Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers
Background and purpose: Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory ag...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Medical Journals Sweden
2024-11-01
|
| Series: | Acta Orthopaedica |
| Subjects: | |
| Online Access: | https://actaorthop.org/actao/article/view/42361 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850159365140512768 |
|---|---|
| author | Lotje A Hoogervorst Yijun Ren Tom Melvin Ashley A Stratton-Powell Anne Lübbeke Robert E Geertsma Alan G Fraser Rob G H H Nelissen Enrico G Caiani Perla J Marang-van de Mheen |
| author_facet | Lotje A Hoogervorst Yijun Ren Tom Melvin Ashley A Stratton-Powell Anne Lübbeke Robert E Geertsma Alan G Fraser Rob G H H Nelissen Enrico G Caiani Perla J Marang-van de Mheen |
| author_sort | Lotje A Hoogervorst |
| collection | DOAJ |
| description |
Background and purpose: Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as “outlier.” We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants.
Methods: The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined according to the Medical Device Regulation (MDR) as “a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.” Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports.
Results: 787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with “Manufacturing/Packaging/Shipping” problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA outliers with safety notices.
Conclusion: 55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.
|
| format | Article |
| id | doaj-art-490362f2a52e43cda86ea72564fb7102 |
| institution | OA Journals |
| issn | 1745-3674 1745-3682 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Orthopaedica |
| spelling | doaj-art-490362f2a52e43cda86ea72564fb71022025-08-20T02:23:35ZengMedical Journals SwedenActa Orthopaedica1745-36741745-36822024-11-019510.2340/17453674.2024.42361Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliersLotje A Hoogervorst0https://orcid.org/0000-0001-5343-6965Yijun Ren1https://orcid.org/0000-0001-5361-2447Tom Melvin2Ashley A Stratton-Powell3Anne Lübbeke4https://orcid.org/0000-0002-6905-6120Robert E Geertsma5https://orcid.org/0000-0003-0979-9077Alan G Fraser6Rob G H H Nelissen7https://orcid.org/0000-0003-1228-4162Enrico G Caiani8Perla J Marang-van de Mheen9Department of Orthopaedics, Leiden University Medical Center, Leiden, the NetherlandsDepartment of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, ItalySchool of Medicine, Trinity College Dublin, Dublin, IrelandSchool of Medicine, Trinity College Dublin, Dublin, IrelandDivision of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKCentre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, the NetherlandsDepartment of Cardiology, University Hospital of Wales, Heath Park Way, Cardiff, UKDepartment of Orthopaedics, Leiden University Medical Center, Leiden, the NetherlandsDepartment of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan; Istituto Auxologico Italiano IRCCS, Milan, ItalyDepartment of Orthopaedics, Leiden University Medical Center, Leiden; Safety & Security Science and Centre for Safety in Healthcare, Delft University of Technology, Delft, the Netherlands Background and purpose: Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as “outlier.” We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants. Methods: The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined according to the Medical Device Regulation (MDR) as “a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.” Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports. Results: 787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with “Manufacturing/Packaging/Shipping” problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA outliers with safety notices. Conclusion: 55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance. https://actaorthop.org/actao/article/view/42361Arthroplasty registriesKneeOutliersPerformanceReal-world dataSafety notices |
| spellingShingle | Lotje A Hoogervorst Yijun Ren Tom Melvin Ashley A Stratton-Powell Anne Lübbeke Robert E Geertsma Alan G Fraser Rob G H H Nelissen Enrico G Caiani Perla J Marang-van de Mheen Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers Acta Orthopaedica Arthroplasty registries Knee Outliers Performance Real-world data Safety notices |
| title | Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers |
| title_full | Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers |
| title_fullStr | Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers |
| title_full_unstemmed | Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers |
| title_short | Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers |
| title_sort | safety notices and registry outlier data measure different aspects of safety and performance of total knee implants a comparative study of safety notices and register outliers |
| topic | Arthroplasty registries Knee Outliers Performance Real-world data Safety notices |
| url | https://actaorthop.org/actao/article/view/42361 |
| work_keys_str_mv | AT lotjeahoogervorst safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT yijunren safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT tommelvin safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT ashleyastrattonpowell safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT annelubbeke safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT robertegeertsma safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT alangfraser safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT robghhnelissen safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT enricogcaiani safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers AT perlajmarangvandemheen safetynoticesandregistryoutlierdatameasuredifferentaspectsofsafetyandperformanceoftotalkneeimplantsacomparativestudyofsafetynoticesandregisteroutliers |