Oral Presentation Australasian Association of Bioethics & Health Law and New Zealand Bioethics Conference

Do physicians have a duty to report medical device adverse events in patients? (1046)

AMINATH Mariya 1
  1. Maldives Institute for Psychological Services, Training & Research (MIPSTAR), Male', Kaafu, Maldives

Over the past decade, malfunctioning medical devices have caused thousands of incidents of patient harm and hundreds of deaths in Australia. Therapeutic Goods of Australia make it mandatory only for sponsors and manufacturers of medical devices to report adverse events. Between 2013 -2017, there were 16,696 medical device adverse events reported under the mandatory reporting requirement. Adverse events reported voluntarily by physicians during the same period amounted to only 4% of total reported incidents. Physician’s lack of motivation to report medical device adverse events negate the crucial nexus they form between the patient and the medical device industry. Australia’s Charter of Health Care Rights identifies embedding of the patient’s right to safe and high-quality health care in Australian health system as the principal objective of the Charter. Guided by the Hippocratic Oath, the primary goal of a physician is to ensure that through their patient-physician relationship this objective of providing a patient-centred health service which promotes patient safety while minimising or avoiding incidents of adverse events is achieved. The Charter places a duty on the physician to participate in existing patient safety systems; recognising the role of the physician in the advancement of healthcare to the wider community. This paper proposes to examine the role of physicians and analyse whether patients faced with medical device adverse events and the wider community at risk of harm from medical devices have a right to have physicians report such events to the regulatory body through an analysis of rights using a claim-right paradigm.