East Michigan News

Congressman John Moolenaar, Senator Gary Peters, Senator Debbie Stabenow, and Congresswoman Debbie Dingell have introduced the Shandra Eisenga Human Cell and Tissue Product Safety Act. This bipartisan legislation aims to prevent tuberculosis (TB) outbreaks caused by infected human cell and tissue product (HCTP) donations and holds tissue product providers accountable for outbreaks of infectious diseases.

The passing of Shandra Eisenga, who died from complications of tuberculosis infection, was a preventable tragedy. To honor her memory and prevent future outbreaks, the Shandra Eisenga Human Cell and Tissue Product Safety Act directs the Department of Health and Human Services (HHS) to conduct research and education campaigns to raise awareness about the risks of TB in HCTP donations.

Congressman Moolenaar expressed his gratitude to Senator Peters and his colleagues for their support, stating, "The Shandra Eisenga Human Cell and Tissue Product Safety Act will stop future TB outbreaks and honor Shandra's legacy."

Senator Peters emphasized the importance of preventing similar tragedies, saying, "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."

Senator Stabenow highlighted the need to ensure the safety and integrity of donor cells and tissues, stating, "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."

Congresswoman Dingell echoed the sentiment, stating, "Shandra Eisenga's death was a preventable tragedy... 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."

Dr. Robert Dickson, Medical Director of the Washtenaw County Tuberculosis Clinic and Shandra's physician, emphasized the preventable nature of her death, saying, "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."

Experts in the field also voiced their support for the legislation. MeiLan K. Han, M.D., Chief of Pulmonary and Critical Care Medicine at the University of Michigan Health, commended Senator Peters for his diligence, stating, "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."

Bill Ryan, President and CEO of Transplant Life Foundation, emphasized the importance of oversight in cell and tissue transplantation, stating, "As science and technologies evolve with future innovation to improve patient outcomes, this legislation can and should provide a template for appropriate oversight."

Dorrie Dils, President and CEO of Gift of Life Michigan, expressed support for the legislation and highlighted the need for stronger oversight and penalties for violations, saying, "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."

Marc Pearce, President and CEO of the American Association of Tissue Banks, commended the lawmakers for their leadership and highlighted the benefits of the legislation, stating, "If enacted, the bill would help raise awareness about the risks and life-transformative benefits of human cell and tissue product transplants."

The Shandra Eisenga Human Cell and Tissue Product Safety Act is a response to the death of Shandra Eisenga and the TB outbreak caused by infected tissue donations. It also calls for additional oversight of HCTP by the FDA to prevent future outbreaks.

The introduction of this legislation marks an important step in ensuring the safety and integrity of human cell and tissue products, protecting patients from infectious diseases, and preventing future tragedies like the passing of Shandra Eisenga.