The Impact of Metrology on Health Care Quality and Safety: A Focus on Infusion Therapy and Diagnostics
Metrology, the science of measurement, plays a vital role in enhancing the quality and safety of healthcare. This is particularly significant in two critical areas: infusion therapy and diagnostics. Patient vital signs such as heart rate, blood pressure, and blood oxygen levels can reveal dosing errors resulting from adjustments in the flow rate of an infusion pump in multi-infusion setups. Infusion therapy is the most common method of drug administration in healthcare. The precise flow of liquids into or out of the human body is vital in medical technology. The safety and reliability of many medical devices, such as dialysis machines, infusion devices, and liquid handling systems for in-vitro diagnostics, depend on accurate liquid dosing. Given their widespread use, especially in hospital intensive care units (ICUs), infusion errors can have dramatic consequences, particularly when critical drugs are administered or when very low doses are delivered at low flow rates to premature or neonatal infants. Numerous adverse incidents, including morbidity and mortality, have been linked to poor or inaccurate dosing. Calibration is essential for determining flow rate and dosage errors, as well as their uncertainties in multi-infusion systems. The delivery of drug mixtures can vary significantly with adjustments to flow rates, affected by the configuration of the setup. Actual dosing conditions may differ from intended doses due to factors beyond the mixing point in the infusion line. Clinicians often adjust medications based on patient vital signs, which requires a clear understanding of how multi-infusion interactions can impact dosing. Accurate delivery from infusion pumps is vital, as misinterpretations of single and multi-infusion setups can pose clinical safety risks. A well-defined traceability chain ensures that drug delivery devices meet manufacturers and end users specifications. Upgraded metrological infrastructures in European Metrology Institutes, through the MeDD - Metrology for drug delivery project, have improved infusion therapy safety by developing reliable test methods and protocols. On the other hand, the diagnostics sector is characterized by rapid advances, accelerated by the need to manage infectious diseases and control pandemics such as COVID-19. Metrology has a significant impact on the future large-scale commercialization of next-generation microfluidic devices, such as point-of-care diagnostics, lab-on-a-chip and organ-on-a-chip (OoC), which are increasingly being used in diagnostics. The last decade has seen phenomenal growth in microfluidics. However, quality production of microfluidic devices has largely relied on manufacturers' expertise, without standardized calibration procedures or standards to streamline and accelerate production. Despite the potential societal, health, well-being, and environmental impacts of microfluidics, success stories are relatively rare compared to the number of laboratory developments. This gap is due to the differences between laboratory microfluidic devices (home-made chips, customized test protocols, materials not suitable for mass production) and reliable, reproducible products. To address this, several national metrology institutes, industry partners, and academic institutions are working together in the MFMET - Establishing Metrology Standards in Microfluidic Devices project, to develop standards and new methods for characterizing microfluidic devices (including OoC) such as internal volume, hydraulic resistance, surface roughness and liquid properties, among others.