Post-market surveillance as a tool for assuring quality of in-vitro diagnostics in low-resource settings

Post-market surveillance for medical devices (which include in vitro diagnostics (IVDs)) is welldefined and widely implemented in settings with stringent regulatory control but it is relatively nonexistent in low resource settings. Coupled with inadequate pre-market assessment, this leaves testing services in low resource settings extremely vulnerable to supply of IVDs that are poor in terms of quality, safety or performance. Post-market surveillance is an activity that allows endusers and IVD manufacturers to work together to detect, investigate and act on any incident observed for an IVD or any adverse event (death or serious deterioration in health – including false negative or false positive results) that might threaten the health of the individual or threaten public health. When used correctly, post-market surveillance has the capacity to protect the patient and the end-user as they would be assured that any significant problem would be detected, contained, corrected and prevented from reoccurring by the manufacturer.