Press Releases

Washington, D.C. -Today, Rep. Phil Roe, M.D. (R-Tenn.) Ranking Member of the House Committee on Veterans’ Affairs reintroduced the Biological Implant Tracking and Veterans Safety Act of 2019.

“This bill was one of the first items I introduced in the 115th Congress, and I am pleased to reintroduce it once again today. Currently, the Department of Veterans Affairs (VA) does not use a standardized process to systematically identify or track biological implants used in VA medical facilities.  My bill would ensure that if a given biological implant was identified as potentially contaminated or made subject to a recall, VA would be able to identify which veteran patients may be at risk and take the appropriate steps to remedy any potential concerns. 

"This piece of legislation would require VA to adopt FDA's unique device identification system (UDI), or a comparable standard identification system, which would be used to label all biological implants and would require that these implants only be procured from vendors who meet certain quality requirements. Additionally, VA would need to implement an automated inventory system to make sure that veterans receiving biological implants can be monitored and easily notified in the event of a recall.

"The millions of veterans that VHA serves annually deserve the best standard of patient care, especially within a system that prides itself on data collection. This bill passed the House last Congress. I hope that this Congress does the same and that my colleagues in the Senate decide to take this needed action and send it to the President's desk so that VHA will have the necessary tools to enhance accountability and patient safety."

Background:

In 2014, a Government Accountability Office (GAO) report found that the Department of Veterans Affairs (VA) does not use a standardized process for tracking biological tissue from cadaver donor to living veteran recipient. In the event of a recall, it would often be impossible to track down which patient received contaminated tissue.The same GAO report detailed the Veterans Health Administration’s (VHA) failure to consistently ensure they are purchasing tissue from biological implant vendors that have registered with the Food and Drug Administration (FDA). Additionally, VHA does not maintain an inventory system to keep expired tissues from remaining in storage alongside unexpired tissues. Click here for more information.