Risk management of medical devices in the ICID

Abstract

Risk management is a requirement that must be met by medical devices manufacturers; therefore, as established by the ISO 14971, a methodology to properly manage design, production and post-production risks was introduced at ICID. So, a team of experts conducted a preliminary diagnosis and proposed a schematic representation associated with the risk management process. Finally, a risk management procedure was implemented in January 2012. The procedure implementation allowed the identification, estimation and evaluation of the risks in the whole life cycle of products. It facilitated the analysis of the data related to the classification of the hazards, its effects and possible causes to determine which risks are unacceptable, and to propose necessary corrective and preventive actions to reduce the impact of these on the safety and efficacy of medical devices. The result in the application of a defibrillator validated the proposed methodology, identified 88 hazards, 32 of them unacceptable, which was proposed control measures and risk prior to introduction to the production were evaluated, becoming acceptable risks.