Assessment of Adverse Events Associated with Medical Devices Among Respiratory Patients at Tertiary Care Hospital

Aim: To assess the pattern of medical device associated adverse events (MDAEs) in respiratory patients and to determine the predictors of MDAEs.
Methods: A prospective active surveillance was carried out amongst respiratory patients admitted to the Intensive Care Units of a tertiary care hospital over a period of 6 months. Patients were monitored for MDAEs on a daily basis through patient interviews and case sheet reviews, interaction with healthcare professionals. The reported MDAEs were assessed for causality and severity, and device disposition based on Materiovigilance Program of India (MvPI) guidelines version 1.2. The MDAEs were assessed, categorised and presented based on the medical devices, device risk classification, and type of events. The predictors were calculated at a 95% confidence interval using odds ratio.
Results: A total of 152 MDAEs were reported amongst 90 patients, majority were males [60 (66.7%)], elderly patients in the age group of 61-70 years experienced MDAEs [20 (22.2%)]. Ventilator associated pneumonia were marginally higher amongst mechanical ventilators utilisers [59 (38.8%)] and with non-implantable devices [114 (75%)]. Regarding device risk classification [106 (69.7%)] category C has been most frequently reported. The causality assessment for [84 (55.2%)] was probable with [118 (77.6%)] non-serious events. Almost all MDAEs [71 (46.7%)] were device associated and were disposed within the healthcare facility [96 (63.2%)]. Concerning the patient outcomes, the study population were recovered [141 (92.7%)]. Comorbidities and length of hospital stay were significant predictors [OR= 2.6 CI: 1.05-6.76, p= 0.039].
Conclusion: MDAEs amongst respiratory patients compromise the prognosis and complicates therapeutic outcomes. MDAEs should be monitored for early detection to restrict their implications on patient care.