Marina talked about ISO 10993-1 becoming more closely aligned with ISO 14971 and described a change in the next version of ISO 10993-1 from 'Biological Endpoints' to 'Biological Effects'. My comment is to align those comments with Peter Sebelius' presentation that the MedTech Safety Conference in Amsterdam during April of this year.
Peter presented on the need for for practitioners of ISO 14971 to continue the Sequences of Events Leading to Harm all the way to a harm and presented on the problems caused when the sequence of events stops at an event that does not cause harm.
I see the change in ISO 10993-1 from 'Biological Endpoint' to 'Biological Effect' as aligning ISO 10993-1 better with ISO 14971 because a 'Biological Endpoint' is not a harm and a 'Biological Effect' can be a harm. If someone enters a Sequence of Events Leading to Harm that ends with a 'Biological EndPoint, then they have done exactly what Peter Sebelius warned us to avoid. A 'Biological EndPoint' is a **marker** for a biological condition that can lead to harm, but an EndPoint is not a Harm.
Instead, a Sequence of Events Leading to Harm that ended at a Biological Marker needs to be extended by adding additional events until an actual harm has occurred.
Marina talked about ISO 10993-1 becoming more closely aligned with ISO 14971 and described a change in the next version of ISO 10993-1 from 'Biological Endpoints' to 'Biological Effects'. My comment is to align those comments with Peter Sebelius' presentation that the MedTech Safety Conference in Amsterdam during April of this year.
Peter presented on the need for for practitioners of ISO 14971 to continue the Sequences of Events Leading to Harm all the way to a harm and presented on the problems caused when the sequence of events stops at an event that does not cause harm.
I see the change in ISO 10993-1 from 'Biological Endpoint' to 'Biological Effect' as aligning ISO 10993-1 better with ISO 14971 because a 'Biological Endpoint' is not a harm and a 'Biological Effect' can be a harm. If someone enters a Sequence of Events Leading to Harm that ends with a 'Biological EndPoint, then they have done exactly what Peter Sebelius warned us to avoid. A 'Biological EndPoint' is a **marker** for a biological condition that can lead to harm, but an EndPoint is not a Harm.
Instead, a Sequence of Events Leading to Harm that ended at a Biological Marker needs to be extended by adding additional events until an actual harm has occurred.
Thanks for sharing this insight Richard.
That's interesting consideration and thankm you for sharing it.
Current version of ISO 10993-1:2018 uses word "endpoint" so if we stick to the standard, we are using this word e.g. in our template.
But I do agree with you
Enjoy your day!
BR,
Marina