Post-market surveillance of IVDs in non-laboratory settings
What is post-market surveillance?Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from in vitro diagnostic medical devices (IVDs) that have been placed on the market, and to identify the need to take any action if the safety, quality or performance is impacted. This means that users of IVDs, all testing providers, must be empowered to detect and document product problems, then to report these as user feedback to the manufacturer or local authorized representative. Post-market surveillance is a crucial tool to ensure that IVDs continue to be safe and well performing, as manufacturers will evaluate if any new or increased risks of use of the IVD outweigh the benefits. |
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Post-market surveillance of IVDs in non-laboratory settings presents unique challenges due to decentralized data management and varied user expertise.
Clear definitions of types of user feedback, standardized user feedback reporting forms, and simplified communication channels are necessary. These should be outlined in the form of simple standard operating procedures outlining the roles and responsibilities, step-by-step.
User/testing provider training
Users of IVDs in non-laboratory settings must be trained to recognize problems with IVDs such as rapid diagnostic tests (RDTs) document and report this as user feedback to manufacturer and/or local authorized representative. This concept should be integrated into existing user/provider training schedules.
Simplified reporting mechanisms
Traditional user reporting mechanisms may be too complex for non-laboratory settings. Practical reporting tools such as simple paper-based forms may be used, these can be photographed and sent via smartphone or email. The most critical information is the lot number and expiry date of the product concerned, and what went wrong; with this information the manufacturer can start investigating.
Data management
Site-level information management systems will collect data to satisfy monitoring and evaluation purposes. These data can also be reviewed to detect, among other things, false negative or false positive results, unreasonable rates of invalid results. It is important to document the number of RDTs that are affected.
Response mechanisms
When the manufacturer indicates the risks of continuing to use the IVD outweigh the benefits, they will give the user/testing provider instructions on what to do. This is called a field safety corrective action, it may be a modification (such as change to the labelling or instructions or a modification of clinical management of the patient), or recall (return or destruction of device). For example, if the risk of false negative results is increased, the manufacturer may call for retesting of previously tested patients or review of previous testing results. Clear instructions for users/testing providers responding when manufacturers implement field safety corrective actions is critical to protect public health.
Implementation considerations
A phased approach to implementing measures to support post-market surveillance works best:
- Begin with a pilot in selected facilities to identify implementation challenges.
- Expand to cover priority testing areas (e.g. HIV, TB, malaria).
- Gradually scale to include additional tests and facilities.
- Continuously refine processes based on feedback from stakeholders and performance metrics.
Where quality management systems already exist, activities to support post-market surveillance should be integrated.