Keys to classifying failures for quality engineers

Medical device failures are a common-and costly-occurrence. They can lead to a product recall, affect the product development cycle, and result in extra expenses for manufacturers. The reasons devices fail can be complex, making it difficult for quality engineers to classify the problem.
 
What can quality engineers do to remedy this problem? Consider these factors:
 
  • Understand why failures occur: Most device failures are caused by a misunderstanding of how a material’s properties, processing, and environment work together. In many cases, failures can result from a combination of wrong material selection, poor chemical resistance, high-stress design, or inconsistencies in manufacturing processes.
  • Collaborate with your supplier: Working with material suppliers on material selection, testing, part and tooling design review, and secondary operations can give quality engineers access to knowledge and resources they may not otherwise have.
  • Test your materials: Find a testing method that helps you choose the best plastic for your project. Eastman’s 4-step test for chemical resistance, for example, helps predict the reliability of a material after exposure to harsh cleaners and drugs commonly used in hospital settings.
 
Understanding the root causes of failures and working with industry experts to make better material choices can help quality engineers improve device design, have a more successful product launch, and save on costs.
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A safer connection for stopcocks
Drug- and lipid-resistant polymers are playing an increasingly important role in enhancing patient safety. Stringent sterilization techniques can cause cracking, crazing, and hazing in commonly used plastics. They can also have a yellowing effect on certain polymers, which can impact color-coding systems in connector applications.

Eastman Tritan copolyester is resistant to a wide array of medical fluids, such as oncology drugs, drug carrier solvents, and lipids. Along with its toughness, low residual stress, and color stability post-sterilization, Tritan is an excellent choice for fluid management components.

Regulations in the medical market are constantly changing. When Elcam Medical, a world-class manufacturer of disposable medical devices for the OEM market, wanted to further improve the safety and efficacy of its fluid management devices, they turned to Eastman to find a polymer that complies with new regulations while still optimizing performance.

Working with our technical experts, Elcam developed drug- and lipid-resistant BPA-free stopcocks and connectors made with Tritan. They are designed to meet new ISO 80369 standards, which encourage worldwide consistency in small-bore connectors for liquids and gasses in healthcare applications to reduce the risk of misconnections between medical devices and accessories.
For more information about Elcam Medical and their fluid management components made with Tritan, visit www.elcam-medical.com.   

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We are putting final touches on plans for Tritan on Tour!


Join us for Tritan on Tour—an exclusive event showcasing how new materials and manufacturing processes can improve medical device performance.

Hear new information about simulating, molding, bonding, and welding Eastman
Tritan™ copolyester.

Gain key insights on the latest with Tritan material and case studies; learn about speed to market through design for manufacturing/design for reliability (DFM/DFR).

Observe a Tritan tool running at the press and on-site presentations/demos from Nexeo Solutions, Beaumont Technologies, Henkel and Dukane!

Plus, we'll begin the day with donuts and end with cocktails! Hope you can join in the fun!
 
Tritan on Tour—September 11
Advanced Molding Technologies
8700 Rendova Street NE
Circle Pines, MN 55014

View the full agenda and RSVP!
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Secure connections for safer devices
Small-bore connectors are important components of many enteral feeding devices. Good design is critical, as tubing misconnections or failure can put patients at risk for serious injury or death.

Global design standards for tubing connectors are now helping improve patient safety and device efficacy. ISO 80369 requires small-bore connectors to be made of semirigid and rigid materials, making incorrect interconnections less likely. Enteral devices were the first of all the clinical applications to undergo this change.
To meet this standard, you may have to adjust your design, which means you may need a new mold or new materials. Eastman Tritan copolyester is a rigid material with the properties needed to comply with these regulations.

BPA-free Tritan demonstrates excellent chemical resistance, toughness, and color stability post-sterilization. It also helps maintain device safety and efficacy by ensuring that connecting parts retain their shape, dimension, and clarity during and after sterilization.

Using a rigid material that won’t be compromised by sterilization helps ensure patient safety and the efficacy of your device. Contact us for more information on switching to Tritan.
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Tritan on Tour: Save the date!

Save the date!

Eastman and Advanced Molding Technologies are partnering to share innovative solutions to some of the biggest challenges in today's medical market. 

Get ready for an information-packed day, including insights from leading experts: Advanced Molding Technologies, Eastman, Nexeo Solutions, Beaumont Technologies, Henkel, and Dukane.

Tritan on Tour—September 11
Advanced Molding Technologies
8700 Rendova Street NE
Circle Pines, MN 55014

 
 
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