Medical Device Vigilance in Sri Lanka: Identifying Gaps and Developing National Guidelines

Abstract

Background: Medical Device Vigilance (MDV) systems are essential for ensuring patient safety through post-market surveillance. In low- and middle-income countries such as Sri Lanka, MDV systems remain underdeveloped despite increasing reliance on advanced medical technologies.Objectives: This study aimed to identify gaps in MDV practices in Sri Lanka and develop context-specific national guidelines aligned with international best practices.Methods A pragmatic mixed-methods design was used. A desk review of international frameworks (WHO, IMDRF, EU MDR 2017/745, FDA) was conducted alongside a cross-sectional survey of key stakeholders, including healthcare professionals, biomedical engineers, device importers, and regulatory staff. Quantitative data were analyzed using descriptive statistics and non-parametric tests.Results A total of 128 respondents participated. Awareness of MDV was high (83%), but only 22.7% had received formal training. Reporting of device-related adverse events remained low, with only half of those encountering incidents submitting reports. Key barriers included lack of training (mean = 3.33), unclear reporting procedures (mean = 3.10), and administrative burden (mean = 3.16). Nurses reported significantly higher perception of inadequate training compared to other groups (p < 0.05). System effectiveness was rated as neutral or poor by the majority of respondents.Conclusion MDV underreporting in Sri Lanka is primarily driven by structural and system-level barriers rather than lack of awareness. A simplified, digital, and feedback-oriented reporting system supported by continuous training is urgently required.