Chain of Custody

Chain of custody is the legal and operational concept of maintaining an unbroken documented record of who had possession of a specific item at every point in time. In the DME context, a chain of custody record for a serialized unit answers: when was it received, who delivered it to which patient, when was it returned, who reprocessed it, and where is it now.

Chain of custody documentation is required for high-value and high-risk medical equipment. For ventilators, power wheelchairs, and respiratory therapy devices, the chain of custody is the evidentiary record that a supplier would need to produce in the event of a patient adverse event, an FDA recall, or a Medicare audit.

In practice, a complete chain of custody is built from the same records that operational tracking generates: check-out records, check-in records, reprocessing sign-offs, maintenance logs, and status change events. A system that captures these events automatically as part of normal operations creates the chain of custody as a byproduct of doing the job.

Gaps in the chain of custody — periods where a unit's location is unknown — are exactly what auditors and litigants look for. A gap of even a few days between a patient's death and the unit's return record is the kind of ambiguity that creates legal exposure. Continuous, prompt recording closes those gaps.