6 Core Capabilities Your Digital DHR Must Have

Understanding the Essential Elements of Electronic Device History Record Software

In medical technology manufacturing, organizations must maintain complete and accurate device history records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the agency has made it clear. If the DHR doesn’t include complete information relating to the production and control of each lot or batch, the medtech manufacturer risks product quality issues or worse. Between 2017-2021, DHRs were among the top medical device warning letters issued by the FDA.

When using a paper-based or partially digitized system to record all of the required information – dates of manufacture, quantities manufactured and released for distribution, acceptance records, labels, unique device identifiers (UDIs), and more – maintaining complete and orderly records per FDA 21 CFR Part 820 requirements can be an inefficient process.

Many medtech manufacturers think they have an electronic DHR (eDHR) system, but often it is incomplete because it isn’t end-to-end. While an incomplete eDHR system can provide some value, it won’t be complete in the context of the electronic record. An incomplete eDHR system offers insufficient visibility, traceability, and data integrity, often resulting in product quality issues, recalls, warning letters, even consent decrees.