Build a Risk-Based Monitoring Path With FMEA
Use FMEA choices to focus a clinical monitoring plan on high-priority failure modes.
Remote ECG capture is new, high-impact, and not equally risky at every step. Use FMEA to move from what could go wrong to which failure modes deserve extra prevention or detection. Name the process Score failure modes Choose controls Apply to a new procedure Step 1: define the process boundary The team must choose what part of ECG capture to analyze first. FMEA works best on a specific process slice with meaningful risk. Step 2: score failure modes, not departments Three failures are on the table: wrong lead placement, delayed upload, and late cardiologist read. Risk belongs to a failure…
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