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Uniform recall procedure for therapeutic goods, V2.2
Step 3. Conducting a risk analysis
As the sponsor, analyse the risks associated with the affected therapeutic good(s). You will need this in Step 4 to help you determine the type of recall or non-recall.
Immediate recalls: go to Step 9.
Medical device risk analysis
The manufacturer of medical devices (including in vitro diagnostic (IVD) medical devices) is responsible for implementing an appropriate Quality Management System, and using it to identify any potential risks associated with:
- an adverse event
- a medical device failure
- a complaint.
Risk analysis is part of the risk management process, described in ISO 14971 Medical devices - application of risk management to medical devices.
The risk analysis report includes details of:
- the defect or deficiency
- potential failure mode
- failure rate
- how the defect was identified
- any reported patient injuries
- severity and probability of occurrence
- stock affected
- proposed market action by the manufacturer
- potential root causes and corrective actions (if available).
Sponsors undertaking a recall or non-recall action
As the sponsor, you should receive this risk analysis report when the manufacturer notified you of the device defect.
Make sure you are satisfied with the conclusions and recommendations.
You will be submitting this risk analysis in Step 7.
If you do not have the manufacturer's risk analysis
If you do not have the manufacturer's risk analysis, for example, your recall or non-recall action is in response to information you receive from customers (e.g. consumers or health care professionals):
- Gather as much information as you can to help you determine in Step 4 what action to take.
- Send the report(s) to the manufacturer and request the risk analysis.
Biologicals, human blood and blood components
The manufacturer of biologicals, human blood and blood components must both:
- investigate adverse events and product complaints
- implement and maintain a written procedure for product recall.
Sponsor undertaking the recall or non-recall action
Ensure you are satisfied with the conclusions and recommendations before submitting the risk analysis, and go to Step 4 Deciding the type, class and level of recall.
We will review the manufacturer's investigation report in Step 8.
- Appendix 11, Risk management in the Australian regulatory guidelines for biologicals
Human blood and blood components
There are two processes for human blood and blood components:
- Recalls due to process failure and suspected bacterial contamination due to transfusion reaction with a related component.
- Other recalls such as those triggered by Single Donor Notifications (e.g. report of a post donation illness). The Blood Service reports these recalls to TGA by providing a compiled list on a monthly basis, broken down into common categories.
Medicine risk analysis
The sponsor (when also the manufacturer) is responsible for analysing the risks with medicines.
If the sponsor is not also the manufacturer, the sponsor may conduct the risk assessment in conjunction with the manufacturer.
In the risk analysis report include details of:
- Both the potential hazards and the likelihood of these hazards
- Whether any illness or injury has already occurred from use of the medicine
- Whether any existing conditions could contribute to a clinical situation that could expose people to a health hazard
- The hazard to individual groups within the exposed population (such as children, the elderly, consumers having surgery or those who are immunocompromised)
- The degree of seriousness of the health hazard to which the population will be exposed
- The consequences (immediate or longer term) of occurrence of the hazard
- Alternative treatment options, including the hazard associated with providing no treatment where an alternative is not available
- The potential harm to the user because of the issue
- The likelihood of the issue occurring
- Results of tests and other investigations on suspect or other samples
- The ability of the consumer, caregiver or health professional to discover or identify the issue prior to or during use
- Whether the medicine is outside the manufacturer's specifications
- The availability of another medicine or alternative therapeutic good, or the risk associated with not providing treatment if another medicine or alternative therapeutic good is not available.
Incorporate other relevant analysis or clinical investigation into your risk analysis and ensure you are satisfied with the conclusions and recommendations.