Medical device Incident Reporting and Investigation Scheme (IRIS)

An adverse event is an event that led to:

• death
• a serious injury or serious deterioration to a patient, user or other person, including
  • a life-threatening illness or injury
  • permanent impairment of a body function
  • permanent damage to a body structure
  • a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

A 'near adverse event' is an event that might have led to a death or serious injury. It may be that due to the timely intervention of a healthcare practitioner 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 happened
• if the event occurred again, it might lead to death or serious injury
• testing or examination of the device or the information supplied with the device, or scientific literature indicated some factor that could lead to a death or serious injury.

A medical device is any material instrument, apparatus, appliance, implant etc including any component part or accessory including software, and in-vitro diagnostics, which is used in health care.¹

1. Therapeutic Goods Act 1989

Everyone is encouraged to report any adverse event or near (potential) adverse event with a medical device, including consumers. Every incident report that is received by the TGA can assist in identifying issues.

Health professionals have expert knowledge related to device use and safety; through astute monitoring the rapid identification of device-related problems can occur. Reporting of these problems² can reduce the risk of harm to others.

1. Medical Device Problem Reporting for the Betterment of Healthcare, Health Devices, Vol 27 No 8, August 1998, pp277-292. Kohn L, Corrigan J, Donaldson M. To Err is Human: building a safer health system. Washington, D.C.: National Academy Press, 1999.

"Adverse Event Reporting is the communication of an adverse event or incident to those who are likely to provide or contribute to a constructive response."

An effective adverse event reporting system determines which adverse events should be reported and to whom, and provides a mechanism to make, act on, and track reports, and to track any corrective actions. Effective systems assist with preventing adverse events from recurring.

Typical causes of adverse events with Medical Devices include:

• multifactorial causes
• mechanical or material failure
• design issues
• labelling, packaging or manufacturing errors
• software deficiencies
• device interactions
• user/systemic errors

Medical device adverse incidents involving actual harm to a patient / caregiver or that could have resulted in harm should be notified to the facility's Quality / Risk Manager who should coordinate reporting to external organisations, such as the supplier of the device and the TGA. These events should be investigated as quickly as possible.

In cases where it is difficult to judge whether to report or not, then reporting is recommended.

When the Quality/Risk Manager receives a report of a quality issue, user difficulty or malfunction of a medical device, the Health Care facility will respond to the event in several ways relevant to the incident and the resources available to the facility. It is also important to record the event and be able to track it to assess the rate of occurrence. It is recommended that if the incidence rate becomes unacceptable or the response from the device supplier is not consistent with solving the issue an incident report is then sent to the TGA.

The investigation action plan should include directions for:

• Preserving and impounding evidence (actual device, error codes in device memory, control settings, batch/serial numbers & medication used);
• Assembling an investigation team (i.e. clinicians, biomedical engineers, risk manager etc);
• Collecting and reviewing all related information (patient & device) including interviews with attending personnel at the time of the event;
• Assessment of any injury or damage; and
• Reporting the event to the supplier and the TGA.

Always include the contact details of both the person writing the report and person to whom the event happened if it isn't the reporter. (These people may need to be contacted to provide further information.)

These details can remain confidential, but are needed by the TGA to be able to progress with the investigation and to provide feedback.

Other important information to include:

• Identifying features of the device - device name, manufacturer, supplier, catalogue /batch/serial numbers, expiry date, when purchased;
• A comprehensive description of the event; and
• The outcome or in the case of a "near event" the possible outcome, had intervention not taken place.

Without a description of what, how and where the event happened, the report is of limited value in helping to prevent future events. It is often useful to include a clinical history of the patient involved, but care should be taken to remove any patient identifiers.

• TGA Incident Reporting forms are available online at:

  • Report a medical device adverse event (medical device consumer)
  • Report a medical device adverse event (medical device health professional)
  • Report a medical device adverse event (sponsor/manufacturer)

  or on request.

• A written report including the reporter's details is required; the TGA cannot act on verbal (over the phone) reports alone.

The IRIS is responsible for the management of all reports of adverse events or problems associated with medical devices that are reported to the TGA.

See Overview of how TGA manages medical device adverse event reports, for information on how the data is analysed and actions that may follow the analysis of medical device adverse event reports.

The health facility's quality system, through the Quality/Risk Manager should ensure that the recommendations from investigations are disseminated, followed up and implemented. Careful analysis of incidents reveals both the multifactorial causes and the good practices that can help minimise repetitions.³

1. Australian Patient Safety Foundation. Iatrogenic Injury in Australia: Department of Health and Aged Care, 2000.

• Use the online reporting form
  • Report a medical device adverse event (medical device consumer)
  • Report a medical device adverse event (medical device health professional)
  • Report a medical device adverse event (sponsor/manufacturer)
• Phone: 1800 809 361
• Email: iris@health.gov.au