In September 2013, the Food and Drug Administration issued a final rule requiring most medical devices distributed in the United States to carry a Unique Device Identification (UDI) code on their label and packaging. Certain combination products and devices regulated under the Public Health Service Act — such as donor screening assays — are also covered by the requirements of the rule. The purpose of the UDI system created by the rule is to reduce existing obstacles to the adequate identification of medical devices used in the U.S., thus making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use. Use of the system described in the rule will enhance the quality of information reported for adverse events related to medical devices, which may help identify and track issues related to such devices. Additionally, the UDI system is intended to reduce medical errors and simplify the integration of device-use information into data systems at users’ facilities. The UDI system also can facilitate more targeted and specific recalls and ultimately has the potential to improve patient safety.
As it will appear on medical devices, a UDI is a numeric or alphanumeric code that consists of two components: the device identifier (DI) and the production identifier (PI). In brief:
DI + PI = UDI
The DI is the mandatory, fixed portion of the UDI that identifies the labeler and the specific version number or model of the medical device. The DI portion of the UDI must be issued under a system operated by an FDA-accredited issuing agency and will be searchable in a global public database. Guidelines exist in 21 CFR Part 830, Subpart C for agencies to apply to be an issuing agency. Three agencies were accredited when the rule was published: GS1, Health Industry Business Communications Council (HIBCC) and International Council for Commonality in Blood Banking Automation (ICCBBA).
The PI is a conditional, variable portion of the UDI. When provided the PI includes one or more of the following:
The final rule stipulates that the UDI must be applied by the labeler. The labeler is considered the person who causes a label to be applied to a device or to be modified. In most cases, the labeler will be the device manufacturer, but the labeler also may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager or a relabeler.
As previously mentioned, a global database, the Global Unique Device Identification Database (GUDID), will be established for the UDI system. The GUDID will include a standard set of basic identifying elements for each device that bears a UDI. The information contained in the database will be made available to the public so medical device users are able to easily look up information about the device. In June 2014, the FDA issued a final guidance to provide labelers with an overview of how to use the GUDID. .
The UDI regulations apply to HCT/Ps that are subject to the medical device regulations. Examples of HCT/Ps regulated as medical devices include, but are not limited to, an allogeneic demineralized cancellous bone used for filling of osteochondral defects, an allogeneic demineralized bone matrix combined with human-derived collagen and an allogeneic decellularized cryopreserved pulmonary conduit tissue used for pulmonary repair and reconstruction. In order to comply with both the UDI system and HCT/P requirements, HCT/Ps regulated as medical devices should, at a minimum, include the distinct identification code in the PI portion of the UDI. The HCT/P regulations define the distinct identification code as an alphanumeric code that allows the HCT/P to be tracked from the donor to the recipient. The distinct identification system is a labeling/tracking system required under the Good Tissue Practice regulations for HCT/Ps. Additional information on the labeling/tracking system requirements for HCT/Ps are found in 21 CFR 1271.55(a)(1), 1271.290, and 1271.370.
Blood establishment computer software (BECS) is a medical device and must be compliant with the requirements of the final rule. 21 CFR 801.50 provides direction for manufacturers and users of stand-alone software, whether packaged or downloaded from a website, to also meet the requirements. The requirements can be satisfied by displaying easily readable, plain-text statements when the software is started or through a menu command once it is running. Software that is distributed in packaged form and downloaded from the manufacturer’s website may display the same device identifier.
The UDI rule also applies to medical devices involved in collection (e.g., cord blood or whole blood collections) or donor screening assays (subject to regulation in part by the Public Health Service Act). Blood collection bags have device identifiers, but currently the component bags display DIs that differ by one character. The current system helps prevent manufacture of components in an inappropriate bag, for example, whole blood-derived platelets must be manufactured in the component bag developed specifically for platelet manufacture, and also acknowledges that the components will be transfused to different patients. However, the DI should be at the lowest level of sale – which is the bag set. At this time, it is not known how this discordance with the rule will be resolved.
The inclusion of a UDI on medical devices that will be utilized in HCT/P and transfusion medicine activities will allow for better tracking, inventory management and reporting of adverse events that may occur with the medical device.
The FDA is phasing in the implementation of the UDI requirements. Depending on the classification and/or type of the medical device, the compliance date may be as little as one year or up to seven years after Sept. 24, 2013, the date the final rule was originally published. Information on specific compliance timelines is available on the FDA’s UDI website. However, as many of the aforementioned medical devices are regulated as class II devices, establishments should not expect them to bear a UDI code until Sept. 24, 2016, three years after the publication of the final rule.
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