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FDA Launches Medical Device Tracking System

May 6, 2015

Nearly three years ago, Congress called for medical devices to be marked and tracked with unique identifiers and data on the tracked devices is now being made available to the public.

Recently, the Food and Drug Administration (FDA) launched the online Global Unique Device Identification Database, AccessGUDID, where the public can look up device information submitted by manufacturers, Modern Healthcare reports. The goal of UDI is to provide a better means for consumers, health care providers and product manufacturers to identify and report adverse events associated with a device and more quickly manage a recall when warranted. The FDA estimates about 50,000 serious adverse events related to medical devices are reported each year. Such adverse events result in about 3,000 deaths annually.

The identification system was established under a provision of the 2012 Food and Drug Administration Safety and Innovation Act. The FDA issued its final rule in 2013, providing for an implementation in phases, beginning with requiring manufacturers of Class 3 devices such as implanted pacemakers and heart valves to include a unique device identification (UDI) on their products. By 2020, all medical devices will be required to have one. Under FDA definitions, Class III is the most stringent regulatory category for devices. Class III devices are usually those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”

But the system's implementation has come under criticism by some, including the Centers for Medicare and Medicaid Services (CMS), which says including device identifiers in payment claims would be costly for providers who already face heavy administrative challenges associated with adopting electronic health records systems, according to Modern Healthcare. The FDA counters that including UDIs in claims would provide a much more comprehensive means of tracking devices and address the problem of sharing data across various systems. In 2012 and 2013 the FDA undertook an 18-month demonstration project with the Mercy Health Care System to identify the challenges and opportunities of implementing UDI in a large hospital system.

The FDA says that, when fully implemented, the UDI system will offer a range of benefits to the device industry, the FDA, consumers, health care providers and health care systems by:

  • Allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
  • Reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device.
  • Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries.
  • Providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
  • Leading to the development of a medical device identification system that is recognized around the world.

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