Assessment of adverse events associated with medical devices among respiratory disorder patients at a tertiary care hospital.

Background & objectives Medical devices (MDs) play a vital role in delivering healthcare to critically ill individuals, which sometimes may also lead to adverse events ranging from serious to non-serious. So, this study was undertaken to assess the pattern of adverse events associated with MDs among individuals with respiratory disorder and to determine the predictors associated with MD related adverse events. Methods A cross-sectional study was carried out among individuals with respiratory disorders admitted to the Intensive Care Unit of a tertiary care teaching hospital between August 2022 and July 2023. Individuals were monitored for MD-related adverse events (MDAEs) daily through interviews, case-sheet reviews, and interaction with healthcare professionals. The reported MDAEs were assessed for causality, severity, and device disposition based on the Materiovigilance Programme of India (MvPI). The MDAEs were assessed, categorised, and presented based on MDs, device risk classification, and type of events. The predictors were calculated at 95 per cent confidence interval (CI) using Chi-square tests. Results A total of 152 MDAEs were reported among 90 individuals; the majority were males [60 (66.7%)], and elderly between the ages of 61-70 yr experienced the majority of MDAEs [20 (22.2%)]. Ventilator-associated pneumonia (VAP) was higher among mechanical ventilator users [59 (38.8%)] with non-implantable devices [114 (75%)]. Regarding device risk classification [106 (69.7%)], category C was frequently reported. The causality assessment revealed that the majority of events were categorized as 'probable' [84 (55.2%)]. Subsequently, the severity of the events was classified based on criteria such as death, life-threatening conditions, disability, hospitalization, or the need for intervention to prevent permanent impairment. Among the total MDAEs, 118 (77.6%) were classified as non-serious, while 34 (22.4%) were identified as serious. Almost all MDAEs [71 (46.7%)] were device-associated and were disposed off within healthcare facilities [96 (63.2%)]. In terms of patient outcomes, 141 participants (92.7%) achieved recovery. The presence of comorbidities and hyperpolypharmacy significantly affected the adverse events caused by the MDs [P=0.04]. Interpretation & conclusions MDAEs among individuals with respiratory disorder compromise the prognosis and complicate therapeutic outcomes. Individuals with a comorbid condition and hyper polypharmacy experienced significantly high MDAEs suggesting that such individuals, should be monitored for early detection of MD associated adverse drug events to restrict their implications on patient care.