Could Expansion of National Sentinel List to Include Medical Device Adverse Event Reporting Be an Effective First Step Towards Addressing Underreporting of Adverse Events by Health Professionals?

Ms Aminath MARIYA1

1University of Adelaide, ADELAIDE, Australia

For sponsors of medical devices, reporting of medical device adverse events or near adverse events (MDAEs) to Therapeutic Goods Administration (TGA) is an automatic condition of inclusion of a medical device on the Australian Register of Therapeutic Goods. Reporting of MDAEs under the Therapeutic Goods Act 1989 is voluntary for healthcare professionals. This has been identified as a possible raison d’être for the egregious under-reporting of MDAEs by health care professionals. In response to a recommendation to implement mandatory reporting of MDAEs by medical practitioners, by the Senate Community Affairs References Committee report (Senate Inquiry) on the Number of Women in Australia Who Have Had Transvaginal Mesh Implants and Related Matters, TGA clarified their remit extends to only sponsors and manufacturers of medical devices and lack the authority to mandate health practitioners to report MDAEs. Hospitals in Australia collect many types of data; including mandatory data on ten national categories of sentinel events (NSEs) identified by Australian Commission on Safety and Quality in Health Care. This paper suggests that expansion of current NSEs list to include reporting of MDAEs as an eleventh category will be a significant step forward in addressing under-reporting of MDAEs by health professionals. Australian national sentinel event list has its genesis in a US list which has since evolved and is now called ‘serious reportable events’. Is it time for the mandatory NSEs list to evolve and serve a broader agenda and more comprehensively address patient safety through better data capture and communication?


I am an MPhil (Law) candidate at the University of Adelaide. I am also a lawyer (registered – Maldives) with a background in corporate and commercial law. I completed a Master of Laws from Monash University. My research interests include issues relating to bioethics, patient safety, health law and regulation.

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