Leading companies in enteral industry work together to improve patient safety
Kingsport, Tenn., USA — Nov. 12, 2014 — Injection molder and mold maker
A. Hopf GmbH has developed newly designed enteral connectors made with
Eastman Tritan™ copolyester. The development proactively addresses growing concerns for medical-device misconnections and future regulatory changes expected for enteral connectors. A. Hopf GmbH is an associate member of the Global Enteral Device Supplier Association (GEDSA) and will be supporting the members as an original equipment manufacturer (OEM). A. Hopf GmbH is an OEM of enteral connectors, which are consistent in design according to ISO/DIS 2 80369-3 requirements. Upon anticipated release in 2015, the requirements will help prevent misconnections between enteral connectors and connectors for other medical applications.
“Back in 2012, leading enteral companies worked together to introduce systems with safety connectors, but they lacked a consistent design,” said Michael Hopf, sales manager, A. Hopf GmbH. “Now, industry partners are working together on ISO/DIS 2 80369-3 with the goal of worldwide consistency in the design of enteral connectors, helping to eliminate any confusion about different safety connectors and ultimately improving patient safety.”
In addition to the upcoming ISO/DIS 2 80369-3, the company anticipates regulatory changes for medical devices could be on the horizon for France and even throughout Europe. This prompted A. Hopf GmbH to search for a raw material suitable for the needs of medical devices, including neonatal enteral devices. This comes after France’s legislation banning bisphenol A (BPA) in food contact materials — intended for use by children up to 3 years of age — went into effect Jan. 1, 2013. Now, a second phase will become effective Jan. 1, 2015, which bans BPA in food contact materials and applications (regardless of age).
“While working on the new design of stopcocks and y-connectors with the standard connector, we also had to consider the material that would be used in its development,” Hopf said. “At A. Hopf GmbH, we saw Eastman Tritan™ copolyester as the future raw material for medical-device connectors like stopcocks and y-connectors because it’s a BPA-free, new-generation copolyester that provides toughness, chemical resistance and stability post-sterilization.”
Eastman Tritan™ copolyester maintains clarity and color after sterilization, providing excellent aesthetic appeal and helping boost patient and health care provider confidence. In addition, devices retain clarity and functional integrity following ethylene oxide and gamma sterilization.
“The significance of this initiative is reinforced by the number of industry leaders joining forces to proactively improve enteral connectors,” said Cedric Perben, application development, EMEA, Eastman Chemical Advanced Materials B.V. “Eastman has a material in Eastman Tritan™ copolyester that can further help the initiative and improve patient safety. We are committed to the long-term needs of the medical industry worldwide and look forward to working with A. Hopf GmbH on additional projects in the future.”
A. Hopf GmbH has previously introduced connectors manufactured with Tritan. In fall 2012, the company launched its non-luer Hopf® three-way stopcocks and Hopf® y-connectors made with Eastman Tritan™ copolyester for use in enteral feeding systems.
For more information or to see the connectors in person, visit Eastman during COMPAMED at Stand P04 in Hall 08a. During COMPAMED, A. Hopf GmbH will be at Stand J41 in Hall 08a and during MEDICA, the company will be at Stand E92 in Hall 03.
For more information about Eastman Tritan™ copolyester, visit