Page 87 - Safety Risk Management for Medical Devices

66 Safety Risk Management for Medical Devices

mind on some of their initial estimates, collect the new data and update the HAL
with the latest input from the clinicians. You can repeat this process until consensus
is achieved.

Tip What is the harm of prolongation of a surgery? This is a difficult question to answer
because no two surgeries are the same. The same prolongation time may have vastly differ-
ent Harm severities in different surgeries. A potentially useful reference is from the
Medicines and Healthcare Products Regulatory Agency (MHRA)—the UK Competent
Authority, who considers a prolongation of surgery time requiring additional anesthetic as a
serious injury, with a benchmark of an additional 30 minutes as the trigger point.