This last year, medical device recalls hit a four-year high, exceeding 1,000 events and affecting over 440 million units.
These recalls create urgent compliance challenges and potential patient safety issues. In a recall event, every minute matters, particularly in emergency and surgical departments. But traditional recall workflows that rely on email, printed lists and manual audits create a lag between when an alert hits and when clinicians act. By the time hospital staff detect a cardiac monitor malfunction and manually cross-reference lot numbers against emailed PDF lists, hours may have passed, and the faulty device could have been used a dozen more times in that window.
Manufacturers determine how recall information reaches the bedside long before a device ever enters a hospital. To enhance efficiency, medical device companies need to be able to instantly flag all affected devices the moment a safety risk is triggered — no emails, no PDF lists and no manual research required. That technology exists, and it fits in the palm of your hand.
By encoding recall status into the device itself using a GS1 Digital Link and an intelligent QR code architecture, manufacturers can enable faster responses, better patient safety outcomes and greater operational efficiency.
Overcoming Label Clutter in a Complicated Compliance Landscape
Implementing QR codes eliminates manual workflows and the potential for errors, but they also introduce potential safety issues. In fact, nearly one in four companies face security issues when implementing QR codes, underscoring the need for safe, compliant solutions.
In the medical device space, the combination of the FDA’s and EU’s rules for labeling devices further complicates compliance:
- In the U.S., the FDA’s Unique Device Identification (UDI) system requires that every medical device include a Human Readable Interpretation (HRI), an alphanumeric string of text, and an Automatic Identification and Data Capture (AIDC) barcode for traceability. A standard QR code can’t contain this required data structure.
- In the EU, electronic Instructions for Use (eIFU) standards allow manufacturers to place a QR code on device labels to link directly to device manuals. With eIFUs, manufacturers can remove extensive paper booklets that previously added bulk to packaging. However, this requirement adds another digital link to device packaging.
For a device label to meet both the FDA’s traceability requirements and the EU’s digital information requirements, it needs a high-density DataMatrix for the UDI and a QR code for the instructions, contributing to label clutter and introducing real clinical risk.
Here’s how. An ER nurse attempts to scan a GS1 DataMatrix on a product, but instead captures the QR code. This scan opens the device manual — not what she needed. And she doesn’t have time to troubleshoot. Instead, she manually enters the serial number and bypasses the recall check entirely. What’s meant to be an easy and safe workflow can compromise patient safety if the product is flagged.
Devices need a labeling alternative that allows organizations to balance regulatory compliance with efficiency. GS1 Digital Links within an intelligent QR architecture offer that solution.
How a GS1 Digital Link and an Intelligent QR Architecture Transform Recall Operations
By embedding GS1 Digital Links within an enterprise-grade QR code architecture, medical device manufacturers can improve operational efficiency while maintaining critical compliance requirements at scale.
How GS1 Digital Links Work:
A GS1 Digital Link collapses all regulated product identifiers — Global Trade Item Number (GTIN), serial number, lot number and expiration date — into a single code. That code serves as a reference point for traceability, clinical information and recall status across the device’s entire history.
Unlike traditional barcodes that encode static data, GS1 Digital Links connect to live, manufacturer-controlled information. As a result, the same scan used to log a device into inventory can also surface safety alerts, recall status, instructions for use and required regulatory documentation for clinicians, auditors and regulators.
However, to implement GS1 Digital Links at an enterprise level, organizations need an intelligent QR Code platform that supports compliance, content governance, uptime assurance and control. Here’s how it brings those requirements together:
- Compliance: A secure QR platform helps ensure HIPAA and SOC 2 Type 2 compliance when QR workflows involve patient interaction, using encrypted access and auditable controls to prevent tampering with data.
- Content Governance: An intelligent QR platform enables manufacturers to update a QR code’s destination in real time, without reprinting packaging. With this feature, recall workflows can include a dynamic kill switch, so as soon as a device is recalled, the next scan of a GS1 link can immediately display a clear “STOP – RECALLED” alert with quarantine instructions. This kill switch eliminates lag in recall workflows and ensures frontline staff receive instant verification at the point of scan, so they don’t use a recalled device on a patient.
An intelligent QR platform also allows manufacturers to manage different version histories. For example, a device manufactured in 2023 will still link to the 2023 version of the manual, even if the current manual has changed.
- Uptime Assurance: Recalls require immediate communication to thousands of users, so a QR infrastructure must be able to handle surges in information. Many enterprise QR platforms maintain 99.99% uptime, so recall status is always accessible when patient safety is at stake.
- Control: Role-based permissions and approval workflows within a QR platform ensure that only authorized personnel can issue or modify recall alerts, reducing the risk of false or disruptive actions.
The benefits of an enterprise QR code system are clear, but implementation in regulated environments presents unique challenges. This checklist outlines key steps medical device manufacturers must take when adding GS1 Digital Links and QR codes to device labels.
Implementation Checklist: How to Safely Add QR Codes to Regulated Environments
Step 1: Audit SKUs for label clutter and cost-saving opportunities
Before implementing GS1 links or redesigning labels, manufacturers should audit the packaging of existing Stock Keeping Units (SKUs) to identify label clutter and potential cost-saving opportunities.
They should then identify which SKUs, particularly those eligible for eIFUs, can move to a paperless workflow. For those devices, GS1 Digital Links and QR codes can reduce package weight and reclaim label space.
Step 2: Build codes that survive hospital environments
In hospital environments, QR codes on medical device packaging are exposed to blood, saline, and disinfectants, which can make them difficult or impossible to scan. To ensure they’re usable even with potential damage, manufacturers should use high-error-correction codes.
Unlike standard retail QR codes, which typically use low or medium error correction (allowing only 7-15% data recovery when damaged), manufacturers need to use a high correction setting. Even a minor obstruction, such as a single blood smear, can make codes with lower error correction unreadable. Codes also need to be rigorously tested for reliability to ensure they continue to scan in an operating room setting after exposure to cleaning agents and hospital-grade sterilization.
Step 3: Assess QR platform reliability
Medical device manufacturers must ensure their QR code system is reliable enough to meet regulatory requirements and protect patient safety.
When hospital staff scan a GS1 Digital Link QR code, it opens a website URL. But if the server goes down, and a “404 Not Found” error pops up, the product gets effectively “misbranded,” triggering regulatory action. More importantly, it blocks access to information clinicians need to verify device status, instructions for use or recall alerts.
In time-sensitive clinical settings, these failures push staff to bypass the scan or rely on manual checks, increasing the risk that recalled or expired devices remain in use. For this reason, manufacturers must invest in QR platforms that deliver enterprise-grade uptime of 99.99% or higher to keep critical device information accessible.
Step 4: Ensure QR codes integrate with Electronic Health Record (EHR) systems
QR codes on medical devices must integrate with a hospital’s EHR system so that clinicians aren’t forced to manually enter device information. These systems typically use specialized software to automatically read QR codes and extract key information, such as a product’s GTIN and expiration date. This process ensures the data collected is accurate and ready to use.
But if manufacturers use a generic link shortener to generate a QR code, hospital scanners will reject it because it doesn’t contain the specific product codes (called GS1 Application Identifiers) that the EHR system needs.
To ensure the QR code works, manufacturers must format data exactly according to the GS1 standard. Before deploying QR codes, manufacturers should test physical QR codes and run tests with hospital partners to confirm that their scanners can read the code and automatically enter the data into the correct fields without anyone having to type in information manually.
The Impact: Supporting Better Medical Device Safety
Medical device recalls and quality issues cost the industry between $2.5 billion and $5 billion per year. When a safety alert triggers and recall workflows begin, response time matters. The difference between a six-hour and a six-minute response time could make all the difference in both patient safety and clinician liability.
Traditional recall workflows don’t meet the demands of today’s clinical environments. By adopting a GS1 Digital Link-enabled QR code strategy, manufacturers can identify and stop affected devices in minutes rather than hours, improving patient safety, reducing clinician risk, strengthening hospital operations and lowering the overall cost of recalls.
Editor’s Note: Ravi Pratap Maddimsetty is the co-founder and CTO of Uniqode, responsible for all technology strategy, product innovation and engineering execution. Ravi likes to describe himself as a compulsive technologist with roots in the Linux/open-source world. Before founding Uniqode, Ravi spent four years at Washington D.C.-based technology startup Hillcrest Labs as a manager in its software products group. Prior to Hillcrest, Ravi was with Morgan Stanley in New York as an associate in its technology group. Ravi holds a master’s degree in computer science from Washington University in St. Louis and a bachelor’s degree in chemical engineering from the Indian Institute of Technology (IIT) Madras.