ISMRM & SMRT MR Safety Resources

Incident Reporting Guidance

Incident Reporting

Incident reporting is essential in order to learn from when things go wrong and reduce the risk of similar incidents occurring again. At a local level identifying the cause of an incident allows improvement in working practices, policies and procedures. At the national level incident reporting allows emerging risks and issues to be identified that might not be recognised locally.

Reporting Levels

Local

  • Incidents should always be reported using the local incident reporting or risk management systems. This may be through your department, hospital or university.
  • In many cases the local risk management team will then take over responsibly for reporting the incident to state, territory or province agencies along with your national regularity agency.
  • Depending on locality this may include near misses where there was no injury or damage.

Manufacturer

  • All incidents must also be reported to the device manufacturer as soon as practicable.
  • Determination of whether equipment is possibly at fault or damaged must be done by the manufacturer and not the facility.
  • This may be the MR system itself or ancillary equipment such as contrast injectors or patient monitoring equipment.

National

  • Almost all countries have national regulatory agency that will accept reports for incidents involving medical devices.
  • Reporting links for Australia, Canada, Denmark, New Zealand, UK and USA are below. What should be reported varies between country so please follow the links to see if the incident is reportable.
  • Additionally the FDA will accept reports from any country where the device, or a similar device, has been cleared or approved for use in the USA.
  • Depending on the type of incident reporting may be mandatory.

Reporting Links

Australia

Therapeutic Goods Administration (TGA)

Canada

Health Canada

Denmark

Sundhed.dk

New Zealand

MedSafe

United Kingdom

The Medicines and Healthcare products Regulatory Agency (MHRA)

United States

Food and Drug Administration (FDA)