Résumé
A global effort was made to respond to COVID-19 using convalescent plasma therapy. The United States Food and Drug Administration Emergency Use Authorization facilitated rapid deployment, enabling the treatment of 94,287 patients by August 2020. The guidelines continuously evolved to emphasize the importance of a high titer plasma and specific immunocompromised patient groups. Korea has developed guidelines for treatment with convalescent plasma based on the successful treatment of two patients. By December 2023, convalescent plasma was collected from 67 donors at nine blood centers and transfused to 67 patients at 10 hospitals in Korea. The Association for the Advancement of Blood and Biotherapies recommendations, based on recent research, are believed to encompass the therapeutic effects of convalescent plasma therapy in COVID-19 patients. Korea initially considered convalescent plasma but experienced difficulties in development because of the switch to hyperimmune globulin and monoclonal antibodies. The insights gained from COVID-19 convalescent plasma treatment will be helpful in future pandemics caused by new infectious agents, underscoring the importance of domestic readiness for timely policy implementation.
Résumé
Background@#Due to the importance of the cold chain related to vaccine transportation, it is necessary to establish a blood cold chain operation strategy by checking the status of blood transportation from blood donation to transfusion. @*Methods@#The blood transportation system and blood storage facilities were checked by inspecting the Korean Red Cross (KRC) Blood Centers and its affiliated supplier and Hanmaeum Blood Center. The status of the cold chain was evaluated through an interview with the quality control manager or blood supply team leader. For the hospital, the status was investigated from the perspective of the 30-min rule. A questionnaire survey was conducted for medical technicians and nurses working at the hospital. @*Results@#Data on temperature during transport of blood components were computerized, and all standards were met. A nationwide network that could supply blood from the blood supply center to the hospitals within 2 hours was established. The frequency of temperature monitoring in the blood transport box and constant temperature check in the transport box during long-distance transport were evaluated. @*Conclusion@#This study confirmed that blood storage and transportation in Korea complied with the cold chain standards of high-income countries or higher. The evaluation of the cold chain is a constantly evolving process requiring continuous attention. When standards for storage and transportation of blood products are established, strict regulations and examinations will be required.
Résumé
Information on the blood safety management system in Japan was collected by visiting the Ministry of Health, Labour and Welfare (MHLW), Japanese Red Cross Blood Service Headquarter, Kanto-Koshinetsu Block Blood Center, and Yurakucho Blood Room of Tokyo Metropolitan Blood Center, in July 2014, to improve the quality of the blood management system in Korea. In Japan, all blood products are supplied by the Japanese Red Cross Blood Service. In April 2012, the function of screening tests and blood product production of the provincial blood centers was transferred to the block blood centers. Donor suitability is assessed by medical doctors and EKG was tested for donors over 40 years old annually. To prevent bacterial contamination, the shelf life of platelets was shortened to 4 days after production, but routine bacterial screening test was not performed. Adverse reactions and infection following transfusions are reported to MHLW through the Red Cross Blood Service, and the case was reviewed by Pharmaceuticals and Medical Devices Agency (PMDA). Before transfusion, HBsAg, anti-HBs, anti-HBc, anti-HCV, and HCVcAg of the recipient is tested, and testing for HIV antigen is performed if the recipient has risk factors for HIV infection. Even when hepatitis B NAT is positive, look back is not performed if anti-HBc is negative and there is no history of blood donation within 125 days before the current donation. Good Manufacturing Practice (GMP) for blood centers was introduced in the 1990s and PMDA performs the test every 5 years. In introduction of GMP in Korea, it is necessary to decide how to absorb the expense.