美国FDA指导原则 Medical Devices and EMI The FDA Perspective.docxVIP

Medical Devices and EMI: The FDA Perspective Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email \o Print this page Print Note: Figures added 1/13/2000 Don WittersCenter for Devices and Radiological HealthFood and Drug AdministrationRockville, MD 20850 The EMI Problem An electric powered wheelchair suddenly veers off course; an apnea monitor fails to alarm; a ventilator suddenly changes its breath rate.[1,2,3] These are just a few examples of the problems that might occur when radiated electromagnetic (EM) energy interacts with the sensitive electronics incorporated into many medical devices. Over the years, many incidents of suspected electromagnetic interference (EMI) with medical devices have been documented.[4] In addition, recent congressional hearings [5] and media attention [6,7] have heightened concern for the safe and effective use of devices in the presence of EMI. For medical devices the environment has become crowded with potential sources of EMI (figure 1). Because of its concern for the public health and safety, the Center for Devices and Radiological Health (CDRH) part of the Food and Drug Administration (FDA), has been in the vanguard of examining medical device EMI and providing solutions. Extensive laboratory testing by CDRH [8,9,10], and others [11,12,13,14], has revealed that many devices can be susceptible to problems caused by EMI. Indeed, the CDRH has been investigating incidents of device EMI, and working on solutions (e.g. the 1979 draft EMC standard for medical devices [15]), since the late 1960s, when there was concern for EMI with cardiac pacemakers.[16] The key to addressing EMI is the recognition that it involves not only the device itself but also the environment in which it is used, and anything that may come into that environment. More than anything else, the concern with EMI must be viewed as a systems problem requiring a systems approach. In this case the solution requires the involvem