Instrumentation & Measurement Magazine 23-4 - 48

Challenges for Medical Metrology
Baki Karaböce

alibration and testing of instruments used in the
field of health has been one of the areas of interest in
metrology science in recent years. While the metrology approach in measurements is strong enough in military
and industrial fields, the same cannot be said for the health
field. It is well known that patient safety is the priority for measurements in the medical device industry and the health sector.
Therefore, it is necessary to periodically check all devices used
in diagnosis and treatment, to ensure the reliability of medical devices and to standardize procedures as a quality control
regime. In the manufacture of medical devices, it is an important criterion to consider the safety of patients and operators,
as well as testing, measurement and calibration.
In this paper, the concept of medical metrology has been
introduced and critical cases have been outlined. The current
situation all over the world has been summarized through
the lens of metrology institutes and international organizations. Measurement parameters in medical devices have been
investigated, and calibration systems, traceability and standards have been given. It is anticipated that this manuscript
could give an obvious idea for the importance of accurate measurements in the medical field and guidance for research in
medical metrology.

Challenges for Medical Metrology
Medical decisions about diseases are generally based on clinical findings, including medical examinations, and the results
of statistical studies from patients over the years. Data obtained from patients with medical devices are important for
reaching clinical findings and generating consistent statistical data [1]-[3]. With the rapid development of technology, the
variety of devices used in imaging, diagnosis and treatment
in health care facilities has been increasing in recent years and
their usage areas have been expanding [4]-[6]. A simple thermometer, computerized imaging systems, clinical measuring
devices or computer-controlled, highly accurate surgical
robots are varying examples of medical devices with a measuring function. The data obtained from measurement systems
may be more valuable and larger than the findings obtained
48

from examinations. For example, a hernia that cannot be detected by the medical practitioner in the examination findings
can be clearly visualized on an MRI [7], [8].
As a result of the measurements, analyses and tests made
in the field of clinical metrology, the direct treatment method
can be determined. To illustrate, a medical doctor will immediately start insulin therapy if a patient has a high blood
sugar level. Incorrect measurement of the amount of glucose
in the blood will cause either unnecessary drug intake or delayed treatment. Obviously, an incorrect measurement of the
patient's blood sugar will create a health risk in addition to
unnecessary treatment expenses. Blood glucose measurements with high accuracy or low uncertainty guarantee the
right treatment and less expenditure, as is seen in Fig. 1 [9].
Improvement in precision in cholesterol measurements since
1969 has been estimated to save US $100 M/year in treatment
costs. In clinical measurements, method validation and the
development of standard reference materials (SRMs)-here
the development of serum cholesterol SRM-saves treatment
costs and also delivers timely and accurate results.
It is very important that health care institutions and organizations are able to provide traceability for devices used in
diagnostic and treatment to national and/or international standards in order to establish a unity of measurement within the
country [10]. To call attention to the importance of measurements
and calibrations used in the field of health, training programs
must be provided to all related staff, including hospital administrators, calibration laboratory workers and device operators.
A legal regulation of the calibration, control and testing of
medical devices will create appropriate motivation to ensure
the measurement reliability of national and international standards in medical measurements. Regular audits by the legal
authority should cover especially technical areas.
In this paper, the current situation, needs and infrastructures in the field of medical metrology will be investigated.
Measurement parameters, those mostly used in medical devices, will be given and the metrological approach in medical
measurements will be demonstrated through an example calibration of an infusion pump device.

IEEE Instrumentation & Measurement Magazine
1094-6969/20/$25.00©2020IEEE

June 2020

Instrumentation & Measurement Magazine 23-4

Table of Contents for the Digital Edition of Instrumentation & Measurement Magazine 23-4