Sparta Systems Releases Software Solution for UDI Compliance

The clock is ticking.

Last week’s issuance of Unique Device Identification (UDI) system rules by the U.S. Food and Drug Administration (FDA) activates a staggered yet strict conformity timeline for medtech firms based on risk. The FDA is phasing in the UDI system over a five-year period, focusing first on devices that carry the greatest risk to patients such as pacemakers, defibril-lators, heart pumps and artificial joints. Many low-risk products like bandages, examination gloves and select handheld instruments are exempt from some or all of the requirements.

The UDI codes—designed to help regulators better track products, monitor their safety and expedite recalls—will become part of a database (aptly named the Global Unique Device Identification Database) the FDA will maintain as a publicly searchable reference catalog. The code itself is simply a unique number assigned by the manufacturer to the particular version or model of a device; the identifying character also will include production-specific information such as product lot or batch number, expiration date and manufacturing date.

Companies are obliged to integrate the UDI into existing information systems, test barcode printing software and train employees. They also must redesign device labels to incorporate a barcode and install necessary equipment to print and verify the UDI on labelers.

“Implementation of a UDI system will be a costly and challenging endeavor, affecting all medical technology manufacturers,” Janet Trunzo, a senior executive with the Advanced Medical Technology Association (AdvaMed), said after the FDA issued its final UDI guidance on Sept. 20. “It is imperative that it is implemented correctly the first time.”

To help minimize implementation errors, Sparta Systems Inc. released UDI compliance software on Sept. 23 that provides a system of “checks and balances” to medtech manufac-turers creating UDI codes. The company’s TrackWise UDI eSubmission Manager packages and transmits product registration statistics to the GUDID database, which in turn, sends back an acknowledgement (or receipt) that can be used as proof of initial UDI registration. Product changes recorded through the TrackWise Change Control Process is handled the same way, thereby maintaining the history of UDI updates as required by the FDA.

“It’s all about the workflow process,” Industry Solutions Director Mohan Ponnudurai told Medical Product Outsourcing after the first day of sessions at AdvaMed 2013: The Medtech Conference in Washington, D.C. “It [UDI eSubmission Manager] puts in a system of checks and balances as companies go through the process of entering data for the submission of their UDIs. And since TrackWise is part of our quality management platform, the UDI soft-ware will determine whether a company needs to resubmit a UDI code when there are changes to a product.”

Sparta’s release of its UDI eSubmission Manager is the Hamilton, N.J.-based company’s fifth supported electronic reporting standard. TrackWise is a Web-based software application used by quality, manufacturing and regulatory affairs professionals to manage quality and compliance issues.