RISK MANAGEMENT REPORTING AND ITS CONTRIBUTION TO PATIENT SAFETY

Abstract

The present study aimed to identify risk management reporting of products related to technovigilance and pharmacovigilance between 2002 and 2004 and 2007 and 2013. Retrospective, documentary study with quantitative approach. Data were collected from April to August 2014, analyzed and presented using absolute and relative frequency calculations. A total number of 529 notifications were reported. Most notifications occurred in in-patient units: n= 218 (42%). The Technovigilance notification type led with n=494 (93.4%), the subgroup venipuncture had a prevalence of n=218, 41.2%. Defective product corresponded to n=324, 61.2% of the reported events. Regarding the association between sector and notified materials, the venipuncture group, in the Emergency department stands out with n=68 (70.1%). This data contributes to the generation of a quality indicator and to ensure better health products that promote safety to patients and health professionals.

Keywords

• Risk control
• Health care quality assurance
• Patient safety
• Nursing
• Risk management