The Scheme is a joint venture between the Australian Therapeutic Goods Administration and New Zealand's Medsafe with the aim to improve the standard and to minimise the adverse effects of problems with medical devices through the investigation of incidents associated with their use. The Scheme is intended to complement local incident reporting and investigation procedures. While suppliers and/or manufacturers are responsible for their products, the Scheme can play an important role in ensuring effective and efficient resolution or prevention of problems.

What should be reported?

If you purchase, use or maintain medical devices, you are encouraged to report problems or difficulties associated with their use.

Always report any incident that has caused, or could have caused, an injury to the patient or the device user. Suppliers and manufacturers must always report such incidents. In addition to reporting safety issues, everyone is also encouraged to report any issues regarding the quality and efficacy of medical devices.

Investigation of incidents

All reports receive an initial risk assessment.

Reports of incidents that have led, or are likely to lead, to serious injury, usually receive priority for investigation.

Unusual problems, problems that may have led to injury, or problems that have unusually high levels of incidence are routinely investigated. Isolated incidents or problems that are not likely to lead to any injury or have a detrimental effect on effectiveness are not usually investigated. Every report is entered into the Scheme's database for future reference.

The company responsible for the device is notified of every incident report that is received. Where a full investigation takes place, this is carried out in conjunction with the company. TGA and Medsafe exchange information on significant incident investigations.

Outcome of investigations

If action is considered necessary, it may involve any of the following:

• Recall
• Safety Alert
• Report in the Therapeutic Device Bulletin or other appropriate journal (s).
• Product improvement
• Referral to other TGA or Medsafe Sections for regulatory action

Above: The plastic liner in this hip prosthesis was too thin causing it to fail.
The particles generated as a result of the failure led to substantial bone degradation. This implant was the subject of a hazard alert.

Where to report

If the incident occurred in Australia:

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The Manager
Medical Device Incident Report Investigations
Therapeutic Goods Administration
PO Box 100 Woden ACT 2606
Fax: (02) 6232 8555
E-mail: iris@tga.gov.au
Telephone: 1800 809 361

If the incident occurred in New Zealand

Compliance Team
Medsafe
Ministry of Health
PO Box 5013
Wellington
Fax: (04) 496 2599
E-mail: trevor_nisbet@moh.govt.nz
Telephone: (04) 496 2364