Risk Assessment in the Calibration of Medical Equipment

The calibration process of any health critical equipment is very important from the perspective of patient care. However, the calibration process is prone to human errors. A systematic and easy to implement methodology for detection and mitigation of the same is essential for any sustainable healthcare program. In this study, the entire calibration procedure is divided into sub-processes and the different modes of errors were identified. Expert opinions are collected for risk quantification. This assessment shows an overview of the calibration steps, along with the different modes of failures associated with the process. Then a failure mode and effect analysis (FMEA) based risk assessment is used to prioritize the failure modes followed by their identification and mitigation measures. The risk priority number (RPN) computed from the FMEA ranks the risks in the order of their priority. The methodology is demonstrated through calibration of a mechanical ventilator, and the results are presented. This framework can detect avoidable sources of errors, thereby increasing the reliability of critical patient care systems.