New Parts for Old

Dr S.G. Higgins (Department of Pathology, UNSW)

Lecturers/Presenters: Dr S.G. Higgins (UNSW)

Mr Mike Flood (Therapeutic Goods Administration)

2:00-2:20 Lecture: Introduction/Efficacy of Implanted Devices

Web Presentation of Lecture Slides or
Download PDF Version

2:20-2:45 Lecture: The Heart - How it Works: Normal Contractility/Valves and Pacemakers/ Prosthetic Valves

2:45-3:00 Lecture: Breast Implants

3:00-4:00 Practical demonstrations

Room 502 Leader: Dr Grace Higgins

Room 512 Leader: Mr. Mike Flood

Students will interchange after 30 mins.

Room 502 will be devoted to:

Orthopaedics: hip/knee specimens and prostheses; prosthetic limbs; amputation specimens; ischaemia, gangrene and sarcomas of the limbs; burns - materials

Room 512 will be devoted to:

Cardiac assist devices - pacemakers + specimens; heart valves + specimens; Breast implants

4:10-4:40 Discussion: Healthy Scepticism

Commence with Spotted Handkerchief - A Hypothetical: Does Modern Medicine Provide the Answers or are We Still Trying to Find the Question?

4:40-5:00 Lecture: Care of the Community

The Role of the TGA

Assignment Topics:

1. Design a website that you consider would assist the community to be informed about current issues involved in treating patients with medical devices. In this assignment highlight conceptual issues that should be covered rather than the technical problems in actually creating the bulletin board.

To assist you may wish to consult the Australian Therapeutic Goods Administration homepage or the United States of America Food and Drugs Administration homepage and then click on the Medical Devices/Radiological Health icon.

OR

2. Present a well reasoned discussion to determine who should accept the risks of failed medical device. Is it the patient, the implanting surgeon, the manufacturer or the regulatory agency that approved the device for supply.

The issues can be gleaned from the internet after searching specifically for silicon breast implants and the cardiac pacing lead known as the Atrial "J" lead.

OR

3. Present a well reasoned argument to answer the question - "Can technology make up for amputated or missing limbs?"

To assist you may wish to do an internet search using the keyword "prosthesis" and investigate sites dealing with information for amputees, anthropology and prosthetics and the many sites provided by prosthesis manufacturers and associations, especially the site established by the Northwestern University Prosthetics Research Laboratory.

References:

Guide for Further Reading

1. Annual Book of ASTM Standards. Published annually by the American Society for Testing and Materials, Philadelphia, PA. Volume 13 contains standards relevant to medical devices.
2. International Standards Organisation (ISO) Standards including ISO 9000-9004 - a group of standards on quality assurance. ISO is currently preparing ISO 10993: Biological Evaluation of Medical Devices.
3. Andreas Von Recum (Ed.) A Handbook of Biomaterials Evaluation: Scientific, Technical and Clinical Testing of Implant Materials. New York: MacMillan (1986) [wide ranging and detailed].
4. D.F. Williams & R. Roaf (Eds.) "Implants in Surgery". London, Philadelphia, Toronto, W.B. Saunders Co. Ltd., 1973 [historical perspective].
5. B.D. Ratner, A.S. Hoffman, F.J. Schoen, J. E. Lemons (Eds.) Biomaterials Science: An Introduction to Materials in Medicine. San Diego, London, Boston, New York, Sydney, Tokyo, Toronto. Academic Press (1996). MBQ610.28/190 Biomedical library, UNSW

Ethical Issues - Background reading

1. "Cannibals, Cows, CJD, Catastrophe" by Jennifer Cook ISBN 0091836913.
2. R. Rhodes. "Deadly Feasts". Published 1997, Simon and Schuster, ISBN 0684823608. Books a) and b) cover the history of Kuru disease in New Guinea to bovine spongiform encephalopathy to CJD and are written in non-scientific language.
3. J.H. Fielder (1994). "More Bad News about Bjork-Shiley C/C Heart Valves". IEEE Engineering in Medicine and Biology, April/May 1994, pp182-184 (copies available).
4. J.H. Fielder (1993). "Getting the Bad News about your Artificial Heart Valve". Hastings Report, pp22-28 (copies available).

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Last modified: 25/07/2002