After Investigation Reveals Deadly Flaws, FDA Issues Warnings About Duodenoscopes

Regulatory NewsRegulatory News | 19 February 2015 |  By 

US regulators have issued a warning to healthcare providers about design flaws inherent in a type of endoscope which could increase the spread of harmful infections in surgery patients.


The device, known as an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, is a flexible, lighted tube commonly used in surgical procedures to inject contrast dye or to obtain tissue samples.

"Unlike most other endoscopes, duodenoscopes also have a movable 'elevator' mechanism at the tip," FDA explained in a notice posted on its website. "The elevator mechanism changes the angle of the accessory exiting the accessory channel," which allows the device to be much more nimble and useful.

As a recent USA Today investigation found, while the innovative design of the device makes it more effective, it also makes it considerably more difficult to clean. The device has been associated with the transmission of carbapenem-resistant enterobacteriaceae (CRE), a hardy and potentially deadly bacterium.

"Some parts of the scopes may be extremely difficult to access and clean thoroughly," FDA told the newspaper. USA Today's investigation faulted the products' manufacturers and FDA for failing to "publicize" or offer guidance regarding the scope of the problem and how to avoid it.

New Warnings

Now, less than a month after USA Today published its investigation, FDA is announcing new precautions meant to help assure the devices' safe use.

In a warning issued on 19 February 2015, FDA said it wanted to "raise awareness among healthcare professionals … that the complex design of ERCP endoscopes may impede effective reprocessing."

FDA's notice explains that "microscopic crevices" within the devices' elevator mechanism can trap "residual body fluids and organic debris," which can in turn transmit microbial contamination to subsequent patients.

The agency continues to monitor the association between the devices and "the transmission of infectious agents," it said. To date, the agency says it knows of at least 135 patients in the US affected by microbial contamination potentially transmitted by the devices. "It is possible that not all cases have been reported to the FDA," it added.

FDA's warning advises device reprocessing facilities to "meticulously clean the elevator mechanism" of the device, and to implement a "comprehensive quality control program for reprocessing duodenoscopes."

No new regulatory requirements have yet been announced at this time.


FDA Warning

USA Today Investigation


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy