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The Risk-Based “Big Three”

Incorporating Biocompatibility, Chemistry, and Toxicology into your Biological Risk Evaluation

In the past, biocompatibility consisted of determining the contact of your medical device, looking at the Table A.1 in ISO 10993-1 and running the test prescribed. This approach put too much emphasis on checking boxes of antiquated tests to screen the biocompatibility risk for modern-day complex devices.

The better approach for biocompatibility is to assess the risk of the device through consideration of its materials, geometry, and process residuals. This creates a change to the “Big Three” of biocompatibility which were cytotoxicity, sensitization, and irritation.  The “Big Three” for this new risk based approach are:

  • Biocompatibility assessment can evaluate the impact of the geometry of the device, chemistry results, material research, intended use of the device, and toxicological evaluation to give an overview of risk and safety
  • Chemistry (e.g., chemical characterization, extractables/leachables) gives an understanding of the compounds that are released from a medical device. It provides insight on what the patient’s exposure would be from the use of the device.
  • Toxicological principles, chemistry results, genotoxicity, systemic toxicity, and carcinogenicity risks from the device are all evaluated.

Incorporating these new “Big Three” into your biocompatibility assessment will help to truly understand the risk associated with the medical device and allows the evaluation to be done with the least impact to cost and timelines.