Medical device manufacturers producing devices that involve patient contact are required to perform biological safety evaluations, which may include the need for biocompatibility tests to ensure patient safety, as specified by ISO 10993.
On June 16, 2016, the U.S. Food & Drug Administration (FDA) expanded and clarified how manufacturers should comply with the ISO 10993-1 standard for evaluation and testing within the risk management process. The guidance is firmly established in a risk-based approach and provides detailed recommendations in all aspects of biological safety evaluation. Within this process, material characterization can help support the biocompatibility testing process and reduce the need for in vivo testing. In some cases, biological safety evaluations can decrease turnaround times and associated costs, and possibly eliminate the need for biocompatibility testing altogether.
While risk is not a new term or concept when considering biological evaluations, the approach or method of conducting a risk analysis has not always been well-defined. A considerable part of risk documentation starts with materials and processes in medical device manufacturing. Documentation may be provided with materials to substantiate biocompatibility, ensuring reactants and additives in the device are safe; however, processes such as washing, anodization/passivation, rinsing, and sterilization could impact the safety of the final medical device.
Traditional biocompatibility tests evaluate the biological effects of compounds extracted from devices or the effect of direct interaction of the device with a surrounding tissue through in vivo and/or in vitro methods. Chemical characterization testing of device extracts utilizes analytical chemistry to identify and quantify the amount of chemicals extracted from a device, and evaluates toxicological risk associated with the exposure level. The process of a combined chemical characterization with a biological risk assessment characterizes both the product material – typically a polymer, metal or ceramic – and the extractable or leachable compounds that come from those materials or by-product residuals on the device during the manufacturing process.
As stated in the U.S. FDA guidance issued June 16, 2016, “Therefore the risk assessment should evaluate not only the materials used in the device, but also on the processing of the materials, the manufacturing methods (including the sterilization process), and any residuals from manufacturing aids used during the process.
Using analytical chemistry and data from compound libraries to assess the finished device can yield more specific data regarding extractable compounds than biocompatibility testing. The known properties of the compounds can then be used to create a toxicological risk or safety assessment based on the predicted biological response to the extracted compounds.
It is clear that the focus internationally in the assurance of biological safety must start with chemical and material characterization along with an assessment of toxicological risks as prescribed in ISO 10993-1, ISO10993-18, ISO 10993-17, and ISO 14971. The process presented in these ISO standards aids in the selection of optimal materials and help control the uniformity of materials and devices throughout their lifetime.
In an effort to provide a better understanding of how chemical characterizations and biological risk assessments together can augment and refine the biocompatibility testing process, while still meeting ISO requirements, NAMSA recently published white paper, “Chemical Characterization and Biological Risk Assessment Value Move Beyond Safe and Effective.” Discussed is how a well-executed biocompatibility program utilizing specified tools can create significant time and cost efficiencies.
Highlighted topics include:
- Risk-Based Analysis of Biocompatibility
- Essential Biocompatibility Tests
- Materials Characterization Testing
- Characterization Test Methods
- Direct Material Characterization
- Extractable/Leachable Analysis
- Real-World Case Studies
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We invite you to view this white paper by clicking here.
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