Clinical Verification and Validation of Robotic Systems: From Technical Testing to Patient Safety Assurance (Prof. Dr. Mehdi Ebady Manaa)

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The clinical adoption of robotic systems in hospitals should not begin with procurement or installation, but with structured verification and clinical validation to demonstrate that the robot is safe and effective in real-world use. A hospital is not deploying a “machine” in isolation; it is deploying a socio-technical system where hardware, software, and human workflow interact, meaning that even small failures can translate into patient harm. Therefore, verification and validation are essential to transform robotics from a technological novelty into a clinically reliable tool—under the principle that robotics remain supervised and their value is proven through measurable outcomes rather than impressions. Clinical verification and validation typically follow a staged pathway that starts with baseline technical tests of motion accuracy, stability, sensor responsiveness, and fault tolerance, then progresses to operational safety testing in simulated or controlled environments that reflect real clinical conditions and infection-control constraints. The process culminates in clinical evaluation, where robotic-assisted practice is compared against conventional practice using indicators such as procedure time, complication rates, error frequency, outcome quality, and patient/team satisfaction. At this stage, isolated success cases are insufficient; institutions need systematic evidence, documented training, standardized protocols, and downtime contingency plans—because true clinical readiness is defined by repeatability and resilience under routine workload pressure, not ideal conditions. Beyond clinical metrics, validation is incomplete without addressing interoperability, governance, and cybersecurity. Robots often exchange data with hospital systems, requiring comprehensive audit trails, strict access control, update management, and network segmentation to reduce exposure. Hospitals must also establish accountability mechanisms: who authorizes use, who monitors performance, how incidents are reported, and how protocols are revised based on evidence. When these elements are managed as part of an ongoing quality program, robotics move from “technical deployment” to a genuine patient-safety assurance framework that supports sustained improvement in care delivery.