The Final Chapter: Unveiling the Complete Device History Record

This is the final article in a three-part series. For background, see the introduction to DHF here and to DMR here.

Device History Records

Creating device history records (DHR) is one of the last steps in medical-device compliance. Subpart M of 21 CFR Part 820 requires every manufacturer—whether using paper or web-based systems—to maintain a DHR for each batch, lot, or unit. The record must show that production matches the device master record.

Unlike most sections of the regulation that govern overall quality processes, the DHR is product-specific. It must include acceptance records, product counts, labels, and any unique identifiers assigned.

Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

(e) The primary identification label and labeling used for each production unit; and

(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

By documenting each batch in this way, the DHR creates traceability throughout the supply chain and can help identify the source of any non-conformance that may arise.

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Benefits of the DHR

1. Complaints: When a non-conformance or customer complaint reaches the CAPA team, the UDI, UPC, or other product identifier recorded in the DHR lets staff pinpoint the affected batch or production run and trace the root cause. Quality managers can then judge whether the problem is isolated to one batch or spans multiple lots.
2. Process improvement: If a batch passes acceptance criteria yet later contains some non-conforming units, DHR data help link the defect to its origin. This insight can guide updates to acceptance protocols and reduce the chance of recurrence.
3. Limit liability and save money: The DHR shows that each batch was tested against the DMR before release. When complaints cluster in a single batch, a targeted recall of that lot may suffice, avoiding the cost of recalling every shipped batch.

Further reading:

• U.S. FDA