FDA Reminds Doctors: Please Don't Transplant Sepsis Into People
Published Date: 1/7/2025
Notice
Summary
The FDA just released new rules to help stop infections like sepsis from spreading through donated human cells and tissues. This affects all places that check donors before using their cells or tissues in treatments. These updated recommendations start right away and aim to keep patients safer without adding big costs or delays.
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Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Immediate sepsis screening guidance
The FDA released a final guidance titled "Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" that is available for immediate implementation as of January 7, 2025. If you make donor eligibility determinations for human cells or tissues, the guidance provides recommendations to reduce the risk of transmitting infections that cause sepsis.
Separate tuberculosis screening guidance
In the same Federal Register issue, FDA announced availability of a separate final guidance titled "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by HCT/Ps" that is also for immediate implementation as of January 7, 2025. If you make donor eligibility determinations, that guidance provides recommendations for screening donors for evidence of, and risk factors for, Mtb, which can cause sepsis.
Supersedes 2007 sepsis guidance
The new guidance supersedes the sepsis-related information in the August 2007 guidance on donor eligibility for HCT/Ps. If your establishment used the August 2007 recommendations, you should review and consider the updated recommendations announced January 7, 2025.
No new paperwork burden
The guidance itself contains no new collection of information and refers to previously approved collections under OMB control number 0910-0543 for 21 CFR 1271 activities such as donor screening, testing, and recordkeeping. If you operate an HCT/P establishment, the guidance does not add new paperwork requirements beyond those already covered under OMB 0910-0543.
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