Olympus, the maker of a medical scope linked with fatal superbug outbreaks, has announced it will recall and attempt to redesign the faulty scope. The company’s duodenoscope incorporated a design flaw making it virtually impossible to properly disinfect between uses, exposing hundreds of patients to the carbapenem-resistant Enterobacteriaceae, or CRE.
Here’s a look at the type of scopes involved, the risk of infection, and what to do if you’ve been injured by an Olympus scope.
Scope Safety
A duodenoscope is a flexible, lighted tube inserted to inspect the top of the small intestine and diagnose and treat problems in the pancreas and bile ducts. The scopes are reusable, and require a detailed, multistep process to clean, disinfect, and sterilize. According to the Los Angeles Times, the problem with the scopes generally, and the Olympus scope in particular, was “an internal mechanism inside the reusable device that had been almost impossible to disinfect before being used in the next patient.”
Scope Superbugs
Thus far, the scope has been linked to 25 superbug outbreaks, infecting over 100 patients and killing at least three. Olympus makes about 85 percent of the duodenoscopes on the market, and it is believed the CRE infection was passed through bacteria which could remain in the scope even after it was disinfected according to Olympus’ instructions. (It probably doesn’t help that as hospitals were asking for safer replacement scopes, Olympus was jacking up their prices.)
Legal Liability
Medical device manufacturers can be held liable for defective devices that cause injury. Evidence suggests Olympus knew about problems with its duodenoscopes as far back as 2012, and a Congressional report stated the company and two other manufacturers “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues.” The U.S. Justice Department is also investigating Olympus’s role in the recent CRE outbreaks.
If you’ve been infected following a procedure with an Olympus scope, you may be entitled to compensation. You should contact an experienced personal injury attorney to discuss your case.
Related Resources:
- Injured by Olympus Scopes Superbug? Get your claim reviewed by an attorney for free. (Consumer Injury)
- FDA Says Endoscope Makers Failed to Report Superbug Problems (NBC News)
- When to Bring a Medical Device Lawsuit (FindLaw’s Injured)
- Defective Products and Products Liability (FindLaw’s Injured)