12/16/2024 | Press release | Distributed by Public on 12/16/2024 17:32
Today, Congressman John Moolenaar's bipartisan legislation, the Shandra Eisenga Human Cell and Tissue Product Safety Act, was unanimously passed by the House of Representatives. The legislation requires the Department of Health and Human Services 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.
Moolenaar introduced the bill with Congresswoman Debbie Dingell, in honor of Shandra Eisenga, of Marion, 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.
Moolenaar spoke on the House floor in support of the legislation, as Shandra's family, including her daughter, Amber Herlein, and sister, Tarin Brunink, who serves in Moolenaar's office as the Director of Casework, attended the debate on the bill.
"Nothing can erase the heartbreak of my mother's passing, but she would be proud that we have helped make a positive difference in her name. I am so thankful the House approved this bill today so no family has to go through an experience like this," said Amber Herlein, Shandra's daughter.
"I am grateful my legislation to honor Shandra's legacy was passed by the House. 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. My bipartisan bill accomplishes this by ensuring the FDA requires screening for TB and holds tissue suppliers responsible for infections they spread," said Moolenaar.
"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. I am thankful our bill passed the House with bipartisan support. 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," said Dingell.
Moolenaar with Shandra's family, before the passage of the Shandra Eisenga Human Cell and Tissue Product Safety Act. (From left to right, Leo Cornell, Porter Herlein, Congressman Moolenaar, Tarin Brunink, Reyna Herlein, Amber Herlein, Brandon Herlein.)
The text of the Shandra Eisenga Human Cell and Tissue Product Safety Act can be found here. Moolenaar spoke during the debate of the legislation on the House floor about Shandra's tragic story and the need for reform. A transcript of Moolenaar's remarks is below and video can be found here.
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Thank you, Mr. Speaker and I thank the gentleman for yielding.
I also want to thank my colleagues on the other side of the aisle, especially Congresswoman Dingell, my fellow Michigander, who has worked very closely with me on this.
I rise in support of my bipartisan legislation, the Shandra Eisenga Human Cell and Tissue Product Safety Act.
In 2023, 36 patients across seven states contracted tuberculosis from infected bone grafts.
One of these patients was my constituent, Shandra Eisenga, of Marion, Michigan, who tragically passed away on August 10, 2023 from TB.
We are joined today in the gallery by Shandra's daughter, Amber, her husband, Brandon and their children, as well as Shandra's fiancé, Leo, and her sister, Tarin Brunink, who also serves in my office as the Director of Casework. This family has been forever hurt by the loss of Shandra, and today we are taking concrete action to stop more families from having the same experience. Shandra's passing as well as the nine other patients over the past three years was completely preventable if it was not for the inadequate oversight of tissue material suppliers.
When it comes to tissue donations, the FDA requires screening for diseases like hepatitis, syphilis, and HIV.
This bipartisan bill will require screening for tuberculosis as well and put an end to preventable TB deaths like Shandra's.
My bill will also require HHS to conduct research and public education campaigns on the risks of surgery requiring a tissue donation.
I urge my colleagues to support this vital bipartisan legislation.
Thank you, Mr. Speaker, I yield back.