New agency rule designed to help identify faulty medical devices.
The Food and Drug Administration (FDA) recently published a final rule announcing a Unique Device Identification (UDI) system aimed partly at improving faulty medical device identification. Medical devices, such as pacemakers and artificial replacements, will now require unique ID numbers identifying the make, manufacturing date, and lot number of all products.
After several years of well-publicized product recalls involving medical devices like heart defibrillators and artificial hips, one FDA official claims that the FDA’s new identification system could help “companies, health care professionals, and patients . . . report medical device adverse events more accurately.”
The FDA website notes that, as of last month, over 60 medical devices have been recalled this year. Many of these devices are designed to provide patients with respiratory support or prevent instances of heart failure in life sustaining situations.
Concerns about regulation in this area are not new. In 2007, a highly publicized recall of heart defibrillator wires led some critics to question the efficacy of the existing U.S. medical device regulatory system. The product in question was ultimately recalled because “a small number of fractures” were detected in the product’s wires. Doctors at some hospitals had noticed earlier patterns of the product’s occasional fractures resulting in patient shocks, but the product’s deficiencies were unnoticed until both the FDA and manufacturer identified broader trends and recalled the product.
More recently, the FDA recalled a medical scanning tool used in diagnosing organ functions and in evaluating instances of cancer, cardiovascular disease, and neurological disorders. Following a patient’s death from injuries incurred during a scan, the manufacturer notified hospitals of the recall and distributed a correction letter to customers. However, affected products had already been distributed for over twenty years.
FDA officials expect the new product ID system to provide a more effective means for the agency to organize and find relevant information in hospital and insurance company records when there is a product malfunction or recall. If there are future faulty heart defibrillator wires or scanning tools, the FDA can now trace product ID numbers, target potential customers, and warn patients about newly discovered flaws much earlier. This may help protect patients, whose ability to recover damages for personal injuries caused by faulty medical devices was hindered when the U.S. Supreme Court ruled that device manufacturers are immune from such suits as long as they have FDA approval. While it does not affect that decision, the new rule could help prevent patients from incurring these damages in the first place by providing a mechanism to rapidly alert them to problems with their device.
The FDA plans to “phase in” requirements over a seven-year period to help ease compliance with the new rule. It will also develop a searchable database, the Global Unique Device Identification Database (GUDID), organizing product information and the ID numbers. The agency plans to make the database–patient information omitted–available to the public.
Under the regulation, manufacturers of high-risk (“Class III”) medical devices are required to place ID numbers on product labels and device packages within a year. Manufacturers of life-sustaining devices have an extra year to provide product information and labeling. Less risky medical devices, moderate-risk (“Class II”) or low-risk (“Class I”), are granted three years and five years periods, respectively, to come into compliance. In addition, some devices may remain unclassified or exempt from the labeling requirements altogether.
The final rule adopted changes to the FDA’s proposed rule of July 2012. The final rule now allows manufacturers of Class III devices to request extensions for additional time and provides a three-year period to comply for devices already in public circulation.
The ID initiative began as a critical component of a “National Medical Device Post-Market Surveillance System” created to collect and disseminate health-related data in September 2012. The FDA developed four actions to strengthen post-market medical device surveillance in response to “several high-profile medical device performance concerns.” The new system is an effort to “meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology.”
According to FDA spokesperson, Jeffrey Shuren, the new system provides “a consistent and standard way to identify medical devices throughout their distribution and use.”
In theory, the new ID system will help improve adverse medical device reporting, allow more efficient product recalls, and reduce counterfeit devices. Although the new rule does not require that physicians include medical device IDs in patient health records, officials hope “it will also offer a clear way of documenting device use in electronic health records and clinical information systems.”
The rule will be effective on December 23, 2013.
