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ROI CalculatorA device history record (DHR) contains all the documents necessary to demonstrate that the guidelines set out in the instruction manual have been adhered to during the manufacturing process. DHR also refers to the manufacturing dates, the number of medical devices made, the acceptance records of those devices, and the unique identifiers (UDI) assigned to each medical device.
Even though the particular section devoted to DHR no longer exists in the same shape and form after the update of the regulation, the production and traceability records that correspond to DHR are still mandatory under the ISO 13485 standards contained in the updated regulation.
The establishment of DHR is one of the final activities necessary for successful completion of the compliance procedures for medical devices. The subject of DHR falls within the subpart M of 21 CFR Part 820 governing the record-keeping standards for organizations involved in medical devices production. The provisions of these regulations apply to manufacturers regardless of the format in which the records are kept. The entries in the DHR contain information regarding the acceptance of each product's unit and group.
DHR plays an important role in the quality system for medical device companies. Here are a few ways that businesses are leveraging DHR to enhance their processes, get superior results, and stay compliant with modern standards and regulations:
To facilitate CAPA investigations - If any non-conformance problem from customers is received, the CAPA team can get the product identifier such as UDI/UPC linked with the issue. This will help in knowing the bad lots or the manufacturing production runs to identify the cause of the problem. Thus, you and your quality manager will come to know if the non-conformance problem was just for one good lot or some other lots too.
Using DHR to facilitate process improvement - A product lot passes the acceptance criteria but later on, it is recognized that the non-conformance product has a larger share than the acceptance limit. So, tracing the non-conforming products back would let you know about the needed changes in the acceptance criteria.
Using DHR to limit liability and save money - DHR gives all the manufacturers the opportunity to prove that a lot is tested for the acceptance criteria first before getting it released into the market. This will also help in recalling the lot only if it gets qualified for the non-conformance. By analyzing your DHR, you will see that you are dealing with a faulty batch, which means that you can choose to call back only that particular batch, instead of recalling all out of the total 100.
State-of-the-art QMS solutions allow the management of DHRs. These solutions improve the processes of data collection, data retrieval, and compliance with laws like FDA 21 CFR Part 820 and ISO 13485, thus allowing you to access data quickly and accurately. DHR is a living document and must be updated each time a new batch of product is manufactured with unique device identifiers and perform tests against acceptance criteria for a new batch of products.
