Consumer Reporting in Materiovigilance: Awareness, Attitudes & Barriers to Action

Abstract

Background: Materiovigilance is an essential component of patient safety, involving the monitoring, identification, reporting, and analysis of adverse events associated with medical devices. Consumer reporting plays a crucial role in detecting faulty medical devices early. However, underreporting remains a significant challenge, often due to a lack of awareness or perceived barriers in the reporting process. 

Aims: This study aims to assess consumer awareness, attitudes, and barriers to reporting adverse events related to medical devices under the Materiovigilance Programme of India (MvPI).

Materials & Methods: A cross-sectional study was conducted at Jawaharlal Nehru Medical College & Hospital, Aligarh Muslim University. Consumers were provided with a structured questionnaire in various OPDs and IPDs. Out of 102 screened participants, 76 were selected after obtaining verbal informed consent. Data were collected on awareness, attitudes, and reporting practices and analyzed using descriptive statistics.

Results: The study revealed a significant lack of awareness, with only 12 out of 76 participants aware of Materiovigilance. While 49 participants acknowledged the importance of reporting faulty medical devices, 27 expressed hesitancy. Among 39 participants who encountered medical device issues, only 9 reported them. The primary barriers to reporting included a lack of knowledge (n=37) and doubts regarding the impact of reporting (n=22).

Discussion: The findings highlight a pressing need for improved public awareness and simplified reporting mechanisms. Unreported faulty medical devices may continue circulating, increasing risks to patient safety. Overcoming these barriers requires targeted educational initiatives, streamlined reporting channels, and greater consumer engagement.

Conclusion: Enhancing consumer participation in Materiovigilance through awareness programs and social media outreach can significantly improve reporting rates. Addressing existing barriers will contribute to a more effective surveillance system, ensuring the safe use of medical devices and reducing adverse health outcomes.