In 1972, Congress amended the Federal Food, Drug, and Cosmetic Act with the Drug Listing Act. This required registered drug establishments to provide the US FDA with a current list of all drugs manufactured for commercial distribution. More importantly, the listed drugs are identified and reported using a unique, three-segment number called the national drug code (NDC). Though the writers and implementers of this law could not have foreseen the technology explosion of the last two decades, the ubiquitous use of this number has laid the groundwork for an important tool to improve patient safety.
In response to the Institute of Medicine’s report "To Err is Human: Building a Safer Health System" and the patient safety initiatives that followed, the FDA published the Barcode Rule on 26 February 2004. This rule requires manufacturers to encode the NDC number in a one-dimensional barcode on the package of drug and biological products. The barcode enables healthcare professionals to use barcode scanning equipment in conjunction with computerised medication administration systems, to reduce medication errors in hospitals and other healthcare settings.
The barcode rule, however, does not apply to medical devices. As the FDA stated, medical devices do not have a standardised, unique identifying system comparable to the NDC number for drugs, which complicates efforts to put barcodes on medical devices.
BENEFITS OF UNIQUE DEVICE IDENTIFICATION
Despite these difficulties, a comprehensive unique device identification (UDI) system seems likely to benefit patient safety. It would reduce the number of device-related medical errors that occur due to compatibility and interoperability issues, help identify the specific device in an adverse event report and make the device recall process more efficient.
Additionally, an effective system of device identification would make it easier to include device information in electronic health records and would assist in fighting counterfeit devices. Our ability to identify potential problems with the use of medical devices is highly dependent on the quality and availability of device use information.
But this information is currently limited by both the lack of informative reports and, quite often, an inability to identify specifically which devices are being reported. UDI would help facilitate analysis of adverse events, along with active surveillance systems, and better document specific medical device use in electronic health records and health databases.
Moreover, if safety concerns warrant recalling a device, the UDI could significantly help identify the location of the device and the patients who have used or received it. UDI could also be used to improve interoperability issues, such as identifying the specific accessories to be used with a medical device, as well as compatibility issues. UDI systems may additionally address concerns regarding medical device counterfeiting, offering a way to better track devices and detect counterfeit products.
DEVELOPMENT AND IMPLEMENTATION
We published a notice in the Federal Register on 11 August 2006, describing our interest in UDI and soliciting comments on 20 specific questions. In the notice, we outlined the following three steps in developing and implementing an effective UDI system:
1. A standard scheme for uniquely identifying devices.
We envision that manufacturers would uniquely identify their devices at the unit of use (infusion pump, box of gloves) with an unintelligent number, which would be created by combining information about the device and its attributes, including:
- Manufacturer, make and model
- Unique attributes (size, length, quantity)
- As applicable, the serial number, lot number and expiration date
It is important to note that the addition of a serial/lot number in the unique identifier would make this system more specific than the pharmaceutical barcode rule, as well as more specific than the current practice of many device manufacturers. The barcode rule and most device manufactacturers currently identify the product only. It must also be recognised that this additional level of identification significantly increases the cost and complexity of UDI implementation and maintenance of the UDI database.
Some devices, such as certain implantable or reprocessed devices, may benefit from improved levels of identification such as serialisation, where each individual unit is assigned a unique number. However, serialisation may not be necessary for all devices, and manufacturers have indicated that serialisation would increase their labelling costs.
It is relatively clear that a new device would get a completely "new" UDI. But, rarely do "new" devices come on the market – most 510(k)s are changes or updates to currently marketed devices and a PMA will include many supplements. We are struggling with what changes would require the device to take on a ‘new’ UDI. We would need to strike a balance between requiring a new UDI to reflect changes in a device that essentially make it "new" and changing the UDI too frequently.
2. The placement of the UDI on the device or its packaging.
To be effective, the UDI must obviously be accessible, which means that it is on the device, its packaging, or both at the unit of use.
The UDI should be both human-readable and incorporated into an automatic identification technology such as a barcode. The human-readable element is necessary because of delays in technology uptake or even the possibility that some domains may never have the technology to scan, and because Auto ID technologies do sometimes fail.
It also seems apparent that the UDI would be on the device itself for most capital equipment and that the UDI would be on the package for most disposable products. For many other devices, it is not clear what should happen. For those devices that are used or available after they are removed from the package, or those that are reprocessed and reused, it would be useful to have the device itself marked with the UDI.
However, for many products this may be prohibitively expensive, technologically difficult, or both. We also recognise that the automatic identification technology world is changing rapidly, that new technologies are on the horizon, and that we cannot anticipate what the situation will be in five years. Therefore, we would require only that the UDI be encoded in an ‘appropriate’ automatic identification technology at the unit of use.
3. The development, population and maintenance of a UDI database.
In the end, the UDI is simply the device’s "license plate" – an unintelligent number – which points to more information about the device. A database of UDI information is central to the successful implementation and use of UDI. In addition to the information used to create the UDI, we envision other information associated with the device, which we call "information for safe use."
Taken together, the information used to create the UDI and the information for safe use would be called the device’s minimum data set (MDS). We predict that the MDS will be publicly available and evolve over time – and that different device types may have different or unique information. The MDS looks likely to be a dynamic record that will reflect changes to the device over time.
A comprehensive UDI system will greatly improve the safe use of medical devices.The UDI can help reduce device-related errors; improve medical device post-market surveillance; enhance the effectiveness of device recalls and tracking; facilitate the inclusion of device information in patient electronic health records and other health databases; and promote better device use and interoperability. A UDI system can also assist in combating the counterfeiting of devices.
There are still significant issues that must be addressed, such as how the minimum data sets would be obtained and maintained, and how to make them publicly available. The rapidly evolving world of automatic identification technology also creates challenges for both device manufacturers and healthcare organisations that want to use the UDI. We remain committed to moving towards a comprehensive unique device identification system.