Challenge
Astute Medical manufactures biomarkers that are used to identify high-risk, acute medical conditions in critically ill patients. The Federal Drug Administration (FDA) issued a mandate that medical devices must carry a Unique Device Identifier (UDI), which requires a greater volume of information than had been previously required.
Astute Medical sought a compliance labeling solution that would meet UDI requirements in accordance with GS1 Standards. The manufacturer also wanted to receive accurate and repeatable verification results and a solution that included a Validation Protocol to document compliance with these requirements. We needed to not only comply with federal regulations but also ensure that we were sending out our medical devices with a high-quality barcode, “to avoid returns,” explained Susan Shelton, Materials Management and Procurement Manager of Astute Medical.
Analysis
Astute Medical designs, engineers, and manufactures novel biomarkers that enable clinicians to identify acute conditions in their critically ill patients before the symptoms become evident. Products like the NephroCheck Test and Astute140 Meter fall under the guidelines of the FDA’s Unique Device Identification rule. This system was established to identify medical devices throughout their distribution and use, providing critical traceability that benefits the patient, caregiver, manufacturer, and distributor.
To comply with the UDI rule, Astute Medical needed to change its labeling process to follow GS1 standards for barcodes and provide device information in both human and machine readable formats. Astute Medical sought the help of Barcodes EDGE., a leading provider of barcoding solutions in North America for more than two decades.
The FDA’s guidelines for medical device labeling require a large volume of data:
- A device identifier (DI), which identifies the labeler and the specific version or model of the device; and
- A production identifier (PI), which identifies the lot or batch number, serial number, expiration date, and/or manufacture date.
A 1D barcode wasn’t sufficient to code the data, so a 2D barcode would be required. The next step was to analyze the barcode type and size and match it to a product model that could handle the minimum X-dimension and required a field of view for the required barcode.
Solution
To provide an appropriate solution, Asif Kamal, Account Manager for Barcodes EDGE, worked hand in hand with Webscan, a company that has earned an international reputation for delivering ease of use and unsurpassed accuracy across every barcode application. They determined that Webscan’s TruCheck Optima presented the best fit for Astute Medical’s needs. The fully integrated barcode verifier confirms that 1D and 2D barcodes meet all compliance requirements. The print quality of the barcode is verified to ISO 15415 and ISO 15416 standards, along with compliance to GS1 guidelines. The TruCheck Optima not only verifies that the barcode readability meets these guidelines with a minimum of a “C Grade,” but also checks the data content of the barcode to ensure that the data is encoded correctly with all the required formatting characters.
Data format failures, which are all too common in barcodes, are clearly spelled out by the verifier software, making it easy to take corrective action when necessary. In addition, healthcare applications require documented evidence of compliance, and the Webscan software prints and saves reports in standard PDF file format.
The TruCheck Optima verifier connects to a PC through the USB port and doesn’t require any focusing or alignment, so setup is quick and operation is foolproof.
“The best part about the TruCheck Optima is the ease of use. Our users simply had to position the imager over the barcode, press the button, and review the results,” Shelton said.
Kamal packaged the barcode verifier with Seagull Scientific Automation barcode label software,
ensuring that Astute Medical could design and print the labels to their liking.
To specifically verify UDI compliance, Barcodes EDGE added Webscan’s available Validation Protocol and GS1 Calibration Card to the Webscan TruCheck Optima. A Validation Protocol is required by FDA regulations to confirm that a process meets all of its intended requirements consistently and accurately. The Webscan Validation Protocol is a thorough set of challenges to all of the functions of the verifier, including its ability to detect errors and low barcode readability.
“Medical device manufacturers risk fines, restrictions, and even product recall if they don’t comply with the FDA’s mandate for UDI,” explained Kamal. “We had to ensure that Astute Medical’s solution worked within their manufacturing process and ensured compliance.”
Results
The barcode verification solution was easily deployed into Astute Medical’s manufacturing process.
Since purchasing the barcode verifier solution from Barcodes EDGE, Astute Medical has experienced an increase in production and decrease in resources required to verify compliance of all labeling.
“Now that we have in place a verifier and labeling solution that works, we’re able to confidently send out our medical devices without the worry of them being returned for bad labels, and we remain in UDI compliance,” Shelton says.
“We’re thankful to Barcodes EDGE, for their expertise and to Webscan for making a solution that is easy to use and saves us time and money.”
Astute Medical now has the peace of mind that every device is accurately labeled so that these biomarkers can provide caregivers the information they need to protect their critically ill patients.