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Medical device incident reporting & investigation scheme (IRIS)

14 March 2012

What is an adverse event?

An adverse event is defined as an "injury resulting from a medical intervention, not the underlying condition of the patient"¹, and is "unintended or unintentional harm or suffering arising from any aspect of health care management"². It has long been recognised that adverse events pose a threat to the safety of patients³.

IRIS is focused on adverse events or incidents related to the use of medical devices.

What is a medical device?

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.⁴

Who can report an adverse event?

Everyone should be encouraged to report any adverse event or potential adverse event with a medical device.

Healthcare professionals have expert knowledge related to device use and safety, through astute monitoring, rapid identification of device-related problems, and reporting these problems⁵. They should always be involved in the initial investigation into an adverse event.

What is adverse event reporting?

"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."⁵

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

What should be reported?

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.

Health facility adverse event investigation

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.

What to include in the report to 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.

How to report to the TGA

• TGA Incident Reporting forms are available at Report a medical device adverse event (medical device user) and 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.
• Reporters are encouraged to complete an online reporting form on the TGA website as an alternative to downloading and completing a word or pdf form and then submitting via email, fax or mail.

What happens to the report at the TGA?

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.

Every report receives a risk assessment.

• Serious adverse events are investigated immediately and given priority.
• A panel of scientific, engineering and clinical experts assesses all reports recommending what level of investigation to undertake.
• Unusual incidents, incidents that led to injury or with unusually high levels of occurrence are investigated routinely.
• Isolated incidents or incidents not likely to lead to injury or a detrimental effect to patients or operators are not routinely investigated.
• Reports that are to be investigated are assigned to the most appropriately qualified investigator.
• All reports are entered into a database for future reference.
• Reports, regardless of investigation, are notified to the suppliers for trending purposes.
• The TGA has extensive expert knowledge, experience and testing facilities that may be used during investigations.

The investigator will:

• Contact the supplier of the device,
• Work with the supplier and the reporter of the incident to resolve issues,
• Inform the reporter and supplier of the investigation outcomes, and
• Treat all reports confidentially.

Final outcomes may include recall, safety alert, product improvement, user education, compliance testing, referral to the Office of Manufacturing Quality (TGA) for follow-up audits, and articles in the TGA News and other publications.

The TGA also exchanges information on significant incident investigations with overseas regulatory authorities.

Completing the reporting cycle

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.¹

Where to send an adverse event report?

• Use the online reporting form
  • Report a medical device adverse event (medical device user)
  • Report a medical device adverse event (sponsor/manufacturer)
• Phone: 1800 809 361
• Post: IRIS, TGA, PO Box 100, Woden ACT 2606
• Fax: 02 6203 1713
• Email: iris@tga.gov.au

References

1. Australian Patient Safety Foundation. Iatrogenic Injury in Australia: Department of Health and Aged Care, 2000.
2. Medical Devices - Reporting Adverse Incidents and Disseminating Safety Warnings, UK Medical Devices Agency circular MDA SN200 1 (01) 2001.
3. Leape LL. Error in medicine. JAMA 1994;272(23):1851-7.
4. Therapeutic Goods Act 1989
5. 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.

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