Didactic Introduces BPA-free Medical Infusion Devices Made With Eastman Tritan™ Copolyester
Looking for a material free of bisphenol A (BPA) in expectation of future regulatory changes, French company Didactic turned to material supplier Eastman Chemical Company and injection molder A. Hopf GmbH to expand its range of medical infusion devices, including stopcocks.
Forward-thinking solution
To further differentiate its products from those already on the market in France, Didactic tasked itself with finding a BPA-free solution for medical infusion devices. With France’s Jan. 1, 2013 ban of the use of BPA in food contact materials for use by children under the age of 3, the company anticipates regulatory changes for medical devices could be on the horizon for France and even throughout Europe. Didactic has expanded its range of infusion devices CE marked under 93/42/EEC and 2007/47/EC directives with its new infusion sets and extension tubes.
In addition to choosing Eastman Tritan™ copolyester because it is free of BPA, Didactic also turned to the material because it maintains clarity and color after sterilization, providing excellent aesthetic appeal and helping boost patient and health care provider confidence. In addition, devices remain intact after ethylene oxide and gamma sterilization.
“Because all Didactic infusion medical devices are sterilized with ethylene oxide, it was very important to select a material that is compatible with nationwide sterilization protocols as well as our own processes,” said Pascal Jean, pharmacist and products manager, Didactic.
Eastman Tritan™ copolyester also offers excellent resistance to lipids for stopcocks and infusion sets. Under stress and in an environment with chemical exposure, devices can form cracks, increasing the possibility of a device failure, which can directly affect patient safety. Stress can result from applied stress or residual stress.
“Eastman is committed to the long-term needs of the medical industry worldwide, and providing a material with the attributes our customers are asking for — and sometimes requiring — is something we pride ourselves on,” said Theo Wubbels, medical market development manager, EMEA, Eastman Chemical Advanced Materials B.V.
Global collaboration
The launch of Didactic’s new offerings brought together companies from three countries: Didactic in France, A. Hopf GmbH in the Bavaria area of Germany, and Eastman, headquartered in the United States.
Didactic’s most immediate future plans include providing health care facilities with products using Eastman Tritan™ copolyester for dialysis treatments, neonatology and intensive care.
“It has been a pleasure to be a part of this successful global effort,” Jean said. “Eastman’s forward-thinking approach to material innovations and technical expertise coupled with A. Hopf GmbH’s injection molding knowledge have aided in creating products that not only help ensure patient safety but also go above and beyond what is currently required within the health care system.”
Proven product
A. Hopf GmbH has previously collaborated with Eastman. In fall 2012, the company launched its non-luer Hopf® three-way stopcocks and Hopf® Y-connectors made with Tritan™ copolyester for use in enteral feeding systems. A. Hopf GmbH turned to Tritan because the material is clear, tough and resistant to chemicals, lipids and the effects of radiation sterilization.
“Combining Hopf’s demonstrated experience with Eastman’s proven material for these new devices from Didactic has been a rewarding collaborative effort for these three companies,” said Michael Hopf, sales manager, A. Hopf GmbH. “In addition, the lasting value, performance and peace of mind these devices will offer to medical professionals and patients alike is even more rewarding.”
Source: Eastman Chemical Company
