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Medical device incident report statistics

Medical technology is becoming more complex. In the medical device sector, the computerisation, miniaturisation and combination of different components mean that medical devices are providing new treatment options to new groups of patients everyday. While these technological advances provide significant benefits to patients, the TGA encourages reports of adverse incidents involving patients treated with a medical device, even where it may initially appear that the device may not have been the cause of the incident.

Monitoring the safety of medical devices is an important part of the TGA's role. Since 2001, the TGA has routinely published statistics on the reports submitted to its medical device Incident Report Investigation Scheme (IRIS). The IRIS system is used to record and track reports of adverse events or problems associated with medical devices submitted to the TGA.

Reports of incidents associated with use of medical devices do not necessarily mean that the devices used were faulty. Incidents may occur due to factors related to the individual patient, the healthcare providers or system, or the medical device itself. The TGA conducts a review of all incidents reported to IRIS, and reports of device failure and serious injury are also reviewed by a committee of clinical experts who provide advice to the TGA.

It is important to recognise that the summary data presented here are only a snapshot of the data collected and need to be read in context. They do not reflect the many millions of successful uses of medical devices that occur every year, and should not be used to make generalised conclusions about the safety of a particular type of medical device.

Where significant safety issues related to the medical device are identified by the TGA, the TGA undertakes regulatory actions which may include advising consumers and healthcare professionals of the identified risks, working with the manufacturer or sponsor of the device to correct identified vulnerabilities in design, modifying labelling or instructions for use of the device, or recalling devices from the market.

The TGA is currently working to enhance the information it provides to consumers and the broader healthcare community, and will be updating the format and information contained in these reports.

Headings contained in these data:

  • Number received: This is the number of device incident reports for which the TGA's assessment and investigation have been completed in the last three months.
  • Cause of problem: All submitted incident reports are reviewed and a nominal cause assigned. This helps to determine the priority for review and by whom the report is initially reviewed.
  • Effect: The effect reflects the outcome for the patient. This does not mean that the device has caused the death or injury reported as it may be that the patient's disease process or other factors relating to the way the device was used may have been the cause of the death. For example a patient with severe heart failure may die while awaiting a heart transplant. If they have been treated during their final illness with a medical device this will be coded as a death in the IRIS system, even though that death may have been the result of the underlying disease process, not the medical device.
  • Severity of Effect: It is important to note that the data table defines serious injury as
    • a life threatening illness or injury,
    • a permanent impairment of a body function, or
    • a condition necessitating medical or surgical intervention to prevent permanent impairment or permanent damage to a body structure.
  • This means that any patient who requires a second procedure is automatically coded as a serious injury, even though they may have never actually been harmed in any way by a medical device.
  • Source category: The source of each incident report is recorded here. An incident may be reported by anyone, whether or not they have been directly involved in the care of the patient or the incident. Reporting of adverse events by sponsors is mandatory while reporting by others is voluntary.
  • Result of investigation: This summarises the actions taken by the TGA following the investigation of the incident report.
  • Not investigated: Reports submitted to IRIS undergo an initial risk assessment and are then considered by a technical and clinical panel if further analysis is required. Where designated as "Not Investigated" it has been determined that further investigation of the report is not necessary at that time. This may arise because regulatory action has already commenced or corrective action has already been undertaken, or the panel has concluded that the reported incident is not causally related to the device. Nevertheless, every report remains logged in the database for future reference and subsequent monitoring of trends.

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Medical device incident report statistics 2009

Medical device incident report statistics 2008

Medical device incident report statistics 2007

Medical device incident report statistics 2006

Medical device incident report statistics 2005

Medical device incident report statistics 2004

Medical device incident report statistics 2003

Medical device incident report statistics 2002

Medical device incident report statistics 2001

Medical device incident report statistics 2000

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