Issues affecting refurbishment and re-use of pacemakers.
This paper discusses the problems associated with the refurbishing and re-use of medical devices which are sold by manufacturers as 'single use items' by focusing in particular on the re-use of pacemakers. Re-use of single-use devices such as pacemakers does occur in Australia, and in many other parts of the world, but there has been little public awareness of this fact. The paper explains and discloses medical, legal and ethical issues which arise through the re-use of pacemakers. It also discusses the recommendations of the 1995 'Draft report of the NHMRC Expert Panel on Re-Use of Medical Devices Labelled as Single Use'.
Jackson
M
M
Faculty of Business, Royal Melbourne Institute of Technology, Victoria, Australia.
D001315:Australia; D004866:Equipment Contamination; D004868:Equipment Failure; D017743:Equipment Reuse / Q000191:economics / Q000331:legislation & jurisprudence*; D004992:Ethics, Medical; D006801:Humans; D007239:Infections / Q000635:transmission; D007258:Informed Consent; D016365:Liability, Legal; D010138:Pacemaker, Artificial / Q000592:standards / Q000706:statistics & numerical data*; D013242:Sterilization