Emerging innovations in metrology for medical device technologies: advancing healthcare precision

Abstract

The lack of uniformity among working standards for medical equipment calibration poses a significant challenge in achieving comparable measurements across Spanish hospitals. Furthermore, although beyond our scope, each Spanish Autonomous Community utilizes medical record systems that may not be interoperable between different levels of care, impeding patient care and healthcare system efficiency. While resolving this issue is complex, it is crucial to acknowledge it and collaborate to establish a unified document management system and standardize calibration and verification procedures.While progress is made towards this goal, the Health Laboratory of the Spanish National Metrology Institute (CEM) is addressing a challenge by leading three research projects based on the calibration of medical equipment, specifically focusing on diagnostic imaging equipment such as ultrasound and computed tomography (CT) scanners, electrocardiographs (ECG), and blood pressure monitors to ensure measurement traceability. The main innovation of diagnostic imaging has been based on the design and manufacture of a standard for the verification of ultrasound and CT scanners, called Phantometer, designed to verify the dimensional measurements of ultrasound machines, expandable to diagnostic imaging equipment such as CT, and provide metrological traceability to the International System of Units (SI) in the quantity of length.This new healthcare approach intends for the Phantometer to have several significant advantages over other similar phantoms due to the material it uses, the number of removable reference spheres it possesses, and its versatility in placement for verifying ultrasound and CT scanners.Another main challenge of this laboratory is to ensure that the results of electrocardiographs are traceable both to the volt (for signal amplitude) and to the second (for time measurement), ensuring precision in detecting the heart's electrical activity. To this end, reference standards that can quantify and evaluate the quality of measurement in these increasingly technologically evolved devices are being studied. As a future goal, CEM will focus on obtaining reliable databases for Machine Learning (ML) training, which will allow the creation of more realistic models that can be related to real medical quantities. Therefore, one of the current challenges in the field of electrocardiography is the evaluation of the quality and decision uncertainty of simplified devices such as fitness wearables for the early detection of cardiac abnormalities and diseases. The main challenge for blood pressure monitors is based on ensuring the accuracy and quality of measurement with different equipment. It is intended to include the study of the integration of new technologies in different blood pressure monitors that will help improve the accuracy of these devices through the implementation of advanced algorithms to process signals and reduce errors, and position detection, finding the optimal position of the cuff to prevent measurement errors. All these challenges are fundamental to achieving two strategic objectives: first, the unification of calibration procedures with reliable measurements traceable to the International System of Units (SI), and second, addressing the integrating ML in quality assessment of medical equipment and uncertainty analysis in diagnostic devices. This approach simultaneously ensures metrological consistency and technological advancement in medical diagnostics.