Safety and performance evaluation methods for implantable cardioverter defibrillator

An implantable cardioverter defibrillator (ICD) is an active implantable medical device that is utilized in correcting atrial or ventricular fibrillation through the delivery of an electrical shock to the heart via an implanted electrode in the human body. Since an ICD is remains in the body of a patient for a long period of time and since adverse reactions to the device or defects in the device can cause critical injury to the human body, more sophisticated evaluation methods should be employed similar to the procedures used in evaluating ordinary electronic medical devices. Ensuring safety and high performance of an ICD is essential. However, much needed reference standards for the assessment of safety and efficacy of ICDs have not been defined in Korea. In this study, ICD issues were investigated, including product characteristics and permission status, to provide grounds for test items, establish methods and standards in testing and assessing the safety and performance of ICDs, which conform to international standards. Relevant documents such as those pertaining to domestic standards and FDA guidance were analyzed. Moreover, safety and performance assessment items, test standards, and test methods were successfully formulated in conformity with international standards by test validation of the proposed test methods. The output of this study is expected to contribute to the competitiveness of Korean electronic medical device industry by promoting quality and safety of ICDs.