ERM

Abstract

Indian multi-specialty hospitals are increasingly dependent on complex, high-cost, network-connected medical equipment for diagnosis, therapy, monitoring, life support, procedural care, and digital clinical workflow (Central Drugs Standard Control Organization, 2017; U.S. Food and Drug Administration, n.d.; World Health Organization, 2021). This dependence creates a distinctive enterprise risk profile: a medical device failure is not only a biomedical engineering issue, but also a patient safety, cybersecurity, regulatory, financial, legal, reputational, and governance risk. This conceptual and practice-oriented monograph proposes an integrated Enterprise Risk Management (ERM) framework for medical equipment lifecycle risk management in Indian multi-specialty hospitals. The monograph draws on the governance logic of Chanakya's Arthashastra, the COSO 2017 ERM framework, ISO 31000:2018, ISO 14971:2019, patient safety principles, NABH accreditation expectations, CDSCO and AERB regulatory anchors, connected-device cybersecurity guidance, and illustrative Indian healthcare cases (Atomic Energy Regulatory Board, n.d.; Central Drugs Standard Control Organization, 2017; Committee of Sponsoring Organizations of the Treadway Commission, 2017; International Organization for Standardization, 2018, 2019; Kautilya, 1915; National Accreditation Board for Hospitals & Healthcare Providers, n.d.; U.S. Food and Drug Administration, n.d.). The proposed framework treats medical equipment risk as an enterprise-level concern across planning, procurement, installation, commissioning, clinical operation, maintenance, calibration, cybersecurity monitoring, upgrade, replacement, decommissioning, and disposal. It integrates risk taxonomy, risk appetite, FMEA, risk registers, key risk indicators, vendor risk management, regulatory compliance, and board-level reporting into a life cycle-based governance model for a 500-bed multi-specialty hospital. The monograph is positioned as a conceptual framework and practical implementation guide rather than an empirical study. Its contribution is the synthesis of classical governance foresight, contemporary ERM standards, and Indian hospital operating realities into a structured model that can be adapted by boards, hospital administrators, biomedical engineering leaders, quality teams, clinical departments, CIOs/CISOs, procurement heads, and risk managers.