Medical Robots Between Precision and Governance: Safety and Regulatory Requirements for Clinical Integration (Prof. Dr. Mehdi Ebady Manaa)

  Share :          
  69

The adoption of medical robots in hospitals is often seen as a hallmark of modernization, yet their true value is not defined by advanced hardware alone but by measurable improvements in clinical outcomes under a robust governance framework. While robotic systems can enhance precision, standardize performance, and reduce certain types of human error, they also introduce operational complexity that requires clear credentialing policies, well-defined roles and responsibilities, and standardized operating procedures to ensure that robotics augment clinical decision-making rather than replace it. From a safety and regulatory standpoint, medical robots are typically treated as medical devices that must undergo structured verification, testing, and documentation before routine deployment. This includes systematic risk assessment for foreseeable hazards (e.g., motion faults, navigation failures, unsafe human–robot interaction), multidisciplinary team training, and contingency planning for system downtime or service interruptions. Importantly, decisions to expand robotic use should be driven by objective monitoring—quality indicators, procedure time, complication rates, and patient/team satisfaction—rather than prestige or technology-driven narratives. Beyond physical safety, medical robots raise critical issues in privacy, cybersecurity, and interoperability with hospital information systems. Because robots are networked devices that may include sensors and cameras, protecting them becomes part of patient safety, requiring controls such as network segmentation, least-privilege access, regular patching, and comprehensive audit logging. Integration with EHR/HIS platforms also strengthens traceability by documenting who requested what, when it occurred, and what actions were taken—an essential element for accountability and continuous quality improvement. Al-Mustaqbal University the first university in Iraq.