Part 3/3 — The Device History Record
This is the last part of a set of three articles. For more information, check https://medium.com/@kaiyan_medical/part-1-3-the-design-history-file-d681a7945968 with the introduction to DHF and https://medium.com/@kaiyan_medical/part-2-3-the-design-master-record-c8348c1e029a for the introduction to DMR.
Device History Records
The establishment of device history records (DHR) is one of the last steps in the compliance process for medical devices. It falls under subpart M of 21 CFR Part 820, which deals with general record-keeping requirements for medical device companies. The FDA mandates that all medical device companies should have the documentation related to manufacturing and tracking according to the information in the device master record.
Manufacturers are subject to this part whether they keep records on paper, or use web-based software. The DHR serves as a production record for medical devices that you manufacture. The entries into this document must include acceptance records for individual units or batches of product, along with product counts, labels, and any unique product identifiers that have been applied.
Most sections of 21 CFR Part 820 refer to establishing overall quality processes that affect your product design and manufacturing, but the DHR is different in that it is applied to each batch of products that you produce.
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;
© 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.
The DHR mandate requires that new batches of products are tested to ensure that they meet the product specifications established in the device master record. The mandate also ensures that batches of products are correctly labeled and assigned identification numbers. This creates traceability throughout your supply chain, enabling you to better identify sources of error in case any non-conformance issues arise with your products.
Benefits of the DHR
- Complaints: If a non-conformance issue or customer complaint is presented to your CAPA team, the team can determine the UDI, UPC, or other product identifier associated with the complaint. This allows your team to identify potentially problematic batches or production runs of devices and find the root cause of the issue. This allows your quality manager to determine whether non-conformance issues were confined to a specific batch of product, or if the issue is affecting products in all batches.
- Process improvement: Imagine that a batch of product passes your acceptance criteria, but is later found to contain a proportion of the non-conforming product. The ability to trace non-conformance issues back to a specific batch can help you understand the problem and redesign your acceptance criteria to prevent future occurrences of the defect.
- Limit liability and save money: The DHR allows manufacturers to demonstrate that batches of the product were tested for acceptance with the DMR before being released for distribution. It also allows targeted recalls if only a certain batch is found to be defective. Imagine you release 1,000 batches of product for distribution and receive 10non-conformance complaints from the same batch. Referencing your DHR, you’ll realize that it’s just a single batch that has defects, and you can issue a targeted recall of that batch instead of recalling all 1,000.