Quick Tip: Simplifying IVD risk management
Risk management of in-vitro diagnostic devices can be challenging because of only an indirect link to patient harm. Use these tips to simplify your IVD risk management process.
Unlike a therapeutic medical device, risks associated with an in-vitro diagnostic device (IVD) have an indirect link to the patient. This is because, an IVD only provides information to be used for diagnosis and planning appropriate treatment.
If the IVD provides inaccurate results, either as a false positive or a false negative, it can lead to incorrect or delayed treatment. Similarly, if test results are delayed or invalid, there is only an indirect impact to the patient.
This is what makes IVD risk management challenging because it is not practical to outline all potential sequences or combinations of events that can lead to patient harm. Test results generated by an IVD is only an intermediate step in the overall sequence of events. Unless the IVD is used directly by a consumer/patient, results generated by an IVD are used by trained technicians and/or clinicians to make clinical decisions. In most cases, the IVD manufacturer has no direct control over the final patient outcomes.
Instead of playing out too many hypothetical what-if scenarios, it might be useful to take a simpler approach to analyzing, controlling and evaluating IVD-related risks to patients. Here are 5 tips you can use:
Focus on user needs: identify the right user(s) and make sure to include all relevant user needs as design inputs.
Use guidance in Annex H of ISO/TR 24971: there are “22 pages of goodness” in Annex H of ISO/TR 24971 for IVD risk management. Using this guidance, a risk management procedure and supporting templates can be established to create a risk management file for an IVD.
Leverage public data on IVD-related adverse events: use FDA’s MAUDE and TPLC databases to search for device issues and patient injuries for a similar or related IVD. This will help in identifying potential harms and device related causal factors for risk controls.
Benchmark similar IVDs: identify performance expectations and testing requirements for your IVD based on other devices using a similar technology and method of detection. Look at applicable standards, literature and other industry best practices to plan your IVD design and development requirements.
Secure management support: it is important to secure top management support for a robust design and development of your IVD, including rigorous testing to ensure reliable performance. This is particularly important in a startup or a small resource-constrained business environment.
