# Study of Adverse Events Associated With the Use of Medical Devices Reported Under the Materiovigilance Programme of India in a Tertiary Care Teaching Hospital

## TL;DR

This study analyzes adverse events from medical devices in a hospital, identifying patterns in gender, age, device types, and risk levels to improve patient safety.

## Contribution

The study provides a detailed analysis of medical device adverse events in an Indian hospital, highlighting risk classifications and corrective actions.

## Key findings

- Males accounted for 62% of medical device adverse events compared to 38% in females.
- Patient monitors, IV catheters, and syringes were the most frequently implicated devices.
- Most events were classified as low to moderate risk (Class B) or moderate to high risk (Class C).

## Abstract

Background

Medical device adverse events (MDAEs) are critical incidents in healthcare systems that can lead to patient harm, necessitating thorough investigation and management. This study aims to comprehensively analyse MDAE reports collected over six months at a Medical Device Management Centre (MDMC). The investigation focuses on various aspects, including gender distribution, age demographics, types of medical devices implicated, department-wise distribution within hospitals, risk classification according to regulatory standards, and subsequent corrective and preventive actions undertaken.

Methods

The study collected and analysed 80 spontaneous MDAE reports from the MDMC database. Data were meticulously extracted, categorised, and quantified to facilitate detailed analysis. Mean and standard deviation were calculated for quantitative variables, and proportions were calculated for categorical variables to elucidate patterns and trends in MDAE occurrences.

Results

Analysis revealed a gender disparity, with a higher proportion of MDAEs occurring in males (62%) compared to females (38%). Middle-aged individuals (41-50 years) constituted the largest age group affected by MDAEs, comprising 36.25% of reported cases. Patient monitors, IV catheters, and syringes emerged as the most frequently implicated medical devices, with patient monitors alone accounting for 18.75% of reported events. The Medicine ICU and Dialysis Unit reported the highest number of MDAEs, with 12.5% and 10% of total cases, respectively. Risk classification based on regulatory standards categorised the majority of events as Class B (51.25%), indicating low to moderate risk, while a notable proportion were classified as Class C (32.5%), signifying moderate to high risk. Additionally, in our study, most corrective actions after an MDAE involved repairing and returning the device for hospital use (94.59%). Two cases (5.41%) were sent to the manufacturer for replacement. Additionally, 43 out of 80 adverse events involved discarding single-use devices in hospital facilities. Preventive measures, such as staff training programs, were proposed to mitigate future risks.

Conclusion

This study highlights important patterns in patient safety risks. Risk classification demonstrated that most events fell within Class B and Class C categories. Overall, this study emphasises the importance of systematic reporting, analysis, and management of MDAEs to reduce patient harm. Strengthening preventive measures, enhancing staff awareness, and ensuring robust regulatory compliance are essential steps toward improving medical device safety in hospital settings.