How to Simplify Tracking of Patients with Implanted Medical Devices and Improve FDA Compliance

Publisher's Spotlight: Introducing the Scantron TRaC II Digital Solution

No one knows better than device manufacturers just how difficult it can be to keep track of patients with implantable medical devices, much less reach them and their doctors in event of a recall. And yet that is exactly what the FDA’s medical device tracking guidelines require. They specify that manufacturers of certain devices establish and maintain a written standard operating procedure related to tracking devices, quality control, and audit procedures.

And when an FDA recall does occur, device manufacturers have just a few days to notify patients and doctors. The resulting frenzy can cost the unprepared business millions and may yield large FDA fines. Add the likelihood of bad press or the threat of lawsuits and compliance, executives face significant challenges.

To improve its FDA tracking compliance, one of the largest medical device manufacturers turned to Scantron, a leading provider of data collection tools and services to develop a custom medical device and patient tracking solution. Scantron leveraged its 40-years of experience of data collection for kindergarten through higher education to develop a new tool and service to meet the specific challenges of the implantable medical device market.

Since then, Scantron has perfected tracking patients with implanted medical devices. In fact, Scantron now has more than 10 years of successful experience tracking patients and devices. Their robust application links multiple data sources allowing the highest levels of validation, access and reporting. Scantron’s operations team uses procedures and processes that have been proven over time and result in less than a 1% lost-to-follow-up ratio. They support over 100,000 transactions per month and over 20 million patients, devices, physicians, facilities, data records and images tracked on an on-going basis.

Scantron has now developed and launched a commercially available version called Scantron TRaC II Digital Solution. The Scantron TRaC II Digital Solution has been designed to meet the needs of class II and class III medical device manufacturers that need to comply with the requirements for medical device tracking in compliance with 21 CFR Part 821.

Scantron provides all the systems, processes and expertise in a single scalable solution that can meet the needs of any device manufacturer. Scantron offers a full-service solution, where they directly receive registration documents, handle all follow-up, have a dedicated investigative team and call center, and can quickly respond to changing FDA requirements. Scantron also offers à la carte outsourcing options, including document scanning and indexing, data collection and validation, data management and reporting.

With a less than 1 percent lost to follow-up ratio, Scantron can ensure any manufacturer quickly and accurately responds to FDA queries and maintains accurate patient and physician data over the life of any medical device.

To learn more about: how outsourced solutions can improve FDA compliance; the current medical device regulatory trends; the challenges facing manufacturers of implantable devices; medical device tracking; the advantages of outsourcing and a recall scenario, download the free 8-page white-paper or visit Scantron online.

To request additional information contact Brian Hammill at [email protected] or 651-683-6024 or Dan Sharkey at [email protected] or 952-492-6302.