Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products

Published:2024-05-28 Issue:20 Volume:331 Page:1703
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Dickson Robert P.¹²,Dingell Deborah A.³

Affiliation:

1. Washtenaw County Tuberculosis Program, Ypsilanti, Michigan

2. University of Michigan Medical School, Ann Arbor

3. US House of Representatives, Washington, DC

Abstract

This Viewpoint discusses the death of a patient caused by unregulated biological products and efforts to encourage federal government oversight of such products.

Publisher

American Medical Association (AMA)

Link

https://jamanetwork.com/journals/jama/articlepdf/2818353/jama_dickson_2024_vp_240049_1716416448.75896.pdf

Reference6 articles.

1. Nationwide tuberculosis outbreak in the USA linked to a bone graft product.;Schwartz;Lancet Infect Dis,2022

2. Second nationwide tuberculosis outbreak caused by bone allografts containing live cells.;Wortham;MMWR Morb Mortal Wkly Rep,2024

3. ISASS recommendations and coverage criteria for bone graft substitutes used in spinal surgery.;Abjornson;Int J Spine Surg,2018

4. Investigating the efficacy of allograft cellular bone matrix for spinal fusion.;Diaz;Neurosurg Focus,2021

5. The role of polymerase chain reaction in the management of osteoarticular tuberculosis.;Pandey;Int Orthop,2009

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Mycobacterium tuberculosis Infection After Grafting of Infected Bone: A Case Series of Four Patients;Cureus;2024-08-10