Abstract People usually do not make any difference between laws and regulations but there is certain difference in hierarchy between laws and regulations. In the United States, e.g., Congress, and only Congress, creates laws. Federal executive departments and administrative agencies write regulations to implement the authority of laws. Regulations (as well as Executive Orders and Proclamations) are ancillary or subordinate to laws but both laws and regulations are enforceable. The US Code is the official compilation of current, codified laws by subject; the US Statutes-at-Large is the official chronological compilation of all laws; and the Code of Federal Regulations is the official compilation of regulations.

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 Cardiovascular diseases (CVD) cause an average of 17.7 million deaths each year (44% of NCD fatalities) making it one of the most deserving topics for research on prevention. CVD are a group of disorders of the heart and blood vessels which is the most significant cause of death globally. Despite the critical fatality rate 90% CVD can be prevented by taking necessary precautions.

Abstract Medical devices with a measuring function have to be periodically inspected. Periodical inspection of these devices is necessary to protect the end users as well as personnel who use them for establishing diagnoses for patient treatment. Incorrect and imprecise measuring results can lead to misdiagnosis, and therefore to wrong treatment. To avoid these unwanted situations, medical devices with the measuring function have to be regularly inspected in accordance with the prescribed inspection procedures. These procedures have to be approved by a state authorized body responsible for this area. Also, medical devices with measuring function in some countries are a part of the legal metrology system. Because of the high importance of these devices, their inspection needs to be carried out by inspection bodies with proven competences. The most reliable way of proving competences is through the fulfillment of requirements resulting from ISO/IEC 17020. This chapter briefly elaborates on the requirements arising from this standard as well as the mode for its implementation. This chapter aims to facilitate the implantation of the ISO/IEC 17020 standard for future inspection bodies for performing the inspection in a competent and impartial manner. Accurate and precise medical devices with measuring function will enable professional personnel to properly establish diagnoses for patient treatment. There are many advantages of regular inspection of medical devices, and the greatest advantage is the protection of the patient’s lives.

Due to the development of information communication technologies (ICT), the number of medical devices (MDs) with telemetric possibilities is rising, so the concept of homecare is gaining importance. Also, new generation medical devices are equipped with artificial intelligence that is able to perform real-time analysis of measurement result and provide diagnosis prediction. This is the Industry 4.0 happening now. However, there is still traditional approach in management of medical devices. As medical devices have been sophisticated, management systems should improve so they can encompass all the important aspects regarding safety of patients and quality of care. This chapter presents how the technology of Industry 4.0 can be used to improve medical device maintenance systems by application of artificial intelligence (AI). Clinical engineering and health technology management departments benefit from such systems in terms of increase of safety and quality of patient diagnosis and treatments, and cost optimization in medical device management.

Abstract Medical devices (MDs) are sophisticated electronic systems whose performances vary depending on the production quality and the environmental conditions in which they are used (European Commission, n.d.-a). Safety and performance of MDs are defined by international standards issued by prominent worldwide organizations and national regulatory bodies (International Organisation for Standardization – ISO, n.d.; International Electrotechnical Commission, n.d.). Although, production process of MDs is regulated by various international and national legal frameworks and procedures (World Health Organisation, n.d.), safety and quality of MD performance in real settings are still not defined. That is the reason why, despite the existence of regulations for MDs unfortunate incidents are not uncommon around the world. Existing frameworks are mostely based on postmarket surveillance performed by manufacturers and distributors, or local health technology assessment (HTA) units. This is done through the establishment of databases for reporting incidents involving MDs. That practice is adopted in United States. The Food and Drug Administration (FDA) (n.d.) receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with MDs. These incidents are, in United States, reported either by healthcare institution or by manufacturer to central database of incidents called Manufacturer and User Facility Device Experience (MAUDE) (Food and Drug Administration (FDA), n.d.). In the Europe, as part of IDABC (Interoperable Delivery of European eGovernment Services to public Administrations, Businesses, and Citizens) program, information system for exchanging legal information related to the application of European Union Directives on medical devices [European Union database on Medical Devices (EUDAMED)] was established (European Commission, n.d.-c). Nowadays, most manufacturers recommend different preventive maintenance procedures for preoperative checking of MD as only method of assessment during usage. All of this suggests that evidence-based performance and safety inspection of MDs already used in health care should be adopted to ensure safety and performance reliability of MDs. Performance inspection regulations exist for other devices with measuring function (electricity meters, gas meters, scales) and it is conducted periodically based on metrological procedures so measurements are traceable to international standards. Therefore, this chapter gives an overview of key elements for legal metrology framework for inspection od MD safety and performance that can be part of various HTAs protocols.

Abstract It has been stated multiple times that we live in modern age, where technology has a great impact on our lives. We perform a lot of tasks using technology, so we communicate much quicker, plan, organize, pay bills, and control appliances at home and all by using one application. But what is the most important thing for a human? Is it the technology, money, or something else? Are you capable of performing any task if you have increased body temperature, high blood pressure, or unbalanced heart rate? Health has always been, is, and will always be the most important thing that for sure should be taken care of.The development of medical devices has dramatically changed the way medical care is provided to patients. Nowadays, medical professionals are working with sophisticated medical devices, but the interpretation of obtained values and understanding of their function is very important. Due to the gap in this area, patient safety issue is gaining on its importance. Recently, a majority of healthcare institutions are undertaking accreditation procedures, depending on national legislation, to ensure the quality of treatment provided to their patients. The reason for such activities is increasing competitiveness on national and international markets, especially now when a major shift from public to private health care can be observed. However, even in these situations, mechanisms for ensuring patient safety, in terms of medical device reliability achieved through postmarket supervision, are not well defined. This is proven by numerous incident reports involving various medical devices including infant incubators, but importantly emphasized by recent amendments to medical device directives at the European level.