title: Testing of mechanical ventilators and infant incubators in healthcare institutions.
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.
authors.affiliation: Verlab Ltd, Sarajevo, Bosnia and Herzegovina.|Faculty of Engineering and IT, International Burch University, Bosnia and Herzegovina.|Faculty of Electrical Engineering, University of Sarajevo, Bosnia and Herzegovina.
authors.forename: Almir
authors.initials: A
authors.lastname: Badnjevic
authors.affiliation: Verlab Ltd, Sarajevo, Bosnia and Herzegovina.|Faculty of Engineering and IT, International Burch University, Bosnia and Herzegovina.
authors.forename: Lejla
authors.initials: L
authors.lastname: Gurbeta
authors.affiliation: M. Sc. Bioengineering Candidate, Trinity College Dublin, University of Dublin, Ireland.
authors.forename: Elvira Ruiz
authors.initials: ER
authors.lastname: Jimenez
authors.affiliation: Department of Information Engineering, Università degli Studi di Firenze, Italy.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Iadanza
mesh_terms: D004868:Equipment Failure; D006801:Humans; D007186:Incubators, Infant / Q000592:standards*; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D061214:Patient Safety; D012122:Ventilators, Mechanical / Q000592:standards*
keywords: Health technology management; clinical engineering; healthcare; infant incubators; mechanical ventilators; output parameters; safety; standards; testing