The application study of harmonization code in medical device adverse event reporting
Abstract 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 r...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-11-01
|
| Series: | BMC Health Services Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12913-024-11885-1 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846165428720631808 |
|---|---|
| author | Soo Jeong Choi Sooin Choi Songhyeon Park Ki Chang Nam Hye Jung Jang Jin Kuk Kim You Kyoung Lee Hiroshi Ishikawa Eric Woo |
| author_facet | Soo Jeong Choi Sooin Choi Songhyeon Park Ki Chang Nam Hye Jung Jang Jin Kuk Kim You Kyoung Lee Hiroshi Ishikawa Eric Woo |
| author_sort | Soo Jeong Choi |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-bc37bc1ccc294561bb9e4f89c91dc682 |
| institution | Kabale University |
| issn | 1472-6963 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj-art-bc37bc1ccc294561bb9e4f89c91dc6822024-11-17T12:17:00ZengBMCBMC Health Services Research1472-69632024-11-0124111110.1186/s12913-024-11885-1The application study of harmonization code in medical device adverse event reportingSoo Jeong Choi0Sooin Choi1Songhyeon Park2Ki Chang Nam3Hye Jung Jang4Jin Kuk Kim5You Kyoung Lee6Hiroshi Ishikawa7Eric Woo8Division of Nephrology, Department of Internal Medicine, Soonchunhyang University College of MedicineCenter for Medical Device Safety Information Monitoring, Soonchunhyang University Bucheon HospitalSoonchunhyang Medical Device Clinical Research Center, Soonchunhyang UniversityDepartment of Medical Engineering, Dongguk University College of MedicineDepartment of Medical Devices, Clinical Trial Center, Yonsei University Health System Severance HospitalDivision of Nephrology, Department of Internal Medicine, Soonchunhyang University College of MedicineCenter for Medical Device Safety Information Monitoring, Soonchunhyang University Bucheon HospitalAdvanced Biomedical Research, University of YamanashiECRI InstituteAbstract 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.https://doi.org/10.1186/s12913-024-11885-1Medical devicesSafety managementAdverse eventPost-market surveillanceIMDRFInternational medical device regulators forum |
| spellingShingle | Soo Jeong Choi Sooin Choi Songhyeon Park Ki Chang Nam Hye Jung Jang Jin Kuk Kim You Kyoung Lee Hiroshi Ishikawa Eric Woo The application study of harmonization code in medical device adverse event reporting BMC Health Services Research Medical devices Safety management Adverse event Post-market surveillance IMDRF International medical device regulators forum |
| title | The application study of harmonization code in medical device adverse event reporting |
| title_full | The application study of harmonization code in medical device adverse event reporting |
| title_fullStr | The application study of harmonization code in medical device adverse event reporting |
| title_full_unstemmed | The application study of harmonization code in medical device adverse event reporting |
| title_short | The application study of harmonization code in medical device adverse event reporting |
| title_sort | application study of harmonization code in medical device adverse event reporting |
| topic | Medical devices Safety management Adverse event Post-market surveillance IMDRF International medical device regulators forum |
| url | https://doi.org/10.1186/s12913-024-11885-1 |
| work_keys_str_mv | AT soojeongchoi theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT sooinchoi theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT songhyeonpark theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT kichangnam theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT hyejungjang theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT jinkukkim theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT youkyounglee theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT hiroshiishikawa theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT ericwoo theapplicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT soojeongchoi applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT sooinchoi applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT songhyeonpark applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT kichangnam applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT hyejungjang applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT jinkukkim applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT youkyounglee applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT hiroshiishikawa applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting AT ericwoo applicationstudyofharmonizationcodeinmedicaldeviceadverseeventreporting |