Proposta de modelo de gerenciamento de risco aplicado ao desempenho de equipamentos eletromedicos em estabelecimentos assistenciais de saude / Proposal of risk management model applied to the performance of medical device in hospitals

AUTOR(ES)
DATA DE PUBLICAÇÃO

2004

RESUMO

There is growing concern of the health professionals for the safety of their teams and the patients in the hospital environment. Among the factors that affect the safety are the hazards resulting from functional problems of medical electrical equipments (MEEs), that can happen during its useful life. With the objective of reducing the functional risks of those equipments in the hospitals, the clinical engineering has been developing programs of preventive maintenance, routines of performance and calibration tests of medical electrical equipment (PEDROSO &CALlL, 2002). Associated to this programs, the introduction of the risk management comes to contribute for the efficiency of these risks control. Through the implementation of its management stages (risk analysis, risk evaluation and risk control), safety problems can be identified and the actions of the clinical engineering group can be taken for the risk reduction. Thus, it was presented here a proposal of risk management model applied to the MEEs performance at the hospitals, elaborated through the adaptation of precepts, techniques and procedures defined by the literature and by the Standard ISO 14971:2000. The developed model was systematized in a sequence of activities divided in three stages defined by the previous Standard - risk analysis, risk evaluation and risk control. After the elaboration of the management model, a case study was carried out in the surgical center of the "Hospital das Clínicas UNICAMP", where the risks that can be produced by the use of defibrillators were evaluated. The proposed management model proved to be a management system with investigative, logic and structured methodology. Its application supplies traced arguments and based on the knowledge for the taking decision concerning the procedures of risk control, with views to maintain the risk in established levels by the risk management committee

ASSUNTO(S)

medical device performance gerenciamento de segurança engenharia biomedica risco risk management instrumentos e aparelhos medicos desempenho hospitais - serviço de manutenção clinical engineering

ACESSO AO ARTIGO

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