Blood is Not Just Blood - Why a Predicate Sample is Recommended in Hemocompatibility Testing

The ISO guideline 10993-4 describes the test design and parameters required for the hemocompatibility analysis of medical devices in direct or indirect contact with blood. Several tests can be performed to assess the interactions of medical devices with blood.

However, the ISO-guideline does not specify strict exclusion criteria for the evaluation of a clearly positive or negative effect of the device. Therefore, an effect induced by the medical device cannot always be excluded on the basis of the negative control alone or, if applicable, in comparison with the historical data. Especially the results of ELISA tests cannot be conclusively assessed as clearly negative. Therefore, the parallel testing of a predicate device can be crucial to exclude a relevant biological effect of the test device.

The webinar will cover the following key points in general:

• What is a predicate device and how should it look like
• Which tests can benefit from a predicate device
• Example of data interpretation and discussion of a real case