Implementation of Materiovigilance Programs and Appraisal of Medical Device Adverse Events –– An Observational Study at Different Departments in a Tertiary Care Hospital in Kerala, India

A BSTRACT Background: Healthcare professionals are in a unique position to contribute to the proactive evaluation of device-related risks and the understanding of device-related adverse events and their identification and prevention, thereby ensuring patient safety. Objectives: The objective of the study is to ensure patient safety indirectly by identifying and reporting an adverse event associated with the -use of the medical device in different departments of a tertiary care hospital, generating safety data by systematically collecting information on adverse events and identifying the trends and pattern, creating awareness among various health care professionals by conducting seminars/workshops and establishing an expert committee comprising healthcare professionals and other stakeholders to validate the effectiveness of materiovigilance programs. Material and Methods: This is an observational prospective study carried out over 6 months among the inpatients and outpatients of Orthopedics, Gynecology, Urology, Dermatology, Pulmonology, ICUs, Surgery, and General medicine departments in a tertiary care hospital. Relevant medical devices were selected, and medical device adverse events (MADEs) were confirmed with the help of causality criteria provided by the materiovigilance program of India. Results: A total of 385 suspected cases were observed, and 114 (29.61%) medical device adverse events have been identified. About 87% of medical device adverse events observed were nonserious, and 13% were serious. The majority of the events occurred in the ICU (37.72%). 35.09% (n = 40) of medical device adverse events was due to Foley’s catheter. Based on risk classification of the medical devices involved, 23% of the reported adverse events were associated with devices classified as category A (low risk), 64% with category B (low-moderate risk), and 13% with category C (moderate-high risk). Conclusion: The study provides a peripheral view of adverse events caused by medical devices; it highlights the necessity of mandatory reporting of adverse events with regard to medical devices. By raising awareness among healthcare professionals and establishing an expert committee, we aim to validate the effectiveness of the materiovigilance program and ensure patient safety indirectly.