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Health Failure Mode and Effect Analysis for Clinical Engineering: Application on Cardiac Defibrillators

Attempting to guarantee the quality of cardiac defibrillators, a study was performed at a Brazilian public hospital applying the Health Care Failure Mode and Effect Analysis. Although this technique was developed for applications within the healthcare process, it can be adapted for usage by the clinical engineering to identify the failure modes of medical equipment and to assess the involved risks. Through this study, problems that interfere with the performance of cardiac defibrillators were identified and, subsequently, some actions were proposed to help reduce the risks of these potential problems. These actions certify the safe functioning of this device within the standards of safety and quality.