Stabenow, Peters, Moolenaar, and Dingell Introduce Bill to Help Prevent Tuberculosis Infections in Surgical TransplantsThursday, February 01, 2024
WASHINGTON, DC – U.S. Senators Debbie Stabenow (MI) and Gary Peters (MI), along with U.S. Representatives John Moolenaar (MI-02) and Debbie Dingell (MI-06) today introduced bipartisan, bicameral legislation, the Shandra Eisenga Human Cell and Tissue Products Safety Act, to help prevent the spread of tuberculosis through transplanted human cell and tissue products (HCTP). Last year, an outbreak of tuberculosis in transplanted bone graft material led to serious health complications and deaths for patients across the country, including in Michigan. The legislation is named in honor of Shandra Eisenga of Marion in Osceola County, Michigan, who passed away on August 10, 2023 from post-surgical tuberculosis after receiving an infected graft.
“When someone is going through the stress of a transplant procedure, the last thing they should be worried about is the safety and integrity of donor cells and tissues. This legislation will hold the companies that make these products accountable and protect patients like Shandra Eisenga,” said Senator Stabenow.
“Shandra’s death was a preventable tragedy. We will continue to honor her memory by strengthening guidelines and improving education for transplants so no other family has to suffer through this again,” said Senator Peters.
“The passing of Shandra Eisenga was a preventable tragedy caused by a lack of oversight and accountability for tissue donation services. Nobody should have to go through what Shandra and her family experienced. The Shandra Eisenga Human Cell and Tissue Product Safety Act will stop future TB outbreaks and honor Shandra’s legacy. Thank you to Senator Peters and my colleagues for their support of this legislation,” said Congressman Moolenaar.
“Shandra Eisenga’s death was a preventable tragedy, and we’ve seen far too many people lose their lives due to tuberculosis infection from bone graft material,” said Congresswoman Dingell. “This bill will support efforts to increase awareness of the risks of human cell and tissue product transplants and implement additional safeguards to protect patients from the dangers of these infections.”
The Shandra Eisenga HCTP Safety Act is absolutely critical, as it addresses the spread of tuberculosis in human cell and tissue products across the United States,” said MeiLan K. Han, M.D., Chief of Pulmonary and Critical Care Medicine at the University of Michigan Health. “As a pulmonologist, I commend Senator Peters for his diligence in introducing this legislation because it ensures patients across the country will have access to safe and oftentimes lifesaving medical products while reducing their risk of exposure to this dangerous disease.”
“Shandra survived three kidney transplants, only to contract tuberculosis from a contaminated bone graft product she received during an elective procedure. This infection, and her death, were completely preventable. I think we owe it to Shandra's memory to stop this from happening to others,” said Shandra's Physician Dr. Robert Dickson, Medical Director of the Washtenaw County Tuberculosis Clinic.
“The Transplant Life Foundation supports this legislation as an important step in the protection of patients involved in cell and tissue transplantation,” said Bill Ryan, President and CEO of Transplant Life Foundation based in Grand Rapids, Michigan. “As science and technologies evolve with future innovation to improve patient outcomes, this legislation can and should provide a template for appropriate oversight. Thank you to Senators Peters and Stabenow, and Representatives Moolenaar and Dingell, for leading this needed effort.”
“Gift of Life Michigan thanks Senators Peters and Stabenow for introducing legislation that would strengthen safeguards for entities that process human tissue for transplant. Gift of Life works with these entities by providing them with tissue we recover from the generosity of Michigan donors. Though tens of thousands of tissue grafts are processed by these entities and successfully transplanted into patients annually, even one death is tragic and unacceptable. We welcome the review called for by this legislation and stronger oversight by the FDA, including steep penalties for violations. We also support doctors educating their patients about the risks and benefits of tissue grafts. These steps should help improve public safety and strengthen the public’s trust in the tissue transplantation system,” said Dorrie Dils, President and CEO of Gift of Life Michigan.
“The American Association of Tissue Banks (AATB) commends Senators Peters and Stabenow and Representatives Moolenaar and Dingell for their leadership in introducing the Shandra Eisenga Tissue Product Safety Act. If enacted, the bill would help raise awareness about the risks and life-transformative benefits of human cell and tissue product transplants. It would also empower the Food and Drug Administration (FDA) to take additional steps to improve patient safety, such as by updating guidance for industry on determining eligibility of donors of human cell and tissue products. AATB looks forward to working with Congress and the FDA to advance the legislation,” said Marc Pearce, President and CEO of the American Association of Tissue Banks.
The Shandra Eisenga Human Cell and Tissue Products Safety Act addresses the spread of tuberculosis in human cell and tissue products by conducting a national, evidence-based educational campaign to increase public and health care provider awareness regarding the risks of HCTP transplants so that patients understand their risks. The bill also requires a report to Congress on HCTP accreditation, FDA inspection activities, and recommendations on potential guidance to be issued. It also creates a civil penalty for companies that have violations not meeting compliance standards.
Last year, the members sent a letter urging the U.S. Food and Drug Administration to provide additional guidance and updated donor ineligibility criteria for human issue transplant products.
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