According to researcher Lee Ann Jarousse: “Lack of data standards in the healthcare supply chain make it difficult to track and trace products, creating inefficiencies that raise cost and impact patient safety” (“Data Standards in the Supply Chain”).
That’s all about to change with the implementation of unique device identification (UDI).
On Sept. 27, 2007, President George W. Bush signed into law FDAAA (Public Law 110-85). Section 226 of FDAAA amended the Federal Food, Drug and Cosmetic Act by requiring the Food & Drug Administration (FDA) to develop regulations establishing a unique device identification (UDI) system for medical devices.
After years of work, the FDA has finalized its proposed rule, comments on which are due by Nov. 7, 2012.
According to the rule summary:
The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device, such as devices sold over the counter and low-risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient; for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database (UDID) that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
The Global Harmonization Task Force (a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States, Canada, Japan and Australia) says a globally harmonized and consistent approach to UDI is expected to increase patient safety and help optimize patient care by facilitating:
- Traceability of devices, especially for recalls and other field-service corrective actions;
- Adequate identification of the device through its distribution and use;
- Identification of devices in adverse events;
- Reduction of medical errors; and
- Documentation and longitudinal capture of data on medical devices.
HMT attended the recent UDI Conference, which was held in Orlando Sept. 18-19. For a relatively small event still in its infancy, it was well attended by approximately 400 people and 21 vendors, including:
- VeriTeQ, the manufacturer of the world’s first implantable RFID microchip cleared for use by the FDA as a UDI to identify medical devices and patients. (VeriTeQ also likely made the chip in your dog.)
- GS1 Healthcare US, one of 24 GS1 Healthcare user groups around the world that supports the adoption and implementation of global standards developed by GS1, the most widely used supply chain standards worldwide.
- PTC, specializing in solutions that aggregate, analyze and manage product information to drive strategy and achieve compliance.
- Ramtron, which pioneered the integration of ferroelectric materials into semiconductor products, called ferroelectric random access memory (F-RAM) and used in portable medical devices and radio frequency identification (RFID) systems.
- Label Vision Systems Inc. and Webscan, both manufacturers of barcode verifiers that check conformance to standards.
- Manufacturers of UDI labeling and printing equipment, such as ID Integration Inc., Monode Marking Products Inc., Primera Technology Inc., RMI Laser LLC and Roland DGA.
- And several software companies specializing in solutions related to UDI, including A2B Tracking Solutions, Acsis Inc., Evanhoe & Associates Inc., Global Healthcare Exchange (GHX), PRISYM ID, Seagull Scientific and TEKLYNX International.
Jay Crowley, senior advisor for patient safety, Center for Devices and Radiological Health, FDA, says medical devices include a wide range of medical products, such as traditional hospital-based devices (beds, ventilators, monitors, infusion pumps, etc.), implants, patient/home-use devices (glucometers), disposables, accessories (test strips, catheters), in vitro diagnostic devices (IVDs) – both clinical labs and point of care, health information technology (HIT), convenience kits, combination products and products used at alternative sites, such as a home or dentist’s office.
According to Ken Koldan, chair of the Association for Automatic Identification and Mobility (AIM) North America UDI Committee, UDI transactions comprise three parts:
- Reformat existing data using approved issuing agency;
- Encode into auto ID and data capture (AIDC) format; and
- Update database (UDID).
“The unique device identification database (UDID) is a repository of UDI information for all marketed medical devices,” says Indira Konduri, UDID program manager. “The database serves two main functions: It captures the device identifier (DI), and it unlocks and integrates device information from multiple sources.”
According to Crowley, the UDID will include the device identifier type/code, make/model, brand/trade name, clinically relevant size, device version number and GMDN (global medical device nomenclature) classification.
Crowley says organizations should start implementing UDI now: Develop a UDI code, created and maintained by the product manufacturer, according to ISO 15459 (the international standard for naming medical devices), and including a device identifier (DI) and production identifier (PI). The label or mark needs to have a human-readable identification (HRI) component and be encoded in a form of AIDC (the GS1 standard is most widely used; others include HIBCC, ICCBBA and DUNS).
HMT will continue to cover UDI as it progresses from proposed rule to final rule, from implementation to how it will interface with EHRs. HMT
