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 |