Those of you who follow the application of auto ID (automatic identification) symbology are likely to recognize the acronym UID. This acronym refers to the program whereby the U.S. Department of Defense (DoD) seeks to mark all mission-critical, high-value, and serialized parts with a unique ID (UID) in the form of a distinctive item number encoded in a 2D Data Matrix code, etched or printed directly onto each part.
Close readers of the Microscan catalog will know that Microscan supports this program by offering products in the form of the UID Label and Data Plate (LDP) Verifier and the UID Direct Part Mark (DPM) Verifier - casually referred to as the Coffee Maker and the Espresso Machine.
While the DoD aims to achieve incredible savings by using UID to keep track of their guns, bombs, and rockets, there is now a new initiative from another part of the federal government that aims use some of the same technologies (and the same letters) to improve public health devices and save a few health care dollars: The UDI program.
So what is UDI?
The UDI (Unique Device Identification) program is an initiative from the U.S. Food and Drug Administration (FDA). The goal of the program is to improve the nation's management of healthcare information (and thereby the nation's health) by standardizing the marking of medical devices. Standardization ensures that all entities involved in the production, distribution, stocking, and use of medical devices can readily identify the device in question and have reliable access to critical data concerning its use and history.
Those few who have read this far may be asking, " Just how hard can this be? - Just stick a bar code on the box!" Well it turns out that it is not so simple. Some medical devices - such as heart valves, stents, and more - tend to change their identity as they move through the supply chain. These devices may start with a manufacturer's part number, get re-branded for a particular market, get re-numbered by a distributor, and then get new stock number when they get to a hospital stock room.
The aim of the UDI program, (the proposed rules for which were published this July by the FDA), is to provide a permanent unique ID for each device. This ID could be used as an index into a database that will contain critical data for each device - no matter where the device has been or how it has otherwise been altered. The proposition is that this ID will enable efficient recalls & adverse event tracking, deter counterfeits, and promote the accuracy of (currently incredibly unreliable) patient records.
The proposed UDI rule from the FDA - 44 pages of deathless prose - contains much that is of interest to the auto ID (barcode) community.
The key points are:
- The FDA requires that auto ID technology be used to mark the device package with product identification data (manufacture ID and model number) by means of 1D or 2D symbologies or some other auto ID technique such as RFID. These data are referred to in the UDI rule as the device identifier.
- The FDA rule does not specify the data carrier - it can be 1D, 2D, RFID, etc. - but it does require that 1D or 2D symbols be accompanied by Human Readable (HR) text.
- The UDI rule does not require serialization - but it does require that the auto ID symbology contain the serial number, expiration date, etc., if these symbols are marked elsewhere on the package. These symbols are referred to as the production identifier.
- The UDI rule specifies that the identification and (if present) the production data are formatted within the mark using one of a small number of established standards such as those provided by GS1 and HIBCC (Health Industry Business Communications Council).
- The UDI production identifier for a given manufacturer's product/model/package will be issued and registered by a small number of agencies such as GS1 and HIBCC. In the case of GS1, this will be based on the GS1 Global Trade Item Number (GTIN) which can be thought of as a grown-up version of the UPC code that surrounds us at the supermarket.
- The UDI device identifier will be an index into a database of product master data, which will include version and model information for each product along with clinically important information such as sterilization requirements and latex content.
- Implantable and sterilizable devices must be marked with direct part marks (DPM) where possible.
The proposed UDI rule was published by the FDA in July 2012. We are now in the midst of a six-month wait period that allows for comment by interested parties. Microscan is represented on the technical committee that has been tasked by AIM (The Association for Automatic Identification and Mobility - our trade association) with formulating comments and suggestions.
If the final rule is issued on schedule, it will come into force in May 2013 and this will start the clock running for the first group of devices for which UDI labeling is required. First up would be Class III devices that are critical for life support, which must have UDI labels within one year after the rule is in force. The next group up to bat is implantable/sterilizable devices that must be DPM'ed within two years. Class II devices, which include clinical analyzers and reagents, must be labeled three years after the final rule is published.
We are ready! Clearly the widespread adoption of auto ID codes to identify medical devices from manufacturing to the bedside or surgical suite will promote the use of handheld and fixed 1D and 2D code readers. Microscan has these solutions available for reliable reading of both printed and directly marked symbols, and our readers (many with their own integrated illumination) are especially adept at reading tiny marks and codes. There will also be important requirements at the upstream end of the UDI application process when the information on labels and parts must be verified and validated. The current release of Microscan's simplified machine vision software, AutoVISIONâ„¢, has important label verification capabilities derived from the built-in ability to match data in 1D and 2D codes to their human readable equivalents and to verify the format (grammar, if you like) of GS1-formatted symbologies. In the near future we will be adding the capability to extract the individual data fields from GS1 marks, grade and inspect 1D and 2D codes to formal ISOspecifications, and verify the legibility of human readable text using an Optical Character Verification (OCV) tool.
Microscan looks forward to doing our part to improve the U.S. healthcare system by supporting the new UDI program. When the medical device industry at last turns to UDI, Microscan will be ready to provide manufacturers, distributors, and healthcare providers with the right instruments to meet their requirements and promote patient safety!
Visit www.microscan.com to learn about our barcode and machine vision solutions that support UDI.
For further reading on the proposed UDI rule, read Microscan's white paper " Understanding the Role of Auto ID in the FDA's UDI Initiative" or visit the FDA's website.
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