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Duodenoscopes under FDA scrutiny


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It is possible that the “complex design” of duodenoscopes may make them hard to clean, to disinfect, and to sterilize, thus infection-prone. That assessment is from the U.S. Food and Drug Administration, not from any law firm, which issued a safety communication Feb. 19 in regard to the medical devices. These devices are described technically as Endoscopic Retrograde Cholangiopancreatography, or ERCP, endoscopes.

The reason for the regulatory agency’s concern is recent adverse event reporting that associates the emergence of multidrug-resistant bacterial infections with the use of sterilized and reused, or “reprocessed,” duodenoscopes. As the agency further explains, “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”

More than a half-million ERCP procedures using duodenoscopes are performed every year in the U.S. “The procedure,” according to the FDA, “is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). 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 bottom line, from the federal perspective, is that duodenoscopes can be hard to clean. And that characteristic may be the origin of lingering serious infections.

“For example,” the FDA wrote, “one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

The FDA has received medical device reports, or MDRs, dealing with infections that appeared to have been spread through the reuse of these instruments. “In total, from January 2013 through December 2014, the FDA received 75 MDRs encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes. It is possible that not all cases have been reported to the FDA,” according to the agency.

Obviously, infection rates and the reasonableness of the risk of serious infection bear further analysis. Nevertheless, there is a broader perspective on this situation: There have been chapters in this country in which courts have sided with injured patients who claimed that their injuries stemmed from the use of a medical device that posed an unreasonable risk.

For instance, the Transvaginal Mesh Litigation Team at the law firm of Reich & Binstock has fought hard for the compensation its clients deserved for infection, mesh erosion through the vagina, and numerous additional complications resulting from the implantation of a failed synthetic device.

Reich & Binstock also sat at the table next to victims of metal-on-metal hip implants and aggressively pursued recoverable damages for the metallosis and other problems the patients suffered because of the metal ions churned into tissue from the friction within the devices.

Additionally, the law firm, which operates in every state, will investigate and provide a free legal analysis to women who believe that their cancer diagnosis may be linked to the use of laparoscopic power morcellation in the performance of hysterectomy or myomectomy in women with uterine fibroids.

Reich & Binstock offers a free consultation to patients who come forward and tell one of its experienced product liability attorneys about injuries that may very well result from the use of a medical device or a harmful drug.

The most essential step is to request a free consultation, confidant that your concerns will be addressed promptly and professionally. Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its website.

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