Policymakers and Clinicians Call for More Oversight Over Human Cells and Tissues Used for Surgeries

A JAMA viewpoint story, released on May 2, has prompted calls from policymakers and officials at the University of Michigan to shore up the process through which donated tissue products are screened and ensured to be safe. Michigan Medicine’s website has the news.

Shandra Eisenga received spine surgery for back pain “only to inexplicably contract tuberculosis” and eventually died of the disease, according to the story. Robert Dickson, M.D., of the University of Michigan, “connected the outbreak to a previous one in 2021” that was linked to “cadaveric bone material infected with TB and subsequently implanted in some 113 patients.”

Dickson went to Representative Deborah Dingell of Michigan “to enlist her help in understanding how these products could fall through the regulatory cracks.”

Bone graft material “falls within a category of therapeutics called ‘human cells, tissues, and cellular and tissue-based products’ that are only minimally regulated for safety or efficacy by the FDA.”  Dickson and Dingell are seeking to “close the loophole that allows these products to go inadequately screened for TB, to raise physician and patient awareness about the risks of such products and to impose penalties for manufacturers whose tissue products result in infectious disease outbreaks.”