FDA In Brief: FDA clears design changes to Pentax duodenoscope to improve cleaning and disinfection; voluntary recall of duodenoscope model to implement correction

For Immediate Release: Feb. 7, 2018

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"Reducing infections associated with duodenoscopes remains a top priority for the FDA, and we believe the new design changes to the Pentax duodenoscope will make these devices easier to clean and high-level disinfect to help enhance their safety,” said Suzanne Schwartz, M.D., associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “We will continue to encourage new innovations for these devices to protect public health while enabling patients to have continued access to minimally invasive, life-saving endoscopy procedures."

In a new Safety Communication, the FDA is alerting health care facilities about a voluntary recall of the Pentax ED-3490TK duodenoscope to make corrections to the scope’s design that will help facilitate the proper cleaning and high-level disinfection of these devices. The FDA has cleared a new 510(k) for the ED-3490TK model with a new elevator channel sealing mechanism at the tip of the scope; the design change is intended to prevent the seepage of fluids and bacteria into crevices in the device that are difficult to clean and reprocess. This can be a potential source of infection transmission between patients. The FDA rigorously reviewed the modifications and cleared the device for marketing. The agency also worked with the company on its corrective action to remove the older model from health care facilities to make the necessary modifications to the scope’s design. In February 2016, the FDA issued a Safety Communication and Pentax issued updated, validated manual reprocessing instructions for the ED-3490TK duodenoscope to replace those provided in the original device labeling. In January 2017, the FDA updated the Safety Communication to warn that cracks and gaps in the adhesive that seals the ED-3490TK distal cap to its distal tip can occur, which can lead to microbial and fluid seepage. The recall and new device design cleared today are intended to address these safety issues.

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum) and are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. In fall 2013, the FDA learned about a potential association between multi-drug resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that device users were following proper manufacturer cleaning and disinfection or sterilization instructions.

The FDA continues to work with manufacturers and other stakeholders to improve the safety of duodenoscopes and other reusable medical devices to help protect patients from bacterial infections associated with these medical devices.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.