Bacteria-resistant infections potentially connected to procedures involving the reusable duodenoscope have been reported across the country, notably in Southern California, where reportedly three infected patients died. If manufacturers and federal officials had thought they had contained the problem, they were mistaken, as another hospital announced Wednesday that some of its patients developed a suspected duodenoscope-related infection.
This outbreak comes on the heels of a federal agency’s condemnation of the way in which the maker of this particular duodenoscope model has handled key information about the infection risk.
Wednesday’s announcement came from Huntington Hospital in Pasadena, Calif. The infections there involved three patients. The infections are not contagious.
The Pasadena Public Health Department swiftly announced Thursday that it had launched an investigation, in which the Los Angeles County Public Health Department has been participating.
These duodenoscope-linked strains are called “superbugs” because they fight tooth-and-nail against the otherwise healing properties of antibiotics. The Pasadena-based hospital identified the bacteria as Pseudomonas, “a different type of bacteria than was detected in similar cases at other hospitals in Los Angeles County,” according to a PPDH statement. In other cases, the infection was CRE or carbapenem-resistant Enterobacteriaceae.
A Huntington Hospital executive said Wednesday that the health care facility quarantined the suspected equipment “after discovering a potential link between bacterial growth in a small number of patients who had undergone an ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure,” a duodenoscope procedure which, according to the U.S. Food and Drug Administration, is performed about a half-million times a year.
“Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum),” according to the FDA. “They contain a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities.”
The problem is preparing, or “reprocessing,” these medical devices for reuse. “Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices, and can result in infection transmission if reprocessing instructions are not followed in every step of the process,” the FDA wrote on Aug. 4.
Hospitals and duodenoscope makers have been sued. The manufacturer of the duodenoscope involved in Pasadena is Olympus, which has been named a defendant in duodenoscope lawsuits. Pentax Medical similarly has been involved in duodenoscope lawsuits.
Both corporations are based in Japan, and both say they want to be a part of the solution.
For instance, Pentax issued a statement in February that read, in part, “Pentax Medical is actively engaged with the FDA, professional medical societies and other industry partners in analyzing these occurrences and uncovering potential vulnerabilities in duodenoscope design and reprocessing methodologies.”
Olympus said in May, “We express our sympathy to those who have experienced these infections … We are investigating the situation with respect to our TJF-Q180V duodenoscope in the United States and working with the United States Food and Drug Administration, other competent authorities, relevant medical societies and our customers to enhance safeguards with respect to cleaning and reprocessing this model on a global basis.”
But, the FDA put Olympus on the hot seat this month regardless of the corporation’s “sympathy” and its efforts to “enhance safeguards.” Apparently, Olympus was caught red-handed failing to report within 30 days duodenoscope infections leading to death or serious injury, as federal regulations require.
The agency Aug. 12 let Olympus President Akihiro Okubo have it. The agency’s letter read, in part: “… Complaint #GIR/OBV-11055 references 16 patients who contracted a Pseudomonas aeruginosa infection, of which some resulted in abscesses, after undergoing an endoscopic procedure with your firm’s devices. Your firm submitted one MDR [medical device report] to account for all the patients involved in the event. Your firm failed to submit an initial MDR for each event referencing patients sustaining abscesses as a result of contracting a Pseudomonas aeruginosa infection after undergoing an endoscopic procedure involving your firm’s devices. Your firm became aware of the event on May 16, 2012. The referenced MDR and all additional MDRs associated with the event were received by FDA in 2015, which is beyond the 30 calendar day timeframe.”
The FDA directed Olympus to “investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.”
As one would expect, the federal agency is not the only entity that holds manufacturers accountable when their products are linked to death or serious injury, especially when the health risk that the devices pose is unreasonable. There is a justice system in place to deal with such – and this is being polite – errors. Patients or patients’ families have filed duodenoscope lawsuits. This is product liability litigation like the type in which the attorneys at Reich & Binstock engage in.
No one should be exposed to unreasonable health risks that a manufacturer either knew or should have known about and, frankly, could have averted if it had not seemingly put safety ahead of profit. Other infected patients also might want to consult an attorney.