FDA Final Rule for Unique Device Identification System

 

Right before the government shutdown, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

BACKGROUND

“‘UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,’ said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.

The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.

The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.

Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.”

As reported in FierceHealthIT: “A proposed rule had been issued by the FDA in July 2012, one year after the agency originally sent a UDI proposal to OMB. Updates made last fall called for implantable devices to bear an identifier as a permanent marking one, three or five years earlier than initially proposed, depending on the class of the device, and a proposed final rule was sent to OMB in June.

In July, a range of patient advocacy groups urged OMB to publish a final rule as soon as possible. In a letter to OMB Director Sylvia Mathews Burwell, 18 groups noted that owners of recalled cars have more information than patients with dangerously defective pacemakers. Those groups included Consumers Union, Public Citizen and the National Women’s Health Network.”

DETAILS OF THE RULE

I. GOALS

This final rule will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule will reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It will allow FDA, health care providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.

II. STATUTORY REQUIREMENTS

The rule fulfills a statutory requirement of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the FD Act) (21 U.S.C. 360i(f)) that directs FDA to issue regulations establishing a unique device identification system for medical devices. The rule also meets statutory requirements added by section 614 of the Food and Drug Administration Safety and Innovation Act (FDASIA), including a deadline for publication of this final rule and requirements concerning when the rule must apply to devices that are implantable, life-supporting, or life-sustaining.

Under the UDI system established by this rule, the health care community and the public will be able to identify a device through a UDI that will appear on the label and package of a device. The UDI will function as the key that can be used to obtain critical information from the GUDID about the medical product. The GUDID will include only information that is important to the identification of devices, and will not include any information that would identify a patient. UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology. If a device is intended to be used more than once, and intended to be reprocessed before each use, it must also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package.

III. IMPACT ON THE PUBLIC HEALTH

By establishing a system for the adequate identification of medical devices through distribution and use, the rule will serve several important public health objectives:

A. Reduce Medical Errors

The presence of a UDI that is linked to device information in the GUDID will facilitate rapid and accurate identification of a device, thereby removing a cause of confusion that can lead to inappropriate use of a device. Using a device’s UDI, you will be able to use the GUDID to positively identify the device and obtain important descriptive information, preventing confusion with any similar device which might lead to misuse of the device. Health care providers will no longer have to access multiple, inconsistent, and potentially incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information.

B. Simplify the Integration of Device Use Information Into Data Systems

UDIs, particularly when provided through AIDC technology, will allow rapid and accurate data acquisition, recording, and retrieval. For example, the use of UDIs in computerized physician order entry systems will help ensure that the intended device will be used in the treatment of a patient, rather than some similar device that may not fully meet the needs of the health care professional who ordered the use of the device.

C. Provide for More Rapid Identification of Medical Devices With Adverse Events

An essential prerequisite to resolving adverse events is the timely and precise identification of the particular device or devices that may have a connection with an adverse event. The inclusion of UDIs in adverse event reports would lead to greater accuracy in reporting by eliminating uncertainty concerning the identity of the device that is the subject of a report.

D. Provide for More Rapid Development of Solutions to Reported Problems

The rule requires the inclusion of UDIs in adverse event reports that are required under part 803 (21 CFR part 803). This will allow manufacturers and FDA to more rapidly review, aggregate, and analyze related reports regarding a particular device, leading to more rapid isolation and identification of the underlying problems, and development of an appropriate solution to a particular concern.

E. Provide for More Rapid, More Efficient Resolution of Device Recalls

Delays in identifying recalled devices can result in the continued use of those devices on patients and involves an increased risk for patient harm. A device labeled with a UDI can be identified rapidly and with great precision. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced or eliminated.

F. Better Focused and More Effective FDA Safety Communication

By citing UDIs, FDA will be able to more precisely focus safety alerts, public health notifications, or other communications, eliminating confusion with similar devices and allowing more rapid responsive action. Users of similar devices that are not the subject of the safety alert would be relieved of the uncertainty concerning whether they have been exposed to, or are affected by, a problem or risk.

G. Standard Format for Dates Provided on a Device Label

The rule will also better ensure dates on device labels are not confusing or misleading to users thereby ensuring the safe use of devices, by requiring that dates on medical device labels conform to a standard format consistent with international standards and international practice—year-month-day (e.g., 2013-09-30). This will ensure dates on medical device labels are unambiguous and clearly understood by device users.

H. Additional Benefits

FDA expects the UDI system will provide additional benefits. For example, UDIs can be used in educational and informational materials to allow readers to quickly obtain additional information from the GUDID and other FDA databases; UDIs could play an important role in inventory management; and UDIs may be useful in the provision of high-quality medical services. UDIs and GUDID data, when linked with other FDA data, will help identify alternative devices in the event of a shortage and will contribute to better detection of counterfeit devices.

In addition, while not required, FDA anticipates that providers will include the UDIs of a wide variety of devices in patients’ Electronic Health Records (EHRs) and Personal Health Records (PHRs). This information will strengthen the health care community’s ability to identify the specific devices implanted into patients and will improve response to postmarket surveillance activities, including adverse event reporting and recalls. For example, this information will contribute to the rapid identification of risks and benefits associated with a device within specific subpopulations. By linking clinical detail and information regarding device use, more effective device safety surveillance and evaluation studies could be conducted, contributing to a more complete safety and effectiveness profile for devices and enabling more appropriate and timely remedies when potential safety concerns are identified.

IV. Summary of the Major Provisions of the Regulatory Action in Question

This rule will require the label and device packages of medical devices to include a UDI, except where the rule provides for an exception or alternative placement. Each UDI must be provided in a plain-text version and in a form that uses AIDC technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. The rule requires the submission of information concerning each device to the new GUDID. FDA plans to make most of the data reported under this rule available to the public. The GUDID will not include patient information. The rule will also require dates on device labels and packages to be presented in a standard format that is consistent with international standards and international practice.

The UDI system established by this rule builds on international regulatory cooperation activities and makes use of internationally recognized standards relating to unique identification and data exchange. The rule specifies the technical requirements of a UDI. Each UDI will consist of two portions:

(1) A device identifier that corresponds to the specific version or model of the device and the labeler of the device (the labeler is the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler); and:

(2) A production identifier that more precisely identifies the specific device by providing variable information, such as the lot or batch, the serial number, expiration date, the date of manufacture, and, for human cells, tissues, or cellular and tissue-based products (HCT/Ps) regulated as devices, the distinct identification code required in § 1271.290(c) (21 CFR 1271.290(c)).

The rule explains when a UDI is required and when its use must be discontinued. The rule requires all UDIs to be issued under a system operated by an FDA-accredited issuing agency. The rule provides a process through which an applicant would seek FDA accreditation as an issuing agency, specifies the information that the applicant must provide to FDA, and the criteria FDA will apply in evaluating applications. The rule provides for the suspension and revocation of the accreditation of an issuing agency, and explains the circumstances under which FDA will, or may, act as an issuing agency.

Whenever a device must bear a UDI, the labeler of that device is required to submit information concerning the device to the GUDID, which will facilitate the rapid identification of the device and the labeler and provide links to other FDA data. FDA plans to make this information available to the public through a variety of channels.

As discussed in the rule’s “Compliance Dates” section, FDA has established a set of compliance dates that will phase-in the requirements of this rule in stages, over a period of 7 years, to ensure a smooth implementation and to spread the costs and burdens of implementation over time, rather than having to be absorbed all at once.