The use of the duodenoscope, which is used to examine a part of the small intestine, has been linked to the outbreak of drug-resistant so-called "superbugs" at hospitals in Los Angeles and elsewhere in the U.S. While some of the victims have filed product liability lawsuits against one of the device's leading manufacturers, the U.S. Food and Drug Administration has issued a new list of measures intended to clean the device between uses.
But the agency readily admits there is a problem with implementing the new "reprocessing" procedures: Not all hospitals have the expertise to do the procedures correctly.
"FDA recognizes that not all health care facilities can implement one or more of these measures, which require specific resources, training, and expertise," the agency wrote in a safety update issued Aug. 4. "Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer's instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks."
In other words, it's complicated.
As the FDA continued, "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. While there will always be a risk of infection transmission with devices used internally, it is important to take all possible steps to minimize that risk so that patients may realize the benefits of these devices ... The FDA is aware of instances of persistent bacterial contamination even following strict adherence to manufacturer reprocessing instructions. Because of this, FDA recommends that facilities and staff that reprocess ERCP duodenoscopes establish and implement a comprehensive quality control program for reprocessing duodenoscopes."
The agency goes on to explain to the health care profession the specific cleaning procedures.
The Centers for Disease Control and Prevention is working with the FDA and with state health departments on taking steps to minimize outbreaks.
In the meantime, Japan-based Olympus Corporation has been defending itself from product liability lawsuits that injured patients filed, and it has been dealing with a U.S. Justice Department investigation related to potential infractions of federal anti-kickback false claims acts. The manufacturer in May set aside about $450 million to settle these potential claims.
As Olympus admitted in its own financial statement issued in May, "In March 2015, the U.S. Department of Justice issued a subpoena to Olympus Medical Systems Corp., a subsidiary of ours. The subpoena seeks information relating to duodenoscopes that Olympus manufactures and sells. In addition, subsidiaries of Olympus have been named as defendants in civil lawsuits in the United States alleging that the plaintiffs were harmed [by] our group's duodenoscopes. Depending on the developments in these matters, our consolidated results of operations and financial condition may be affected."
The family of a woman who died following an October 2014 procedure at UCLA medical center is one of the plaintiffs in a product liability lawsuit. The victim's spouse alleged that Olympus redesigned the duodenoscope model that was used on his wife, but the company failed to issue proper "reprocessing" protocols for the redesigned device. Hence, the device was not properly cleaned and disinfected, and the result, in her case (and, frankly, in other cases allegedly), was fatal. She was 48.
The lawsuit alleged numerous causes of action, including wrongful death and negligence.