You are required to make sure that the risks have been analysed. You need to send the TGA a copy of the risk analysis in Step 9.

In Step 5: Reliability of your information | Medical device risk analysis | Biologicals, human blood and blood components investigation | Medicine risk analysis

Reliability of your information

Gather and assess the reliability of all available information about the potential hazard.

Medical device risk analysis

It is the medical device manufacturer's responsibility to identify any potential risks associated with an adverse event, product failure or complaint through use of an appropriate quality management system. Analysing risk is part of the risk management process, described in ISO 14971 Medical devices - application of risk management to medical devices.

Provide the TGA (in Step 9) with the risk analysis report produced by the manufacturer (often known as a health hazard evaluation or HHE report). You should have received this from the manufacturer when you were notified of the product defect.

The risk analysis report should include 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).

Ensure you are satisfied with the conclusions and recommendations before submitting this risk analysis, then continue to Step 6.

For more information, go to medical device risk analysis in the guidance on Roles in recalling therapeutic goods.

Biologicals, human blood and blood component investigation

Biologicals, human blood and blood components are manufactured according to the Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products.

This good manufacturing practice code specifies that the manufacturer will investigate adverse events and product complaints and will implement and maintain a written procedure for product recall. Provide the TGA (in Step 9) with the investigation report produced by the manufacturer.

Continue to Step 6.

Medicine risk analysis

The sponsor is responsible for analysing the risks with medicines.

When you analyse risk, consider both the potential hazards and the likelihood of these hazards. Consider all of the following:

1. whether any illness or injury has already occurred from use of the therapeutic product
2. whether any existing conditions could contribute to a clinical situation that could expose humans to a health hazard
3. the hazard to individual groups within the exposed population (such as children, the elderly, consumers having surgery or those who are immunocompromised)
4. the degree of seriousness of the health hazard to which the population will be exposed
5. the consequences (immediate or longer term) of occurrence of the hazard
6. alternative treatment options, including the hazard associated with providing no treatment where an alternative is not available
7. the potential harm to the user as a result of the issue
8. the likelihood of the issue occurring
9. results of tests and other investigations on suspect or other samples
10. the ability of the consumer, caregiver or health professional to discover or identify the issue prior to or during use
11. whether the therapeutic product is outside the manufacturer's specifications
12. the availability of an alternative therapeutic product, or the risk associated with not providing treatment if an alternative therapeutic product is not available.

Incorporate any a risk analysis or clinical investigation conducted by another relevant entity into your risk analysis and ensure you are satisfied with the conclusions and recommendations before submitting this risk analysis.

Continue to Step 6.