Medical device manufacturers operate in a highly regulated industry and, as a result, are required to ensure products meet relevant industry standards to ensure safety and quality for the end consumer.

Federal agencies and other regulatory authorities are responsible for closely monitoring manufacturers across life sciences industries. As such, businesses must keep up-to-date documentation detailing a variety of specifications pertaining to their products, as well as the processes involved in production.

Historically, medical manufacturers have relied on device history records (DHR) to ensure a comprehensive record was kept for products coming off their line. These records also ensure that manufacturers make products that adhere to the specifications and standards set in the device master record.

However, traditional, paper-based device history records present several opportunities for errors, making compliance more complicated and time-consuming than it needs to be.

With the technologies available to today's medical manufacturers, more and more businesses are digitizing these compliance efforts with electronic device history records, or eDHR.

Scroll on to find out more about device history records as a whole and how eDHRs help streamline this burdensome compliance activity.

What is a device history record?

For medical device manufacturers to bring products to market in the United States, they need approval from the Food and Drug Administration (FDA). One of the key elements to receiving and maintaining FDA approval is to keep a detailed and comprehensive device history record (DHR).

A device history record is a collection of a variety of product-centric characteristics and components that show that a given medical device was manufactured to emulate the specifications in the device master record. The FDA enforces this through CFR 820.184, enabling manufacturers in this field to comply with industry-standard regulations.

A typical device history record is made up of:

  • Dates when the given device was manufactured

  • The number of medical items produced

  • The number of finished products sent out to clients

  • Test and acceptance records that prove that the medical device adhere to specifications in the device master record

  • Unique identification labels used for each item in a given batch

With these in place, medical device manufacturers have a better handle on managing quality in the production process. Additionally, manufacturers should ensure that they keep the DHR updated. After all, they regularly upgrade their products to offer more value and distinguish their brands from the competition.

The role of device history records in quality management

While documentation is necessary for proving compliance in life sciences industries, device history records also play a significant role in a medical device manufacturer’s quality management efforts. Some of the key benefits of DHRs include:

More manageable corrective and preventive action: DHRs allow manufacturers to accurately identify product batches or specific items that fall short of the quality requirements.

As such, medical device manufacturers can examine that batch to determine the root cause of the nonconformance or product failure. The manufacturer can then implement preventive actions, preventing the problem from reoccurring.

A tool for continuous process improvement: As described earlier, DHRs allow manufacturers to identify the source of quality issues and implement corrective and preventive actions to address the root cause.

Further analysis shows the origin of faults in the production process. Manufacturers can then use this ongoing documentation to improve processes, ensuring less non-conforming products roll off the production line in the future.

A better handle on liability management: The accurate traceability afforded by a DHR enables manufacturers to limit their liability in the market. They can quickly identify and recall entire batches of faulty medical devices before being distributed any wider.

This prevents more people from falling victim to these defective products. Additionally, timely intervention can mitigate the negative business impacts stemming from the production and distribution of faulty medical devices.

Using electronic device history records for compliance

An electronic device history record goes further than traditional DHR in a modern medical device manufacturing setting. Smart factories have plenty of data originating from the machines on the floor, making manufacturing execution more complex.

Such advanced manufacturing systems require an equally refined and robust device history record system. As such, using paper-based device history records can’t cut it due to the real-time management involved.

Using electronic device history records provides a number of benefits for manufacturers in this field including:

  • Reduced errors due to human input, resulting in increased information integrity in the device history record.

  • Improved production process visibility due to real-time data logging by electronic device history record tools.

  • Ability to accurately and diligently capture device history data improves traceability, enabling manufacturers to handle quality events swiftly.

  • Electronic device history records mesh well with related digital solutions like enterprise resource planning (ERP) and distribution management systems (DMS) to foster complete adherence to standards and regulations.

  • eDHRs provide instant and automatic alerts, bringing attention to possible quality events on the production line, enabling timely intervention and containment.

All this boils down to error-proof production processes in a modern medical device manufacturing environment. Consequently, manufacturers significantly reduce overhead while improving consistent production quality and capacity.

Digitize your device history records with Tulip

Learn how leading medical device manufacturers are using Tulip to capture real-time data, track production, and streamline compliance efforts.

Day in the life CTA illustration