Duodenoscopes Used for ERCP Procedures Linked to “Superbug” Outbreaks

Recent outbreaks of the “Superbug” infection, Carbapenem-Resistant Enterobacteriaceae (CRE), have been linked to complex endoscopic procedures (ERCPs) utilizing a device called a duodenoscope. There is evidence that duodenoscopes can carry CRE infections even when the scopes are cleaned using the manufacturer’s instructions. These cases of bacterial infection are potentially deadly and cannot be treated with antibiotics.

What is a Duodenoscope?

Duodenoscopes are a type of endoscope that are generally used for patients with pancreatitis. Doctors guide the scope in through the mouth, down the throat and through the stomach to the duodenum. The duodenoscope is a thin tube that has a tiny lighted camera at its tip so that physicians can diagnose and treat disease in the pancreas and bile ducts.

The medical procedure is called an Endoscopic Retrograde Cholangiopancreatography (ERCP). Duodenoscopes are cleaned after each procedure and reused. The problem appears to be that the manufacturer’s recommended cleaning procedure does not always thoroughly disinfect the scope,meaning that dangerous bacteria can be passed among patients.

Superbug Outbreaks

• California - 179 people were exposed to, and seven were infected by, the deadly “superbug” (CRE) at UCLA’s Medical Center. Two people died of the exposure.
• North Carolina – 3 outbreaks and one death occurred in North Carolina.
• Washington – 35 people were infected with CRE and four deaths occurred at Seattle’s Virgina Mason medical Center
• Illinois – 44 people experienced infection at Advocate Lutheran General Hospital.
• Minnesota -The outbreaks actually date back to 1987 when Dr. John Allen traced ten cases of this same “superbug” to scopes used in his hospital.

The FDA claims they have seen 135 duodenoscope-related cases of CRE in the last two years, but the medical community believes that many of these bacterial infections have gone unreported.

The FDA Warning

The outbreaks of CRE have prompted the FDA to issue a safety warning to hospitals. In the warning the FDA explains that the “complex design” of the duodenoscopes may render the standard cleaning procedures ineffective. The FDA recommends that medical staff follow more thorough manual disinfection of duodenoscopes, concentrating on the tips of the scopes that can retain deadly bacteria and spread it among patients. While the warning is welcomed news, many medical professionals believe that the warning does not go far enough, and that the problem lies more with innate design of the duodenoscopes which makes complete sterilization virtually impossible.

Legal Action Involving Duodenoscopes

Duodenoscope manufacturer Olympus, is faced with a growing number of lawsuits from the recent “superbug” outbreak in California. The basis of the suits is that Olympus was negligent in marketing its product without proper instructions for decontamination of the duodenoscope.

Additionally there is speculation that Olympus may have learned of the problem after CRE outbreaks in 2013 and failed to publically warn doctors and medical personnel of the risks of the scopes spreading bacteria among unsuspecting patients. With nearly 500,000 patients a year undergoing ERCPs and other procedures that utilize a duodenoscope, there is a clear reason to demand answers.

Do you need to Discuss a Defective Medical Device Case with an Attorney in Kentucky?

Kentuckians who believe that they or a family member may have been diagnosed with the dangerous virus, CRE, as the result of an ERCP or another duodenoscope procedure can contact attorney, Brett Oppenheimer, for a free consultation. Brett is a Louisville, Kentucky lawyer who represents and advocates for clients throughout Kentucky who have been injured or harmed by defective medical devices. You may call Brett directly at (502) 242-8877.