Units
Health Legislation in the Medical Environment
Unit code: ENB437
Contact hours: 4 per week
Credit points: 12
Information about fees and unit costs
This unit provides an introduction to the types of legislative control in the health and medical industries. It highlights the minimum requirements in relation to the role of medical engineers and their contribution to successful and ethical relationships with medical, health legislative and regulatory affairs professionals. Content includes: national and international legislative controlling bodies and codes (EC, TGA, FDA); structure and sources of legal system (State and Federal); Good Manufacturing Practice (GMP); ISO9000 Quality Systems; Total Quality Management; ethics committees and clearance; industry case studies.
Availability
| Semester | Available |
|---|---|
| 2013 Semester 2 | Yes |
Sample subject outline - Semester 2 2013
Note: Subject outlines often change before the semester begins. Below is a sample outline.
Rationale
As a biomedical engineer, you must ensure that your designs and work practices meet certain standards and ethical, legal and government requirements. This unit will give you information on these requirements to ensure that you can successfully design, produce, and/or maintain a marketable and safe product.
Aims
The aim of this unit is to enable you to successfully work within, and comply with, the regulatory requirements and good management principles within medical equipment design, manufacturing industry and hospital environments and to raise your awareness of the legal and ethical aspects of medical devices, their sale and use by the medical fraternity.
Objectives
On completion of this unit you should be able to:
1. Describe the structure of legal system in Australia and interpret important laws relevant to Medical engineering.
2. Analyse a given scenario and identify the laws relevant to that specific situation.
3. Compare the medical device regulations as enacted in Australia with those of the European Union (EU) and the United States of America (USA).
4. Classify the medical devices according to the relevant risk categories.
5. Demonstrate awareness and technical appreciation of the standards relating to the design, manufacturing and maintenance of biomedical equipment and medical devices.
Content
Module 1
Module 2
Approaches to Teaching and Learning
Teaching Mode:
Total hours per week: 4.
Lectures: 2 x 2 hrs/wk
Lectures and tutorials will cover the basic theories and laws relevant to biomedical engineering. Illustrative case studies will be extensively used to elucidate the theory in real world and some of them will be presented by practising industry professionals. Additional reading will be required to reinforce the concepts introduced in lectures. The reading material will be placed on QUT intranet or Blackboard site.
Assessment items will simulate the need to retrieve relevant information, access the relevant regulations and acts of legislation, and to apply various methods of assessing the risk of medical devices, followed by an outline of the required pathways to achieve regulatory approval for a specific medical device. These are designed to strengthen your understanding of the basic concepts and techniques and to develop skills required in ensuring that new products achieve the necessary level of government approval.
Assessment
Assessment will consist of Case Study, Quiz and Examination (theory).You will receive formative feedback on your progress during tutorials and discussions. Written comments on the Case study and Quiz will be given.
Assessment name:
Mid-Semester Quiz
Description:
You will have to describe and show awareness of relevant Australian laws and legal system.
Relates to objectives:
1, 2.
Weight:
20%
Internal or external:
Internal
Group or individual:
Individual
Due date:
Mid-Semester
Assessment name:
Examination (Theory)
Description:
You will have to demonstrate knowledge of legal and ethical aspects of medical device in Australia and interpretation of the relevant Australian laws in short answer and essay types of written examination.
Relates to objectives:
All.
Weight:
40%
Internal or external:
Internal
Group or individual:
Individual
Due date:
Exam Period
Assessment name:
Case Study
Description:
You will analyse a given scenario and demonstrate the limitations and effectiveness of medical device regulations in the given case.
Relates to objectives:
2, 5.
Weight:
40%
Internal or external:
Internal
Group or individual:
Individual
Due date:
Week 6
Academic Honesty
QUT is committed to maintaining high academic standards to protect the value of its qualifications. To assist you in assuring the academic integrity of your assessment you are encouraged to make use of the support materials and services available to help you consider and check your assessment items. Important information about the university's approach to academic integrity of assessment is on your unit Blackboard site.
A breach of academic integrity is regarded as Student Misconduct and can lead to the imposition of penalties.
Resource materials
Lecture power point slides will be available at Blackboard site.
Textbook:
Nil.
References:
1. van Gruting CWD (1994) Medical Devices: International Perspectives on Health & Safety. Amsterdam: Elsevier.
2. MacFarlane PJM (1999) Qld Health Law Handbook 9th ed. Brisbane : Queensland Department of Health.
3. Latimer P (1998) Australian business law 17th ed. North Ryde, NSW : CCH Australia.
4. Fries RC (1997) Reliable Design of Medical Devices. New York : Marcel Dekker.
5. National Health and Medical Research Council (1997) Report of the NHMRC expert panel on re-use of medical devices labelled as single use.
6. Pallikarakis N et al (1996) Information Exchange for Medical Devices. IOS Press ;Tokyo : Ohmsha.
6. Therapeutic Goods Act
7. Witkin KM (ed) (1998) Clinical evaluation of medical devices : principles and case studies Totowa, N.J. : Humana Press.
8. Braybrook JH (ed) (1997) Biocompatibility : assessment of medical devices and materials. Chichester ; New York : Wiley.
9. Hunziker JR & Jones TO (eds) (1994) Product liability and innovation : managing risk in an uncertain environment. Washington, D.C : National Academy Press.
10. Alpert S (1995) Use of international standard ISO-l0993, "Biological evaluation of medical devices Part 1: Evaluation and testing". Washington, D.C : U.S. Dept. of Health and Human Services.
Risk assessment statement
You will undertake lectures and tutorials in the traditional classrooms and lecture theatres. As such, there are no extraordinary workplace health and safety issues associated with these components of the unit.
Disclaimer - Offer of some units is subject to viability, and information in these Unit Outlines is subject to change prior to commencement of semester.
Last modified: 12-Mar-2013
