Verification, Safety and Reliability of Medical Equipment

Description: Consideration of indicators of reliability of medical products and reliability of systems with different connections of elements. Application of methods for calculating reliability in the development of medical equipment, assessing the reliability of technical equipment in the conditions of a medical-biological organization, and solving the problem of ensuring reliable operation. We study how to check devices and complexes for various purposes using automatic verification systems. Particular attention is paid to the legal basis for servicing medical equipment, methods for ensuring the safety of electronic medical equipment, safety regulations, as well as electrical safety of medical equipment.

Amount of credits: 6

Пререквизиты:

• Introduction to engineering

Course Workload:

Component: Component by selection

Cycle: Profiling disciplines

Goal

• The purpose of the discipline "Verification, safety and reliability of medical equipment" is to familiarize students with the methods of verification of medical equipment, to master the basics of the theory of reliability developed for the study of technical systems and the specifics of the application of this theory to solve problems on the problems of ensuring reliable operation of technical means in a medical and biological organization.

Objective

• Objectives of the discipline: formation of conceptual apparatus, knowledge, skills in the field of verification, safety and reliability of medical equipment necessary for further training and subsequent professional activity; justification of the choice of the main indicators of reliability of medical devices; rational coordination of reliability indicators of the main components of medical devices, safety tasks of medical equipment.

Learning outcome: knowledge and understanding

• To know: test signals, simulators of biological signals and biological objects; computer simulation programs; automated verification systems; test benches; verification schemes for diagnostic; therapeutic; surgical devices and systems; verification methods; test stations of industrial enterprises; climatic, energy tests, reliability assessment, maintenance safety tests; legal bases of medical equipment maintenance; methods ensuring the safety of electronic medical equipment; design of non-standard equipment and devices for biomedical experiments; regulatory documentation for maintenance and development.

Learning outcome: applying knowledge and understanding

• be able to: use the means for certification, metrological support and safe operation of developed devices, apparatuses and systems; possess: methods of organization of routine maintenance, verifications and certifications of medical equipment; methods of calculation and experimental evaluation of the reliability of medical equipment during its development, operation and repair; methods of verification, calibration and testing of standard medical equipment, devices and complexes, as well as technical means of biological laboratories.

Learning outcome: formation of judgments

• The student should be able to form judgments about the safety of medical devices based on current standards and regulations such as GOST, ISO and others.

Learning outcome: communicative abilities

• The ability to present technical data and analysis results (for example, accuracy and reliability indicators) using graphs, tables, and reports to colleagues, supervisors, or regulators.

Learning outcome: learning skills or learning abilities

• Development of self-education skills, including the search and assimilation of relevant information about new verification methods, improvements in the field of safety and reliability of medical devices.

Teaching methods

Online platforms: The use of specialized distance learning platforms such as Moodle, Coursera, and edX allows students to access lectures, tests, and training materials at their convenience. Modules and courses: Students can study materials on the topic of verification and safety of medical equipment through interactive modules that include video tutorials, tests and self-monitoring tasks. Virtual laboratories: The ability to conduct virtual laboratory work with models of medical devices and simulators allows you to study the verification and calibration processes in an online format.

Assessment of the student's knowledge

Teacher oversees various tasks related to ongoing assessment and determines students' current performance twice during each academic period. Ratings 1 and 2 are formulated based on the outcomes of this ongoing assessment. The student's learning achievements are assessed using a 100-point scale, and the final grades P1 and P2 are calculated as the average of their ongoing performance evaluations. The teacher evaluates the student's work throughout the academic period in alignment with the assignment submission schedule for the discipline. The assessment system may incorporate a mix of written and oral, group and individual formats.

The evaluating policy of learning outcomes by work type

Evaluation form

The student's final grade in the course is calculated on a 100 point grading scale, it includes:

• 40% of the examination result;
• 60% of current control result.

The final grade is calculated by the formula:

 

Where Midterm 1, Midterm 2are digital equivalents of the grades of Midterm 1 and 2;

E is a digital equivalent of the exam grade.

Final alphabetical grade and its equivalent in points:

The letter grading system for students' academic achievements, corresponding to the numerical equivalent on a four-point scale:

Topics of lectures

• Fundamentals of medical equipment verification: theory and practice
• Regulation and safety standards of medical equipment in the Republic of Kazakhstan
• The main methods of testing and verifying medical equipment
• Methods and devices for verifying the accuracy of measurements in medical technology
• Quality management systems in the production of medical equipment: requirements and standards
• Assessment of risks in the operation of medical equipment and their minimization
• Review of international standards for the verification and safety of medical equipment
• Verification of electromedical equipment: features and requirements
• Safety of medical equipment for patients and operators: principles and approaches
• Reliability of medical equipment: how to ensure the durability and safety of equipment
• The role of technicians in maintaining the safety of medical equipment
• Safety methods for maintenance and repair of medical equipment
• Energy security of medical devices: problems and solutions
• Laboratory research and testing of medical equipment: practice and protocols
• Kazakhstan's regulatory framework in the field of verification and safety of medical equipment

Key reading

• "Основы медицинской техники" (Под ред. А.Н. Абраменко)
• "Техническая эксплуатация и безопасность медицинской техники"
• "Безопасность и надежность медицинской техники" (И.Н. Марков, М.Ю. Киреев)
• "Методы и средства поверки медицинских приборов" (М.И. Кибрик)
• ГОСТ Р 52778-2007 "Медицинская техника. Общие требования безопасности"
• Медицинская техника и оборудование: стандарты, требования безопасности и методы тестирования
• "Надежность и отказоустойчивость медицинских приборов" (Под ред. Н.И. Митин)
• ISO 13485:2016 "Системы менеджмента качества. Требования к производителям медицинской техники"
• "Основы метрологии" (Е.А. Васильев)
• "Медицинские приборы. Классификация, безопасность, эксплуатация" (Под ред. И.А. Шаталова)
• "Медицинская техника: эксплуатация и техническое обслуживание" (Ю.П. Лобанов, А.Ю. Соловьев)
• "Техническое обслуживание медицинских приборов и оборудование" (В.А. Иванов)
• "Электронные системы медицинской техники" (В.И. Мищенко)
• "Физика и техника медицинских приборов" (Г.Г. Соловьев)
• ISO 14971:2019 "Применение управления рисками для медицинских изделий"

Further reading

• "Инженерная экология и безопасность жизнедеятельности в здравоохранении" (М.Е. Семенов)
• "Основы медицинской информатики" (Е.Е. Кузнецов, С.В. Козлов)
• "Современные методы и технологии тестирования медицинской техники"
• "Медицинская техника: стандарты и сертификация"
• "Риски и безопасность в области медицинской техники"