Affiliations: [a] Verlab Ltd, Sarajevo, Bosnia and Herzegovina | [b] Faculty of Engineering and IT, International Burch University, Bosnia and Herzegovina | [c] Faculty of Electrical Engineering, University of Sarajevo, Bosnia and Herzegovina | [d] M. Sc. Bioengineering Candidate, Trinity College Dublin, University of Dublin, Ireland | [e] Department of Information Engineering, Università degli Studi di Firenze, Italy
Correspondence:
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Corresponding author: Ernesto Iadanza, Department of Information Engineering, Università degli Studi di Firenze, Italy. E-mail:ernesto.iadanza@unifi.it
Abstract: The medical device industry has grown rapidly and incessantly over the past
century. The sophistication and complexity of the designed instrumentation
is nowadays rising and, with it, has also increased the need to develop some
better, more effective and efficient maintenance processes, as part of the
safety and performance requirements. This paper presents the results of
performance tests conducted on 50 mechanical ventilators and 50 infant
incubators used in various public healthcare institutions. Testing was
conducted in accordance to safety and performance requirements stated in
relevant international standards, directives and legal metrology policies.
Testing of output parameters for mechanical ventilators was performed in 4
measuring points while testing of output parameters for infant incubators
was performed in 7 measuring points for each infant incubator. As
performance criteria, relative error of output parameters for mechanical
ventilators and absolute error of output parameters for infant incubators
was calculated. The ranges of permissible error, for both groups of devices,
are regulated by the Rules on Metrological and Technical Requirements
published in the Official Gazette of Bosnia and Herzegovina No. 75/14, which
are defined based on international recommendations, standards and
guidelines. All ventilators and incubators were tested by etalons calibrated
in an ISO 17025 accredited laboratory, which provides compliance to international standards for all measured parameters. The results show that 30% of the tested medical devices are not operating
properly and should be serviced, recalibrated and/or removed from daily
application.
