Title
Medical devices in legal metrology
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 de- ices in diagnosis and patient care will increase and that the costs of the health care system in BH will be reduced.
Year
DOI
Venue
2015
10.1109/MECO.2015.7181945
Embedded Computing
Keywords
DocType
ISBN
ISO standards,biomedical equipment,defibrillators,electrocardiography,health care,paediatrics,patient monitoring,pumps,reliability,ultrasonic therapy,ECG devices,IMBIH,ISO 17020 standard,Institute of Metrology of Bosnia and Herzegovina,anesthesia machines,clinical centers,correct diagnosis,defibrillators,dialysis machines,fully operational national laboratory,health care system,health centers,hospitals,independent testing,infusion pumps,legal metrology system,medical device accuracy,medical device functionality,medical device inspections,medical device reliability,medical doctors,neonatal incubators,patient care,patient monitors,patient treatment,pediatric incubators,perfusors,private health institutions,reliable diagnosis,respirators,standard inspection regulations,standard regulation,therapeutic ultrasounds,units of measurement,healthcare system,legislative,medical device,metrology,standard
Conference
978-1-4799-8999-7
Citations 
PageRank 
References 
1
0.63
0
Authors
4
Name
Order
Citations
PageRank
Almir Badnjevic1109.40
lejla gurbeta210.63
Dusanka Boskovic396.33
zijad dzemic410.63