Response 520387437

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Facilities that could be included and/or excluded from mandatory reporting

Question 3. Are there any healthcare facilities licensed/accredited through national schemes (listed in the discussion paper) that should not be included in any proposed mandatory reporting of medical device adverse event reports?

Please select one item
Yes
No

The type of medical device-related incidents or events that could be reported to the TGA

Question 7. What type of medical device-related incidents or events do you consider should be reported through to the TGA? Select all that apply

Please select all that apply
Incidents resulting in death
Incidents resulting in serious injury
Near misses that could have resulted in death or serious injury
Issues identified during routine maintenance where the device is fixed or replaced prior to use
Incidents that occur outside of a hospital setting e.g. malfunction of an implant and the patient presents to a healthcare facility
Other (please specify and provide reason)

Declarations and Acknowledgements

Q22. Declarations and acknowledgments:

Please select all that apply
(Required)
I acknowledge the above