The tubes and catheters that carry oxygen, medication, nutrients, and fluids to hospital patients had been connected to delivery systems via universally designed small-bore Luer connectors, with that standardization occasionally leading to misconnections and subsequently, patient injury or death.
In response, an international collection of clinicians, manufacturers, and regulators, including the FDA, worked with the International Organization of Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI) to develop ISO 80369 standards that govern the redesign of small-bore (inner diameter of less than 8.5 mm) connectors, with one goal, according to the Global Enteral Device Supplier Association (GEDSA): “make it difficult, if not impossible, for unrelated delivery systems to be connected.”
GEDSA launched its Stay Connected initiative to support the changeover, calling the new connectors ENFit to differentiate them from the traditional luer connectors. Feeding tubes with the ENFit connector are projected to be available in the second quarter of 2015.
The new connector design standards will initially apply to liquids and gases in healthcare applications. Eventually they will dictate connector size and shape for breathing systems and driving gases, enteral, limb cuff inflation, neuraxial, and intravascular-hypodermic applications. Once the standards are completed, luer connector will only be used for intravascular and hypodermic applications. All other small-bore connector delivery systems will be changed to ensure they can’t be misconnected to luers.
Proactively Switching Resins
German injection molder and mold maker A. Hopf Gmbh, Zirndorf, recently announced the development of newly designed enteral connectors utilizing Tritan copolyester from Eastman, Kingsport, Tenn., to proactively satisfy the ISO/DIS 2 80369-3 requirements. The company noted that the application of copolyester, versus PC, also satisfies French legislation banning BPA in food-contact materials for children, passed in 2013. That ban expanded to cover all such applications in January 2015.
At the MD&M West show in Anaheim, Calif. this February, Eastman discussed the new regulations in the small-bore connector market and how they’re impacting connecter molders and their material suppliers.
In the past, the use of flexible materials—like PVC, TPE, and TPU—in connectors, could allow a healthcare worker to “force” the connectors together, creating the potential for error. As part of the new design standard, materials must be stiff, with a flexural modulus above 700 MPa. In this space, Tritan will compete with materials including PC, ABS and PMMA. Eastman said that in addition to moldability and toughness, Tritan also maintains clarity, color and functional integrity after ethylene oxide and gamma sterilization.
In a July 2014 letter to its customers, medical device supplier Covidien, which is a charter member of GEDSA, noted that new enteral feeding tubes with ENFit connector would be available in April 2015, with the transition to the new ISO standard connectors completed in January 2016.