FDA Enteral Device Connector Concerns

CDRH Office of Device Evaluation director William Maisel says the agency is concerned by continued reports of misconnections with enteral devices. In a letter to enteral feeding tube manufacturers, healthcare professionals, and hospital purchasing departments and distributors, Maisel says FDA recommends that hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or are otherwise designed to reduce the risk of misconnections.

The letter says that misconnections between enteral devices and other medical devices, such as tracheostomy tubes, have been associated with patient death and serious injuries. FDA also is concerned, it adds, that many misconnections are not reported, or are reported as medication errors.

The letter contains recommendations for manufacturers, healthcare professionals, and hospital purchasing departments and distributors.