How To
Meet Biocompatibility Needs Of Polymeric Medical
Components
Vinny Sastri, Ph.D.
President
Winovia LLC, U.S.A |
Medical device
manufacturers need to ensure that their products are
safe and effective. Safety considerations should
include usability, energy, operation, informational,
and chemical and biological hazards. Biological
hazards can be extensive and complex. When materials
come in contact with human skin or tissue, their
biocompatibility should be evaluated. The importance
of patient safety with respect to biocompatibility
continues to be an important area that regulatory
bodies continue to focus on.
The international standard ISO 10993-1Biological
evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process, updated in
2009, added the risk management process based on ISO
14971 in the selection and evaluation of biocompatible
materials. In 2016, the United States FDA published
its final guidance titled Use of International
Standard ISO 10993-1, Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk
management process. |
.This guidance document covers the use of the standard
including specific requirements that the agency expects in
selection, testing, evaluation and documentation. In June
2016, the European Parliament and the Council of the
European Union published its draft proposal on its new
Medical Device Regulation. Section 7 of Annex 1 details
the requirements for a medical device and material
chemical, physical and biological properties.
In September 2016, the Center for Devices and
Radiological Health (CDRH) in the USA published the CDRH
Regulatory Science Priorities (FY2017). One of the top 10
priorities for 2017 is to “Modernize biocompatibility and
biological risk evaluation of device materials”. The
report states that “it is critical to perform
biocompatibility evaluation to assess the risk of adverse
events” “to determine the safety profile of implantable or
patientcontacting medical devices” The report emphasizes
that “less burden some approaches that are more
patient-centric and predictive of realworld device
performance are needed to modernize and transform
biocompatibility evaluation of medical devices and their
materials.”
The medical device manufacturer is ultimately responsible
for the safety and effectiveness of the final device. The
device, its components and raw materials that come into
contact with human tissue must all be evaluated for
biocompatibility. As a result, suppliers of parts,
components and resin that are used to build the device
should also do their part in ensuring that the products or
processing conditions do not adversely affect the
biocompatibility of those products. Figure 1 illustrates
the raw material to finished device value chain with
respect to plastic materials and components. There may be
instances where the resin manufacturer directly supplies
the raw material to the medical device manufacturer who
does their own processing and converting.
Vinny Sastri, Ph.D., is the
President of WINOVIA® LLC a company that provides
customized solutions, strategies and training in the
implementation of effective quality management
systems. Areas of expertise include FDA and ISO
quality management systems for medical devices and
pharmaceuticals, product development processes, design
controls, manufacturing and process validation, risk
management, six sigma and design for six sigma, CAPA
and plastics. He is a certified Six Sigma black-belt.
Dr. Sastri is the author of the
book Plastics in Medical Devices: Properties,
Requirements and Applications the 2nd Edition of which
published by Elsevier, London in 2013. |
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