Which Health Impacts of Medical Device Adverse Event Should Be Reported Immediately in Korea?

Choi, Sooin; Choi, Soo Jeong; Kim, Jin Kuk; Yoon, Chiho; Nam, Ki Chang; Kwon, Bum Sun; Lee, You Kyoung

doi:10.1097/pts.0000000000000877

Cited by 2 publications

(1 citation statement)

References 7 publications

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“…의료기기는 질병의 진단, 예방, 치료에 중요한 역할을 하지만, 심각한 부상과 사망의 잠 재적 위험이 수반되기도 한다. 의료기기 이상사 례의 적절한 수집, 평가, 분석 및 전파를 통한 의 료기기 감시는 공중 보건 보호에 매우 중요하다 [4]. 하지만 의료인들의 의료기기 안전성에 대한 인식은 부족한 실정으로 [5], 지금까지 국내에서 수혈관련 의료기기의 이상사례에 대한 문헌보고 는 없었다.…”

Section: 서 론unclassified

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

Choi

Kim

et al. 2022

Korean J Blood Transfus

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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.

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Section: 서 론unclassified

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

Choi

Kim

et al. 2022

Korean J Blood Transfus

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The application study of harmonization code in medical device adverse event reporting

Choi,

Park

et al. 2024

BMC Health Serv Res

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Background The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events. Methods An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases. Results All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders. Conclusions We identified the diversification in terminology and code selection for reporting MDAEs. Supplementary Information The online version contains supplementary material available at 10.1186/s12913-024-11885-1.

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Which Health Impacts of Medical Device Adverse Event Should Be Reported Immediately in Korea?

Cited by 2 publications

References 7 publications

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

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

The application study of harmonization code in medical device adverse event reporting

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