbidity.
Two of the nation’s recent CRE outbreaks linked to contaminated duodenoscopes have been described in the medical literature. The outbreak in Seattle (WA) between 2012 and 2014 can be read by clicking here and the outbreak in Park Ridge (IL) in 2013 may be read by clicking here.
Legal Reviews and Reports for Consumers, Hospitals, Manufacturers: Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.
Questions asked of manufacturers
Some of the questions that Congressman Lieu’s letter asks, first of Olympus, include:
1. “What plans, if any, is Olympus pursuing to redesign its duodenoscope so that the scope can be cleaned reliably?”
2. “What plans, if any, does Olympus have to recall the current duodenoscope and replace it with one that can be cleaned reliably?”
(Editorial note: On March 26, 2015, Olympus issued an “urgent safety notification” that provides new reprocessing instructions for the unapproved Olympus TJF-Q180V duodenoscope.)
3. “When did Olympus first learn that its duodenoscope was causing CRE infections and outbreaks? What did Olympus do with that information?”
(Editorial note: Bloomberg Business reported on February 27, 2015, that the manufacturer may have known as early as 2008 or 2009 of the potential for duodenoscopes to transmit deadly superbugs such as “CRE”.)
4. “What information does Olympus believe should be provided to patients who undergo procedures that require the Olympus duodenoscope?”
5. “Why did Olympus not seek FDA approval of the redesign of Olympus’ duodenoscope in 2010?”
Congressman Lieu’s second letter to Pentax asks a similar set of questions, although not the 5th question, because only Olympus’s TJF-Q180V duodenoscope was marketed and placed into clinical use (in 2010) without first receiving a legal clearance or approval from the FDA.
Instead, the congressman asked uniquely of Pentax: “Olympus America, another leader in duodenoscope manufacturing, has updated their cleaning guidelines. What is PENTAX’s opinion of these guidelines, and will you follow Olympus’ lead and release similar cleaning guidelines?”
Congressman Lieu is recognized for his commitment and focused efforts on public health, and for his letters and discussions about how to prevent deadly superbug transmissions during ERCP.
Posted by Lawrence F Muscarella, PhD on April 8, 2015, Rev A. Dr. Muscarella is the president and owner of LFM Healthcare Solutions, LLC. Some of the healthcare quality services his company provides are listed here.
One thought on “Congressman Lieu Asks Questions of Endoscope Manufacturers in the Wake of Several Deadly “Superbug” Outbreaks”
Hoping to see Olympus’ response to Congressman Lieu’s letter published. Olympus’ windfall profit from their own flawed and non-approved product is not acceptable.