VHA innovation leads to implant tracking initiative

Last month, I attended the Department of Veterans Affairs’ national healthcare summit on medical device registries. The meeting was designed to bring together thought leaders from the Veterans Health Administration (VHA), other government agencies, including the Food and Drug Administration (FDA), academia and private industry, to develop the largest implant registry and device tracking system in the nation. You might think that sounds ambitious, especially given the highly publicized challenges the VHA has faced recently. But if we consider history, it may just be the VHA that can spearhead a healthcare initiative of this magnitude. That’s because the VHA was the primary force behind two significant healthcare programs that have increased patient safety and data access for not only veterans but millions of Americans.

The first is the pharmaceutical barcode rule. In past columns, I have noted how the 1999 “To Err is Human” report, which documented nearly 100,000 preventable deaths annually in hospitals, was the impetus behind the FDA rule published in 2004. It required certain drugs to have barcodes to reduce errors. But it was nearly 10 years earlier when a nurse at the VA Medical Center in Topeka recognized that the same barcode scanning technology used by rental car companies to track cars could be used to scan patients and medications to ensure the right medication match. What began as a pilot at the Topeka Center evolved into the Bar Code Administration System implemented across the VA and served as the foundation for the 2004 FDA rule.

The second was the Blue Button program, which is designed to provide patients with online access to their personal health information. The first program was launched in 2010, making it possible for veterans to go to the VA website and click a prominent blue button to view and download their health records. Today, the program is run by the Office of the National Coordinator for Health IT as a public-private sector partnership. In addition to the 5.4 million veterans using the program, it is available to nearly 150 non-military Americans.

The VHA has similar ambitions with the medical device registry and implant tracking initiative. Acting Veterans Administration Secretary Peter O’Rourke kicked off the summit, noting that the goal is a patient-centered implant tracking system that helps create “a safer, more efficient healthcare system for all, not just veterans.” The objectives are multi-faceted:

• More effective identification of veterans who have received implants that have proven to be faulty
• Easier determination of whether veterans presenting in the emergency room have previously had devices implanted
• More robust data sources to study the performance of medical devices in routine clinical practice and to accelerate the approval of new devices or uses for previously approved devices based on real world evidence

Carolyn Clancy, MD, the VHA executive in charge, noted that having the same electronic health record (EHR) in place at both the Department of Defense (DoD) and the VHA will help consolidate information about military personnel during and after active duty. Congress recently approved the VHA’s decision to move forward with Cerner as its EHR, which is the same system in place at the DoD. But Dr. Clancy added that it will take ten years before Cerner is in place across the entire VHA. Further, she and other physicians speaking at the summit noted that many veterans receive care outside of the VHA system. This is particularly true for total joint replacements, one of the most common procedures for veterans. For this reason, speakers called for coordination between government and private sector registries. A common way to automate the process of identifying medical devices, such as is enabled by the unique device identifier (UDI), was also noted as important.

Perhaps the most significant outcome of the Registry Summit was the sense of collaboration and inclusion among a multitude of stakeholders, including patients. One of the first and often referenced speakers was Christine Stake with Arthritis Power, the first ever patient-led and centered research registry that securely gathers patient generated data for research purposes. A hip replacement recipient, she noted how very few patients receive any information in advance about the devices to be used in their surgeries, the options available to them or the performance of those devices. Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery at the VA Palo Alto Health Care System highlighted the value of the patient as an integral data contributor, noting research that demonstrates how patient reported outcomes, such as the experience of pain, can be an early predictor of potential device failures.

Finally, Peter Provonost, MD, with UnitedHealthcare (and known best for his work on checklists to promote patient safety) reiterated the importance of a collective approach, noting that while we have had tremendous advances in medical science, we still harm too often and learn too slowly. In his opinion, this is not a technology problem, but rather one of leadership. The good news is- based on past history- the fact that the VHA is taking a leadership role may signal that the pathway to a solution has been laid.