Risk analysis of medical instruments - Case study of Cardiac Output Monitor

摘要

Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems which could be encountered in connection with the use of any number of things, from driving a car, riding on public transportation, taking a drug, or using a medical instrument. We live in a world full of risks, with varying likelihoods and consequences. Risk analysis and management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity. Risk analysis is now routinely used during the design phase for medical instruments. In this paper we will describe the case study of Cardiac Output Monitor with respect to its safety and risk management process that must encompass the life span from its conception to the technology transfer. Optimum safety and performance require cooperation among all those involved in the life span of a medical device: the manufacturer, importer/vendor, government, user and public - each has a specific role to play in risk management. It also provides an introduction to standards and describes the use of voluntary standards and their increasing prominence in medical instrument regulation. In the end, risk analysis using FMEA, FTA and tools is carried out.