Epidemiological profile of technical complaints and adverse events in technovigilance reported by professionals of an intensive care unit
International Journal of Development Research
Epidemiological profile of technical complaints and adverse events in technovigilance reported by professionals of an intensive care unit
Received 14th September, 2019; Received in revised form 06th October, 2019; Accepted 07th November, 2019; Published online 30th December, 2019
Copyright © 2019, Paulo Victor Caldas Soares et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective: To identify the epidemiological profile of technical complaints and adverse events in technovigilance reported in an Intensive Care Unit of a Belém Hospital. Methods: This is a descriptive, cross-sectional, retrospective epidemiological study with a quantitative approach. We collected 16 samples of technical complaints and adverse events notifications from a total of 12 products registered by the Risk Management in the Intensive Care Unit of Hospital Ophir Loyola in 2017. Results: Of the 16 samples of notifications collected, 12 (75%) were related to technical complaints and 4 (25%) related to adverse events. The products that most reported complaints of technical complaints were: disposable needle, multipath equipment, disposable glove and hypodermic syringe, where each one of them had 2 complaints records (12.5%). The item with the highest occurrence among adverse events was the adhesive tape with 2 reports (12.5%). Conclusion: Among the limitations of the study are the few studies that demonstrate the epidemiological profile of products with notifications of technical complaints and adverse events in technovigilance. Another limitation found in the study was the description of the quality deviation presented in the product, which made it difficult to systematize the data.
