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4 Common Pains in Managing Device History Records for Medical Device Manufacturing

In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). For those manufacturers using a paper-based or partially electronic system, maintaining complete and orderly DHRs according to U.S. Food and Drug Administration (FDA) 21 CFR Part 820 requirements is an inefficient process with inaccurate or missing information, poor data tracking, and other unnecessary risks.

A new white paper identifies some of the common pains that manufacturers face in their DHR processes, and it explores key ways an electronic DHR system can help to resolve these pains.

Everyday DHR Pains and How to Resolve Them

Common challenges among medical device manufacturing companies that have not automated their DHR systems include the following.

Pain #1: Inefficient DHR Processes

DHR processes conducted manually are inherently slow, cumbersome, and prone to errors. Yet most manufacturers still manage their DHRs via manual processes, meaning every step of the DHR process is conducted by a person and on paper. Examples of this pain point include:

  • Wrong information on DHR documentation – Inaccurate or missing information often occurs with DHR documentation, due largely to scribal errors, and manifests as missing values or erroneous values on forms.
  • Poor preventive maintenance – Preventive maintenance challenges can include difficulties in updating maintenance standards, slow tracking of completed maintenance actions, and downtime while documenting maintenance actions.
  • Slow, inaccurate product recalls – With a manual, paper-based system, a product recall is likely to involve long review times for physical documents and/or difficulty parsing offline data accurately and completely, thus prolonging the recall.

What can manufacturers do to resolve inefficient DHR processes? Leveraging DHR automation can relieve some of the common problems associated with inefficient DHR processes in multiple ways, including: real-time DHR form validation; faster equipment maintenance processes that reflect best practices; and faster, more accurate product recalls should they be needed.

Pain #2: Insufficient Tracking Capabilities

Manufacturers that rely on manual, paper-based DHR systems limit their ability to track manufacturing changes, identify quality events, and take corrective actions in real time. Insufficient tracking limits the potential value of this data and practically ensures the occurrence of bottlenecks, a critical problem if defective batches need to be identified:

  • Slow deviation tracking – A manufacturer using a manual DHR process will often face problems before, during and after a deviation, including slow detection of a necessary deviation, higher occurrence of in-process deviations, and a lack of deviation control.
  • Limited awareness of quality events and delayed corrective actions – Device specifications and data input throughout production can be helpful for diagnosing or anticipating quality problems. Yet poor access to such data means limited awareness of quality events, leading to delayed corrective actions.

An eDHR system with real-time nonconformance- and deviation-tracking tools can give manufacturers greater access to production data to make more informed decisions about deviations. It will enable manufacturers to improve their ability to report quality events, initiate corrective actions, access production data quickly, and achieve right first time (RFT).

Pain #3: Disconnected Systems

Manufacturers continue to rely on multiple systems to monitor, collect and aggregate data across business operations, from enterprise resource planning (ERP) to learning management systems (LMS). Poor synchronization across the company’s systems can seriously limit the throughput between manufacturing and other critical business areas. If a manufacturer’s relevant systems are unable to communicate with one another, common DHR problems arise:

  • Training records that don’t match record documentation – In a disconnected system, workers’ training records often don’t match device record documentation. This is often due to manual, paper-based records making it difficult to confirm up-to-date training and discouraging a proactive approach to training.
  • Poor collaboration between users and departments – A disconnected, manual DHR system often interferes with physical operations and generally discourages collaboration between team members and stakeholders in different departments – including between quality and manufacturing teams – or locations.

Robust eDHR tools can enable connections between systems, interfaces and people in some key ways: maintaining compliance in personnel training by verifying training requirements and proactively scheduling training; and facilitating productive connections between people throughout the entire company.

Pain #4: Poor Life Cycle Tracking

The life cycle of a medical device is long, and a product’s DHR may be needed long after customer use. Postmarket problems can arise, and without detailed production information on hand, both time and money are often wasted looking for a resolution. Details are critical in manufacturing, yet maintaining those details can be a challenge in numerous ways, including:

  • Postmarket needs can change without warning – A medical device’s life cycle may include product recalls, maintenance and onsite services, and for each part of this life cycle is an appropriate resolution. Finding that resolution can be time-consuming and costly if it requires searching for a lost physical report.
  • Paper reports limit awareness – DHRs allow for a constant intake of information throughout the product life cycle. When updates to product stats or specs must be made known to relevant parties, paper reports complicate a manufacturer’s ability to inform large groups of stakeholders quickly and accurately.

An eDHR software system can help manufacturers track all entered information accurately and ensure availability to all involved stakeholders throughout the entire product lifecycle. Especially for medical device manufacturers, maintaining accurate and accessible DHRs can be a lifesaver. 


David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a content marketing specialist at MasterControl, he previously served as editor of Thomas Publishing’s Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.

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