How does a biomed program assign risk levels?

Hey Emfig21,

We perform a risk assessment for anything that the FDA hasn't already deemed life safety. We use 4 levels; Low Risk, Moderate Risk, High Risk and Life Safety. We use a scale from 0-20 to determine class. High risk gets treated essentially the same as life safety. My risk assessment is an amalgamation of the risk assessments from three different hospital systems. ECRI used to have handy risk assessment resources but an associate of mine said he couldn't find them anymore but I'd check there. My version of the assessment includes risk to patient, to operators, equipment history and manufacturer's recommendations with the reference to documentation.

Good Luck!