The Food and Drug Administration (FDA) has issued a new rule requiring that most medical devices distributed in the United States carry a unique code. The code, also known as a unique device identifier (UDI), will include information about each specific device, including: model number, lot or batch number, serial number, the date the device was manufactured, and, if applicable, an expiration date.
These codes will be stored in a database accessible to the public, but it will not include personal information about patients. The Global Unique Device Identification Database (GUDID), will enable doctors, companies and regulators monitor safety concerns more efficiently.
According to the FDA website, the UDI system will have many benefits when the system is fully implemented – in 7 years. The Associated Press reports:
The FDA will begin phasing in the new system in the coming year, starting with high-risk devices like heart stents and defibrillators. The requirement will then be expanded to moderate-risk devices such as X-ray systems, surgical needles and power wheelchairs. Makers of those devices will have three years to implement the tracking codes. Many low-risk devices, such as bandages, will be exempt from the requirements.
Given the number of patients harmed by recalled medical devices, doctors and patient advocate groups are pleased with the new regulations. Patients have recently reported adverse reactions to a wide range of devices, including hip replacement systems, knee replacements, surgical mesh, and the Mirena Intrauterine Device.
“The rule that came out today is a victory for patients, hospitals and clinicians,” said Josh Rising, director of Pew Charitable Trusts’ medical device initiative. “Up until now medical devices were among the only products on the market that could not be uniquely identified. This is going to be a tremendous victory for all of those interested in improving the performance of devices.”
If you have been injured by a defective product, it is very important to report the incident. Call the experienced medical device attorneys of Elk & Elk for more information at 1-800-ELK-OHIO or contact us online.
“FDA requires tracking codes on medical implants” by Matthew Perrone, Associated Press/USA Today, September 20, 2013.
The final rule was published in the Federal Register today (9/24/13) and is available online at http://federalregister.gov/a/2013-23059.