Samples for testing - Protocol for sending medical devices to the TGA for testing

Medical devices involved in an adverse event may be sent to the TGA for testing. The TGA accepts devices that are contaminated. The TGA can test or visually inspect all medical devices. There are some devices for which the TGA cannot do a complete examination as the equipment available for some of the tests is specific to the device manufacturer. The TGA will however, test or examine the device and if granted permission by the reporter the device will be sent to the manufacturer for further testing. Analysis of the manufacturer's testing is required by the TGA as part of its investigation of the adverse event report.

It is important to keep the device after submitting a report, until the IRIS has contacted you to say whether the device should be sent to the TGA or the sponsor/manufacturer.

When sending medical devices to the TGA please follow these steps:

1. Clean the device as much as possible without destroying any evidence that you feel contributed to the adverse event.
2. All devices should be doubled packaged in plastic bags designed for transport of normally used when transporting bio-hazardous objects. The outer package must be clearly labelled with the contents and warnings if the device is contaminated.
3. If the device has sharp edges or components such as suture needles, please pack these items into a sealed plastic container in addition to the plastic bags.
4. Medical devices should be sent to:
   • The Coordinator Incident Report Investigation Scheme
     TGA
     Office of Devices, Blood and Tissues
     136 Narrabundah Lane
     Symonston ACT 2909
5. If you require assistance with transporting medical devices, please contact the coordinator on 1800 809 361.

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