The Food and Drug Administration Amendents Act (FDAA) of 2007 established the Unique Device Identification (UDI) to address the need for a standardized identification system for medical devices. The UDI is analogous to the National Drug Code, which requires that drugs carry a unique identifier of the vendor, the product, and the packaging. The intent of the UDI is to allow unique and coordinated identification of devices to promote better safety and recall systems, to track device effectiveness, to assist with accurate billing, and to help streamline the supply chain.
The first phase of the UDI labeling regulations went into effect in September 2014. The September 2014 date includes Class III devices; other classifications are phased in to encompass all Class II and I devices. The UDI timeline can be viewed at www.fda-udi.info/udi-timeline/.
Medical device overview
Medical devices cover a broad range of instruments and supplies used in the hospital and the laboratory such as implants, ventilators, infusion pumps, beds, IVD kits, instruments, point-of-use reagents and meters, as well as devices used by patients at home such as glucometers.
The FDA defines a medical device as: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
UDI configuration and use
The UDI must be on the medical device in a humanly readable form and in a form which allows for automatic identification and data capture (AIDC) such as a barcode or radio-frequency identification device (RFID) tag. The UDI is to be present on all packaging levels down to the single patient point of use where applicable. The UDI consists of two parts:
The device identifier (DI), which is a mandatory portion of the UDI that identifies the manufacturer and a version or model number of the device; and
The product identifier (PI), which is a non-mandatory portion that identifies some but not all elements including the lot number, expiration date, serial number, date of manufacture, and, if the device is classified as Human Cells, Tissues and Cellular and Tissue-Based Products, a distinct identification code.
The UDI information must be submitted by the manufacturer to a global database administered by the FDA for the standardized and unambiguous identification of all medical devices. The DI information can be used to gather information about the device. The PI information is not submitted to the Global UDI Database (GUDID), although there are flags in the GUDID indicating which, if any, of the PI information is used for the particular device.
An important function of the UDI is using AIDC, such as barcode scanning, whereby the device can be identified and the data transferred to a computer system, reducing the manual entry by staff. The UDI DI, and PI information for AIDC is based upon standard formats from one of three FDA-accredited issuing organizations:
- Global Standard 1 (GS1)
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA)
The UDI information is typically a barcode, either 1D or 2D, although an RFID tag can also be used. The label, both in AIDC and humanly readable form, is to be placed onto the device where it is visible for the AIDC process of taking inventory.
Studies on the use of the UDI
A few studies have begun to evaluate how to implement and operationalize UDI. Initial challenges are for manufacturers to label all medical devices with the UDI, the education of all healthcare staff as to the purpose and use of UDI, and having the computer systems, such as the Electronic Health Record (EHR) and inventory or purchasing systems, be able to accept the scanned UDI. The UDI information for devices such as implants will then be associated with an individual patient and encounter.
While there are challenges, strong arguments can be made that the benefits greatly outweigh the challenges. Some of the benefits of UDI include:
- Improving patient access to device- specific information
- Complete device information to providers at the point of care
- Improved care coordination
- Reduction in medical errors
- Improvements to supply chain and inventory management
- Ability to actively identify devices for surveillance and recall
- Improved safety and effectiveness evaluation of a device
- Accurate and timely claims and payment processes
- Long-term reductions in the overall cost of healthcare
- Biomedical equipment management
- Fraud detection (improper use and billing)
- Anti-counterfeit detection
- Regulatory compliance.
A pilot project to identify challenges and benefits was undertaken at Mercy Health System, St. Louis, MO, with an 18-month project in the OR and Cardiac Cath Laboratory.1 The primary challenge was how to incorporate the scanned UDI information into various computer systems. However, numerous benefits were identified and some were quantified:
- Charge capture was improved for accurate and timely patient billing.
- A more accurate patient record was entered in the EHR regarding which device was used.
- Devices that were ready to expire were identified and were used prior to expiration, with projected savings of more than $300,000.
- There was a time savings of approximately 200 hours of staff time per year in regard to taking a routine count of the inventory.
- Accurate Cath Lab inventory value before UDI and AIDC was estimated to be $800,000 while using UDI and AIDC the actual on hand value was $1,900,000.
A study by Booz Allen2 concluded that the challenges in implementation and use of UDI are the AIDC and IT needs, while the benefits will primarily be to healthcare providers and patients and less so to the manufacturers and vendors of the devices. Improvements in all aspects of the supply chain, especially inventory management, are to be expected, along with improved accuracy and timing in patient billing. In addition the ability to obtain basic and standardized information for all devices is seen as a significant benefit both by suppliers and providers of care.
A report from The Brookings Institution3 studied the use of UDI in four Kaiser Permanente locations and demonstrated inventory reduction by at least 20%, reduced out-of-stock situations by 33% to 97% depending upon location, and improved contract compliance, while also improving clinician satisfaction with device availability, management, and documentation of use.
A report from McKinsey & Company4 estimates significant savings both in morbidity and mortality, as well as significant savings to the healthcare system: “Implementing global standards across the entire healthcare supply chain could save 22,000 to 43,000 lives and avert 0.7 to 1.4 million patient disabilities.” They also estimate that global UDI standards would allow device inventory reduction of $60 to $94 billion, reduce inventory storage and management costs by $10 to $14 billion, and reduce device expiration/obsolescence by $19 to $27 billion.
Benefits of UDI to the lab
The clinical laboratory should expect to see significant financial benefits from the use of UDI and AIDC due to supply chain improvements, including:
- Reduced staff time for counting inventory with the use of AIDC
- Reduction of products that will expire before use
- Possible reduction of inventory levels to better match usage
- More streamlined process to order supplies
- More accurate determination of inventory value
- Improved ability to track equipment and instrumentation
- More rapid response to product recalls or performance problem notifications.
Having all IVD reagents labeled using the UDI may also lead to inclusion of the UDI information (DI and PI) in the LIS/EHR associated with individual patient testing, as is currently being implemented for devices such as implants. Currently the IVD and lot number used is typically associated with specific patient testing from internal lab records, typically not in the LIS.
Other benefits, such as improved communication to providers of devices which may not be performing as expected and the ability of providers to obtain more comprehensive performance data, will likely also become evident.
- Drozda JP, Helmering P, Moore V, Smith TR. Advancement of innovative methodologies and medical device specific infrastructure for evidence-based regulatory science and public health surveillance. Implementation of Unique Device Identification demonstration projects. final report. Summary of deliverable due December 31, 2013. “Final report of UDI demonstration project in Subtask 2.1.” http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm416128.pdf. Accessed May 5, 2015.
- Kroupnik A, Moretti S. May 2013. Booz Allen study: Unique Device Identifier study. Adoption and use trends for medical devices. May 2013.http://www.boozallen.com/content/dam/boozallen/media/file/UDI_Study.pdf. Accessed May 5, 2015.
- Junk L, Wilson N. Unique Device Identification (UDI) implementation webinar. The value of UDI for healthcare systems and providers. 2012. Engleberg Center for Health Care Report at Brookings. The Brookings Institution. http://www.brookings.edu/~/media/events/2012/11/05%20udi%20webinar%201/udi%20webinar%201%20presentation.pdf. Accessed May 5, 2015.
- Ebel T, George K, Larsen E, Neal E, Shah K, Shi D. 2012. Strength in unity: The promise of global standards in healthcare McKinsey & Company report , found at www.mckinsey.com.