Nina Nwoko
Themes it raises
The comment as filed
I am a board-certified Adult-Gerontology Acute Care Nurse Practitioner with more than 20 years in critical care. I write to urge FDA to add time pressure and reversibility as explicit risk modifiers in the proposed two-axis framework.
In acute and critical care, the same AI output carries very different risk depending on how quickly a clinician must act on it. A recommendation reviewed at leisure in clinic is not equivalent to one delivered during a deteriorating patient’s rapid response, when there is no time to verify the source.
On escalation functions, I ask FDA to treat under-escalation as the more dangerous failure mode in acute settings. A missed sepsis or respiratory-failure signal can be irreversible within hours. Over-escalation has real costs too: alarm fatigue is already a documented patient-safety problem at the bedside, and a tool that floods nurses with low-value alerts trains them to ignore it. Acceptance criteria should report both error types separately, by care setting, not as one blended accuracy number.
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Nina Nwoko, MSN, AGACNP-BC
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Nina is a board-certified acute care nurse practitioner who works in ICU practice, remote hospital
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