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About Transplant Safety | Transplant Safety

Overview

Transplant safety has two categories: organ safety and tissue safety.

Transplant transmitted infections are very rare; public health entities and academic groups suspect about 1% of transplants cause infections and have confirmed cases in far fewer. When these events occur, the complications can include graft failure or death. Efforts to improve transplant safety are ongoing, (for example, improvements to donor screening and donor testing) and informed by investigations of disease transmission from transplanted organs and tissues.

CDC is responsible for surveillance, detection, and warning of potential public health risks within the organ and tissue supply. These public health efforts increase transplant safety by reducing the potential for transmission of communicable diseases.

Fast facts Frequently asked questions

To the body, transplanted organs are foreign. When the body attacks transplanted organs, it is known as rejection. To prevent this response, doctors prescribe medication to organ recipients. A side effect of these medications is the body's inability to fight infections as well as a healthy person.

Most types of transplanted tissues (i.e., bone, tendons, heart valves, and cornea) are not recognized as foreign and do not require these medications.

Hospitals are required to have written agreements with organizations that coordinate organ and tissue donation and recovery. There are 57 organ procurement organizations (OPOs) and a larger number of tissue recovery and eye recovery banks that work with hospitals in the United States for this purpose. Hospitals also obtain organs (kidneys and livers) from living donors.

Organ procurement organizations (OPOs) administer questionnaires to collect:

OPOs, tissue banks, and eye banks are also required to perform certain tests to see if the potential donor may have infections (e.g., human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus, syphilis, and cytomegalovirus (CMV)). They provide test results to the healthcare facility where organ or tissue transplantation occur.

Hospitals evaluate living potential donors for behaviors or medical history that may increase the risk of infection in the donor.

The Organ Procurement and Transplantation Network (OPTN) requires organizations procuring organs to report suspected donor-derived disease transmissions to the OPTN and all centers receiving potentially affected organs. Additionally, OPOs must contact tissue banks and eye banks that recovered tissues from that same donor.

Tissue and eye banks are required to investigate if they suspect transplanted tissue caused an infection and:

The tissue or eye bank that released the tissue must submit findings to the FDA through its MedWatch surveillance system.

CDC encourages healthcare facilities performing tissue transplants to report suspected transmissions to the tissue supplier through the MedWatch system. Reporting is voluntary.

When living patients donate organs, the hospitals performing the procedure must notify local or state public health authorities if the donor has a notifiable infectious disease. Each state maintains a list of notifiable diseases found on the health department's website.

What CDC is doing

CDC helps the healthcare community, state, and local health departments trace diseased organs back to the original donor and identify people who may have received contaminated organs and/or tissue. This process informs regulatory decisions and risk reduction guidance for transplant safety.

CDC laboratories can also help test for and identify bacteria, viruses, etc. that may contaminate organs and tissues.

Research

Virus Transmissions

Bacteria Transmissions

Fungus Transmissions

Parasite Transmissions

Other Publications

Other transplant safety organizations

Organs

The Health Resources and Services Administration (HRSA) is a government agency that provides oversight of organ recovery and transplantation through the Organ Procurement and Transplantation Network (OPTN). Congress established the OPTN under the National Organ Transplant Act of 1984.

The Centers for Medicare and Medicaid Services (CMS) is a government agency that establishes performance standards for transplant centers and OPOs to determine certification or recertification. Medicare reimbursement is linked to meeting CMS performance standards.

The Association of Organ Procurement Organizations (AOPO) is a national, non-profit organization offering voluntary accreditation service to its 57 OPO institutional members in the United States and its territories. AOPO helps to ensure compliance with federal regulations and AOPO standards. AOPO also provides education and advocacy for its members.

Tissues

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) is a federal agency that regulates human tissue, including ocular tissue, for transplantation. Regulations cover all tissue establishments involved in the recovery, processing, storage, and/or distribution of tissue. Healthcare facilities participating in the recovery, processing, or distribution of tissue for transplantation are also required to follow FDA tissue regulations. All tissue and eye banks must register with and follow FDA regulations.

The American Association of Tissue Banks is a professional, non-profit scientific educational organization providing an accreditation program for transplant tissue banks. Accreditation is mandatory for maintaining status as an AATB institutional member. Based on AATB's Standards for Tissue Banking more than 125 tissue establishments are currently compliant and accredited. These Standards include requirements consistent with applicable FDA regulations and guidance.

The Eye Bank Association of America is a national, non-profit organization offering accreditation service for its 83 U.S. and 12 international member eye banks, ensuring compliance with EBAA-published medical standards. Accreditation is required for active membership in the EBAA. EBAA medical standards define the minimum requirements for the recovery, preservation, processing, storage, and distribution of ocular tissue for transplantation. Medical standards include requirements to maintain eye bank compliance with applicable FDA regulations.

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