OBJECTIVES: To determine the rate, patterns & predictors of medical devices associated adverse events (MDAEs).

METHODS: An active surveillance is being carried in intensive care units (ICUs) of a tertiary care teaching hospital located in southern India. The patients are being monitored for MDAEs and the same are being reported on daily basis through patient’s case sheet reviews and, patient and healthcare professional interviews. The reported MDAEs are being assessed for causality and severity based on guidance document version 1.2 issued by Materiovigilance programme of India (MvPI). The predictors are being calculated at 95% confidence interval.

RESULTS: In the interim data analysis, a total of 107 MDAEs were reported amongst 74 patients [49 (66.2%) were males & 25 (33.7%) were females]. Majority of events were caused by urethral-catheters [30 (28%)], that are classified as low-risk (category A) devices followed by ventilators [16 (15%)] which are moderately high-risk (category C) devices. The elderly patient population experienced majority of MDAEs [68(63%)]. The causality assessment for 76 (71%) MDAEs was probable & 31 (29%) were possible. Majority of events were not severe & 6 (5%) were serious which resulted in prolonged hospitalization. Majority of the devices were single use devices 69 (64.5%) and most of the devices were destroyed 69 (64.5%) while 38 (35.5%) were retained within healthcare facility. With the interim data, the predictors identified were old age and duration of the device used.

CONCLUSIONS: In an already patient overburdened healthcare system, the active surveillance of MDAEs is a challenge. Clinical pharmacists can play an active role in Materiovigilance reporting by reducing economic burden incurred by MDAEs via extending hospital stay of patients.