See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/275039364

Measurement in medicine – Past, present, future

Conference Paper · March 2015

CITATIONS READS

8 51

4 authors, including:

Almir Badnjevic Lejla Gurbeta Pokvic

University of Sarajevo International BURCH University
115 PUBLICATIONS   757 CITATIONS    70 PUBLICATIONS   534 CITATIONS   

SEE PROFILE SEE PROFILE

Dusanka Boskovic
University of Sarajevo
50 PUBLICATIONS   208 CITATIONS   

SEE PROFILE

Some of the authors of this publication are also working on these related projects:

Medical device inspection - Analysis of machine learning for performance prediction View project

International Conference on Medical and Biological Engineering (CMBEBIH 2017) View project

All content following this page was uploaded by Almir Badnjevic on 12 May 2016.

The user has requested enhancement of the downloaded file.


Measurement in medicine – Past, present, future
Almir Badnjević1*, Lejla Gurbeta1, Dušanka Bošković2, Zijad Džemić3
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
Abstract
This paper presents the results of study conducted by the In-
stitute of Metrology of Bosnia and Herzegovina (IMBIH) that
highlight the necessity of introducing metrology into medicine
and defining standard regulations for inspections of medical
devices. As it has been previously done for other kinds of de-
vices that are under jurisdiction of the Institute of Metrology of
BH, this research provides a foundation for the introduction of
medical devices into the legal metrology system with precisely
defined units of measurement, their ranges and errors.
The study was based upon data collected through three clinical
centers, 25 hospitals, 63 health centers and 320 private health
institutions in BH over the course of one year.
As a result of this study, the medical devices that have been in-
troduced into the legal metrology system in BH include ECG
devices, defibrillators, patient monitors, respirators, anesthesia
machines, dialysis machines, pediatric and neonatal incuba-
tors, therapeutic ultrasounds, infusion pumps and perfusors.
Furthermore, standard inspection regulations for the aforemen-
tioned medical devices are also defined. Additionally, a national
laboratory for the inspection of medical devices was established
and it currently operates under the ISO 17020 standard.
Keywords: medical device, healthcare system, legislative,
standard, metrology
*Corresponding author:
Almir Badnjević
Verification Laboratory “Verlab”,
Ismeta Mujezinovića 30,
71000 Sarajevo,
Bosnia and Herzegovina
Phone: +38761213699
e-mail: almir@verlab.ba
Folia Med. Fac. Med. Univ. Saraeviensis 2015; 50(1): 43-46 foliamedica.mf.unsa.ba
Original article
Medical devices under legal metrology –
motivation
Around the world, there are variety of health care
systems each with its own characteristics and organi-
zational structure according to nation resources, re-
quirements and needs. Bearing this in mind it is very
difficult to give general definition of health care system.
Basically, it can be defined as normatively accepted sys-
tem of society and government in protecting and im-
proving the health of population, with all system fac-
tors affecting organized and constantly evolving as part
of general country social system [1]. Each health care
system consists of medical institutions which in addi-
tion to personnel and infrastructure must possess the
necessary equipment in order to perform the correct
diagnosis and treatment of their patients. In addition
to the knowledge and experience of medical doctors, in
patient diagnosis and treatment, it is necessary to have
the correct and tested medical apparatus.
Diversity and innovativeness of medical devices, as a
result of evolving field of biomedical engineering, sig-
nificantly contribute to improvement in quality and
efficiency of healthcare services. European commission
define medical device as any instrument, apparatus,
appliance, software, material or other article, whether
used alone or in combination, including the software
intended by its manufacturer to be used specifically
for diagnostic and/or therapeutic purposes. Covering
a wide range of products, from bandages to the most
sophisticated life-supporting products used in diagno-
sis, prevention, monitoring, and treatment of diseas-
es proper functionality of medical devices is crucial.
In particular, it is important in life critical situations,
when doctors have no more than 10 minutes to make
a decision according to diagnosis based on readings of
medical devices [2]. Unfortunately, between 40,000
and 80,000 patients around the world, die due to the
43
 ALMIR BADNJEVIĆ ET AL: MEASUREMENT IN MEDICINE – PAST, PRESENT, FUTURE
malfunctioning of medical apparatus [3] and over
10,000 patients get seriously injured [4]. Due to these
facts, withdraw of series of medical devices from mar-
ket by its manufacturers have been registered in the
past [5].
The health care system of Bosnia and Herzegovina is
very complicated and time consuming for its end users.
It consists of three levels and over 20 sub-levels includ-
ing different ministries, agencies and other institutions.
Each of these levels and sub-levels suffer consequences
of apparent fragmentation of the system on one, and
the diversity of laws and regulations in some parts of
the country, on the other hand. All this significantly
contributes to different treatment of patients, different
possibilities of access to health services, as well differ-
ences in quality of provided services [6].
The aspect of safety of medical apparatus in health care
system around the world is regulated by different agen-
cies or by applying international managing standards
for health care institutions which ensure that safety of
medical devices is checked once a year. On the oth-
er hand, the aspect of safety of medical apparatus in
health care system of BH is left to manufacturers or
distributors of medical equipment, allowing them a
certain kind of monopoly.
In order to comply with the recommendations of the
World Health Organization (WHO), and international
standards for medical devices that are applied in devel-
oped countries of Europe and the rest of the world, as
mentioned, it is necessary to apply the law in the field
of metrology for medical apparatus. In that way every
medical device is considered as a legal metrology which
is regularly checked for deviations of output values.
These deviations must not exceed the defined limits in
order for medical device to be safe for use on patients.
International standards and norms concerning medi-
cal devices are Medical Device Directive 93/42 / EEC
[8], Medical Electrical Equipment ISO 60601 [9] and
Safety Testing of Medical Devices ISO 62353 [10]. In
addition, the international standard ISO 17020 defines
the system of competence management of laboratories
that deals with the inspection [11].
At the state level, in Bosnia and Herzegovina, Institute
of Metrology (IMBIH) which is an integral part of the
European Association of National Metrology Institutes
(EURAMET) has legal jurisdiction over measurement
devices. Among other things, IMBIH has the task to
realize a base of standards in Bosnia and Herzegovina,
to provide traceability of national standards to interna-
tional standards and to prescribe metrological standard
requirements and reference materials [7]. Metrological
legislation in the field of medicine, as well as for oth-
er existing measures and gauges, should be defined by
IMBIH. Currently legal metrology covers regulations
for flow meters, gas meters, electricity meters, heat me-
44 foliamedica.mf.unsa.ba
ters, water meters, mass scales, pressure gauges, ioniz-
ing radiation and other. In order to introduce medical
devices in legal metrology, due to previously discussed
safety importance of medical devices, it is necessary to
conduct a study through the entire health care system
of Bosnia and Herzegovina in order to provide the nec-
essary information to define the laws and regulations in
the field of metrology in medicine.
Measurement in medicine in bosnia and
herzegovina
Methods
The study entitled “Measurement in medicine” was
carried through all public and private health facilities
including three clinical centers, 26 hospitals, 63 health
centers and 320 private institutions. The study was
conducted by national team appointed by the IMBIH.
The research and writing of the study lasted six months.
All health care institutions were asked to define electri-
cal medical devices that they use by name of manufac-
turer and model.
Based on results of processing collected data, the team
from the IMBIH suggested which medical devices
should be defined as legal metrology and become sub-
ject to regular verifications in accordance with the ISO
17020 standard. For every proposed medical device it
was necessary to precisely define which outputs must
be annually verified and the minimum characteristics
of etalons that will be used in verification (inspection).
Results
The results of research and study have shown that cur-
rently in Bosnia and Herzegovina there are a number of
medical devices aged over 20 years. In most cases these
medical devices are not subjects of any service, or any
kind of inspection.
Medical devices of newer generation, as shown in the
study, went under authorized preventive and corrective
maintenance in different ways. In some health insti-
tutions preventive service is scheduled annually, while
in some institutions four times per a year, with a great
impact for the budget of the health care institution and
for the overall health care system. This is another kind
of previously mentioned monopoly.
As a part of preventive service, an authorized service
center performs also certification of apparatuses. Cer-
tification process report is usually a work order doc-
ument. This document only reports the result of the
certification: whether the device passed or failed. The
work order document contains neither any informa-
tion about device output values measurement, nor the
reference to the certification standard.
Based on all collected data, as well as on the basis of in-
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.

[2] BMJ Quality & Safety. Available: http://qualitysafety.bmj.

com/ [last accessed on 22nd April, 2015]

[3] Journal of the American Medical Association. Available:

http://jama.jamanetwork.com/journal.aspx [last accessed on
22nd April, 2015]

[4] Electrical safety of medical equipment. Available: http://

www.ewh.ieee.org/r8/uae/Elect_Safety_Med_Equip.pdf
[last accessed on 22nd April, 2015]

[5] Fierce Medical Devices at http://www.fiercemedicalde-

vices.com/story/ge-recalls-scanners-after-patient-crushed-
death/2013-07-29 [last accessed on 22nd April, 2015]

[6] Mujkić E. Sistem zdravstva u Bosni i Hercegovini: stanje i

pravci moguće reforme. Fondacija Centar za javno pravo
[last accessed on 23rd April, 2015]

[7] IMBH at http://www.met.gov.ba/ [last accessed on 23rd

April, 2015]

[8] Medical Device Directive 93/42 / EEC at http://eur-

lex.europa.eu/LexUriServ/LexUriServ.do?uri=CON-
SLEG:1993L0042:20071011:en:PDF [last accessed on 23rd
April, 2015]

[9] Medical Electrical Equipment ISO 60601, General re-

quirements for basic safety and essential performance, IEC
60601-1-11:2010

[10] Safety Testing of Medical Devices ISO 62353/2014 Eu-

ropen Comission, Medical Devices. Guidence document
at http://ec.europa.eu/health/medical-devices/files/med-
dev/2_1-1___04-1994_en.pdf [last accessed on 23rd April,
2015]

46 foliamedica.mf.unsa.ba Folia Med. Fac. Med. Univ. Saraeviensis 2015; 50(1): 43-46

View publication stats