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The Critical Role of eDHRs in Medical Device Manufacturing

By: Ben Baldwin

2 décembre 2021

The Critical Role of eDHRs in Medical Device Manufacturing

When it comes to verifying the quality of medical devices and diagnostics (MD&D), eDHRs (Electronic Device History Record) and work instruction software are crucial tools. They enable manufacturers to gain complete visibility into how every single product was made. This provides incredible advancements in error-proofing and maintaining superior quality.

In today’s market, medical device manufacturers need to rely on several tools to comply with industry and government standards. This causes manufacturers to have to jump through many hoops. And though this is extremely necessary, it is nonetheless a time-consuming and costly process.

But it doesn’t need to be.

Imagine the potential of assembling medical devices and having a complete process history recorded for you. This is the power of eDHRs within work instruction software. Powerful data and history are automatically captured with little human involvement. Essentially, the eDHR is working to capture every single action and measure taken during production. This information can be pulled up at any time to verify product quality during production and post-production.

Let’s explore the potential of this technology. We'll see why eDHRs are critical to medical device manufacturing and other high regulatory work.

Some Useful Terms: DHR, DMR & DHF

  • The DHF (Design History File) documents how an OEM (Original Equipment Manufacturer) came to the final design and device specifications. The DHF is the history of how the DMR was created.
  • The DMR (Device Master Record) documents what factors need to take place to build the device according to specifications. This includes materials, equipment, environmental requirements, and workforce qualifications. The purpose and focus of a DMR is to provide manufacturers with the necessary materials and methods to build, maintain, and package the device.
  • The DHR (Device History Record) is the documentation of the complete production process as it is performed. This includes the dates of production, the quantity produced, the methods used, the employees that worked on the units, the labels of the final product, and much more.

The Need for Exact Compliance

Medical device manufacturing is a highly regulated business. In the United States, manufacturers are obliged by law to perform post-market surveillance on permanently implanted devices if harm or death could result from device failure. The FDA also has the power to impose device recalls if sufficient quality concerns are found.

So the need for a reliable device history and standardized methods is crucial when manufacturing MD&D. And implementing ways to improve quality and track the unique history of every single device are incredible strides in achieving superior and safe products for the public.

With an intelligent system that tracks and records detailed device history records, our work instruction software is here to help manufacturers seize the greatest level of visibility and control.

What is an eDHR?

Traditionally, manufacturers have used paper to capture DHRs. In the case of an investigation or audit, OEMs (Original Equipment Manufacturer) would retrieve the DHR and present it to the auditor. The documents would then be compared with the DMR (Device Master Record) to verify that the correct procedures were followed.

So what is an eDHR and specifically, what does the “e” stand for?

The “e” in eDHR stands for electronic, which enables it to do everything that a DHR could do with a whole bunch of advanced capabilities. As a medical device is being assembled, our work instruction software is digitally capturing the device history records of every product. This is done autonomously or through operator input.

dhr tracking list

This includes:

  • Lot numbers
  • Barcodes with UPC (Universal Product Code)
  • Manufacturing dates
  • Quantity numbers
  • Distribution methods
  • Workforce tracking (who worked on what)
  • DMR (Device Master Record) compliance records
  • Labeling for each unit

The modern eDHR is a paperless electronic record that enables manufacturers to track each of these factors in real-time. After the production of a medical device, the data and information are easily retrievable.

2 Reasons Why eDHRs Need to be Electronic

Compared to its older brother, the DHR, the eDHR is a much more advanced data collection practice. The reason DHRs should be electronic can be summed up into two major factors.

1. Paper is not a best practice

In its most basic ability, paper will keep an adequate device history record. But the problem is accessing the information quickly and reliably. Paper is hard to find, hard to store, easy to lose, and easy to mess up.

But what happens when we give this practice a technological boost and move towards a paperless solution?

Electronic device history records provide manufacturers with a faster and more reliable method with none of the hang-ups. When recording data digitally, retrieving the right data quickly is easy. Simply search for the device number, lot number, fabrication date, or any other factor to quickly find the right information.

This ability to quickly retrieve data is invaluable when quality and public health are on the line.

2. Digital systems interact with other digital systems

Work instruction software and eDHRs operate alongside other systems like an MES (Manufacturing Execution System) or an ERP (Enterprise Resource Planning). As eDHRs are recorded, other systems are using this information to gain powerful knowledge.

Conversely, data from an MES or ERP supplies the eDHR with more valuable information that workers may not have access to. Instead of operators finding the information and entering it manually, digital systems open up the doorway for a fast, autonomous, and reliable data acquisition. This helps to further optimize your shop floor, achieve the best quality results, and obtain the most quality data available to your operation.

Using paper records does not measure up to the needs of the modern manufacturer. And the ability to connect your eDHRs with other systems is an incredible capability. These two factors prove that within today’s competitive market, DHRs need to be electronic.

How do eDHRs Work?

Within medical device manufacturing, every item has a series of identification numbers. The whole practice of eDHRs hinges on the application of these unique identifiers.

incremental approach

Since 2007, the FDA requires manufacturers to use a unique device identification (UDI) system for medical devices. From lot numbers, barcodes, and final labeling, every component needs to be tracked and properly identified. Each of these is a way for your system and eDHRs to track the specific components and actions of every product and material. These identifiers enable tools like our systems to associate data with specific products. This enables manufacturers to gain viability into the unique history of every item.

Let’s take a look at how eDHRs work in conjunction with work instruction software. We’ll see how tracking these numbers and recording key data enables you to drive superior quality methods.

Visibility in Real-Time

From large production steps to the small unique details of every item, eDHRs track every part of the production process. This enables manufacturers to gain a new level of precision and knowledge as they look at the device history records of their product. Within the medical industry, DHRs have been used primarily to verify quality in post-production.

visibility in real-time

But as we have stated, the eDHR goes much further, bringing new and innovative possibilities to your operation. If capturing eDHRs through our work instruction software, you gain visibility into the device history as it is happening in real-time. This opens up new levels of verification, compliance tracking, and error-proofing.

Identification of Errors

Using a standardized best method will help reduce errors within any production process. And live capturing eDHRs is a further step in this direction. With a detailed history on every single item and product, any error found during or post-production is easily identified and removed.

Imagine that you are a medical device manufacturer and are fabricating a new line of ventilators. During the production of the ventilators, there was a problem with the paint booth. Not a serious problem but sadly, the color on the plastic covering is just not the right shade of egg-shell. Adding to this, the protective acrylic sealer was not added to the paint mix.

As the error is found, you and your team pinpoint that the paint booth malfunctioned from 11:00 to 11:30. With a complete history of all the components for the ventilator, you pull the specific pieces that were affected by the malfunction and correct the issue.

But what happens if the product is finished and already being used by the customer?

Your eDHRs and work instructions software go a long way to preventing errors from ever leaving the shop floor. But in the case of any unknown factors, the records are there to quickly identify which units have been affected. This enables specific units to be easily tracked down and recalled.

Let’s imagine that for your medical devices, you sourced some plastic from your normal supplier. You’ve worked with them for years and there have never been any issues. But they just contacted you to say that a previous shipment of plastic shielding was tainted with a foreign substance.

In this case, your team pulls up the data and quickly identifies which unit numbers were affected and where they are. Per FDA regulations, the medical devices are recalled in record time and your company has protected the public from a potentially defective piece of equipment.

Digital Optimization

The use of eDHRs is not only beneficial for device history but also serves to digitally optimize your production floor. Work instruction software and eDHRs enable modern manufacturers to streamline their processes by cutting out non-value-added activities. This is accomplished through 3 key methods.

  • Cut out paperwork: Storing, filing, and organizing paper records is a full-time job. But with eDHRs and our work instruction software, companies are alleviating the burden of physical reports. Managing digital reports takes very little time and even less space.
  • Streamline the review process: eDHRs provide an easy way for OEMs to review their history records and compare them with the DMR (Device Master Record). This allows manufacturers to decrease the cycle time of a product and fulfill their customer orders faster.
  • Reduce the need for buffer inventories: MD&D manufacturing is a lengthy process with inherent latency due to the length of the review period. Traditionally, to alleviate longer lead times, OEMs have introduced buffer inventories. But since eDHRs speed up the review process, manufacturers reduce their need for a non-value-added inventory. The operation is free to pursue a stronger pull manufacturing system.

Use eDHRs for More Than Medical Devices

precision manufacturing

As we have seen, eDHRs play a critical role in medical device manufacturing. They help manufacturers adhere to the strict guidelines and quality standards of the industry. But Medical Devices and Diagnostics (MD&D) are not the only items that need this type of scrutiny. They are not the only ones that need to make regulatory compliance an integral part of their production method.

From aerospace engineering to military contracts and from highly regulated food and beverage to the automotive industry, eDHRs and work instruction software provide every manufacturer with unparalleled visibility and control. With real-time monitoring and in-depth history records, quality is always at the forefront of innovation.

Check out our Medical Industry page to see how VKS is helping medical manufacturers achieve new levels of precision and compliance within the industry.

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