Device History Record (DHR)

A device history record (DHR) is the complete documented history of a specific DME unit, identified by its serial number. The DHR captures every significant event in the unit's life: manufacture or acquisition, initial deployment, each patient assignment, each return, each reprocessing event, any repairs or parts replacements, preventive maintenance, and ultimately retirement or disposal.

DHRs are required for Class II and Class III medical devices under FDA 21 CFR 820.184 (the Quality System Regulation). While most rented DME is Class I or II, accrediting bodies have adopted DHR-equivalent requirements for all reusable equipment regardless of FDA class. The practical requirement is the same: if a unit left your facility and came back, there should be a record.

The DHR is the primary document an accreditor or auditor will request during a survey or investigation. It answers the questions: where has this unit been, was it properly cleaned between patients, and is there a documented trail from acquisition to current status?

For FDA recalls, the DHR is essential. If a serial number is listed in a recall notice, the supplier must be able to identify immediately which patient currently has that unit (or what happened to it) and initiate the appropriate response. Without a DHR, this process can take days; with one, it takes seconds.