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How To
Meet Biocompatibility Needs Of Polymeric Medical
Components
It is critical that test articles are prepared using the
proper methods and solvents and also using representative
configurations of the end product. Both polar and
non-polar solvents should be used. Extraction conditions
based on the device application and use should also be
employed. Justification of the selected extraction
conditions should be provided.
Developing “finger prints” of the extractables and
leachables can help in decisions for additional
biocompatibility testing if there are changes to materials
and manufacturing conditions. If the “finger prints” match
the rationale not to conduct additional biological tests
can be made..
When biocompatibility tests are required, the decision on
the applicable tests can be identified using the Table A.1
in Annex A of the standard. The evaluation tests described
should be considered and carried out where necessary
tocomplete the data sets needed for the biological
evaluation of the particular medical device or its
materials and components.
Considerations should be made for testing like
cytotoxicity, sensitization, hemocompatibility,
pyrogenicity, implantation, genotoxicity, carcinogenicity,
reproductive and developmental toxicity and degradation
assessments.
5. Biocompatibility Documentation
Due to the diversity of medical devices, not all
biocompatibility tests identified in a category will be
necessary or practical. Documentation of biocompatibility
evaluation and testing should include:
• The strategy, plan and content for the biological
evaluation of the medical device, part or material;
• The criteria for determining the acceptability of the
material for the intended purpose using risk-based
methodology
• The adequacy of the material characterization;
• The rationale for selection of methods used
• The interpretation of existing data and results of
testing;
• The need for any additional data to complete the
biological evaluation;
• The overall biological safety conclusions for the
material component and the medical device.
6. Changes to Product or Process
When there are changes to an existing, approved and tested
material, component or device, biocompatibility should be
reevaluated if there is:
• Any change in the source or in the specification of the
materials used in the manufacture of the product;
• Any change in the formulation, processing, primary
packaging or sterilization of the material or product;
• Any change in the manufacturer’s instructions or
expectations concerning storage, e.g. changes in shelf
life and/or transport;
• Any change in the intended use of the product;
• Any evidence that the material or product may produce
adverse effects when used in humans.
7. Conclusions
In order for plastics processors and resin manufacturers
to understand the critical characteristics and application
of the final device their products go into, the lines of
communication between medical device manufacturer and
their suppliers should be seamless and effective.
Processors of the components and parts should control
their production processes so as not to affect or change
the biocompatibility of the material provided by the resin
supplier. Resin suppliers (virgin or compounded) should
provide the basic biocompatibility characteristic to both
the processor and the finished medical device
manufacturer. Any changes to material or process should be
communicated to the medical device manufacturer, as the
medical device manufacturer is ultimately responsible to
ensure safety, effectiveness and biocompatibility of their
finished device.
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