All medical devices intended to contact the patient are required to undergo a biological evaluation to demonstrate their safety. The overarching guidance document for biocompatibility assessments is ISO 10993-1 that provides a framework for this evaluation and defines the relevant endpoints needing assessment based on the contact type and duration that the specific device has. Regardless of the contact however, cytotoxicity as an endpoint is required for evaluation for all devices that fall under the scope of ISO 10993-1. Cytotoxicity, due to its high sensitivity, as well as quick turnaround time and low cost is commonly used by the medical device industry to screen devices for their potential to have any reactivity to the body. At the same time, this high sensitivity can also lead to elevated reactivity which needs to be followed with an investigation to understand whether the observed results are a concern when the device is used on a patient. This webinar will cover the basics of cytotoxicity testing and will provide some examples on how to perform an investigation and risk assessment on devices that demonstrate cytotoxic reactivity.
Key takeaways:
- Cytotoxicity test: why do we do it, what it is and what it tells us
- Known culprits for cytotoxic reactivity
- How to interpret the data and what additional information is needed to define patient safety
