A Study On Risk Management Of Magnetic Resonance Imaging System

Magnetic Resonance Imaging technology has been developed significantly in the past thirty years since it was invented thanks to the preferences of both doctors and patients and the rapid spread in the field of both clinical applications and scientific researches. And the flexible tuning of imaging parameters and high resolution images compare with other imaging technologies make it a preferred imaging technique in many medical researches and diagnosis cases. However, what makes it more perfect, is the belief that it is a green technology which does no harm to human body and environments. So just imagine if a MRI system was no longer safe enough, the applications and development would certainly be shocked.Risk Management is a sufficient way to prevent arising and extension of potential hazards during applications. It not only is applied to the field of investments and finance, but also plays an important role in medical devices developments. The theory of Risk Management would be helpful to monitor the design phase from development of MRI systems in order to reduce the potential risks during post-product applications, and significative for suggesting the relevant risks to users and patients. And yet, China has not issued any standards about risk management for medical devices. It leads to the urgent need of establishing a risk management process according to characteristics of products by manufacturers to meet the universal safety requirements. And the manufacturers should try to evaluate the efficiency by application data and improve the process continuously.This paper will define and enrich the risk management process for MRI systems basing on the physical principles and design characteristics of MRI with a view to the safety requirements of MRI applications. We set up our points by taking the ISO14971 and other related quality assurance and management techniques standards as fundamental basis. Here are the primary missions of this research:1. Familiarize the physical principles and the development process of MRI system;2. To comprehend the definitions and guidelines in the ISO14971 standard correctly.Further more, we will concentrate on building the specification, methodology, measures related to the risk management for MRI system by reviewing some publications about safety issues of MRI. And also set up a risk management process model according to the development model and product characteristics. What's more, we will present a risk issue about quench situation of a new MRI system as a practical example of our risk management process during MRI system development. It has included risk identify, risk assessment, and risk control which is the classical three-step risk management and decided the measures according to the example. The presentation will be able to verify the feasibility and validity of our process. The process can also act as a reference to other risk management process in the field of medical devices or other MRI related products. Finally, we also raise a new point of view which is controversial in the field of risk management relating to hazard warnings in order to induct further considerations about the improvements of MRI risk management study.