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The House of Representatives today unanimously passed Congresswoman Debbie Dingell (MI-06) and Congressman John Moolenaar's (MI-02) bipartisan bill, the Shandra Eisenga Human Cell and Tissue Product Safety Act. The legislation requires the Department of Health and Human Services (HHS) to make reforms regarding the screening of tissue donation materials, conduct education campaigns, and impose penalties on tissue providers who fail to prevent tuberculosis outbreaks.  

The lawmakers introduced the bill in honor of Shandra Eisenga of Marion, Michigan, who passed away on August 10, 2023, due to a tuberculosis infection. Eisenga was one of 36 patients in seven states to contract TB after receiving a bone graft containing infected tissue donor material. 

“Shandra Eisenga’s death was a preventable tragedy, and we owe it to Shandra, her family, and every other patient who has been affected by contaminated bone grafts to ensure we’re doing everything possible to prevent future cases like this,” said Dingell. “As someone who had multiple bone grafts after osteomyelitis, I was never warned about the dangers. We must do more to educate patients, make sure they are aware of the risks of human cell and tissue product transplants, and implement additional safeguards to protect patients from the dangers of these infections. I’m thankful to Congressman Moolenaar for his partnership, to the University of Michigan doctors who brought this issue to our attention, and most importantly, to Shandra’s family for their tireless advocacy. I am optimistic this legislation will pass the Senate and be signed into law.”

“I am grateful for the overwhelming bipartisan support for our legislation honoring Shandra's legacy. This bill will help prevent TB infections from bone grafts and save families from experiencing the pain and sadness that Shandra’s family has tragically endured," said Moolenaar. "Our legislation accomplishes this by ensuring the FDA requires screening for TB and holds tissue suppliers responsible for infections they spread. I will continue my work in Congress to ensure this commonsense legislation is signed into law."

The legislation 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.

View Rep. Dingell’s remarks on the bill on the House floor here.