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Medical devices in legal metrology

Conference Paper · June 2015

DOI: 10.13140/RG.2.1.4741.2324

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 4th Mediterranean Conference on Embedded Computing
Medical devices in legal metrology
Almir Badnjević/ Lejla Gurbeta Dušanka Bošković
Medical Device Verification Laboratory University of Sarajevo
Verlab Ltd Faculty of Electrical Engineering
Sarajevo, Bosnia and Herzegovina Sarajevo, Bosnia and Herzegovina
Abstract—In addition to knowledge and experience of medical
doctors, correct diagnosis and appropriate patient treatment
largely depend on accuracy and functionality of medical devices.
In a large number of serious medical situations proper
functionality of medical devices is crucial for patients. Therefore
it is necessary to carry out as strict and independent testing of
functionalities of medical devices as possible and to obtain the
most accurate and reliable diagnosis and patient treatment.
This paper presents the results of study conducted by the
Institute 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 devices
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 introduced into
the legal metrology system in BH include ECG devices,
defibrillators, patient monitors, respirators, anesthesia machines,
dialysis machines, pediatric and neonatal incubators, therapeutic
ultrasounds, infusion pumps and perfusors. Furthermore,
standard inspection regulations for the aforementioned 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.
With the introduction of medical devices into the legal metrology
system and with the establishment of a fully operational national
laboratory for inspection of medical devices, we expect that the
reliability of medical devices in diagnosis and patient care will
increase and that the costs of the health care system in BH will be
reduced.
Keywords- medical device; healthcare system; legislative; standard;
metrology;
I. MEDICAL DEVICES UNDER LEGAL
METROLOGY - MOTIVATION
Around the world, there are variety of health care systems
each with its own characteristics and organizational structure
according to nation resources, requirements and needs. Bearing
this in mind it is very difficult to give general definition of
MECO - 2015 Budva, Montenegro
Zijad Džemić
Insititute of Metrology of Bosnia and
Herzegovina
Sarajevo, Bosnia and Herzegovina
health care system. Basically, it can be defined as normatively
accepted system of society and government in protecting and
improving the health of population, with all system factors
affecting organized and constantly evolving as part of general
country social system [1]. Each health care system consists of
medical institutions which in addition 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, significantly
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 diagnosis,
prevention, monitoring, and treatment of diseases 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 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 market 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 including 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
differences in quality of provided services [6].
The aspect of safety of medical apparatus in health care
system around the world is regulated by different agencies or
by applying international managing standards for health care
 4th Mediterranean Conference on Embedded Computing
institutions which ensure that safety of medical devices is
checked once a year. On the other 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 developed 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 medical 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 international standards and to prescribe
metrological standard requirements and reference materials [7].
Metrological legislation in the field of medicine, as well as for
other existing measures and gauges, should be defined by
IMBIH. Currently legal metrology covers regulations for flow
meters, gas meters, electricity meters, heat meters, water
meters, mass scales, pressure gauges, ionizing 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 necessary information to define the laws and
regulations in the field of metrology in medicine.
II. MEASUREMENT IN BOSNIA AND
HERZEGOVINA
A. 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 electrical medical
devices that they use by name of manufacturer 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 subject to regular verifications
in accordance with the ISO 17020 standard. For every
MECO - 2015 Budva, Montenegro
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).
B. Results
The results of research and study have shown that currently
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 institutions
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. Certification process
report is usually a work order document. This document only
reports the result of the certification: whether the device passed
or failed. The work order document contains neither any
information about device output values measurement, nor the
reference to the certification standard.
Based on all collected data, as well as on the basis of
international standards for medical equipment and metrology,
IMBIH team proposed 10 different medical devices to be
introduced in legal metrology. The proposed medical devices
are used in critical patients care and are an integral part of
every intensive care unit, operating rooms, and emergency
care. The proposed devices are: ECG, defibrillator, patient
monitor, infusion pumps, perfusors, respirator, anesthesia
machine, dialysis machine, neonatal and pediatric incubator
and therapeutic ultrasound.
For these medical devices output values that will be subject
to regular inspections are defined. Table 1 presents medical
devices introduced into legal metrology and their respective
output values which are subject to regular inspections.
As a result of the study, legal regulations were published in
the Official Journal of Bosnia and Herzegovina, listing the
medical devices that have become legal metrology. Regulations
also define inspection rules and allowed deviation limits for
each of the measures listed in the Table 1.
Safety inspection of medical devices in health care system
can be performed only by the unbiased, impartial and
independent laboratory accredited according to the ISO 17020
standard and appointed by the state. The laboratory for
inspection of medical devices must possess the equipment
calibrated by a calibration laboratory accredited and operating
in accordance with the ISO 17025 standard. Therefore,
traceability can be traced back to the international standards for
all devices that are subject of verification process.
 4th Mediterranean Conference on Embedded Computing MECO - 2015 Budva, Montenegro

TABLE I. OVERVIEW OF THE MEDICAL DEVICES AND medical devices used in healthcare institutions and therefore
THEIR OUTPUT VALUES IN LEGAL METROLOGY
increase patient safety as old and faulty medical devices are
No. Medical device Output value excluded from use or service is recommended.
1 ECG Voltage amplitude output
TABLE II. OVERVIEW OF IMPLEMENTATION OF LEGAL
Heart rate measured during time interval of REGULATIONS FOR MEDICAL DEVICES
1 minute
2 Defibrillator Energy output Number of
Medical Inspection test Inspection test
observed
Device Passed Failed
3 Patient monitor ECG parameters devices
ECG Device 26 20 (76.9%) 6 (23.076%)
Respiration Defibrillator 15 9 (60%) 6 (40%)
NIBP Anesthesia
7 5 (71.43%) 2 (28.57%)
machine
IBP Incubator 17 13 (76.47%) 4 (23.53%)
Respirator 7 7 (100%) 0 (0%)
Body skin temperature
Patient
5 4 (80%) 1 (20%)
Standard SpO2 Monitor
Therapeutic
CO2 14 8 (57.14%) 6 (42.86%)
Ultrasound
4 Infusomat Flow TOTAL 90 67 (74.44%) 23 (25.56%)
5 Perfusion Flow III. CONCLUSION
6 Respirator Flow The primary role of any health care system is to provide
Flow effective, accurate, safe and equal service to all patients.
Introduction of medical equipment in legal metrology is one of
Volume
the steps for regulation and standardization of the health care
7 Anesthesia Flow system in Bosnia and Herzegovina.
machine
Flow In this way lobby of private companies in the distribution
Volume and maintenance of medical equipment can be reduced. Also,
unbiased control of measuring instruments is performed, using
Concentration of anesthesia gasses etalons that have documented traceability to international
8 Dialysis Conductivity
standards.
machine The most important is that all the steps also increase safety
Temperature
and reliability in health care, resulting in better and more
Pressure reliable patient diagnosis and treatment.
9 Incubators Air temperature
REFERENCES
Body skin temperature
[1] Boris Hrabač, “Healthcare systems and subsystems”, University of
O2concentracion Mostar. 2013/2014
[2] BMJ Quality & Safety at www.qualitysafety.bmj.com
Relative humidity
[3] Journal of the American Medical Association at
Mass www.jama.jamanetwork.com/journal.aspx
[4] Electrical safety of medical equipment at
10 Therapeutic Power output
www.ewh.ieee.org/r8/uae/Elect_Safety_Med_Equip.pdf
ultrasound
[5] Fierce Medical Devices at www.fiercemedicaldevices.com/story/ge-
recalls-scanners-after-patient-crushed-death/2013-07-29
Regulations also define that the inspection of medical [6] Ervin Mujkić, “Healthcare system in Bosnia and Herzegovina: condition
devices in health care institution is done once in a year. and possible directions for reform.”, Foundation Centre for Public Law
[7] IMBH at www.met.gov.ba
Implementation of legal regulations on metrological and [8] Medical Device Directive 93/42 / EEC at www.eur-
technical requirements for medical devices listed in Table 2. lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:2
have shown that 25.56% out of 90 devices from 16 different 0071011:en:PDF
healthcare institutions don't meet the requirements regarding [9] Medical Electrical Equipment ISO 60601, General requirements for
error limits. This may be considered as high percentage since basic safety and essential performance, IEC 60601-1-11:2010
these medical devices are commonly used in healthcare [10] Safety Testing of Medical Devices ISO 62353/2014
institutions for establishing the diagnosis and treatment of [11] Europena Comission, Medical Devices. Guidence document at
various diseases as well as for saving life and life-support. The www.ec.europa.eu/health/medical-devices/files/meddev/2_1-1___04-
1994_en.pdf
introduction of mandatory annual verification of medical
devices in healthcare system directly affects the reliability of
 4th Mediterranean Conference on Embedded Computing MECO - 2015 Budva, Montenegro

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