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.

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.

Putting device durability to the test

When choosing a polymer for a medical device, it’s crucial to understand how the material will perform in the real world. Eastman’s 4-step test helps show how plastics hold up when exposed to frequent disinfection, but it’s also important to see how that translates into actual performance in the field.

 
That’s why we developed the housing drop test. This test can be used alongside the 4-step method to understand how a well-designed device will respond to impact after being disinfected.

 

Four steps for testing housing material performance

When exposed to commonly used aggressive disinfectants and drugs, many materials used in medical devices can crack, craze, discolor, and become sticky. Currently, there are no industry standards for evaluating surface compatibility. That’s why Eastman developed a 4-step test method based on ASTM standards to better understand why plastics fail and how different plastics perform in the real world.
 
This simple, easily-repeatable test can help predict the reliability of a material after exposure to harsh cleaners and drugs commonly used in hospital settings. The method uses a 1.5% constant strain jig together with wet patches for applying chemical reagents. Here’s how it works:
  1. Select the appropriate jig.
  2. Load flex bars onto jig.
  3. Apply chemicals to the flex bars.
  4. Perform reverse side impact test.

A preferred supplier that goes the extra mile

At Eastman, we go above and beyond the typical duties of a preferred supplier. Unlike many of our competitors, Eastman provides you with regulatory and technical services to help you through the manufacturing process—at no extra cost to you. This guidance, along with access to our high quality, innovative materials, will elevate your brand and ensure that you’re optimizing our polymers for your devices.
 
Our regulatory group stays current with global regulatory changes and makes this information readily available to the market. We provide you with all the necessary regulatory information for the safe use of our polymers, including details on compliance with Food and Drug Administration standards, chemical and mechanical properties, and more.
 
We also offer premium technical service for all aspects of the molding process, from conception through bringing your product to market. Eastman Design Services capabilities include:
 

Thank You for Asking

We often receive great questions about molding with Eastman medical grade polymers and are always glad to provide answers and more information. Here is a response to a recent query from our inbox:
 
“How environmentally friendly is Eastman MXF221 copolyester?”

Eastman strives to create solutions that offer more value with less environmental impact.
MXF221 copolyester is one of our many environmentally responsible offerings that meets
industry standards for safety and sustainability. Some of its innovative properties include:
  • It’s made without BPA, halogens, or ortho-phthalate plasticizers.
  • Its toughness and durability can potentially increase product life and reduce waste.
  • The flame-retardant additives used in do not contain antimony, bromine, or chlorine.
  • It’s suitable for transducer housing applications that require contact with the skin.
Read more about how Tritan is improving sustainability and design for devices and diagnostics.

Colorful possibilities with Eastman MXF221 copolyester

Eastman MXF221 copolyester, available as a clear-natural or opaque-colored polymer, provides excellent chemical resistance and durability and is uniquely suited for electronic medical device housings. Not only is it extremely tough and able to stand up to the daily stresses of hospital environments, but it’s also compatible with branding initiatives.
 
Brand owners who use opaque polymers often require precise color matching and vibrant aesthetics to maintain their brand identities. Eastman MXF221 copolyester comes in a wide array of colors with the ability to align seamlessly with any brand standards.
 

Improving Medical Devices with Eastman MXF221 Copolyester

Eastman’s polymers are the key components used in many medical devices, and we’re constantly innovating our materials to help equipment achieve optimum performance and withstand the ever-changing demands of the health care industry.
 
Our latest offering, Eastman MXF221 copolyester, is a biocompatible, fully compounded medical grade polymer that is uniquely suited for medical devices and electronic device housings. Developed from Eastman Tritan copolyester, Eastman MXF221 copolyester offers superior chemical resistance to stringent disinfectants and drugs, improved durability, and greater longevity.
 
Eastman MXF221 copolyester provides many advantages for devices and brands, including:
 
  • Unsurpassed chemical resistance—Unlike polycarbonate or other polymers that lose their impact strength after contact with harsh disinfectants and chemicals, Eastman MXF221 copolyester can withstand many aggressive disinfectants without cracking, crazing, or hazing.
     

Thank You for Asking:

 
“What are Eastman’s recommendations for sonic welding of thin-walled parts?”    

In general, small thick-walled parts made with Eastman Tritan copolyester can be ultrasonically welded by
following the welder’s recommendations for other amorphous thermoplastics.

 

Designing Disinfectant-Ready Medical Devices

Are the devices you design ready for aggressive medical disinfectants? 

The designer is the point where innovative creativity crashes head-on into the real-world needs of durable functionality in a health care environment.
 
Unfortunately, many device housings and hardware designed just a few years ago were made with materials that lack the right combination of impact strength and chemical resistance. They crack, craze, and ultimately fail when challenged by the increased use of aggressive medical disinfectants—combined with the applied stress of greater portability. 
 
Connecting the dots between design flexibility, chemical resistance, and impact strength is critical for selecting the best material for reliable clear and opaque medical devices. That’s why Eastman created a 60-minute webinar to provide new information about: 

Patient safety and HAI prevention

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