Reassurance for Transplant Recipients

From now on, patients receiving transplants of bone, skin, or cardiac valves can rest easier regarding the safety of their new tissue.

For the first time in Korean history, 17 government-authorized human tissue banks have been established. These banks are responsible for providing safe tissue for transplant according to the “Law on the Safety and Management of Human Tissue,” which was enacted last year and put into effect at the start of the current year.

The Korea Food & Drug Administration (KFDA) announced on January 7 that it has officially authorized eight medical institutions, including the Seoul National University Hospital, the Samsung Medical Center, and the Korea University Medical Center, as well as various tissue processors, handlers, and importers, as human tissue banks.

In future, all medical institutions must use tissue provided by these designated banks, with the sole exception of tissue used in autografts (transplants taken from one part of a person`s body and transferred to another part of the same person).

Previously, tissue taken from donors within Korea did not require a separate safety evaluation, which resulted in a relatively high possibility of secondary infections, such as AIDS and Hepatitis B, among transplant recipients.

Such negative side effects will be greatly reduced by the establishment of these official tissue banks, since they can “guarantee” the safety of transplant-eligible tissue through meticulous inspection and disinfection of donors and their tissue.

Anyone who provides or transplants tissue that is infected with a contagious disease, in danger of cancer metastasis, or taken from a donor whose cause of death is uncertain will be sentenced to a minimum of two years to a maximum of life in prison.

A medical institution that has performed a transplant must make a record of the results and submit them to the relevant tissue bank. Any serious side effect, including infectious diseases or malignant tumors, must be reported to the KFDA. Violation of these regulations will incur a fine of three million won or less.

A KFDA official stated, “We anticipate that enhancing the safety of domestically supplied human tissue will improve the public’s perception of transplanting and increase tissue donation within Korea,” and added, “This will lessen the need to import expensive tissue from abroad, thus reducing the patients’ financial burden as well.”

At present, Korean hospitals import a substantial amount of tissue from abroad due to limited domestic availability.

In the case of the amnion (the inner of the two fetal membranes), used for patients with corneal damage, it costs 100,000 won if obtained domestically, but can costs as much as 700,000 won if imported.

Meanwhile, the KFDA plans to inspect 23 additional facilities, including the Kyungpook National University Hospital, and decide on their authorization before the end of January at the earliest.

In addition, the types of tissue handled by tissue banks—which currently encompasses the nine types of bone, cartilage, tendon, ligament, cardiac valve, blood vessel, skin, amnion, and myofascia—will be gradually expanded to reflect the views of the medical industry, academic community, and patients.

Kyung-Joon Chung news91@donga.com