Small bore connectors are important components of many medical devices. As such, good connector design is critical to the safe and effective use of these devices. Tubing misconnections or failure can result in serious patient injury or death. Also, because connectors are prevalent across many modalities, there is a risk of accidentally mismatching connectors and devices according to their use. The medical device industry, in cooperation with regulatory and the standards community, is taking actions to reduce the likelihood of tubing misconnections. This includes the development of standardized connector designs for specific medical applications so they cannot be interconnected with devices for other medical applications.
ISO 80369 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. The standard will be published in different sections; each additional standard in the series will focus on connectors for a specific clinical application. ISO-80369-3 will cover enteral feeding and will be implemented in the fourth quarter of 2015.
How well does your current polymer comply? To meet the new standard, you may have to adjust your design, which means you may need a new mold. That possibility makes today the right time to talk about new materials, as well. By making one simple change to Eastman Tritan™ copolyester, you can meet new standards as they are implemented. Tritan is a rigid material that also: - Demonstrates excellent solvent bonding to tubing
- Offers superior chemical resistance, toughness, and clarity
- Is color stable after E-beam or gamma sterilization
- Is BPA free
One material change can have many benefits. Using a rigid material that won’t be compromised by sterilization helps ensure patient safety … and the efficacy of your device. Switching to Tritan can result in:
- A reduced risk of tubing misconnections
- A reduce risk of leakages in feeding systems
- Greater confidence in your device—perceived by patients and caregivers alike
Tritan also offers cost-saving manufacturing advantages. And, as always, you can rely on Eastman for expert technical design and molding support.
Connect with innovation. To see how Eastman Tritan™ copolyester can help you stay connected—and ahead of the curve—schedule some time to speak with a polymer expert.
View our webinar on
Changing Standards for Medical Device Manufacturers. |