백혈구제거필터 및 수혈세트의 이상사례: 단일기관 보고 경험 및 한국과 미국의 보고현황 (Adverse Events Associated with the Use of Leukocyte Reduction Filters and Blood Transfusion Sets: Experience of a Single Institute in Korea and Status of Adverse Event Reporting in Korea and the Unite)

서지정보

· 발행기관 : 대한수혈학회
· 수록지 정보 : 대한수혈학회지 / 33권 / 3호 / 161 ~ 170페이지
· 저자명 : 최수인, 최수정, 김진국, 이진형, 이유경

초록

Background: Leukocyte reduction filters (LRF) and blood transfusion sets (BTS) are frequently used medical devices to prevent blood transfusion-related adverse reactions. This study attempted to analyze these medical devices related adverse events reported by an institution for 10 years and to understand the status of such reports in Korea and the United States (U.S.).
Methods: From January 2013 to October 2022, adverse events reported at Soonchunhyang university Bucheon hospital (SCHBC) were analyzed. From 2016 to 2022, adverse events registered in the Korean Medical Device Information Portal and the Total Product Life Cycle (TPLC) database of the U.S. were collected and evaluated using the International Medical Device Regulators Forum (IMDRF) code for medical device problems, clinical signs, and symptoms or conditions.
Results: A total of 12, 47, and 1,422 events were identified in SCHBC, Korea, and the U.S., respectively. The medical device problems reported in BTS included fluid leakage, breakage, disconnection, and no flow. In LRF, device or reagent problems, coagulation of device or device components, and filtration problems were reported. Most of the clinical signs and symptoms or conditions were not applicable (98.1%, 1,453/1,481), but hypotension and hemolysis were reported in LRF.
Conclusion: To improve the safety of transfusion-related medical devices such as LRF and BTS, proper attention needs to be paid to adverse events and all medical institutions should participate in the reporting of such events.
The various adverse events and associated IMDRF codes included in this study would help enable reporting of adverse events and improve patient safety. (Korean J Blood Transfus 2022;33:161-170)

영어초록

Background: Leukocyte reduction filters (LRF) and blood transfusion sets (BTS) are frequently used medical devices to prevent blood transfusion-related adverse reactions. This study attempted to analyze these medical devices related adverse events reported by an institution for 10 years and to understand the status of such reports in Korea and the United States (U.S.).
Methods: From January 2013 to October 2022, adverse events reported at Soonchunhyang university Bucheon hospital (SCHBC) were analyzed. From 2016 to 2022, adverse events registered in the Korean Medical Device Information Portal and the Total Product Life Cycle (TPLC) database of the U.S. were collected and evaluated using the International Medical Device Regulators Forum (IMDRF) code for medical device problems, clinical signs, and symptoms or conditions.
Results: A total of 12, 47, and 1,422 events were identified in SCHBC, Korea, and the U.S., respectively. The medical device problems reported in BTS included fluid leakage, breakage, disconnection, and no flow. In LRF, device or reagent problems, coagulation of device or device components, and filtration problems were reported. Most of the clinical signs and symptoms or conditions were not applicable (98.1%, 1,453/1,481), but hypotension and hemolysis were reported in LRF.
Conclusion: To improve the safety of transfusion-related medical devices such as LRF and BTS, proper attention needs to be paid to adverse events and all medical institutions should participate in the reporting of such events.
The various adverse events and associated IMDRF codes included in this study would help enable reporting of adverse events and improve patient safety. (Korean J Blood Transfus 2022;33:161-170)

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