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Device Vigilance Requirements in Australia

Adverse event

An adverse event is an occurrence involving a medical device that meets the following criteria:

  • death of a patient, health care provider, user or other person; or

  • a serious injury or serious deterioration to a patient, health care provider, user or other person, including;

  • a life-threatening illness or injury;

  • permanent impairment of a body function;

  • permanent damage to a body structure; or

  • a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Near adverse event

A 'near adverse event' is an occurrence involving a medical device that might have led to a death or serious injury if, for example, the timely intervention of a healthcare practitioner is the only reason a death or serious injury did not occur. For an event to be defined as a near adverse event, it is sufficient that:

  • an event associated with the device occurred; and

  • if the event occurred again, it might lead to death or serious injury as outlined above.

 

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TGA - Clinical Evidence Guidelines for Medical Devices

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