The Federal Drug Administration (FDA) continues its collaboration with standards organizations, federal partners, professional societies, patient advocacy groups, individual patients and other stakeholders on an important patient safety issue—reducing the chance of medical device misconnections. Such coaction aims for a result that ensures patient safety and facilitates the availability of products that work for various patient populations, uses and care environments.
Inspired by continued reports of misconnections with enteral devices, in September the FDA issued a letter to enteral feeding tube manufacturers and distributors, healthcare professionals and hospital purchasing departments recommending that hospitals and clinicians use enteral devices with connectors that meet the ISO (International Organization for Standardization) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections.
In the two-page letter published on the FDA website, the director of the office of device evaluation indicates that misconnections between enteral devices and other medical devices, such as tracheostomy tubes, have been associated with patient deaths and serious injuries. The FDA is also concerned that many misconnections are either severely underreported, fail to be reported at all or are misreported as medication errors.
For the first time since its 2009 involvement in an international effort to develop and implement standards for noninterchangeable connectors for small bore medical connectors, the FDA’s recent document has strong recommendations for manufacturers, two of which include:
• Implement design changes to meet the ISO standards to reduce the likelihood of errors and provide safeguards for safe use of these devices and products.
• Implement an appropriate strategy that will lead to the eventual removal of legacy devices that have an increased risk for misconnection.