Federal regulators indicated that a newly approved attachment for endoscopes may help prevent cross-contamination problems linked to certain gastrointestinal procedures, where the devices may not be properly cleaned between patients.
On May 23, the FDA sent a letter to healthcare providers nationwide, announcing the approval of a modified Erbe USA Inc. ERBEFLO port connector, which should help reduce the risk of infections seen in recent years with certain types of endoscopes that are used on multiple patients.
The announcement provides an update to an April 2018 warning, which indicated there is a risk of cross-contamination from 24-hour multi-patient use endoscope connectors. While the warning was not limited to one particular manufacturer, the FDA did specifically note the ERBEFLO port connector, by Erbe USA, Inc., which the agency indicated did not include a backflow prevention feature.
The connectors are used in gastrointestinal endoscopy, and are designed to be used with multiple patients over a 24-hour period without the need for reprocessing, or sterilization. The connectors deliver water from a water source and irrigation tubing.
At the time, the agency recommended health care professionals avoid using any 24-hour multi-patient use endoscope connectors, suggesting instead that they stick to single-use endoscope connectors with backflow prevention features. However, this update indicates that Erbe’s new port connector design now contains a backflow feature. The port connector carries labeling which identifies compatible endoscopes and accessories and indicates it should only be used with Erbe irrigation tubing.
The FDA now indicates Erbe was the only manufacturer marketing a 24-hour multi-patient use endoscope connector which did hot have a backflow prevention feature at the time.
Duodenoscope Infection Problems
The letter comes as the FDA still struggles to solve problems linked to a type of endoscope known as duodenoscopes, which are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to examine the bile ducts, pancreatic duct or gallbladder.
In recent years, problems with cleaning the endoscopes have emerged, with several high-profile “superbug” infection outbreaks linked to the devices, even when facilities following the recommendations provided by Olympus Corp. and other manufacturers.
The problems with ERCP duodenoscope infections began to gain widespread media attention in early 2015, after nearly 200 patients treated at California’s UCLA Medical Center were told that they may have been exposed to a deadline bacteria known as carbapenem-resistant enterobacteriaceae (CRE).
In October 2015, the FDA ordered Fujifilm, Olympus and Pentax, the three manufacturers of duodenoscopes in the U.S., to conduct postmarket surveillance studies of the effectiveness of the cleaning instructions.
However, as recently as April of this year, the FDA issued a safety communication warning that it is still receiving a high number of adverse event reports linked to duodenoscopes, and urged doctors and other healthcare professionals to closely follow sterilization instructions for the devices.
The data indicates there were 205 duodenoscope problems reported between October 15, 2018 and the end of March 2019, including 45 incidents of infections. The data also included 159 reports of device contamination. The FDA notes that in 2018, three deaths were linked to the use of duodenoscopes in the United States.
The FDA is currently consulting with the U.S. Centers for Disease Control and Prevention (CDC) to explore what additional steps can be taken to reduce contamination rates.