| BIOMEDICAL ENGINEERING | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
| Course Code | Course Name | Semester | Theoretical | Practical | Credit | ECTS |
| BME3432 | Clinical Engineering | Spring | 3 | 0 | 3 | 5 |
| Language of instruction: | English |
| Type of course: | Must Course |
| Course Level: | Bachelor’s Degree (First Cycle) |
| Mode of Delivery: | E-Learning |
| Course Coordinator : | Dr. Öğr. Üyesi HAKAN SOLMAZ |
| Course Lecturer(s): |
Dr. Öğr. Üyesi HAKAN SOLMAZ |
| Recommended Optional Program Components: | None |
| Course Objectives: | Principles of Clinical Engineering. Hospital organization. Procurement policies. Setting up a clinical engineering department. Medical Equipment Maintenance program. |
|
The students who have succeeded in this course; Students succeed this course will have the outcomes; - Medical device classification, (CE) certification, risks and search for adverse events with medical devices;, - Access to Medical Device Standards and learn to use and interpret them; - Design and create the Clinical Engineering department, inspect, maintain and calibrate medical devices, do safety and performance tests; - Physiological effects of Electrical Currents and Protection against Electrical Shocks and Hazards. |
| Medical Device Directives and device classification, Standards and Safety and Performnace issues, Principles of Clinical Engineering, |
| Week | Subject | Related Preparation |
| 1) | Medical Device Directives and (CE) Marking | |
| 2) | Medical device Reliability; (Bath-tub curve, Mean Time Between Failures) and Safety. | |
| 3) | Acquiring New Technologies, Life Cost Analysis, Value Analysis and Performing Cost Comparison | |
| 4) | "Clinical Equipment Management and Establishing Medical Instrumentation Programs, Organizational chart." | |
| 5) | Health Devices IPM System (Acceptance Testing, Preventive Maintenance and Calibration), Outside Service Management | |
| 6) | Safety and Performance of Medical Devices, Case Studies | |
| 7) | Uncertainty of Measurements, Case Studies | |
| 8) | "Quality of Improvement : TQM and CQI , Clinical Engineering Program (Benchmarking) Indicators MDR and MAUDE (FDA reports, Medical Device Safety Reports (ECRI); Medical Device Vigilance System (European Committee Directives), Reporting Adverse Incidents for Medical Devices (NHS)." | |
| 9) | Standards for Clinical Engineering; A Hierarchy of Standards; Medical Devices; International Standards; Compliance with Standards; Limitations of Standards. | |
| 10) | Adverse Events and Medical Device Recalls | |
| 11) | Codes & Standards, Electrical Safety; Radiation safety; Biological safety; Chemical safety; Mechanical safety; Thermal safety; Ultrasound safety | |
| 12) | "Joint Commission International (JCI) Standard; (JCI) Environment of Care, (JCAHO) Patient Safety Goals Definition; Risk Management: Historical Perspective; Risk Management: Strategies; Risk Management: Application and Case Studies" | |
| 13) | Patient Safety | |
| 14) | Medical Device Risk Management, Risk Management: Strategies; Risk Management: Application and Case Studies |
| Course Notes / Textbooks: | Power Point presentations, Lecture Notes, Clinical Engineering, Y. David et al, CRC Press, 2003 (e-book) |
| References: | • “Joint Commission Accreditation Standards for Hospital” JCI 1st Edition, 2014. • “How to Comply with the JCAHO Standards”, AAMI Medical Equipment management Manual, 1998-1999. • “HEALTH DEVICES Inspection& Preventive maintenance System”, ECRI, 2002. • “A Guide to Continuous Quality Improvement in Medical Imaging”, EVR, 1996. • L. Fennigkoh and B. Smith, “Clinical Equipment Management”, The Joint Commission Plant Technology & Safety Management Series, pp 5-14,No.2, 1989. • J.T. Tweedy, “Healthcare Hazard Control and safety Management, GR/ST. Lucie Press, 1998. • R.C. Fries, “Reliable Design of Medical Devices”, Marcel Dekker, 1997. • “Guideline for Establishing and Administering Medical Instrumentation Programs”, AAMI Recommended Practice, 1984. • “Devices and Dollars”, HEALTH DEVICES SPECIAL Issue, ECRI, 1988. • “Standards for Healthcare Facilities”, NFPA99 |
| Semester Requirements | Number of Activities | Level of Contribution |
| Project | 1 | % 30 |
| Midterms | 1 | % 30 |
| Final | 1 | % 40 |
| Total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 30 | |
| PERCENTAGE OF FINAL WORK | % 70 | |
| Total | % 100 | |
| Activities | Number of Activities | Duration (Hours) | Workload |
| Course Hours | 14 | 3 | 42 |
| Application | 4 | 5 | 20 |
| Study Hours Out of Class | 14 | 4 | 56 |
| Midterms | 1 | 3 | 3 |
| Final | 1 | 3 | 3 |
| Total Workload | 124 | ||
| No Effect | 1 Lowest | 2 Low | 3 Average | 4 High | 5 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Adequate knowledge of subjects specific to mathematics (analysis, linear, algebra, differential equations, statistics), science (physics, chemistry, biology) and related engineering discipline, and the ability to use theoretical and applied knowledge in these fields in complex engineering problems. | 5 |
| 2) | Identify, formulate, and solve complex Biomedical Engineering problems; select and apply proper modeling and analysis methods for this purpose | 5 |
| 3) | Design complex Biomedical systems, processes, devices or products under realistic constraints and conditions, in such a way as to meet the desired result; apply modern design methods for this purpose. | 3 |
| 4) | Devise, select, and use modern techniques and tools needed for solving complex problems in Biomedical Engineering practice; employ information technologies effectively. | 3 |
| 5) | Design and conduct numerical or physical experiments, collect data, analyze and interpret results for investigating the complex problems specific to Biomedical Engineering. | 3 |
| 6) | Cooperate efficiently in intra-disciplinary and multi-disciplinary teams; and show self-reliance when working on Biomedical Engineering-related problems. | 2 |
| 7) | Ability to communicate effectively in Turkish, oral and written, to have gained the level of English language knowledge (European Language Portfolio B1 general level) to follow the innovations in the field of Biomedical Engineering; gain the ability to write and understand written reports effectively, to prepare design and production reports, to make effective presentations, to give and receive clear and understandable instructions. | 5 |
| 8) | Recognize the need for life-long learning; show ability to access information, to follow developments in science and technology, and to continuously educate oneself. | 2 |
| 9) | Having knowledge for the importance of acting in accordance with the ethical principles of biomedical engineering and the awareness of professional responsibility and ethical responsibility and the standards used in biomedical engineering applications | 2 |
| 10) | Learn about business life practices such as project management, risk management, and change management; develop an awareness of entrepreneurship, innovation, and sustainable development. | 5 |
| 11) | Acquire knowledge about the effects of practices of Biomedical Engineering on health, environment, security in universal and social scope, and the contemporary problems of Biomedical Engineering; is aware of the legal consequences of Mechatronics engineering solutions. | 4 |