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Representatives Debbie Dingell (MI-06) and John Moolenaar (MI-012) with Senators Gary Peters (D-MI) and Debbie Stabenow (D-MI) this week introduced the Shandra Eisenga Human Cell and Tissue Product Safety Act. The bipartisan legislation directs the Department of Health and Human Services (HHS) to conduct research and education campaigns to prevent tuberculosis (TB) outbreaks from infected human cell and tissue product (HCTP) donations. Additionally, the bill allows the federal government to pursue civil penalties for tissue product providers who cause an outbreak of an infectious disease, like TB.

The bill comes as a response to the passing of Shandra Eisenga, of Marion, on August 10, 2023, due to complications from tuberculosis infection. Eisenga contracted TB after receiving a bone graft in April 2023 using a tissue donation from an infected donor. Shandra was one of 36 patients in seven states to contract TB from a tissue donation originating from this donor, resulting in two deaths.

"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 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 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’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.

"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 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."
 
"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.

In August, Dingell sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf and Centers for Disease Control and Prevention (CDC) Director Dr. Mandy Cohen expressing concerns about a recent outbreak of tuberculosis (TB) linked to the implantation of contaminated bone graft material, including the case that resulted in Shandra Eisenga’s death.

The text of the Shandra Eisenga Human Cell and Tissue Product Safety Act can be found here.