Risk managment report of Surgical Mask Example

Benjamin Weber

Trusted Information Resource
#11
It's irrelevant for cl. 6.6 of ISO 14971 if your product is already on the market. You have to think about the following:

When you specifiy a risk control measure to reduce a risk, does this risk control measure:
  1. lead to any new risks or not? If yes, start with the risk evaluation for this new risk.
  2. affect any previous risk evaluation results?
You could just add these two questions to each single risk section.
 
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Marco83

Starting to get Involved
#12
Ok after yours advices I have another question to you, if is not too much.
After a little brainstorming I raised to 26 risks!
It is possible to have a NOT ACCETTABLE risk and after a revaluation reducing it?
 

Benjamin Weber

Trusted Information Resource
#13
See here:
ISO 14971, cl. 6.5 "Risk/benefit analysis"

If the residual risk is not judged acceptable using the criteria established in the risk management plan and
further risk control is not practicable
, the manufacturer may gather and review data and literature to determine
if the medical benefits of the intended use outweigh the residual risk. If this evidence does not support the
conclusion that the medical benefits outweigh the residual risk, then the risk remains unacceptable. If the
medical benefits outweigh the residual risk, then proceed to 6.6.
For risks that are demonstrated to be outweighed by the benefits, the manufacturer shall decide which
information for safety is necessary to disclose the residual risk.
Think about additional risk control measures to reduce the risk. If this is not possible, you shall perform a risk/benefit analysis. If you end up wiht the results, that the benefit (for the patient, the patient management, the health system in general) is greater than the residual risk, you can accept the risk. It may be necessary to disclose the residual risk proactively to the patient, user or others, e.g. by information in the instructions for use, warnigs on the packaging or the device/mask itself.
 
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