Hello,
I have a question about defining Risk Acceptability Criteria (RAC) as required by 14971:2007. Specifically about the use of a matrix as per Annex D. Conceptually, when defining a RAC matrix should the acceptable area cover known unavoidable risks associated with the therapy. For example, when using an x-ray there is some harm associated with the therapy. Clearly the benefits outweigh the risk but should I construct my RAC table so severities and probabilities that align with this use (i.e. being exposed to x-rays as an unavoidable consequence) fall into the acceptable region?
The problem I see with this approach is that just because there are some inherit harms (with certain probabilities and severities occurring) you shouldn’t make these acceptable in your matrix as the matrix doesn’t explicitly cover the source of the harm i.e. you should not be able to justify poor engineering just because there is some inherit risk associated with the therapy.
So if I don’t use risk related to therapy to define my matrix, what process should I use to define the acceptable region. Should I limit the RAC criteria to be based on acceptable harm due to design/engineering faults given similar state of the art devices and then perform risk vs benefit analysis to justify risks that are inherit with the therapy or is there some other approach that is more suitable?
Thanks for any input.
I have a question about defining Risk Acceptability Criteria (RAC) as required by 14971:2007. Specifically about the use of a matrix as per Annex D. Conceptually, when defining a RAC matrix should the acceptable area cover known unavoidable risks associated with the therapy. For example, when using an x-ray there is some harm associated with the therapy. Clearly the benefits outweigh the risk but should I construct my RAC table so severities and probabilities that align with this use (i.e. being exposed to x-rays as an unavoidable consequence) fall into the acceptable region?
The problem I see with this approach is that just because there are some inherit harms (with certain probabilities and severities occurring) you shouldn’t make these acceptable in your matrix as the matrix doesn’t explicitly cover the source of the harm i.e. you should not be able to justify poor engineering just because there is some inherit risk associated with the therapy.
So if I don’t use risk related to therapy to define my matrix, what process should I use to define the acceptable region. Should I limit the RAC criteria to be based on acceptable harm due to design/engineering faults given similar state of the art devices and then perform risk vs benefit analysis to justify risks that are inherit with the therapy or is there some other approach that is more suitable?
Thanks for any input.