The Commonwealth Department of Health and Ageing has provided the following advice on formal reporting arrangements for medical device faults in relation to medical devices in the H1N1 VacPacs.

The syringes, needles, alcohol swabs, sticking plaster, and alcohol hand rub in the VacPacs are considered medical devices by the Therapeutic Goods Administration (TGA) and are listed on the Australian Register of Therapeutic Goods (ARTG).

Any problems with medical devices should be reported to the regulator. The easiest way to report is by completing the 'Reporting Form for use by Medical Device Users' on TGA's website at http://www.tga.gov.au/problem/devices.htm.

Wherever possible, the TGA has also requested that unopened samples of problem devices from the remainder of the particular VacPac, with batch ID details, be forwarded to the TGA to inspect and test if required. Details of how and where to forward these sample devices is set out at http://www.tga.gov.au/problem/iris/devices-testing.htm.

15 October 2009