Risk / benefit Analysis in Risk Management Report

#11
Hello, I work in requlatery medicens lab , I want to ask about Risk Mangement:

  • ISO31000 vs ISO 17025
  • What the risk policy of acceptability criteria for pharmacy lab
  • How Idintefy the scope and goals and classify and analysis of strengths and weaknesses by SWOT analysis
  • How identify the interested parties. Thanks
 
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Ronen E

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#12
hello,
does anybody have example of risk-cost-benefit for re-use and re-sterilization of “long time on market” single use medical devices, any guidance please?
(14971: 2012- 6.5)
Not sure what cost has to do with it... S. 6.5 talks about comparing residual risk against medical benefits.

Have you looked at Annex D.6?
 
#13
Risk / benefit analysis for each risk.
Is there an example?
Hi,
There is no example since everyone shall be applying risk management for their devices in a different method. however please go through some of the points below:
1. Risk vs benefit is not applicable for all the risk since you might have already mitigated some of the risks to lower RPN.
2. Risk vs benefit is done only when there exists a risk after mitigation which is beyond your acceptable tolerance.
3. You need to specify the risk and what are its end level effects can be declared as side-effects in the IFU.
4. Benefits have to be specified as intended use is also acheieved (Performance evaluation report might be required.)
5. Thus you give the final statement that since benefits outweigh the risk we accept the risks.
E.g. Iodine bandages when used for bigger wounds can create Iodine-induced Hypothyroidism. Although if bandages changed every 8 hours to normal bandages alternately minimizes the probability of this phenomenon. Nevertheless,the benefit of using a iodine bandages leads to faster healing.
IFU shall state: bandages changed every 8 hours to reduce Iodine-induced Hypothyroidism.

Hope it helps.
 
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