1. ENT 312 Biomedical Acts, Standards & Safety Lecturer Mohd Yusof bin Baharuddin

2. Objectives The course aims to introduce the acts and standards used in biomedical engineering. The course aims to introduce the acts and standards used in biomedical engineering. This includes ethical issues and the power system safety of electrical appliances especially medical equipments. This includes ethical issues and the power system safety of electrical appliances especially medical equipments. The course focuses on the safety issues in the healthcare institution which particularly emphasized on medical devices and their interrelation with the hospital’s environment. The course focuses on the safety issues in the healthcare institution which particularly emphasized on medical devices and their interrelation with the hospital’s environment.

3. Course Outcome CO1: Ability to define and evaluate the acts and safety standards in biomedical engineering practice CO2: Ability to explain the current technologies used in the healthcare industry and evaluate the healthcare technology advancement CO3: Ability to apply the knowledge about acts, standards, ethics, safety and power system safety that are necessary for biomedical engineering practice CO4: Ability to explain power system safety in medical environment

4. Timetable Lectures 1. Tuesday 1100-1300 BKM 1 2. Thursday 1500-1600 BKD 1 Labs / Tutorials 1. Tuesday 1500-1700 Bioinstrument Lab 2. Wednesday 0900-1100 Bioinstrument Lab

5. Assessments 1. Coursework – 50 % Lab Report – 30 % (5 lab) Lab Report – 30 % (5 lab) - please look upon the due date and standard used (AS/NZ and GHTF) - please look upon the due date and standard used (AS/NZ and GHTF) - form 3 people per group (1:2) - form 3 people per group (1:2) Assignment – 5 % (1 assignment) Assignment – 5 % (1 assignment) - given 15/7/08, due date 14/8/08 - given 15/7/08, due date 14/8/08 Quiz – 7 % (every classes) Quiz – 7 % (every classes) Mid Term – 8 % (2 test) Mid Term – 8 % (2 test) - 1 (31/7/08) - 1 (31/7/08) - 2 (28/8/08) - 2 (28/8/08) 2.Final Exam – 50 %

6. Course Content 1 MEDICAL SAFETY STANDARDS Define and explain the global medical device regulations. Discuss the importance of safety standard, acts and regulation to guide equipment manufacturers in the production of safe equipment. Decide the types of international standards which can be used in medical devices 2-3HAZARD OF MEDICAL INSTRUMENTS Explain and discuss on the main hazard connected with the used of medical instruments. Discuss occurrence between macroshock and microshock 4 PHYSIOLOGICAL EFFECTS OF ELECTRICITY ON HUMAN BODY Describe and explain on the accumulation of data from variety of sources has established the effect of alternating electrical currents (frequency 50-60 Hz). Discuss the leakage current 5-8 INTRODUCTION TO POWER SYSTEM SAFETY FOR MEDICAL DEVICES Explain and discuss the concepts and principles of electrical safety. Introduce isolated power system. Discuss the advantages of isolated power system in healthcare institution *Week 6 - Break

7. Course Content 9DEVICES TO PROTECT AGAINST ELECTRICAL HAZARDS Explain several devices available to protect patients and healthcare workers from hazardous electrical current. Discuss devices to protect against high voltage microshock and macroshock hazards 10-11PERSPECTIVE IN HEALTHCARE TECHNOLOGY Introduce the history and evaluation of healthcare technology. Discuss the concept of healthcare technology assessment. Application of biomedical acts and standards in planning, procurement and management in healthcare technology. Discuss the medical equipments maintenance, management and quality assurance in healthcare institution 12-14ETHICS IN BIOMEDICAL ENGINEERING Define and discuss the term of ethics. Discuss the ethical problems and concerns which arise in healthcare, medicine and biomedical engineering 15-16IMPLEMENTATION OF SAFETY AND STANDARD Explain and discuss the implementation of safety and standards towards healthcare institution. Application of standards and medical regulations and compare the medical regulations used for medical devices * Week 13 – Break (Raya)

8. Laboratory Intensively done which based on problem  Lab 1 – Cardiac Cath Lab Design 1  Lab 2 – Cardiac Cath Lab Design 2  Lab 3 – Safety for x-ray room  Lab 4 – Problem solving in healthcare technology management (CT scan)  Lab 5 – Healthcare technology life cycle for defibrillator

9. References Textbook: Joseph D.B., Medical Devices and Systems, Biomedical Engineering Handbook, Taylor and Francis, 3rd Ed, 2006 Joseph D.B., Medical Devices and Systems, Biomedical Engineering Handbook, Taylor and Francis, 3rd Ed, 2006 Reference Book: Yadin D., Wolf W. V. M., David Y., Michael R. N., Clinical Engineering, CRC Press, 2003 Yadin D., Wolf W. V. M., David Y., Michael R. N., Clinical Engineering, CRC Press, 2003 Daniel, A.V., Biomedical Ethics for Engineers, Elsevier, 2007 Daniel, A.V., Biomedical Ethics for Engineers, Elsevier, 2007 John, G. W., Safety Program, Hospital in Encyclopedia of Medical Devices and Instrumentation, 2nd Ed., Vol 6, Wiley-Interscience, 2006 John, G. W., Safety Program, Hospital in Encyclopedia of Medical Devices and Instrumentation, 2nd Ed., Vol 6, Wiley-Interscience, 2006 Joseph D., Clinical Engineering Handbook, Elsevier, 2004 Joseph D., Clinical Engineering Handbook, Elsevier, 2004 Jeremy, S., Electrical Safety in The Handbook of Health and Safety Practice, 7th Ed, Prentice Hall, pg. 791-811, 2005 Jeremy, S., Electrical Safety in The Handbook of Health and Safety Practice, 7th Ed, Prentice Hall, pg. 791-811, 2005 Association for Advancement of Medical Instrumentation (AAMI), Essential Standard for Biomedical Equipment Safety and Performance, Arlington, 1995. Association for Advancement of Medical Instrumentation (AAMI), Essential Standard for Biomedical Equipment Safety and Performance, Arlington, 1995. The Electricity Training Association, Power system protection, Institution of Engineering and Technology, 1995. The Electricity Training Association, Power system protection, Institution of Engineering and Technology, 1995. Feinberg, B. N., Electrical Performance and Safety Testing of Electromedical Equipment, Chapter 16 in Applied Clinical Engineering, Prentice Hall, 1986. Feinberg, B. N., Electrical Performance and Safety Testing of Electromedical Equipment, Chapter 16 in Applied Clinical Engineering, Prentice Hall, 1986.

10. Contact For further question 1) Forum – need to register first http://raz-veinz.com/phpbb 2) Email – myusof@unimap.edu.my myusof@unimap.edu.my 3) Phone - 04 977 3516 / 2251