Biomedical management
T I H Brown
4 points * 26 hours of lectures and practical work * Irregular availability * Clayton
Objectives The student is expected to acquire a knowledge of the management and regulatory context in which medical technology is designed, manufactured and used.
Synopsis History, philosophy and structure of Australian Standards Association, Therapeutic Devices Branch and other regulatory bodies. Electromedical equipment standards ISO and AS3000 series. Acceptance and in-service testing standards. New equipment design, design for overseas, eg UL number protocols, testability, laws, regulations, registrations. Professional affiliations, rights and protections. Therapeutic Goods Act. Introduction to contract law, procurement, hospital administration, financial budgeting, workplace factors. Occupational health and safety, staff selection, education and training.
Assessment Assignment and continuous assessment: 100%
Prescribed texts
Bronzino J D Management of medical technology Butterworth-Heinemann, 1992
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