An identification standards body speaks out on the draft regulation for medical devices.
The Health Industry Business Communications Council (HIBCC; www.HIBCC.org) was originally established in the United States in 1983 to develop bar code standards for use in the healthcare supply chain. Its bar code standard is internationally accredited and widely deployed. FDA in its recent proposed rule for Unique Device Identification (UDI) addressed the importance of leveraging existing standards, such as those administered by HIBCC. PMP News reached out to HIBCC’s CEO, Robert A. Hankin, PhD, about the proposal, the history of its development, and the role HIBCC standards will play in its implementation.
Q: Why has FDA proposed a UDI requirement?
Hankin: For many years, FDA and industry partners have been studying the benefits associated with automatic-identification technologies that have been deployed in both healthcare and non-healthcare industries. With this proposed regulation, FDA is reinforcing the importance of these technologies developed by organizations like HIBCC in support of enhanced safety and cost-containment strategies.
HIBCC has had a long history of working with FDA and other industry partners on this important issue. We are pleased with the proposed rule as it is consistent with our expectations, based upon the on-going industry dialogue. When implemented appropriately, UDI and AIDC (Automatic Identification and Data Capture) systems will help reduce the incidence of error, thereby enhancing patient safety efforts and streamlining supply-chain processes. The net benefit of which will be reduced costs—both physical and financial.
Q: What are the benefits of using the HIBCC standard for UDI?
Hankin: The benefits are numerous. First, HIBCC standards were designed by and for the healthcare industry, and the unique needs of its products, its supply chain, and the patient care environment. For example, because medical devices often contain both alphabetic and numeric characters, HIBCC developed the Health Industry Bar Code Supplier Labeling Standard (HIBC SLS) based upon an alphanumeric format to allow for direct and literal encoding of identifiers. Many industries for which safety is essential, such as aviation, automotive, and blood banking, also rely on alphanumeric-based standards for the same reason.
Second, HIBCC registration is both easy and inexpensive. Companies apply to HIBCC for a Labeler Identification Code (LIC) assignment. The registration fee is based upon an organization’s gross annual sales, is a one-time only fee and there are no reoccurring fees thereafter. Additionally, once assigned, the same LIC can be used on all of the company’s products and can be used as a global identifier.
And third, the data structure of the HIBC SLS was designed to accommodate identification of multiple levels of packaging from pallets down to individual units of measure, using a standardized code and consistent format. This allows for easier identification within various packaging configurations, as well as consistency throughout the global marketplace.
Q: How do HIBCC labelers comply with the requirement?
Hankin: The thousands of current and future HIBCC Labelers are already a long way to complying with the proposed regulation, as the HIBC SLS has been identified by FDA as an acceptable UDI format. As a consequence, HIBCC will apply to FDA to become an issuing agency for data standards as described in FDA’s rule. HIBCC already provides several tools to assist with the creation of UDIs, including the HIBCC resource desk, the on-line bar code formatter, and participation with the AIDC Technical Committee. New labelers will find registration with HIBCC to be both straightforward and inexpensive.
Q: How do manufacturers become HIBCC Labelers?
Hankin: As mentioned, companies should apply for an LIC assignment from HIBCC by submitting an application on-line, by mail, or by fax. The application is available at www.hibcc.org.
The assigned LIC identifies the registered company, not an individual product or device, and thus can be used across multiple product lines. Then, utilizing the HIBC, SLS companies can begin to create identifiers at multiple packaging levels, depending upon the required granularity of identification necessary.
Q: Why did FDA decline to specify a certain AIDC technology?
Hankin: It’s our understanding that FDA didn’t want to be overly prescriptive, believing that the selection decision is best left to the standards development community and the labelers. Linear and two-dimensional bar codes, RFID tags, and other near-field communication carriers were noted as potential options—all of which are compatible with the HIBC SLS. Through the many years of dialogue about these regulations, FDA has maintained that they did not wish to hinder the development of new and improved technologies, nor the broader adoption of them. The ability to map data into multiple carriers is critical in obtaining a solution across the wide variety of situations encountered within the healthcare environment.
Q: What is the timeframe for implementation?
Hankin: As it currently stands, implementation would occur in stages over a period of seven years after the issuance of the final ruling. This will provide the industry ample time to understand the required processes and manage the associated costs.
Q: Where can we get additional information or provide feedback on the proposed UDI requirement?
Hankin: HIBCC is your resource for information on the FDA’s current proposed rule and how to begin planning for implementation of UDI. If you have comments or questions for HIBCC, or for FDA, please contact us via email at [email protected] or via telephone at 602/381-1091. FDA will be accepting public comments on this volume of the proposal for 120 days from its initial release on July 10, 2012.