When we do risk analysis for a medical device, we always include a hazard analysis; i.e., how could the patient or operator be harmed. Normally, with electrical devices, there's a potential for shock or electrical burn. I would expect with a BP cuff, you could have excess pressure applied, causing brusing or blood vessel rupture. We also typically address some of the more indirect hazards such as an incorrect reading (user has high BP but is unaware, potentially leading to stroke or heart attack. Annex C of 14971 has a lengthy list of questions you can consider when determining hazards.
Certainly, the device incorporates measures to ensure such scenarios do not cause harm. For example, it appears that the device was designed to be in compliance to IEC60601. If you get it tested to show conformance, then probably the electrical risks are mitigated. If you have a safety valve to ensure the cuff can't apply excessive pressure, you have mitigated the pressure risk. Your design verification can show these things.
To me it looks more like a failure mode analysis. And that's certainly a valid risk management activity. I just don't know if it would be sufficient in the eyes of the FDA. Also, I would question the premise of including the column for "how is the risk evaluated." The biggest concern is how the risk is mitigated. For example, one of the risks you list says "User can't receive the result of measurement" (from voice function). Instead of saying 'since it is just an additional feature, there's no risk' you could say that the user could get the reading from the display (or whatever the visual is). Your mitigation in this case is the visual. Now if this is targeted to sight-impaired users, that may not be a reasonable mitigation. But I think that's the approach the FDA is expecting.
Hope that makes sense.
Certainly, the device incorporates measures to ensure such scenarios do not cause harm. For example, it appears that the device was designed to be in compliance to IEC60601. If you get it tested to show conformance, then probably the electrical risks are mitigated. If you have a safety valve to ensure the cuff can't apply excessive pressure, you have mitigated the pressure risk. Your design verification can show these things.
To me it looks more like a failure mode analysis. And that's certainly a valid risk management activity. I just don't know if it would be sufficient in the eyes of the FDA. Also, I would question the premise of including the column for "how is the risk evaluated." The biggest concern is how the risk is mitigated. For example, one of the risks you list says "User can't receive the result of measurement" (from voice function). Instead of saying 'since it is just an additional feature, there's no risk' you could say that the user could get the reading from the display (or whatever the visual is). Your mitigation in this case is the visual. Now if this is targeted to sight-impaired users, that may not be a reasonable mitigation. But I think that's the approach the FDA is expecting.
Hope that makes sense.
