Product News and Recalls

Number of Patients Harmed by Contaminated Duodenoscopes Higher than Previously Thought

number of patients harmed by contaminated duodenoscopes higher than previously thoughtIt’s getting harder and harder to know just how much harm has been done in the U.S. and abroad by contaminated duodenoscopes. As more issues come to light about scope design and its impact on device cleaning and sterilization, the number of patients known to have suffered superbug infections from the devices continues to rise.

Now, thanks to a new report commissioned by a congressional investigation, we know that the number of CRE and other antibiotic-resistant infections is significantly greater than what was originally reported or anticipated.

According to Kaiser Health News, an analysis of FDA records dating back to 2010 shows that “as many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan 1. 2010 to Oct. 31, 2015.”

This represents a significant jump from the data contained in a similar report issued by the U.S. Senate in January of this year. That report only looked at incidents from 2012 to 2015. The resulting difference is stark; that investigation yielded just 250 duodenoscope-induced infections spread out among only 25 worldwide healthcare facilities.

There is no reason given for the significantly earlier start date of the previous report.

The discovery of the duodenoscope’s ability to transmit drug-resistant bacteria from one patient to another rocked the medical device industry last year. A cluster of patient deaths in California brought significant attention onto the design of the devices and the difficulties that hospital technicians were experiencing as they readied the $40,000 scopes for the next patient in a system known as reprocessing.

olympus knew about duodenoscope issues for 2 years before alerting american authoritiesInvestigators determined that the overall design of the scope was flawed and, because of that design, complete sterilization of the device could not realistically be guaranteed under a normal cleaning regimen. The end result was that bacteria from inside one patient could be left on the scope and transmitted to the insides of another patient. This situation made the duodenoscope completely unsafe for use.

Most damning of all, however, was the news that Olympus knew about the issues surrounding their duodenoscopes and warned European doctors about those problems some two years prior to notifying doctors in the United States.

Congressman Ted Lieu, whose inquiry led to the reexamination of the FDA’s records, is introducing legislation to prevent that scenario from happening again in the future. One of the key aspects of the so-called DEVICE Act stipulates that medical device manufacturers marketing products in the United States must notify the FDA when they issue warnings about the cleaning and design of their devices in other countries. A second bill forces medical device manufacturers to scientifically prove that the cleaning instructions for their devices actually work.

The reason behind Olympus’ decision to wait for two years before alerting the American healthcare industry to issues with its duodenoscopes may never be fully understood. However, this new legislation may help ensure that patients are never again injured by something that doctors in other countries are already aware of and actively working to avoid.