Ensuring Accuracy: A Report on Calibration Challenges in Medical Devices with Case Studies

Abstract

The work is about how medical devices are ultimate goal for realization of SI units with owing traceability from different Si units It is combination of multiple parameters, that single technical group or technical area can supply fulfill the accuracy requirements, Since the ultimate goal of metrology is to improve quality of life, the medical metrology can be seen with ultimate goal to improve the quality of human health. It is quite evident that in coming years the extent of medical metrology will expend exponential. Medical devices, essential tools in modern healthcare, rely on accurate measurements to ensure patient safety and effective treatment. To achieve this, these devices must be calibrated and verified against SI units, tracing their accuracy back to fundamental standards. As healthcare advances, the demand for accurate medical device measurements will continue to grow. This poster will explore the specific challenges associated with metrology in intensive care units. We will delve into the complexity of tracing these devices to SI units and the multifaceted expertise required for their accurate evaluation. As a case study we present Infusion Pump, and Syringe Pump, a widely utilized device essential to primary healthcare, specifically for giving patients medication, blood, nutrition, and hydration. Therefore, it is essential that the infusion devices produce the most accurate and precise volume and flow possible, particularly when dealing with neonatology (the care of newborns) or cancer treatment. Appropriate calibration technique along with measurement uncertainty evaluation, is essential for maintaining the traceability of these devices. In this study, flow rate measurement with associated uncertainty was carried out with syringe pump and linear peristaltic infusion pump using the gravimetric-based method (primary method for the calibration of infusion devices). In this case study two different infusion devices (Syringe Pump and Infusion Pump) are calibrated using the gravimetric method (GM). The measurement uncertainty of two infusion devices are compared and it is observed that the syringe pump offers relatively lower uncertainty in the proposed range with respect to linear peristaltic infusion pump. Infusion devices (Syringe Pump and Infusion Pump) were evaluated at three flow rates (10 mL/hr, 20 mL/hr, and 50 mL/hr) using the Gravimetric Method (GM). Measured flow rates and their associated expanded uncertainties (U, k=2) were determined. Analysis revealed that the Infusion Pump may not be suitable for low flow rates (10 mL/hr) as the uncertainty values were comparable to the maximum permissible error of the infusion pumps. This limited the ability to confidently assess conformity. However, incorporating occlusion pressure into the evaluation could potentially favor the Infusion Pump over the Syringe Pump. This case study exemplifies how multiple parameters (e.g., flow rate, occlusion pressure) significantly influence the selection and performance assessment of medical devices. We will present other case studies in this poster, showcasing medical devices and their essential reliance on traceability to multiple SI units.