Mr. Frank Wilton
Chairman Coffman, Ranking Member Kirkpatrick, and Distinguished Members of the House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations:
Thank you for the additional opportunity to come before you today in support of the “Biological Implant Tracking and Veteran Safety Act of 2014.” This critical legislation directs the Secretary of Veterans Affairs to adopt a standard identification system for use in the procurement of biological implants by the Department of Veterans Affairs. By building upon the success of the implementation of the Unique Device Identifier, or UDI, this legislation will ensure that biological implants used within the Department can be appropriately tracked from a human tissue donor all the way to the recipient. This critical capability for “track and trace” efforts will enhance patient safety, expedite product recalls when necessary, assist with inventory management, and improve efficiencies.
This legislation takes a bold step to expand the UDI to all tissue products. In addition to human tissue-devices (which are already covered by the UDI), the legislation adds another product category: certain biological implants or, as termed by the Food and Drug Administration (FDA), 361 human cells, tissues, and cellular and tissue-based products, or HCT/Ps. While many of the biological implants do have company specific bar coding information, by requiring a standardized format for those bar codes, as outlined in this legislation, it will be easier for the Department of Veterans Affairs’ medical facilities to utilize universal bar coding conventions and to realize the full benefit of a unique identification system. Finally, by applying a system which has been developed for devices to biological implants, such a solution should also be applicable to other health care settings and other health care systems (such as the Department of Defense health care system or the private sector).
As the Secretary of Veterans Affairs opts to adopt the standard identification protocol for tissues (both devices and non-devices), the American Association of Tissue Banks urges you to ensure that the Secretary provide a menu of options for such adoption. Under the UDI final rule, FDA has done just that by providing for multiple entities called “issuing agencies.” At this time, FDA has provided for three different issuing agencies: (1) GS1, (2) Health Industry Business Communications Council (HIBCC), and (3) ICCBBA. I hope that this flexibility is maintained within the Department of Veterans Affairs. However, given that the bill language already suggests that the unique identification system is comparable to what the UDI provides, we believe the intent to provide that flexibility is inherent in the legislation.
For those of you unfamiliar with my organization, the American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization. It is the only national tissue banking organization in the United States, and its membership totals more than 125 accredited tissue banks and approximately 850 individual members. These banks recover tissue from more than 30,000 donors and distribute in excess of two million allografts for more than one million tissue transplants performed annually in the U.S. The vast majority of tissue banks that process tissue maintain AATB accreditation, and the AATB estimates that only 5-10% of the allografts distributed are from tissue donors who were not determined to be suitable by the medical director of an AATB-accredited tissue bank. The AATB does not have a similar estimation for tissue distributed by tissue distribution intermediaries.
The Association was founded in 1976 by a group of doctors and scientists who had started in 1949 our nation’s first tissue bank, the United States Navy Tissue Bank. Recognizing the increasing use of human tissue for transplant, these individuals saw the need for a national organization to develop standards, promote ethics and increase donations.
Since its beginning, the AATB has been dedicated to improving and saving lives by promoting the safety, quality and availability of donated human tissue. To fulfill that mission, the AATB publishes standards and guidance documents, accredits tissue banks, and certifies personnel. The Association also interacts with regulatory agencies and health authorities, and conducts educational meetings.
First published in 1984 and presently in its 13th edition, the AATB’s Standards for Tissue Banking are recognized in both the United States and around the world as the definitive guide for tissue banking. These Standards are the only private tissue-banking standards published in the United States, and they are the most comprehensive and detailed tissue-banking standards in the world. As such, the AATB’s Standards have served as the model for federal and state regulations as well as several international directives and standards. Currently, the statutes and/or regulations of 19 states (i.e., California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Montana, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and Wisconsin) reference AATB’s Standards, institutional accreditation, or individual certification. And, these Standards are the basis of our accreditation process.
Human tissue is used in a wide variety of medical procedures in the VHA facilities, ranging from wound care management to hernia repair to orthopedic procedures. Human tissue is also used in a wide array of dental services, such as bone augmentation and gum tissue grafting procedures. In fact, according to a Government Accountability Office (GAO) report to this committee, biologics accounted for approximately $75 million in VHA acquisitions in fiscal year 2013. That same GAO report noted that one Veterans Affairs Medical Center (VAMC) had a high percentage of purchases missing serial numbers or lot numbers (16 percent in the first three quarters of fiscal year 2013). I’m hopeful that this legislation will appropriately address this outstanding concern, without providing an undue burden on the health care system. For this and many other reasons, AATB supports this critical legislation.
I realize that some of you may be concerned that this legislation is duplicative and more burdensome than the FDA UDI requirements. If that were the case, it would be difficult for my organization to support its implementation. Rather, as I outlined earlier, the legislation is not duplicative of FDA’s efforts because it expands the standard identification system from only devices to also cover 361 HCT/Ps. Thus, it goes beyond what Congress directed FDA to do with respect to the UDI. However, in talking to executives of the tissue banks who currently have products on the Federal Supply Schedule (FSS), all are strongly considering expanding the unique identifier to their entire product line because they acknowledge that it is an appropriate value-added benefit for hospitals and other facilities who procure tissue and, ultimately, patients, including veterans.
As for the specific timeframes outlined in the legislation, per the UDI, tissue banks will need to develop and implement the new bar coding technology for newly produced biological implants by the end of September 2015. Assuming that this legislation is enacted this Fall and that the Secretary is able to comply with the timeframes outlined in the legislation, then the timeframes for the VHA implementation and the FDA UDI implementation would coincide. Thus, by ensuring that the standard identification system conforms to the requirements and timelines outlined by the FDA, it should not place an undue burden on tissue banks; but, there will be some costs involved.
While I do not have any specific information on the implementation cost of the UDI related to tissue banks, according to a Booz-Allen Hamilton report, the primary cost of the UDI to manufacturers relates to the need to modify or replace information technology or IT systems. For manufacturers, the cost is estimated to be anywhere between $100,000 and $100,000,000, depending on the size and scale of the changes required. Given this broad range, my expectation is that, at least for tissue banks, due to their size, it’s more likely that the change will be toward the lower end of the spectrum. That being said, because there is no return on investment, it is likely that tissue banks will need to increase the fee for tissue products to cover the cost of those changes.
But, such an increased cost to the VHA is worth the end result of enhancing patient safety. As the VHA has acknowledged with the previous efforts to create the Veterans Implant Tracking and Alert System or VITAS, there are current gaps in the information collection process for biological implants. As you know, VITAS was designed to track and retrieve identifying information—including the lot and serial number—of surgical implants placed in patients VHA-wide. Therefore, VITAS was developed to address shortcomings in VHA’s existing ability to “track and trace” surgical implants. And, without additional developments, VHA’s ability to identify and locate patients who received an implant in the event of a manufacturer or FDA recall may be limited. Unfortunately, as outlined in a recent GAO report, due to data-reliability and interoperability challenges, VITAS was suspended at the end of fiscal year 2012. And, as of December 2013, VHA had not decided whether to resume the development of VITAS.
While I can understand your skepticism in requesting the VHA attempt a VITAS-like enterprise in this legislation after failing to do so before, I would note that a lot has changed since 2008 when the VHA first envisioned VITAS. First, there is now a UDI benchmark which allows those developing the necessary software for data capture to move from a design incorporating dozens of different bar coding technologies from all of the AATB-accredited tissue banks to only three different ones outlined by the three different issuing agencies. Thus, the task is much easier. In addition, the VHA is not alone in trying to develop a system for integrating the UDI-like information directly into the medical record. For instance, the Office of the National Coordinator for Health Information Technology (ONC), which is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information, is currently focused on ways in which the UDI can be better operationalized to ensure its adoption into HL7 standards – the key standards for the exchange, integration, sharing, and retrieval of electronic health information. As part of those efforts, ONC is initially focusing on implantables – the very focus of the legislation we are discussing today, suggesting that this is an area of potential “low hanging fruit” in which a small investment can reap a big reward. Therefore, the VHA will not be attempting to establish such a system alone but can partner with other governmental entities to ensure its success.
Finally, when I last discussed this legislation before the Committee, I noted my concern that the draft legislation lacked a requirement that biological implants purchased by the VHA be subject to appropriate accreditation standards. It’s my understanding that those concerns are addressed in the latest version of the legislation by requiring accreditation by AATB or a similar accreditation organization. Thus, with this change, the VHA will be joining the ranks of leading medical centers of excellence which currently require all tissue to be sourced from AATB accredited tissue banks. AATB strongly supports this legislation and urges the committee to favorably report it out of committee.
I welcome your questions.
I yield back my time.