Three people died and 45 people developed infections from contaminated endoscopes, the US Food and Drug Administration said Friday.
The reports of contamination are with a side-viewing duodenoscope used for a medical procedure called endoscopic retrograde cholangiopancreatography or ERCP. “These flexible lighted scopes are vital for minimally invasive procedures to diagnose and treat conditions of the pancreas and bile duct,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
The reusable scopes, which are made by three manufacturers – Fujifilm Medical Systems USA Inc., Olympus Medical Systems Corporation and Pentax of America – are known to be difficult to decontaminate. They have been linked to deadly outbreaks of the superbug carbapenem-resistant Enterobacteriaceae, or CRE. The contamination issues result from damaged scopes and improper decontamination.
In 2015, the FDA required the manufacturers to conduct post-market surveillance studies to fix the problem.
The agency said Friday, “The preliminary results as of March 2019 indicate higher than expected levels of contamination.”
In December, the FDA said the number of infections and instances of contamination found on devices had declined as a result of safety measures put in place in 2015.
“Our analysis of medical device reports associated with patient infections for duodenoscope indicates that the number of medical device reports peaked in 2015 at 250 reports and declined 62% to fewer than 100 reports per year in 2017,” according to a safety communication issued by the FDA on Friday. But new reports of contaminated devices and patient infections emerged “late in 2018,” the agency said.
Among 205 medical device reports that were submitted between October 15 and March 31, there were 45 reports of patient infections, one report of a patient who was exposed to infection but did not become sick, and 159 reports of devices that were contaminated. Those reports also included three deaths in 2018 related to these scopes.
“These reports indicate that although the number of reports has declined, there continues to be a need for improvement of the safety of reprocessed duodenoscopes,” the report says.
The FDA said its recommendations for maintaining and decontaminating the device have not changed. “The FDA is actively working with reprocessing experts, medical device manufacturers, and other government agencies to advance innovative ways to decrease infection related to duodenoscopes,” the agency said in its safety communication.
Shuren added in a statement Friday, “But we’re continuing to evaluate the benefit-risk profile of these devices, and we’d like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections. Currently, that evidence is lacking, and we’re considering what additional regulatory actions may be necessary.”
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The agency also noted that it sent warning letters to all three manufacturers of these devices in March 2018 because the companies failed to deliver sufficient data required by post-market surveillance studies. The FDA said the companies all provided plans for continued study and sample collection.
The agency said it is still tracking reports of infection and device contamination on a monthly basis. It is also working with facilities and care providers to modify processes and reduce the risk to patients.
In addition, efforts are underway to “encourage the development of new technology and design features, such as disposable components, to enhance patient safety.”
Previously, the FDA said that the benefits outweigh the risks of infection from these scopes, which are used for more than 500,000 procedures annually.