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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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