Adverse events associated with medical devices in patients at different clinics and hospitals in Colombia

Abstract

Background The use of medical technology may result in damage to patients. The aim was to determine which adverse events and adverse incidents related to medical–surgical devices were most frequently observed in patients seen at 65 health service providers, clinics and hospitals in Colombia. Methods Retrospective study describing reports of adverse events or incidents related to medical devices between 2014 and 2017. From the database of reports, all cases were identified and classified by the type of device, causes and time of identification of the event. Results The devices that were most frequently reported as having events or adverse incidents were those belonging to the vascular access category, with 45.2% of cases, followed by surgical equipment, with 20.2%. The causes of the events or adverse incidents were most often failures of the mechanical components, at 50.6%, followed by manufacturing defects, at 28.7%. The professionals who reported these issues most frequently were nurses, who did so in 33.1% of the cases. A total of 86.8% of the reports were non-serious adverse events, and the failure was identified at the time of device use in 72.8% of the cases. Conclusions Preventive approaches to events and adverse events related to medical devices can mostly be resolved through stricter quality control measures.

Patient safety pearls

“…Machado-Alba et al examined reports of medicalsurgical device related incidents for a three-year period at hospitals and clinics in Colombia. 6 They found that these were most often caused by mechanical failures and manufacturing defects, suggesting the better quality control measures could reduce device-related harm.…”

Reporting of adverse events related to medical devices

“…[ 5 ] Although medical device application is primarily safe, deaths, serious injuries, and malfunctions can occur occasionally. [ 6 7 8 ] The United States Food and Administration receives 1000 reports of confirmed or possible medical device malfunctions, serious injuries, and deaths every year. [ 9 ] Therefore, it is essential to report any suspected untoward occurrences following the use of a medical device to understand its safety and performance.…”