Metrolgia Medicina 1
Metrolgia Medicina 1
Metrolgia Medicina 1
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Dusanka Boskovic
University of Sarajevo
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1
Verlab Ltd Sarajevo, Medical Device Verification Laboratory, Sarajevo, Bosnia and Herzegovina
2
Faculty of Electrical Engineering, University of Sarajevo, Sarajevo, Bosnia and Herzegovina
3
Institute of Metrology of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina
Folia Med. Fac. Med. Univ. Saraeviensis 2015; 50(1): 43-46 foliamedica.mf.unsa.ba 43
ALMIR BADNJEVIĆ ET AL: MEASUREMENT IN MEDICINE – PAST, PRESENT, FUTURE
malfunctioning of medical apparatus [3] and over ters, water meters, mass scales, pressure gauges, ioniz-
10,000 patients get seriously injured [4]. Due to these ing radiation and other. In order to introduce medical
facts, withdraw of series of medical devices from mar- devices in legal metrology, due to previously discussed
ket by its manufacturers have been registered in the safety importance of medical devices, it is necessary to
past [5]. conduct a study through the entire health care system
The health care system of Bosnia and Herzegovina is of Bosnia and Herzegovina in order to provide the nec-
very complicated and time consuming for its end users. essary information to define the laws and regulations in
It consists of three levels and over 20 sub-levels includ- the field of metrology in medicine.
ing different ministries, agencies and other institutions.
Each of these levels and sub-levels suffer consequences
Measurement in medicine in bosnia and
of apparent fragmentation of the system on one, and
the diversity of laws and regulations in some parts of herzegovina
the country, on the other hand. All this significantly
contributes to different treatment of patients, different Methods
possibilities of access to health services, as well differ- The study entitled “Measurement in medicine” was
ences in quality of provided services [6]. carried through all public and private health facilities
The aspect of safety of medical apparatus in health care including three clinical centers, 26 hospitals, 63 health
system around the world is regulated by different agen- centers and 320 private institutions. The study was
cies or by applying international managing standards conducted by national team appointed by the IMBIH.
for health care institutions which ensure that safety of The research and writing of the study lasted six months.
medical devices is checked once a year. On the oth- All health care institutions were asked to define electri-
er hand, the aspect of safety of medical apparatus in cal medical devices that they use by name of manufac-
health care system of BH is left to manufacturers or turer and model.
distributors of medical equipment, allowing them a Based on results of processing collected data, the team
certain kind of monopoly. from the IMBIH suggested which medical devices
In order to comply with the recommendations of the should be defined as legal metrology and become sub-
World Health Organization (WHO), and international ject to regular verifications in accordance with the ISO
standards for medical devices that are applied in devel- 17020 standard. For every proposed medical device it
oped countries of Europe and the rest of the world, as was necessary to precisely define which outputs must
mentioned, it is necessary to apply the law in the field be annually verified and the minimum characteristics
of metrology for medical apparatus. In that way every of etalons that will be used in verification (inspection).
medical device is considered as a legal metrology which
is regularly checked for deviations of output values. Results
These deviations must not exceed the defined limits in The results of research and study have shown that cur-
order for medical device to be safe for use on patients. rently in Bosnia and Herzegovina there are a number of
International standards and norms concerning medi- medical devices aged over 20 years. In most cases these
cal devices are Medical Device Directive 93/42 / EEC medical devices are not subjects of any service, or any
[8], Medical Electrical Equipment ISO 60601 [9] and kind of inspection.
Safety Testing of Medical Devices ISO 62353 [10]. In Medical devices of newer generation, as shown in the
addition, the international standard ISO 17020 defines study, went under authorized preventive and corrective
the system of competence management of laboratories maintenance in different ways. In some health insti-
that deals with the inspection [11]. tutions preventive service is scheduled annually, while
At the state level, in Bosnia and Herzegovina, Institute in some institutions four times per a year, with a great
of Metrology (IMBIH) which is an integral part of the impact for the budget of the health care institution and
European Association of National Metrology Institutes for the overall health care system. This is another kind
(EURAMET) has legal jurisdiction over measurement of previously mentioned monopoly.
devices. Among other things, IMBIH has the task to As a part of preventive service, an authorized service
realize a base of standards in Bosnia and Herzegovina, center performs also certification of apparatuses. Cer-
to provide traceability of national standards to interna- tification process report is usually a work order doc-
tional standards and to prescribe metrological standard ument. This document only reports the result of the
requirements and reference materials [7]. Metrological certification: whether the device passed or failed. The
legislation in the field of medicine, as well as for oth- work order document contains neither any informa-
er existing measures and gauges, should be defined by tion about device output values measurement, nor the
IMBIH. Currently legal metrology covers regulations reference to the certification standard.
for flow meters, gas meters, electricity meters, heat me- Based on all collected data, as well as on the basis of in-
44 foliamedica.mf.unsa.ba Folia Med. Fac. Med. Univ. Saraeviensis 2015; 50(1): 43-46
ALMIR BADNJEVIĆ ET AL: MEASUREMENT IN MEDICINE – PAST, PRESENT, FUTURE
ternational standards for medical equipment and me- lished in the Official Journal of Bosnia and Herzegov-
trology, IMBIH team proposed 10 different medical ina, listing the medical devices that have become legal
devices to be introduced in legal metrology. The pro- metrology. Regulations also define inspection rules and
posed medical devices are used in critical patients care allowed deviation limits for each of the measures listed
and are an integral part of every intensive care unit, in the Table 1.
operating rooms, and emergency care. The proposed Safety inspection of medical devices in health care sys-
devices are: ECG, defibrillator, patient monitor, infu- tem can be performed only by the unbiased, impartial
sion pums, perfusors, respirator, anesthesia machine, and independent laboratory accredited according to
dialysis machine, neonatal and pediatric incubator and the ISO 17020 standard and appointed by the state.
therapeutic ultrasound. The laboratory for inspection of medical devices must
For these medical devices output values that will be possess the equipment calibrated by a calibration lab-
subject to regular inspections are defined. Table 1 pres- oratory accredited and operating in accordance with
ents medical devices introduced into legal metrology the ISO 17025 standard. Therefore, traceability can be
and their respective output values which are subject to traced back to the international standards for all devic-
regular inspections. es that are subject of verification process.
As a result of the study, legal regulations were pub- Regulations also define that the inspection of medical
devices in health care institution is done once in a year.
Table 1. Overview of the medical devices and their
output values in legal metrology
Conclusion
The primary role of any health care system is to provide
No. Medical device Output value effective, accurate, safe and equal service to all patients.
Introduction of medical equipment in legal metrology
Voltage amplitude output
is one of the steps for regulation and standardization
1 ECG Heart rate measured during time of the health care system in Bosnia and Herzegovina.
interval of 1 minute
In this way lobby of private companies in the distri-
2 Defibrillator Energy output bution and maintenance of medical equipment can be
ECG parameters reduced. Also, unbiased control of measuring instru-
Respiration ments is performed, using etalons that have document-
NIBP ed traceability to international standards.
3 Patient monitor IBP The most important is that all the steps also increase
Body skin temperature safety and reliability in health care, resulting in better
Standard SpO2 and more reliable patient diagnosis and treatment.
CO2
4 Infusomat Flow Declaration of interest
5 Perfusion Flow
The authors declare no conflict of interest for this study.
Flow
6 Respirator Flow
Volume
Flow
Anesthesia Flow
7
machine Volume
Concentration of anesthesia gasses
Conductivity
8 Dialysis machine Temperature
Pressure
Air temperature
Body skin temperature
9 Incubators O2 concentracion
Relative humidity
Mass
Therapeutic
10 Power output
ultrasound
Folia Med. Fac. Med. Univ. Saraeviensis 2015; 50(1): 43-46 foliamedica.mf.unsa.ba 45
ALMIR BADNJEVIĆ ET AL: MEASUREMENT IN MEDICINE – PAST, PRESENT, FUTURE
References
[1] Hrabač B. Zdravstveni sistemi i podsistemi. Sveučilište u
Mostaru. 2013/2014.
46 foliamedica.mf.unsa.ba Folia Med. Fac. Med. Univ. Saraeviensis 2015; 50(1): 43-46