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 United States

Abstract

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.

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics.

“…Currently, regulatory agencies rely primarily on passive surveillance systems to detect the presence of AEs and ARs, a common example being surveillance systems to monitor potential adverse effects of vaccines [12,13]. This model has also been used for other healthcare-related purposes, such as monitoring the safety of point-of-care products, new healthcare products and dengue prevention [14][15][16]. However, the success of these systems is largely dependent on spontaneous reporting by both patients and healthcare professionals, the individual's discretion in recognizing when an AE should be recorded, and their ability to submit a thorough report for assessment [17,18].…”

Real-World Evidence of Point-of-Care Glucometers: Enhanced Passive Surveillance and Adverse Event Reporting Status in Korea and the United States

“…The product codes for the POC glucometers used in Korea and the United States were obtained from the blood glucose test system and NBW (System, Test, Blood Glucose, Over The Counter), respectively. Collected AEs were classified using International Medical Device Regulators Forum (IMDRF) codes for medical device problems (Annex A) and clinical signs and symptoms or conditions (Annex E) [ 9 , 10 ]. This study did not require Institutional Review Board approval, because it did not involve human subjects, including any interaction or intervention with human subjects, or access to identifiable private information.…”