Auxiliar protocol for the investigation of incidents involving the use of pulmonary ventilators in ICU / Protocolo auxiliar para investigaÃÃo de incidentes envolvendo o uso de ventilador pulmonar em UTI

AUTOR(ES)
DATA DE PUBLICAÇÃO

2007

RESUMO

The use of electromedical devices in medicine generates the possibility of hazards for patients and health professionals. To assure a safe use of those devices the ANVISA Agency created a system called âTecnovigilÃnciaâ. The base of the system âTecnovigilÃnciaâ is the notification by the establishments of health of the incidents involving equipment that had produced or could produce hazards to patients. To fill the notification form in is a relatively complex procedure since it is necessary to identify the cause of the incident through an investigation. In this work, an appropriate protocol was developed to help the investigation process for the cases involving incidents with the use of pulmonary ventilators in ICU`s. The protocol is structured in three main categories of incidents which can be caused by: human error, failure of equipment and, environment of the patient and facilities related problems. The development of the protocol was based on Brazilian standards, handbooks and available literature related to ventilators as well as to the investigation process. The protocol was tested for 18 real cases of incidents with pulmonary ventilators. The results showed that human error was the main cause for the studied incidents (61.11% of the total), followed by equipment failure and environment of the patient and facilities, reaching respectively 22.22% and 16.6% of the total. Thus, one can conclude that some actions must be taken in order to avoid incidents and also to facilitate the identification of the cause of the incident. These actions would include more training periods for the professional involved with the use of the equipment (specially at the beginning of the procedure) and the existence of a book where one could register the details of the incident. Finally, the protocol has proved efficient and it can contribute for the quality and safety of the health services

ASSUNTO(S)

anvisa incident notification protocolo de investigaÃÃo anvisa tecnovigilÃncia ventilador pulmonar tecnovigilÃncia protocol of investigation engenharia biomedica biomedical engineering engenharia biomÃdica pulmonary ventilators

ACESSO AO ARTIGO

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