About Risk Analysis for Home Use Monitoring System

W

wan_yin

#1
I am pretty new for regulatory tests of medical devices for FDA. REcently, we are going to do EMC (IEC60601-1-2) tests for our device. So hope that somebody can help me for the following issue.

I know that we should do the risk analysis before we do the EMC tests. I came across an article "Standards and Certification Basic Standard: IEC 60601-1-2 - Essential Performance, Risk Analysis And Immunity Testing".

In the article, one example is "Case #4: Home Use Patient Monitoring System..". It is said that after the risk analysis, "In this case, the requirements state that it is not necessary to perform immunity
tests to declare compliance.". I am little confused about this statement. If I understand correctly, the device is used to monitor patients at home, and it will generate some measurements for physicians to review. If there is no good immunity, noises will be added to the generated measurements, which means some measurements can be totally screwed up. If physicians make a medical judgment based on the wrong measurements, it can be very harmful to patients. Do I understand this scenario correctly? Your any suggestions and comments will be highly appreciated. Many thanks.
 
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R

rclanzillotto

#2
Your responsible for posing hazards and developing mitigating strategies. I would not be persuaded otherwise if you believe rfi immunity testing serves to mitigate the hazard of a misdiagnosis. Sounds perfectly reasonable to me. The case study in the article is essentially mitigating an incorrect output via the qualification of the reviewing physician, who would know enough to obtain additional information prior to making a diagnosis. This too is reasonable..but you should have a doc on board providing you input into how the information provided by your device is used. Good Luck Rich
 
W

wan_yin

#3
Your responsible for posing hazards and developing mitigating strategies. I would not be persuaded otherwise if you believe rfi immunity testing serves to mitigate the hazard of a misdiagnosis. Sounds perfectly reasonable to me. The case study in the article is essentially mitigating an incorrect output via the qualification of the reviewing physician, who would know enough to obtain additional information prior to making a diagnosis. This too is reasonable..but you should have a doc on board providing you input into how the information provided by your device is used. Good Luck Rich
Many thanks for your reply. I am still not very convinced. So let us use an simple example, the blood pressure meter. If the meter reports wrong blood pressure values, due to some RFI interference (suppose that this can happen), to physicians, then the physicians should be able to know that those values are not correct, by using some other information? Is this correct?
 
R

rclanzillotto

#4
I'm not a physician though so take this for what it is worth. I think physicians would seek additional information. prior to making a diagnosis. I know from personal experience, I've had my pressure taken during an exam and it appeared out of whack perhaps due to something I had just eaten. The doctor did not rush me off with a BP medication prescription, he checked my BP again during a follow-up visit. If a home monitoring system gave a reading that appeared out of line with what is expected, the physician would likely have the patient in for a confirming exam and not simply make an immediate diagnosis. BTW i'm not trying to persuade you from doing the immunity testing, just attempting to explain the point of view in the article. regards
 
W

wan_yin

#5
I'm not a physician though so take this for what it is worth. I think physicians would seek additional information. prior to making a diagnosis. I know from personal experience, I've had my pressure taken during an exam and it appeared out of whack perhaps due to something I had just eaten. The doctor did not rush me off with a BP medication prescription, he checked my BP again during a follow-up visit. If a home monitoring system gave a reading that appeared out of line with what is expected, the physician would likely have the patient in for a confirming exam and not simply make an immediate diagnosis. BTW i'm not trying to persuade you from doing the immunity testing, just attempting to explain the point of view in the article. regards
Thank you so much. Actually, we are going to do EMC immunity test regardless. It is always good to know this information before the final test. Thank again.
 
J

Juan Dude

#6
Your responsible for posing hazards and developing mitigating strategies. I would not be persuaded otherwise if you believe rfi immunity testing serves to mitigate the hazard of a misdiagnosis. Sounds perfectly reasonable to me. The case study in the article is essentially mitigating an incorrect output via the qualification of the reviewing physician, who would know enough to obtain additional information prior to making a diagnosis. This too is reasonable..but you should have a doc on board providing you input into how the information provided by your device is used. Good Luck Rich
I agree. You shouldn't let information from an article influence your judgment on risk regarding your own specific device, no matter how similar the device may appear.
 
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