ENT 312 ENT 312 Biomedical Acts, Biomedical Acts,

Standards & Standards & SafetySafety

LecturerLecturerMohd Yusof bin Mohd Yusof bin

BaharuddinBaharuddin

ObjectivesObjectives

The course aims to introduce the acts and The course aims to introduce the acts and standards used in biomedical engineering.standards used in biomedical engineering.

This includes ethical issues and the power This includes ethical issues and the power system safety of electrical appliances system safety of electrical appliances especially medical equipments. especially medical equipments.

The course focuses on the safety issues in The course focuses on the safety issues in the healthcare institution which the healthcare institution which particularly emphasized on medical particularly emphasized on medical devices and their interrelation with the devices and their interrelation with the hospital’s environment. hospital’s environment.

Course OutcomeCourse Outcome

CO1: CO1: Ability to define and evaluate the acts Ability to define and evaluate the acts and and safety standards in biomedical safety standards in biomedical engineering engineering practice practice

CO2:CO2: Ability to explain the current Ability to explain the current technologies technologies used in the healthcare used in the healthcare industry and evaluate industry and evaluate the healthcare the healthcare technology advancementtechnology advancement

CO3: CO3: Ability to apply the Ability to apply the knowledge about knowledge about acts, acts, standards, ethics, safety andstandards, ethics, safety and power power system system safetysafety that are that are necessary for necessary for biomedical biomedical engineering practice engineering practice

CO4: CO4: Ability to explain power system safety in Ability to explain power system safety in medical environment medical environment

TimetableTimetable

LecturesLectures

1.1. Tuesday 1100-1300 BKM 1Tuesday 1100-1300 BKM 1

2.2. Thursday 1500-1600 BKD 1Thursday 1500-1600 BKD 1

Labs / TutorialsLabs / Tutorials

1.1. Tuesday 1500-1700 Bioinstrument Tuesday 1500-1700 Bioinstrument LabLab

2.2. Wednesday 0900-1100 Bioinstrument Wednesday 0900-1100 Bioinstrument Lab Lab

AssessmentsAssessments

1.1. Coursework – 50 %Coursework – 50 % Lab Report – 30 % (5 lab)Lab Report – 30 % (5 lab)

- please look upon the due - please look upon the due date date and standard used and standard used (AS/NZ and (AS/NZ and GHTF) GHTF)

- form 3 people per group - form 3 people per group (1:2)(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)

2.2. Final Exam – 50 %Final Exam – 50 %

Course ContentCourse Content

11 MEDICAL SAFETY STANDARDSMEDICAL SAFETY STANDARDSDefine and explain Define and explain thethe global medical device regulations. global medical device regulations. DiscussDiscuss the importance of safety standard, acts and regulation to guide the importance of safety standard, acts and regulation to guide equipment manufacturers in the production of safe equipment. equipment manufacturers in the production of safe equipment. Decide Decide the types of international standards which can be used in the types of international standards which can be used in medical devices medical devices

2-32-3 HAZARD OF MEDICAL INSTRUMENTSHAZARD OF MEDICAL INSTRUMENTSExplain Explain andand discuss discuss on the main hazard connected with the used of on the main hazard connected with the used of medical instruments. medical instruments. Discuss Discuss occurrence between macroshock and occurrence between macroshock and microshock microshock

44 PHYSIOLOGICAL EFFECTS OF ELECTRICITY ON HUMAN BODYPHYSIOLOGICAL EFFECTS OF ELECTRICITY ON HUMAN BODYDescribe Describe andand explain explain on the accumulation of data from variety of on the accumulation of data from variety of sources has established the effect of alternating electrical currents sources has established the effect of alternating electrical currents (frequency 50-60 Hz). (frequency 50-60 Hz). Discuss Discuss the leakage currentthe leakage current

5-8 INTRODUCTION TO POWER SYSTEM SAFETY FOR MEDICAL 5-8 INTRODUCTION TO POWER SYSTEM SAFETY FOR MEDICAL DEVICESDEVICESExplain and discuss Explain and discuss the concepts and principles of electrical the concepts and principles of electrical safety. safety. IntroduceIntroduce isolated power system. isolated power system. DiscussDiscuss the advantages of the advantages of isolated power system in healthcare institution isolated power system in healthcare institution

*Week 6 - Break*Week 6 - Break

Course ContentCourse Content99 DEVICES TO PROTECT AGAINST ELECTRICAL HAZARDSDEVICES TO PROTECT AGAINST ELECTRICAL HAZARDS

Explain Explain several devices available to protect patients and healthcare several devices available to protect patients and healthcare workers from hazardous electrical current. workers from hazardous electrical current. DiscussDiscuss devices to protect devices to protect against high voltage microshock and macroshock hazardsagainst high voltage microshock and macroshock hazards

10-1110-11 PERSPECTIVE IN HEALTHCARE TECHNOLOGYPERSPECTIVE IN HEALTHCARE TECHNOLOGYIntroduce Introduce the history and evaluation of healthcare technology. the history and evaluation of healthcare technology. DiscussDiscuss the concept of healthcare technology assessment. the concept of healthcare technology assessment. Application Application of of biomedical acts and standards in planning, procurement and management biomedical acts and standards in planning, procurement and management in healthcare technology. in healthcare technology. DiscussDiscuss the medical equipments maintenance, the medical equipments maintenance, management and quality assurance in healthcare institution management and quality assurance in healthcare institution

12-1412-14 ETHICS IN BIOMEDICAL ENGINEERINGETHICS IN BIOMEDICAL ENGINEERINGDefine Define andand discuss discuss the term of ethics. the term of ethics. Discuss Discuss the ethical problems and the ethical problems and concerns which arise in healthcare, medicine and biomedical engineering concerns which arise in healthcare, medicine and biomedical engineering

15-1615-16 IMPLEMENTATION OF SAFETY AND STANDARDIMPLEMENTATION OF SAFETY AND STANDARDExplain Explain and and discuss discuss the implementation of safety and standards towards the implementation of safety and standards towards healthcare institution. healthcare institution. Application Application of standards and medical regulations of standards and medical regulations and and comparecompare the medical regulations used for medical devices the medical regulations used for medical devices

* Week 13 – Break (Raya)* Week 13 – Break (Raya)

LaboratoryLaboratory

Intensively done which based on Intensively done which based on problemproblem Lab 1 – Cardiac Cath Lab Design 1 Lab 1 – Cardiac Cath Lab Design 1 Lab 2 – Cardiac Cath Lab Design 2Lab 2 – Cardiac Cath Lab Design 2 Lab 3 – Safety for x-ray room Lab 3 – Safety for x-ray room Lab 4 – Problem solving in healthcare Lab 4 – Problem solving in healthcare

technology management (CT scan)technology management (CT scan) Lab 5 – Healthcare technology life Lab 5 – Healthcare technology life

cycle for defibrillator cycle for defibrillator

ReferencesReferences

Textbook:Textbook: Joseph D.B., Medical Devices and Systems, Biomedical Engineering Joseph D.B., Medical Devices and Systems, Biomedical Engineering

Handbook, Taylor and Francis, 3rd Ed, 2006Handbook, Taylor and Francis, 3rd Ed, 2006

Reference Book: Yadin D., Wolf W. V. M., David Y., Michael R. N., Clinical Engineering, Yadin D., Wolf W. V. M., David Y., Michael R. N., Clinical Engineering,

CRC Press, 2003CRC Press, 2003 Daniel, A.V., Biomedical Ethics for Engineers, Elsevier, 2007Daniel, A.V., Biomedical Ethics for Engineers, Elsevier, 2007 John, G. W., Safety Program, Hospital in Encyclopedia of Medical John, G. W., Safety Program, Hospital in Encyclopedia of Medical

Devices and Instrumentation, 2nd Ed., Vol 6, Wiley-Interscience, 2006Devices and Instrumentation, 2nd Ed., Vol 6, Wiley-Interscience, 2006 Joseph D., Clinical Engineering Handbook, Elsevier, 2004Joseph D., Clinical Engineering Handbook, Elsevier, 2004 Jeremy, S., Electrical Safety in The Handbook of Health and Safety Jeremy, S., Electrical Safety in The Handbook of Health and Safety

Practice, 7th Ed, Prentice Hall, pg. 791-811, 2005Practice, 7th Ed, Prentice Hall, pg. 791-811, 2005 Association for Advancement of Medical Instrumentation (AAMI), Association for Advancement of Medical Instrumentation (AAMI),

Essential Standard for Biomedical Equipment Safety and Performance, Essential Standard for Biomedical Equipment Safety and Performance, Arlington, 1995.Arlington, 1995.

The Electricity Training Association, Power system protection, The Electricity Training Association, Power system protection, Institution of Engineering and Technology, 1995.Institution of Engineering and Technology, 1995.

Feinberg, B. N., Electrical Performance and Safety Testing of Feinberg, B. N., Electrical Performance and Safety Testing of Electromedical Equipment, Chapter 16 in Applied Clinical Engineering, Electromedical Equipment, Chapter 16 in Applied Clinical Engineering, Prentice Hall, 1986. Prentice Hall, 1986.

ContactContact

For further question For further question

1) Forum – need to register first1) Forum – need to register first

http://raz-veinz.com/phpbbhttp://raz-veinz.com/phpbb

2) Email – 2) Email – myusof@unimap.edu.mymyusof@unimap.edu.my

3) Phone - 04 977 3516 / 2251 3) Phone - 04 977 3516 / 2251