- FDA has sent a letter to feeding tube manufacturers and healthcare professionals that warns of the potential for serious injuries from misconnections between enteral devices and other medical products such as tracheostomy tubes.
- The agency said since 2011 it has received reports of two deaths, 24 serious injuries and 32 device malfunctions related to feeding tube misconnections, and it is concerned that many more such incidents go unreported or are mischaracterized as medication errors.
- FDA is recommending hospitals and clinicians use devices with connectors that meet International Organization for Standardization (ISO) 80369-1 or 80369-3 standards, or that are specifically designed to reduce the risk of misconnection. Connectors meeting the current standards often go by the trade name ENFit, the agency said.
A tubing misconnection is what happens when the tube from one medical device is attached in error to a system serving a different purpose. This can occur when patients are connected to multiple delivery systems for medication, nutrients and fluids.
The problem is considered so serious that California enacted a law in 2016 prohibiting healthcare facilities from using an intravenous or enteral feeding connection that would fit into the port for an unrelated application. Enteral feeding generally refers to the delivery of nutrition by tube.
Tubing misconnections occur because typical connectors for medical devices have followed a universal design for ease of use. California’s legislation warned that the ubiquitous nature of the design has led to misconnections among unrelated systems including vascular, enteral, respiratory and epidural devices.
FDA in 2010 issued its first letter to manufacturers and healthcare professionals about the dangers of tube misconnections. Manufacturers of enteral feeding systems have been working with clinicians, regulators and the ISO over several years to develop and adopt the 80369 standards for safe connectors, according to the Global Enteral Device Supplier Association (GEDSA).
Members of GEDSA include healthcare giants such as Baxter, Boston Scientific, Cardinal Health and Cook Medical among others.
ENFit connectors were created by leading enteral device manufacturers to meet the ISO standards. GEDSA members are adopting the ENFit connector so that all enteral device components, regardless of supplier, will fit together without the long-term use of adapters, according to the group.