The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.
Medical tech industry stakeholders are showing mixed reactions to the FDA’s latest proposal for a system of unique device identifiers that can monitor medical devices for tracking and public health purposes.
Group purchasing organization Novation applauded the FDA’s effort, calling it a "significant milestone for patient safety," but representatives at industry lobby AdvaMed are taking a wary approach.
"We are reviewing the details of the proposed UDI rule and, after consultation with our members, will be submitting detailed comments," AdvaMed spokeswoman Wanda Moebius told reporters.
The proposed UDI rule, which the federal watchdog agency released earlier this week, requires most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
"The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," according to the proposal.
Novation officials lauded the proposal as a measure that could prove a boon for patient safety and potentially streamline healthcare and reduce costs. The program itself will cost the industry a total of $550 million to implement, according to FDA estimates.
"A robust UDI system will significantly enhance product identification, improve the device recall process, and ensure the integrity of the product throughout the transportation process, and most importantly, advance and improve patient safety," Novation information and data services senior vice president Dan Sweeney said in prepared remarks. "A UDI system also has the potential to generate significant savings for the health care industry through improved efficiencies and automated processes. Given the dramatic changes in finances and urgent patient safety needs, health care organizations and patients will benefit most from a swift implementation of a UDI system."
Novation provides holds purchasing contracts with more than 600 suppliers and provides services to more than 65,000 healthcare providers. The group mediated sales of more than $40 billion last year.
AdvaMed, on the other hand, plans to take a closer look at the rule to ensure that it "follows a risk-based and least-burdensome approach" to implementation, senior executive VP of technology & regulatory affairs Jane Trunzo told Politico.
"It is important to understand that any benefit from a UDI system depends on device users consistently and effectively utilizing the UDI system for recalls tracking, adverse event reporting and within electronic health records," she added.
Consumer advocates also weighed in on the program, praising the measure but lamenting the lengthy lead-up to actual implementation. Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.
"These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices," public advocate Consumers Union’s senior policy analyst Lisa Swirsky said in prepared remarks. "Effective post-market surveillance of medical devices depends on having UDI in place. Once it is fully implemented, this system will enhance the FDA’s ability to identify problem medical devices more quickly and inform patients when their safety is at risk."
Consumers Union plans to review the FDA’s proposal and issue comments later this year.
The federal watchdog agency will grant a 120-day comment period to gather suggestions on the UDI proposal and must then issue a final rule within 6 months, meaning the FDA has until April 2013 to define the program.
Implantable medical devices must begin carrying UDI labels within 1 year, according to the proposal, although the FDA’s user fee law, which breezed through Congress and is now awaiting a final sign-off from President Barack Obama, provided 2 years for initial launch.
