Chain of custody

Chain of custody is the documented record of every party that has handled a product from manufacture through to clinical use. In healthcare, an unbroken chain of custody supports patient safety, recall response, regulatory compliance and accurate clinical reporting.

When a medical device, implant or tissue product causes a patient safety event, chain of custody documentation determines how quickly the cause can be identified and other affected patients located. Gaps in the chain make recall response slower and adverse event investigations harder. Modern clinical supply systems capture chain of custody continuously, rather than reconstructing it retrospectively.