The complete documentation about the manufacturing and tracking of every medical device that your company sells is contained in a Device History Record (DHR).
As per current international regulatory guidelines, your medical device company must maintain DHRs (or similar records) for every batch, lot, or unit of a given medical device.
Device History Records allow your company and internal and external stakeholders to identify any potential deviations in the medical devices that you manufacture. Additionally, a DHR is an essential component of the company’s Device Master Record (DMR)/Medical Device File (MDF), which contains all information pertaining to the manufacture of each medical device by your company.
In this article, we will delve into the details of a Device History Record (DHR), the importance of well-documented Device History Records, the contents of a DHR, and electronic device history record management.
But first, let us understand the basics.
- What is a Device History Record (DHR)?
- Key Regulatory Requirements for Device History Records
- Why Are Well-Documented Device History Records So Important?
- What Must a Device History Record (DHR) Include?
- The Role of a Device History Record (DHR) in Quality Management
- Electronic Device History Record (eDHR) Management
What is a Device History Record (DHR)?
Device History Records contain the complete history of every medical device that your medical devices company manufactures. Essentially, each Device History Record should contain complete documentation concerning the manufacture and tracking of each medical device that your company markets.
Current international regulatory standards, including the US FDA 21 CFR Part 820.184 and ISO 13485.2016, state that your medical devices company should maintain Device History Records (or similar records) for every lot, unit, or batch of medical devices.
When a DHR pertains to a particular lot of a medical device, it can also be termed a Lot History Record. By definition, a Lot History Record is the document that authorizes and controls the production of a single lot of components or finished medical devices.
For example, all records about a particular lot of IV catheters that are manufactured in one of your plants will constitute a Lot History Record.
Key Regulatory Requirements for Device History Records
For medical device organizations wanting to sell their products in the US market, FDA 21 CFR Part 820.184 is applicable.
It details Device History Record requirements that your company must maintain.
For medical device companies wanting to sell their products in the European Union market, ISO 13485:2016 regulations will apply.
Since there is no specific requirement mentioned for a “Device History Record”, section 7.1 (Planning Product Realization) highlights that every medical device organization must plan and develop all the required processes for product realization. These processes must be consistent with other requirements of a medical device QMS.
Nowadays, more and more medical device companies, small and large, start-ups, and established ones opt for a modern eQMS to avoid the hassle of maintaining all records and documents using traditional paper-based or hybrid systems.
An eQMS helps medical device companies to manage Device History Records (DHRs) and other quality-related documents electronically in a tamper-proof, audit-friendly manner.
Medical Device QMS software by SimplerQMS provides medical device companies of all sizes with powerful, built-in document control capabilities that ensure that all records and documents are readily retrievable, secure, and never lost or misplaced.
Why Are Well-Documented Device History Records So Important?
You must maintain separate Device History Records for all your medical devices. Not only is a Device History Record (DHR) an essential regulatory requirement, but it also provides all details about a given medical device.
When a DHR is well-documented, it will provide you with the required evidence if any quality issues do crop up.
A Device History Record that you create for a particular medical device should be maintained during the entirety of the lifecycle of that product. At times, it may need to be maintained for longer durations depending on the specific requirements applicable to your medical device company.
Let us take a closer look at the importance of a Device History Record (DHR):
- Device History Record will help ensure compliance by providing auditors with evidence that a given medical device has been manufactured, controlled, and approved following industry-validated standards and specifications.
- Device History Record helps increase efficiency in case there is a customer complaint. The ensuing investigation and root cause analysis will be based on the details stored in a DHR.
- Device History Records are essential for producing higher-quality products. Since Device History Records are a collaborative effort between several departments within the company, you are assured that the best efforts are put in to produce higher quality products.
- Well-documented Device History Records will save your company money and reduce liabilities. You can easily demonstrate that all batches of a given product have been manufactured and tested following industry standards.
A well-documented Device History Record provides you and external stakeholders with irrefutable evidence about all the steps involved in the manufacture of a given product.
In the absence of a well-documented DHR, it would be next to impossible for your company to diagnose the root cause of non-conformances. If you cannot do the correct diagnosis, how will you correct the non-conformance? How will you prevent it from recurring?
Furthermore, the importance of a digital QMS solution such as SimplerQMS becomes even more pronounced in light of the fact that a Device History Record is constantly evolving, and the amount of documentation required for medical device manufacturers is only going to increase in the future.
We will touch on more specific examples and the role played by a well-documented Device History Record in quality management, as well as the benefits of going digital, in just a moment.
First, let us see the contents of a Device History Record (DHR).
What Must a Device History Record (DHR) Include?
There are two key regulatory guidelines that your company will have to follow concerning the documentation requirements for Device History Records. The regulatory requirements depend on where you want to sell your medical devices, the USA, European Union, or both.
FDA 21 CFR Part 820.184 states the following:
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.
ISO 13485: 2016 Section 7.1 explains the following:
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system.
The organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained.
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents and to provide resources specific to the product, including infrastructure and work environment;
c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements.
The output of this planning shall be documented in a form suitable for the organization’s method of operations.
In summary, the requirements mentioned above emphasize that manufacturers of medical devices must maintain Device History Records or similar records for each lot, batch, and unit of every medical device.
Amongst other things, they must contain details of the date of manufacture, quantity manufactured and released, and a Unique Device Identifier/Universal Product Code. All the records that are maintained should provide evidence that the processes used, and the products manufactured are following specifications.
The example given below gives a fair idea of what should a DHR include.
Note. This is based on the provisions of FDA 21 CFR Part 820.184.
- Device History Record creation: The creation of a particular DHR (either lot/unit/batch) will be based on your company’s Device Master Record (DMR) or Medical Device File (MDF). Device Master Record will contain all the information that you require for manufacturing a given product. The Medical Device File will contain descriptions of all design records, manufacturing processes, QMS criteria, and so on.
- The dates of manufacture: The details of the dates on which particular lots/units/batches of a given medical device were manufactured.
- The quantity manufactured: All the details of the quantity manufactured in accordance with a particular batch, lot, or unit of a medical device.
- The quantity released for distribution: Here, you will need to include details of all the quantities that have been released for distribution, based on the batch, lot, or unit of a given medical device.
- Acceptance/inspection records: The details herein will demonstrate to your stakeholders that a given medical device has been manufactured in accordance with the DMR/MDF, the details of which are given in point 1.
- Unique identification number: Here your company will mention a unique device identifier (UDI), or a universal product code (UPC); you may use any other device identification methodology specific to your products.
- Primary identification label: This is the labeling that your company uses for each production unit.
SimplerQMS allows you to maintain Device History Records electronically as well as link them between other related documents, such as results of acceptance/inspection testing reports within your Device History Record (DHR). With all this information in a central location, you can easily retrieve Device History Records when needed – during an audit, for example – and have complete confidence that your Device History Records are up to date.
The Role of a Device History Record (DHR) in Quality Management
As mentioned earlier, we will now look at specific examples and the roles played by a well-documented Device History Record in Quality Management System.
DHR for More Successful Audits
When your medical device company maintains a well-documented Device History Record, it becomes a lifesaver during medical device audits.
The reason is auditors will most likely choose a particular lot from your manufactured devices and will then appraise all related activities. For example, whether the product is compliant with your internal protocols, Device Master Record (DMR), Medical Device File (MDF), and external requirements.
Your Device History Record is crucial for validating these points.
A more specific example could be that the FDA auditor has selected a particular lot of programmable pacemakers and will now review Device Master Record, manufacturing process instructions and drawings, specifications and labeling, and packaging requirements.
DHR for this lot of programmable pacemakers will provide the auditors with all the required details, thus ensuring that the audit is successful.
With medical device QMS software with built-in audit management capabilities like SimplerQMS, the entire auditing process is made even more efficient. The audit management software module will help your company reduce both time and effort by completely automating audit-related activities, including data collection, routing, notifications, follow-ups, approvals, and escalation of activities, when required. Plus, centralized storage and easy retrieval of the records make the entire process much smoother.
DHR for Assisting CAPA Investigations
Whenever a customer complaint or nonconformance issue is submitted, or even after reporting an audit finding, your CAPA team will be able to get to the root cause of the problem by checking a Device History Record for the product identifier. Using these details, they can isolate the problematic lot or batch, and also check whether the problem is affecting one or all batches.
For example, a hospital that has received a batch of programmable pacemakers raises a complaint that one or more devices are malfunctioning. With the help of a Device History Record, the CAPA management team will be able to pinpoint whether it is only that particular batch that is causing problems.
Furthermore, by using an eQMS with a built-in CAPA management solution, the process of identifying, uncovering, resolving, and reporting all CAPAs becomes much more streamlined. The built-in dashboards help you in analyzing data, identify patterns, and give a better understanding of the impact of every complaint, deviation/non-conformance.
DHR for Promoting Continuous Process Improvement
A well-documented DHR will be very beneficial in promoting continuous process improvement.
For example, a batch of programmable pacemakers has been dispatched after passing the acceptance criteria. However, the hospital that received this batch complained of more than one non-conforming pacemaker.
Device History Record will help your team trace back the non-conformance to a specific batch. This will help you get a better understanding of the problem and, therefore, revamp the acceptance criteria.
This will ensure that future defects do not repeat.
DHR for Saving Costs
Device History Record will help your company in executing targeted recalls.
Let’s imagine that you have received 5 nonconformance complaints out of 50 batches of programmable pacemakers that have been distributed. Analysis of a Device History Record shows that the 5 complaints are all from a single batch. This information helps you in executing a targeted recall of that batch, rather than having to recall all 50 batches of pacemakers.
If you have traditional paper-based documentation systems, analyzing the data becomes cumbersome. With SimplerQMS’s QMS software solution, you will easily update a Device History Record for every new batch of medical devices that you release in the market. This helps you easily find a batch in case a recall is necessary.
DHR for Streamlined Liability Management
Similar to the above example wherein a well-documented Device History Record helps you in targeted recalls, it also allows your company to accurately trace and recall faulty medical devices from the market.
This is crucial to reducing your liability.
For example, complaints about faulty programmable pacemakers have come from several sources. With the assistance of a DHR, you will be able to identify and recall all such faulty devices.
DHR for Investigative Purposes
With a well-documented Device History Record, you will know the precise quantities of each medical device manufactured and distributed by your company.
For example, several programmable pacemakers have gone missing from one of your plants. A Device History Record will help you provide precise information to the investigative authorities about the exact numbers missing.
Electronic Device History Record (eDHR) Management
A Device History Record is a living document. Living documents (evergreen documents/dynamic documents) are continually edited and updated. Similarly, a DHR must be revised with every new batch, lot, or unit of a given medical device.
If you are continuing to use traditional manual-based documentation systems or even a hybrid system, you are more than likely to face a few challenges. You may not get the correct information from each manufacturing plant about the exact number of different devices that have been produced. Important documents may get lost, deleted, or stolen. You may find it exceedingly difficult to manually link Device History Records to other documents. Lastly, producing paper records during an inspection is not acceptable.
You can easily bypass or eliminate the above-mentioned challenges when the company invests in a medical device eQMS software solution, like SimplerQMS, that has robust inbuilt document controls.
The SimplerQMS software solution ensures that only authorized personnel have access to approved documents. Such access rights are controllable by role, site, project, and department. The automated workflows in the software solution make certain that only authorized personnel are notified on being assigned tasks such as document review and approval. Another key benefit is that you are assured of compliance with all the relevant standards and regulations applicable to medical device companies.
With SimplerQMS you will be able to seamlessly integrate electronic Device History Records with other related digital quality sub-systems including CAPA, nonconformance, audit, complaint management systems, and many others. This will advance efficiency and compliance with international standards and regulations across the entire organization.
Device History Records include all the information pertaining to the manufacture and distribution of every medical device that your company markets.
Traditional manual-based or hybrid documentation and record management systems can impose challenges on the company. To avoid/eliminate these problems, you can invest in an efficient software solution such as quality management software by SimplerQMS.
Book a demo today and talk to a SimplerQMS system expert if you are keen on streamlining your Device History Record management processes while assuring compliance with the applicable regulatory requirements.