TY - JOUR
KW - Leprosy care
KW - National leprosy eradication programme
KW - Post-market surveillance
KW - WHO 2030 leprosy strategy
KW - materiovigilance programme of India
KW - medical device safety
KW - medical device vigilance in tropical diseases
KW - patient safety monitoring
KW - rehabilitation devices
AU - Pugazhenthan T
AU - Pe S
AU - U A
AU - Naveen V N
AB - <p><strong>INTRODUCTION: </strong></p>

<p>Leprosy remains a major public health challenge in countries like India, Brazil, and Indonesia. The Materiovigilance Programme was established to monitor the safety of medical devices and helps to protect healthcare 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 programme with the national leprosy care programme is essential to improve the safety and wellbeing of leprosy patients.</p>

<p><strong>AREAS COVERED: </strong></p>

<p>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 programmes with leprosy programmes in leprosy treating hospitals.</p>

<p><strong>EXPERT OPINION: </strong></p>

<p>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 programme.</p>

BT - Expert review of medical devices
C1 - https://www.ncbi.nlm.nih.gov/pubmed/41738341
DA - 02/2026
DO - 10.1080/17434440.2026.2638364
J2 - Expert Rev Med Devices
LA - ENG
M3 - Article 
N2 - <p><strong>INTRODUCTION: </strong></p>

<p>Leprosy remains a major public health challenge in countries like India, Brazil, and Indonesia. The Materiovigilance Programme was established to monitor the safety of medical devices and helps to protect healthcare 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 programme with the national leprosy care programme is essential to improve the safety and wellbeing of leprosy patients.</p>

<p><strong>AREAS COVERED: </strong></p>

<p>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 programmes with leprosy programmes in leprosy treating hospitals.</p>

<p><strong>EXPERT OPINION: </strong></p>

<p>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 programme.</p>

PY - 2026
T2 - Expert review of medical devices
TI - The need for materiovigilance in leprosy-treating hospitals in India: a critical perspective on patient safety.
SN - 1745-2422
ER -