Medical Plastic Data Service Magazine

 

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 30th Year of Publication
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Quality

More Than Materials: A Risk-Based Framework For Biocompatibility Assessment

(Courtesy : Lubrizol Life Science Driven by Innovation, Powered by Partnership)

 

Some of the information that could be helpful to an OEM’s chemical assessment may be proprietary to the material supplier. The OEM can provide it to the FDA by reference to the material supplier’s device master file (MAF). The FDA does not mandate any specific content for a device MAF. However, Attachment B of the guidance document lists information that should be included in an MAF to support a biocompatibility evaluation.

 

 

Lubrizol supports all of its medical grade thermoplastic polymers (TPUs) with MAFs. We also provide customers with biocompatibility test results for many of our materials in their processed form. OEMs can use this information as a starting point for device risk assessment, as each medical device manufacturing and sterilization process is different. We also frequently consult with OEMs and their toxicology partners on component and device level chemical analysis, especially related to  potential extractable/leachable components.

Application-specific considerations

As part of the risk-based evaluation of devices intended for longterm function in the body, OEMs may include consideration of the biostability of the device and its constituent materials. Biostability considers the impact of the body on the device. It often includes consideration of the body’s attempt to encapsulate the device or
degrade the device as a result of the foreign body response. (Of course, some devices are intentionally designed to be degradable.) Because the biostability can influence the way a device interacts with the body or can change the device’s biological risk assessment, it may need to be considered in the context of the risk-based approach to biocompatibility testing.

Surface chemistry is important to the biological performance of an implantable device. When in place in the biological environment, biomedical implants are prone to
surface biofouling. Proteins, cells, and other substances in biological fluids may adhere to many biomaterials’ surfaces, changing the original characteristics in a way that impacts the performance of the device. For example, it may be important to prevent protein and cell adhesion to the surface of a vascular catheter in order to prevent blood-clotting and other undesirable clinical conditions.

Because Lubrizol understands nuances of biostability/ biocompatibility needs in the vascular catheter space, we are well positioned to develop innovative chemistry to address surface biofouling.

Conclusion


Understanding the material, process, clinical use, patient exposure, and design interactions within the risk-based framework is essential for biocompatibility evaluation of devices. Your material suppliers may be helpful in several aspects of the biocompatibility assessment process. For questions and more information contact Rajnish.Singh@Lubrizol.com

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