Actions developed by hospital risk management teams in post-market surveillance
DOI:
https://doi.org/10.22239/2317-269X.01909Keywords:
Public Health Surveillance; Brazilian Health Surveillance Agency; Risk Management; Quality Assurance, Health Care; Product Surveillance, Postmarketing SurveillanceAbstract
Introduction: The unsatisfactory and questionable quality of some products marketed for health care is one of the problems faced by hospital institutions. Some hospitals have risk management and are part of the Sentinela Network, implemented by the National Health Surveillance Agency (Anvisa) to face this problem. Objective: Analyze the actions taken
by hospital risk management teams in post-marketing surveillance. Method: Multiple case study, with a qualitative approach composed of four public hospital institutions that are part of the Sentinela Network in Florianópolis, Santa Catarina. Data were collected through triangulation, with semi-structured interview techniques, non-participant direct observation and documentary research, from February to June 2017. Data analysis occurred through the cross-synthesis of cases, from which two categories emerged: organizational structure of risk management and actions developed by risk management. Results: The similarities between the actions taken by the hospital risk management are: an encouragement of notifcations, the investigation of notifcations, feedback on notifcation, and the training of professionals on the subject. Among the main contrasts, we can mention the organizational structure of risk management in each institution and the internal communication of risks. Conclusions: Among the actions developed, the forwarding of notifcations to Anvisa is highlighted via the Notivisa system. This action is essential for the agency to carry out health surveillance of products used in health care, in the post-marketing phase.
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