Abstract Intensive care units are run and staffed by specialists trained in intensive care. Once a patient is admitted to the unit, the intensive care team will manage the care of the patient in consultation with the original team that admitted the patient to the hospital and any other specialists that they think can help to aid the patient’s recovery. The intensive care doctors and nurses will give the best overview and general update on the patient, but they may refer relatives to the specialist teams for discussion of certain aspects of care.

Abstract This chapter will show the extent to which the introduction of medical devices into legal metrology has affected the accuracy and effectiveness of 10 medical devices. Medical devices that are introduced into the legal metrology system of Bosnia and Herzegovina, as of 2015 are: ECG, defibrillator, patient monitor, infusion pumps, perfusors, respirators, anesthesia machines, dialysis machines, neonatal and pediatric incubators, and therapeutic ultrasound. It is extremely important that medical devices work properly and precisely, because analysis, interpretations, prints, and reports are formed from these basic measurements through data processing and calculation, based on which doctors draw conclusions, diagnose, and determine the course of treatment. The development of medical devices is an extremely complex process and is subject to a large number of directives, standards, and recommendations that the device must meet in terms of functionality and, in particular, safety, depending on the purpose of the device. This chapter outlines the role of inspection of medical devices to increase accuracy and efficiency in Bosnia and Herzegovina over a period of 3 years. The analysis is based on data collected in the territory of Bosnia and Herzegovina during the period of January 1, 2015 until December 31, 2017. This was collected through an online software to monitor the status of inspection of legal benchmarks in health care. In this analysis, the quality of the work of nine medical devices (infusion pumps and perfusors are viewed together) was measured over a period of 3 years (2015–17) in order to determine the efficiency of the device by monitoring the number of accurate or faulty devices individually and for all devices together. The data are collected in an Excel file and statistical analyses are made in that file. In the inferential statistical analysis, conclusions regarding the differences were made at the usual level of significance of 0.05, that is, a confidence level of 95%.

Abstract The word “standard” is used for various issues and has different purposes and different meanings and definitions. In this chapter standard is used to describe its application in science and technology. In accordance with ISO/IEC GUIDE 2:2004 in science and technology, the English word “standard” is used with two different meanings, as normative standard and as a measurement standard. In this chapter, the meaning and application of normative standard will be described in detail. Normative standard is a document, established by consensus and approved by a recognized body that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. In essence, a standard is an agreed way of doing something. It could be about making a product, managing a process, delivering a service, or supplying materials—standards can cover a huge range of activities undertaken by organizations and used by their customers. Standards are the distilled wisdom of people with expertise in their subject matter and who know the needs of the organizations they represent—people such as manufacturers, sellers, buyers, customers, trade associations, users, or regulators. Standards are produced for many different products and services, and may be created for company, national, regional, or global application. They may be used on a voluntary basis, or made mandatory by company policy, national or international regulation, or by law. In Europe there are three different categories of standard: ● International Standard—a standard adopted by an international standardization organization. ● European Standard—a standard adopted by a European standardization body. ● National Standard—a standard adopted by a national standardization body and made available to the public.

Abstract Pediatric and neonate incubators today are more sophisticated than the first prototypes but basic functions remained the same. They provide controlled environmental conditions needed to treat prematurely born infants who are not able to endure all the conditions outside the womb or infants born with certain diseases or health conditions.

Abstract Poorly regulated and insufficiently supervised medical devices (MDs) carry high risk of performance accuracy and safety deviations effecting the clinical accuracy and efficiency of patient diagnosis and treatments. Even with the increase of technological sophistication of devices, incidents involving defibrillator malfunction are unfortunately not rare. To address this, we have developed an automated system based on machine learning algorithms that can predict performance of defibrillators and possible performance failures of the device which can affect performance. To develop an automated system, with high accuracy, overall dataset containing safety and performance measurements data was acquired from periodical safety and performance inspections of 1221 defibrillator. These inspections were carried out in period 2015–2017 in private and public healthcare institutions in Bosnia and Herzegovina by ISO 17,020 accredited laboratory. Out of overall number of samples, 974 of them were used during system development and 247 samples were used for subsequent validation of system performance. During system development, 5 different machine learning algorithms were used, and resulting systems were compared by obtained performance. The results of this study demonstrate that clinical engineering and health technology management benefit from application of machine learning in terms of cost optimization and medical device management. Automated systems, based on machine learning algorithms, can predict defibrillator performance with high accuracy. Systems based on Random Forest classifier with Genetic Algorithm feature selection yielded highest accuracy among other machine learning systems. Adoption of such systems will help in overcoming challenges of adapting maintenance and medical device supervision mechanism protocols to rapid technological development of these devices. Due to increased complexity of healthcare institution environment and increased technological complexity of medical devices, performing maintenance strategies in traditional manner is causing a lot of difficulties.