The need for materiovigilance in leprosy-treating hospitals in India: a critical perspective on patient safety.

INTRODUCTION

Leprosy remains a major public health challenge in countries like India, Brazil, and Indonesia. The materiovigilance program was established to monitor the safety of medical devices and helps to protect health-care workers and patients from device-related injuries. Leprosy patients suffer from sensory loss and are at high risk of developing injuries with medical devices. Therefore, integrating materiovigilance program with the national leprosy care program is essential to improve the safety and wellbeing of leprosy patients.

AREAS COVERED: This critical perspective covers the role of materiovigilance in India, the classification of medical devices based on their risk status, devices used in leprosy management, the Indian and international target goals for leprosy elimination, and emphasis on the integration of materiovigilance programs with leprosy programs in leprosy treating hospitals.

EXPERT OPINION: There is a significant gap existing in the leprosy elimination policies regarding the safety concerns with the use of medical devices. Successful integration of materiovigilance framework with leprosy elimination policies will influence the treatment outcomes in a positive manner. The key challenges to overcome are lack of awareness, training, and funding. Implementing the integration strategy in a stage-wise manner will help to identify the lacunae, operational issues, and further strengthen the program.