The FDA yesterday warned healthcare providers against using endoscope connectors in more than one patient without reprocessing, saying it hasn’t seen any acceptable tests demonstrating their safety.
The federal safety watchdog said the connectors, which are used in more than one patient for gastrointestinal endoscopies over the course of 24 hours, connect the endoscope to a water supply. The agency recommended that providers use connectors that prevent patient fluid back-flow into the ‘scope, either as a one-time use or reprocessed after every patient.
Erbe USA is the only company marketing a 24-hour multi-patient use endoscope connector, the Erbeflo port connector, which does not have a back-flow preventer, the FDA said.
“The FDA’s assessment has found that the recommended instructions and device design for the Erbeflo port connector do not adequately mitigate the risks of cross-contamination for endoscopy patients. This is because the connector, tubing, and/or water bottle can become contaminated with blood, stool or other fluids from previous patients that travel back through the endoscope channels into the connector and tubing,” the agency said.