Hundreds of patients in several hospitals nationwide have undergone endoscopic procedures with a scope that may be contaminated with deadly superbug bacteria. Specifically, the Olympus TJF-Q180V duodenoscope, a device that’s difficult to sterilize, has been transferring the antibiotic-resistant bacteria carbapenem-resistant Enterobacteriaceae to patients. At least two people have died; eight have tested positive; and hundreds of others have been informed of potential exposure to the endoscope superbug infection. Lawsuits are cropping up around the country.
Endoscopic Superbug Infections
More than 500,000 endoscopic procedures are performed in U.S. annually, procedures that help diagnose or treat liver disease, bile duct issues, pancreatic disease and certain types of cancer. The problem with the Olympus scope in question is a component on the device called an elevator channel. Even though the company sealed the channel and provided cleaning instructions, the component still may harbor bacteria. “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection but may not entirely eliminate it,” the FDA explained in a report.
This scope has been implicated as the source of a recent outbreak of the carbapenem-resistant Enterobacteriaceae (CRE) superbug infection at Ronald Reagan UCLA Medical Center, Thomas Jefferson University Hospital, and other hospitals in Seattle and Chicago. When doctors use the duodenoscope for endoscopic retrograde cholangiopancreatography (ERCP), they insert the scope through the patient’s throat or anus. If the device isn’t completely sterile, deadly bacteria may enter the patient’s body and cause a life-threatening infection.
Serious & Deadly Infections
The problem with this particular bacteria is that it’s extremely resistant to treatment. Antibiotics do little to deter the bacteria. The Centers for Disease Control and Prevention explain: “Infections with these germs are very difficult to treat, and can be deadly — one report cites they can contribute to death in up to 50% of patients who become infected.”
Symptoms of CRE vary, depending on the organs that have been infected. People who are infected with the bacteria may experience the following.
- Urinary tract infection
Doctors have tried using antibiotics such as aminoglycosides, polymyxins, tigecycline (Tygacil) and fosfomycin (Monurol) to fight the superbug — but have had only a limited amount of success.
The Progression of Superbug Scope Cases
Below are a few highlights of the development of the recent endoscopic superbug infection scare.
- Olympus began selling its TJF-Q180V duodenoscope in 2010 without the FDA’s approval.
- In late 2013, the FDA finally realized its oversight. Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, commented, “Can you imagine a prescription drug getting out on the market that didn’t go through the approval process? Devices need to be regulated more vigorously. This is really”
- In 2014 and 2015, hospitals begin reporting outbreaks of CRE. Some hospitals sent out letters to patients who underwent procedures with the scope that explained the possible exposure.
- In February 2015, the FDA released a report entitled, Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication.
- In March 2015, Olympus issued an urgent update on the cleaning procedures for the device.
- Olympus finally applied for FDA approval for the device. (The application is still pending.)
- In 2015, patients and their family members began filing lawsuits against the manufacturer and hospitals for their damages.
Manufacturers have a legal duty to put only safe products on the market. The FDA holds medical device companies to certain standards. In the case of endoscopes, the company must provide evidence that the device can be 99.99 percent sterile before the agency approves the product for market. Thus far, Olympus has failed to do that.
Victims can file a product liability claim against a manufacturer when the manufacturer was negligent. Many people are already in the process of filing suits for the superbug outbreak. If you or your loved one developed an illness after an endoscopic procedure, you’re encouraged to call our office, Gacovino, Lake & Associates, P.C., for a free legal consultation. We may be able to help you obtain financial restitution for damages. Call us today at 631-543-5450.