Background: Medical devices are important tools for the enhancement of healthcare delivery, but their use may be related to adverse events in patients and operators. Surveillance systems of AE enable healthcare providers to report AE timely in order to monitor the performance and safety of medical devices during post-marketing. Nonetheless, there is limited AE related to medical devices (AEMD) information from low-income countries (LMIC) settings.
Objectives: We aimed to describe the characteristics of AEMD reported to the surveillance system of the Social Security of Health of Peru (EsSalud).
Methods: We conducted a descriptive, cross-sectional study using the AEMD database of EsSalud containing information from 2018 to 2021. AEMD were reported by healthcare providers of EsSalud using a standard notification form. We assessed AEMD characteristics such as type of reporter, type of AEDM, medical device, subjects affected, and consequences of the AEMD. Descriptive statistics are provided.
Results: We identified 630 reports describing a total of 638 AEMD being the low quality of the medical device the main cause of AEMD (52.2%). Most cases were moderate (61%) and recurrent (41%). Roughly 205 operators presented at least one AEMD, being the personal protective equipment, and the medical device with more reports (51%). When it comes to patients, 427 were affected during the use of medical devices being the most reported catheters, syringes, needles, and infusion kits (44.2%). In terms of risk classification of medical devices, those of class II and IV were the most frequently reported (27.6% and 22.4%, respectively).
Conclusions: Although the AEMD reporting rate is low in LMICs such as Peru, in this study we found that both patients and operators may be affected by medical devices mainly due to their low quality. It is relevant for stakeholders to further investigate this factor and to put forward strategies to improve the medical device regulation in order to enforce marketing authorization holders to upgrade the quality and performance of their medical devices.
