The Device History Record (DHR)
The US FDA states the following:
Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR’s for each batch, lot, or unit. The purpose of this requirement is to show that the medical device is manufactured exactly as mentioned in the DMR and that the requirements are met. The FDA states that the DHR shall have in it, or will refer to where it locates these bits of information:
- the manufacturedates
- the manufacturedquantity
- how much quantity was released for distribution
- records showing acceptance that the device is manufactured in accordance with the DMR
- the product’s primary identification label and labeling that went into each production unit; and
- detail of all and any device identification(s) and control number(s) used in the manufacture of the device.
Important facts to remember about the DHR
It is not mandatory to keep the original DHR with the device. It is possible that due to frequent testing and other tasks carried out; the DHR can get tampered. However, before any DHR is removed, there should be a sound set of controls to retain or retrieve data. It should be kept intact, so that there is no loss of record. An authentic way of ensuring this is by having a person in the organization in charge of this aspect. That person can scan the DHR and store it into a repository.
A device that goes into distribution with a DHR is as considered a spurious one. Anyone responsible for doing this is liable for a year’s imprisonment or a penalty of up to $1000.
The manufacturer should ensure clarity on whether the product has an original DHR or the record of a rework. Rework in this case refers to the changes done on a nonconforming product to meet regulatory requirements.
On the other hand, alteration is the repair or servicing carried out on a product that has already entered distribution.
Finally, remanufacturing is the process carried out on a conforming product to make it nonconforming. Also included under this is anything that is done to the device to alter its characteristics. All these three types of work on the device should be recorded in the DHR and maintained.
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