Risk Management Framework for Medical Equipment in Nigerian Tertiary Hospitals: A Professional Development Study

Medical equipment-related adverse events in Nigerian tertiary hospitals represent a preventable patient safety burden, and systematic risk management frameworks aligned to international standards are absent from most Nigerian hospital quality systems. This study develops a risk management framework for medical equipment applicable to Nigerian tertiary hospitals, drawing on fieldwork conducted at tertiary institutions in the North Central zone. The framework development methodology combined systematic adverse event report analysis from three hospitals over a two-year period, structured risk identification workshops with biomedical engineers, clinicians, and patient safety officers, and benchmarking against IEC 80001-1 standard for risk management of IT networks incorporating medical devices, ISO 14971 medical device risk management principles, and ECRI Institute guidance on equipment-related adverse event prevention. Adverse event analysis identified the highest-frequency equipment-related incident categories as infusion pump programming errors, patient monitor alarm fatigue events, equipment electrical failure during procedures, and equipment cleaning product incompatibility causing device damage. The developed framework specifies a risk register structure for equipment-related hazards, risk assessment criteria calibrated to the Nigerian hospital context, risk control hierarchy guidance, and monitoring and review processes. A pilot application at University of Abuja Teaching Hospital demonstrated identification of thirty-seven previously unregistered equipment-related risk items through the framework-guided risk assessment process. Clinical engineering staff rated framework usability as high following a half-day training workshop. The study recommends the Federal Ministry of Health mandate risk management framework adoption at all federal tertiary hospitals. Keywords: risk management, medical equipment, adverse events, tertiary hospitals, patient safety.