07.24.12
FDA Releases Plan for Unique Device Identification System
The U.S. Food and Drug Administration (FDA) will assign medical devices unique identification numbers in an effort to improve patient safety. Most devices—such as catheters, defibrillators, heart stents and artificial joints—fall under the plan, but there are some devices that will be excluded from this program. It isn’t clear yet what kind of devices those will be.
A unique device identification (UDI) system was mandated in 2007 by Congress, but it has not yet been implemented. The FDA user fee bill that was passed in Congress in June contains language mandating the FDA implement such a system within the next two years. The UDI program may cost as much as $68.4 million per year, according to a pending rule proposal available to the public on the FDA website.
“These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices,” said Lisa Swirsky, senior policy analyst for Consumers Union, the policy and advocacy division of Consumer Reports. “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.”
Consumer Reports is a consumer and patient advocacy watchdog organization that has been critical of the medical device industry lately.
Identifiers would include bar codes and other technology, and they would help identify a range of details of the device in question such as batch number, serial number and expiration date. The FDA regulation is not specific about what kind of technology will be used, the identification technology used will be at the discretion of the device manufacturer. The UDI also would help regulators trace and track flaws, failures and incompatibilities before the risk becomes too great—and manage recalls better. On its website, the FDA says that its UDI system has the potential to lead to a global standard for medical device identification.
“Under the proposed system,” reads the published proposal, “the health care community and the public would be able to identify a device through a UDI that will appear on the label and package of a device. The UDI will provide a key to obtain critical information from a new database, the Global Unique Device Identification Database (GUDID), which will include information important to the identification of devices. UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other [Automatic Identification and Data Capture] technology.”
GUDID will not include any personal information such as who uses a device.
The FDA published the proposal in the Federal Register on July 10, and companies have 120 days from that date to submit any comments, suggestions or requested changes. Manufacturers of highest risk devices, classified as Class III, must comply with the final version of the plan within a year of its final publication. Class II devices have three years to meet requirements, while Class I manufacturers will have five years.
The U.S. Food and Drug Administration (FDA) will assign medical devices unique identification numbers in an effort to improve patient safety. Most devices—such as catheters, defibrillators, heart stents and artificial joints—fall under the plan, but there are some devices that will be excluded from this program. It isn’t clear yet what kind of devices those will be.
A unique device identification (UDI) system was mandated in 2007 by Congress, but it has not yet been implemented. The FDA user fee bill that was passed in Congress in June contains language mandating the FDA implement such a system within the next two years. The UDI program may cost as much as $68.4 million per year, according to a pending rule proposal available to the public on the FDA website.
“These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices,” said Lisa Swirsky, senior policy analyst for Consumers Union, the policy and advocacy division of Consumer Reports. “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.”
Consumer Reports is a consumer and patient advocacy watchdog organization that has been critical of the medical device industry lately.
Identifiers would include bar codes and other technology, and they would help identify a range of details of the device in question such as batch number, serial number and expiration date. The FDA regulation is not specific about what kind of technology will be used, the identification technology used will be at the discretion of the device manufacturer. The UDI also would help regulators trace and track flaws, failures and incompatibilities before the risk becomes too great—and manage recalls better. On its website, the FDA says that its UDI system has the potential to lead to a global standard for medical device identification.
“Under the proposed system,” reads the published proposal, “the health care community and the public would be able to identify a device through a UDI that will appear on the label and package of a device. The UDI will provide a key to obtain critical information from a new database, the Global Unique Device Identification Database (GUDID), which will include information important to the identification of devices. UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other [Automatic Identification and Data Capture] technology.”
GUDID will not include any personal information such as who uses a device.
The FDA published the proposal in the Federal Register on July 10, and companies have 120 days from that date to submit any comments, suggestions or requested changes. Manufacturers of highest risk devices, classified as Class III, must comply with the final version of the plan within a year of its final publication. Class II devices have three years to meet requirements, while Class I manufacturers will have five years.