Originally Published MD&DI November 2009
BAR CODE STANDARDS
Mandating the UPN system would help manufacturers better track their products.
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In 2004, FDA published a final rule on bar code label requirements for drug and biological products. It subsequently began considering whether to expand that concept to medical device labeling. Over the past few years, FDA has held several meetings on unique device identification (UDI) to collect input from the device industry. It is expected that the agency will issue a draft guidance on the topic in the near future. The basis for these actions is FDA’s mandate to protect the consumer, in this case, patients. Evidence of significant medical errors related to product identification have made clear the need for regulatory initiatives.
Product identification, whether by traditional bar codes, newer two-dimensional symbols, or radio-frequency identification, is increasingly being used to locate and remove devices that are found to be the source of problems after they have entered the supply chain, or worse, have been used in medical procedures. The use of product identification as a resource in medical practice, as opposed to just a tool to manage inventory and warehouse logistics, is creating an entirely new paradigm. A UDI system based on universal product numbers (UPNs) would be a safe and efficient way to accommodate both hospital and warehouse needs.
The History of UPNs
Ironically, standards that uniquely identify medical products and meet FDA requirements have not only been in place for more than 25 years, but are already present on the vast majority of medical devices. Although widely used, UPNs have not been mandated by FDA, are often not placed on single-use packaging levels, and are frequently ignored in medical-delivery and hospital settings that lack the technology to capture the UPN information.
A primary component of the UPN is the health industry bar code (HIBC). It is maintained by the Health Industry Business Communications Council (HIBCC), which was created in 1983 by major healthcare associations at the behest of the American Hospital Association. HIBCC was specifically tasked with developing standards that met the unique needs of the healthcare supply chain. Traceability was a key concern for HIBCC; therefore, its standards permit manufacturers to directly encode product IDs in their labels, create consistency for packaging at all levels, and provide serialization and lot and batch information for track-and-trace purposes.
HIBC standards were also designed to coexist with generic retail and pharmaceutical standards known as GS1 codes. The codes work well in cash-register and warehouse environments, but are less suitable for medical applications in which safety and error minimization are crucial. Because HIBC standards are alphanumeric and GS1 codes are limited to numbers only, the two can coexist without being confused.
Adoption of UPN Standards
It is logical for FDA to adopt the UPN standards for UDI because they are based on existing, internationally recognized standards and leverage the significant progress that has already been made by the medical device industry in product identification. These standards meet the requirements for track and trace and, if fully implemented, can help reduce medical errors.
The most important aspect of HIBC UPNs, in terms of patient safety, is that they enable device manufacturers to directly encode their existing alphanumeric product identifiers into their labels. This avoids the unsafe practice of changing or cross-referencing them to meet arbitrary new or numbers-only requirements. In short, it would be counterproductive for FDA to add new risk by imposing new standards.
Additionally, a deviation by FDA from existing labeling standards and practices would burden manufacturers with significant costs at a time when reducing healthcare inflation is a critical national priority. Manufacturers that currently use HIBC formats would be required to redesign their labeling systems and implement changes to software in their warehouse and distribution centers.
The HIBC Data Structure
The HIBC supplier labeling standard ANSI/HIBC 2.3 is an alphanumeric standard that encodes key information necessary for track and trace of medical devices. The encoded information includes the following:
• The unique product identifier (the primary bar code).
• Track-and-trace information and expiration information (the secondary bar code).
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Figure 1. (click to enlarge) An example of a primary HIBC label (top) and a secondary bar code label (bottom). |
A typical HIBC-compliant primary and secondary label appear in Figure 1. The primary label begins with the HIBC supplier labeling flag—the + character that represents the red or white cross that universally symbolizes medical care. In the case of HIBC, the + indicates that an item is a medical product and is followed in sequence by the labeler identification code (LIC), which is assigned by HIBCC and uniquely identifies each manufacturer. Next comes the product number that has been assigned by the manufacturer, a unit of measure ID indicating the packaged quantity, and a check sum that is calculated from the previous data in the label. There are two significant aspects to this structure that are designed to minimize error. Manufacturers can use their original product identifiers in the label, thereby avoiding the inherent risks of changing or cross-referencing them. The HIBC structure also includes an additional check character that is not present in other standards to ensure correct scanner reads.
The secondary label (see Figure 1) includes the information that is essential for track-and-trace capability, beginning with the HIBC supplier labeling flag character, followed by expiry date format information and the appropriate date, as well as lot or serial number. For added security, a link character is included in the secondary bar code, which matches the check sum in the primary bar code, and a separate check character is calculated thereafter.
If desired by the manufacturer, the primary and secondary bar codes can be made into a concatenated version. The overriding goal of the various requirements in the standard is to minimize coding or scanning errors and to maximize the ease of traceability of the product.
Manufacturers that adopt the HIBC supplier labeling standard register with HIBCC, which assigns them their unique LIC. As a consequence of the unique LIC and the alphanumeric structure of the HIBC standard, a single LIC per manufacturer provides for a virtually infinite number of identifiers. This is particularly important for manufacturers of medical devices because there are often hundreds of thousands of unique parts to be identified. The forms and appropriate steps for obtaining an LIC from HIBCC are available on the HIBCC Web site at www.hibcc.org.
Point-of-Use Data Capture
It is important for device manufacturers to understand how their product identifiers are used once a product leaves its facility. Point-of-use data capture is the process required to accurately capture information about consumables and other products used in patient procedures. For the most part, this process is performed manually by hospitals using paperwork to record the details. Written notes are placed in a paper-based patient file. Some of the data are entered manually into patient administration systems, but often key information is left out. Consequently, a disproportionate amount of a caregiver’s time is consumed by recording medical devices used, ordering and replenishing, and tracking (in the case of recalls).
This manual process of data capture is prone to errors. Transcribing the lot and serial number(s) of a medical device and then entering them into a computer system carries a much higher risk of mistakes than if the information was directly scanned from a bar code and automatically entered into a database. Errors made in the recording process could lead to a hospital using a recalled or expired device. Additionally, when hospitals incorrectly enter product information, medical device manufacturers can’t accurately manage their inventory.
Like groceries, every medical device should be scanned before it is used. However, there is a vast difference in the healthcare supply chain that makes scanning at the bedside far more challenging than scanning groceries in a supermarket. Unlike a grocery store where the primary reason for scanning an item is a price check, the scanning of medical devices for a patient procedure requires a deeper understanding of the interconnected processes and dependencies that exist to ensure patient safety. These processes include the following:
• Purchasing arrangements. There are numerous variations that exist for medical devices such as consignment stock, loan stock, and purchased stock. Each variation requires a different set of rules for the purchasing and invoicing.
• Billing and rebates. Many medical devices are billed to the patient and the rebates that may apply depend on the health insurance coverage for the patient.
• Tracking devices to the patient. For many hospitals, it is not sufficient
to simply capture the product type used in a procedure. For example, for implants it is necessary to capture the lot or serial number. This ensures that devices can be tracked to a patient and, in the case of a recall, the affected lot can be traced to all patients. It also identifies consignment and loan stock devices used so that the hospital can fulfill its contractual arrangements with the supplier for supplying consignment or loan stock items. The bar code standard used, therefore, must contain a field for lot and/or serial numbers.
• Units of sale. These are more controlled in supermarkets. In hospitals, medical devices and consumables must be issued at the patient’s bedside. Patients might be charged for an entire package of syringes that is brought into their room, even though only one syringe was used. Or the patient might not be charged if the package isn’t labeled because it is part of a larger package that was labeled.
• Expiration dates. To reduce the risk of infections, it is important that medical devices provided in sterile packaging have not reached their expiration date. The bar code standard used must contain a field designated for the expiration date to alert the caregiver that a device has expired when the bar code is scanned.
The following technology issues must also be considered before introducing a point-of-use data capture system:
• What kind of hardware is required to easily capture the medical devices used in a procedure? Caregivers are highly mobile, which should be factored into the design of the system.
• How will medical device product data be stored, maintained, and accessed—i.e., how will all the bar codes, product descriptions, units of issue, etc., be databased in the first place and then maintained on an ongoing basis? The bar code for product identification is, after all, just a string, and the system needs to reference the product attributes when the bar code is scanned.
• What data are required for the system and how will this information be stored and structured?
A Data Capture System that Works
In Australia, a data capture system that relies on UPNs to manage medical devices is already being employed in many hospitals. The system captures all medical devices used in operating rooms by scanning a manufacturer’s bar code and then creating a bill of materials against a patient procedure or episode of care. The system is a software-as-a-service application that consists of handheld computer software and a back-end server. The handheld computer is a mobile device with a built-in bar code scanner. Before the start of a surgical procedure, the caregiver scans the medical record number and episode number for the patient either from a bar code on the patient’s wristband or from the patient’s file.
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Figure 2. (click to enlarge) A handheld computer scans the primary bar code on the pictured label (a). A lot number is required, so the computer prompts the operator to scan the secondary bar code (b). Image courtesy of hTRAK PTY LTD. (Victoria, Australia) |
As medical devices are used in a patient procedure, a user scans the HIBC-compliant UPN labels and automatically captures the devices (see Figure 2). When the procedure is completed, the user synchronizes the handheld device and the data captured is uploaded to the back-end server. Purchase orders for used devices are automatically created in the system. In many cases, this function is interfaced with hospital enterprise resource planning systems.
We have observed a very high compliance rate in hospitals that use this method of data capture. Clinicians find it easier to capture information by scanning bar codes rather than by keeping paper records. Additionally, the system is intrinsically linked to purchasing and patient accounting, which means that clinical staff has a distinct interest in ensuring that all data is captured.
Conclusion
For more than 25 years, the standards created by HIBCC have provided the platform for applications that capture medical device information. These systems offer manufacturers accurate information on devices used in patient procedures, timely receipt of purchase orders, and improved traceability. Forcing the medical device industry to switch to a new format would introduce increased costs and risks.
Kirk Kikirekov is president of HIBCC AU (New South Wales, Australia). Robert A. Hankin, PhD, is president and CEO of HIBCC (Phoenix).
Copyright ©2009 Medical Device & Diagnostic Industry
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