Dear All,
We have used attached template (below the forum question) for our Class IIb medical device that was approved by the regulators 5 years ago. For new medical device, which is, class IIa medical device we used same matrix however regulator made following comments for the definition stating it is unacceptable.
?In the hazard-probability table , the ?probability range? and ?definition? columns are inconsistent (e.g. P1 improbable is stated as <10-6 in the probability range column but only < 1 in 10000 in the definition column)
According to the hazard acceptability matrix , an A5 (catastrophic) event which results in patient death is considered by the manufacturer to be ?acceptable? provided it is improbable (up to 1 in 10000 chance). For manufacturers device, it is not clear how a 1 in 10000 chance of killing a patient can be justified as acceptable.?
Before submitting the application we have evaluated that the matrix and ensured definitions are correct.
The matrix is in reference to the ISO 14971: 2007 Appendix D example figure D5
We have evaluated hazard severity and highest hazard severity is A4, which is critical. Based on risk evaluation none of the risk severity was adjudged as A5
Can someone explain whether;
1. The definitions we put are correct or incorrect,
2. We should not use hazard acceptability as acceptable for catastrophic event
Your comments will help me a lot
We have used attached template (below the forum question) for our Class IIb medical device that was approved by the regulators 5 years ago. For new medical device, which is, class IIa medical device we used same matrix however regulator made following comments for the definition stating it is unacceptable.
?In the hazard-probability table , the ?probability range? and ?definition? columns are inconsistent (e.g. P1 improbable is stated as <10-6 in the probability range column but only < 1 in 10000 in the definition column)
According to the hazard acceptability matrix , an A5 (catastrophic) event which results in patient death is considered by the manufacturer to be ?acceptable? provided it is improbable (up to 1 in 10000 chance). For manufacturers device, it is not clear how a 1 in 10000 chance of killing a patient can be justified as acceptable.?
Before submitting the application we have evaluated that the matrix and ensured definitions are correct.
The matrix is in reference to the ISO 14971: 2007 Appendix D example figure D5
We have evaluated hazard severity and highest hazard severity is A4, which is critical. Based on risk evaluation none of the risk severity was adjudged as A5
Can someone explain whether;
1. The definitions we put are correct or incorrect,
2. We should not use hazard acceptability as acceptable for catastrophic event
Your comments will help me a lot
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