Revised: 30 May 2017
Safety Information
Safety Monitoring of Medical Devices
Medsafe receives reports of issues associated with the use of medical devices from users, healthcare professionals and the medical device industry. The reports can be received via faxes, letters and e-mails. These reports are entered into Medsafe's regulatory database by Medsafe staff. All reports are checked by us for correctness and completeness.
Risk Assessment
All reports are entered into a database, assessed for risk and further investigated as appropriate.
- Serious adverse events are investigated immediately and given priority.
- Reports are assessed and a recommendation as to the appropriate type of investigation (if any) is made.
- Unusual incidents, incidents that led to injury or with unusually high levels of occurrence are routinely investigated.
- Isolated incidents or incidents not likely to lead to injury or a detrimental effect to patients or operators are not routinely investigated.
- Expert opinion may be sought during investigations.
Investigation
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
- keep reporter and patient identifying details confidential.
Final outcomes may include:
- informing health professionals and consumers through articles on Medsafe's website and other publications such as Prescriber Update.
- requesting improvements to the product or changes to the instructions for use or product labelling, such as adding warnings and precautions
- recalling the product from the market
- requesting the sponsor/manufacturer undertake additional user education
- requiring no further action at this stage, but continuing to monitor for trends.
Medsafe also exchanges information on significant incident investigations with overseas regulatory authorities.
