On April 18, 2018, the FDA issued a Safety Alert about the risk of cross-contamination with certain connectors that are used in gastrointestinal endoscopy. Specifically, the FDA warned that it has not received acceptable testing to demonstrate the safe use of 24-hour multi-patient use endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing.
The FDA’s Safety Alert states that endoscope connectors are small accessories used to connect the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. To mitigate the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent patient fluids from flowing backwards into the endoscope (backflow prevention features). These connectors may be either single-use connectors that are discarded after each patient, or reusable connectors that are reprocessed according to their instructions for use prior to each patient.
The FDA singled out Erbe USA Inc., which currently markets a 24-hour multi-patient use endoscope connector, called the ERBEFLO port connector, that does not include a backflow prevention feature. Erbe USA Inc. is the only company marketing a 24-hour multi-patient use endoscope connector. The FDA’s assessment 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 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 FDA stated that alternative endoscope connectors that are designed according to FDA recommendations are widely available on the U.S. market that include backflow prevention features, and may be reprocessed and reused between procedures, or they may be single-use devices.
The FDA advises health care providers and staff at facilities performing endoscopy to not use 24-hour multi-patient use endoscope connectors because they carry a risk of cross-contamination. The FDA encourages health care providers and facilities to use single-use endoscope connectors with backflow prevention features and to use reusable endoscope connectors with backflow prevention features, and ensure that those reusable connectors are reprocessed according to their instructions for use prior to each patient procedure.
The FDA encourges healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
The FDA previously described the recommended testing for endoscope connectors in its November 2016 guidance document, “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.”
If you or a family member acquired a serious infection following an endoscopic procedure, you should promptly consult with a local medical malpractice lawyer in your U.S. state who may investigate your possible endoscopy claim for you and represent you in a claim for compensation due to the injuries you suffered following an endoscopy.
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