News Feature | May 12, 2015

FDA: 142 Reports Of Tainted Duodenoscopes Since 2010

By Jof Enriquez,
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FDA EHR Pilot Program

The FDA recently disclosed more reports related to contaminated duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

According to an FDA report, the agency received 146 medical device reports (MDRs) of ERCP devices linked to a patient infection, exposure, or device contamination for the period covering January 1997 to February 2015. Of the 146 reports, 142 were received since 2010. The total number of infected patients may be higher than the number of reported MDRs, since each MDR refers to cases involving one or more patients. However, the FDA did not state any figures regarding the number of patients affected during the period.

The FDA had previously said that it received about half that many MDRs (75) on contaminated duodenoscopes during 2013 and 2014, according to the Los Angeles Times.
The agency also revealed that it received 152 MDRs associated with automated endoscope reprocessors (AERs), which are devices used to wash, clean, and disinfect heat sensitive endoscopes.

Although MDRs in its MAUDE (Manufacturer and User Facility Device Experience) database is a source of valuable information, the FDA acknowledged that “this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”

Because of late or underreporting, the number of actual infections associated with duodenoscopes may be much higher, according to some experts.

“These reports can come in 18 months to two years later,” Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa., told the Times. “The FDA’s new figures “could significantly underestimate the risk.”

“There is a systemic risk from this instrument. The problem of underreporting is probably high,” said Dr. James McKinnell, an expert on hospital epidemiology at the L.A. Biomedical Research Institute at Harbor-UCLA Medical Center, according to the publication.

The FDA report comes ahead of an agency panel meeting this week that will discuss a new approach to reprocessing devices in light of recent superbug infections wherein hundreds of patients in multiple states were exposed to the deadly pathogen called carbapenem-resistant enterobacteriaceae (CRE). 

The agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will convene to discuss the findings in the report and to “seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information,” according to a notice in the Federal Register.

The FDA had earlier issued a safety alert in the wake of superbug outbreaks in UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center, which were publicly made known in February. In the warning, the FDA said that “the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing,” and that “meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”

The agency later released final guidance documents on the reprocessing of reusable medical devices. The FDA recommends medical device manufacturers more thoroughly test and label new devices.

In the report, the FDA also stood by its decision not to remove the Olympus TJF-Q180V duodenoscope device from the market, because doing so will fail to meet clinical demand in the United States. The device model was linked to the recent superbug outbreaks. Instead, the FDA said it recommends that facilities train staff on updated instructions on how to properly clean the devices.

The FDA said that both an engineering assessment it conducted and a growing body of literature have identified design issues — such as the moving elevator mechanism — as features that make reprocessing of duodenoscopes challenging.

“The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern. Enhancing the safety margin of ERCP by addressing the challenges associated with duodenoscope reprocessing due to its complex design is therefore the main focus of this Advisory Committee meeting,” the FDA stated in its report.

A presenter in the upcoming FDA meeting, Michael Drues, Ph.D. recently wrote an article in Med Device Online about his recommendations in addressing the growing industry problem of reprocessing devices. In his article Can We Design Medical Devices To Be Reprocessed Without Killing People?, he suggests product engineers “design for reprocessing” devices at the start of the product development cycle and as part of usability testing.

He also called on increased collaboration between manufacturers and end users in making sure cleaning instructions for reprocessed medical devices are technically feasible in actual practice.

“Reprocessing validation should not be conducted by the manufacturer in a vacuum, because the manufacturer is not the one that ultimately will be reprocessing the device,” Drues wrote in the article. “Instead, the manufacturer should be working in conjunction with the hospital — or whatever user community will be reprocessing that particular device — to understand how it will be cleaned in a clinical setting and to make sure that the hospital cleans it in a satisfactory way.”