Deadly Bacterial Infection Risk with Duodenoscopes
Southern Nevada Health District issued a Public Health Advisory earlier this year regarding the safety of Endoscopic Retrograde Cholangiopancreatography (ERCP) duodenoscopes used to diagnose and treat problems with bile and pancreatic ducts. The safety concern is with the design of the ERCP duodenoscopes (also called endoscopes) in that it may impede effective cleaning. The advisory relayed information from an FDA Safety Communication aimed to raise awareness among healthcare professionals about the complex design of these scopes. The extra grooves and channels on the surface of the scope can trap antibiotic-resistant superbugs that are difficult to remove and can be passed to other patients. The safety communication warned that the multi-step process to clean and disinfect these reusable devices may be linked to the multidrug-resistant bacterial infections in patients who have undergone procedures with these reprocessed duodenoscopes, even when the manufacturer’s reprocessing instructions are correctly followed. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection but may not entirely eliminate it.
The 93-year-old Japanese electronics giant, Olympus Corp., who just three years ago was amid scandal and plummeting sales of its signature cameras, aggressively broke into health care, selling gastrointestinal scopes to doctors and hospitals in the U.S. and worldwide. The company today owns a commanding 70 percent share of the global market for gastrointestinal endoscopes but now face scrutiny for “superbug” outbreaks at U.S. hospitals. The outbreaks have been linked to deadly bacteria on contaminated Olympus scopes, namely the Olympus TJF-Q180V duodenoscope. Olympus started selling the TJF-Q180V duodenoscope in 2010, but reports are saying the FDA did not notice until late 2013, early 2014. Apparently, Olympus had never asked for clearance to put it on the market, according the deputy director of strategy for the FDA’s Office of External Affairs, Karen Riley.
The outbreak originated at UCLA where 7 hospital patients at Ronald Reagan UCLA Medical Center were infected and 2 patients died. According to hospital officials, an additional 179 people may have been exposed to the deadly bacteria or ‘superbug’ known as carbapenem-resistant Enterobacteriaceae or CRE on contaminated Olympus scopes. The patients allegedly caught CRE following endoscopic procedures. Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak. CRE is perhaps the most feared of drug-resistant superbugs, because it resists even “last defense” antibiotics — and kills up to 40% of the people it infects.
Cedars-Sinai Medical Center in Los Angeles also released a statement of 4 patients being infected with the deadly bacteria linked to these contaminated scopes. The medical scope was used in all 4 patients and 64 other patients that had the duodenoscope procedure with that particular scope were all being informed as a precaution.
An update in the news recently stated that Olympus scopes were also being blamed for spreading this drug-resistant “superbug” infection at Virginia Mason Medical Center in Seattle this year. This time it appears Olympus is firing back, saying in a lawsuit its devices aren’t responsible for death or damages and filed a cross-claim against Virginia Mason. The company said in the countersuit that Virginia Mason failed to clean and use the device properly and that the hospital damaged the company’s reputation with claims that the firm’s duodenoscope could not be properly cleaned.
Contaminated medical scopes have been associated with outbreaks throughout the country. According to the FDA, duodenoscopes from Olympus and 2 other medical device manufacturers have been linked to “142 multidrug-resistant infections in patients across the U.S. since 2010.”
As the outbreaks continue to unfold, Olympus executives have made presentations to medical professionals emphasizing that infections from reusable scopes are rare if cleaning instructions are followed. The company also states on their website that this issue connecting duodenoscopes to CRE infections is receiving the highest level of attention and that they’re investigating the situation and with the FDA, relevant medical societies and customers to increase safeguards with respect to the cleaning and reuse of the TJF-Q180V model duodenoscope on a global basis.
Olympus, as the market leader for such scopes, has drawn the most scrutiny but the concerns also apply to the company’s main rivals, Pentax Medical and Fujifilm. The FDA says it is working with all three of these major manufacturers of duodenoscopes to assess potential design changes and determine whether new disinfection processes can ensure the safety of these scopes in their current configuration.