The Need for Greater Reporting of Medical Device Incidents
Post-market monitoring of medical devices by manufacturers and regulatory agencies aids the identification of novel hazards or increasing trends in the risks associated with devices. This narrative review estimates the rates of under-reporting of medical device adverse events and explores the rea...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Medical Journal
2019-01-01
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| Series: | European Medical Journal Innovations |
| Subjects: | |
| Online Access: | https://www.emjreviews.com/innovations/article/the-need-for-greater-reporting-of-medical-device-incidents/ |
| _version_ | 1819037322555949056 |
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| author | Amanda Craig Patrick O’Meley Pamela Carter |
| author_facet | Amanda Craig Patrick O’Meley Pamela Carter |
| author_sort | Amanda Craig |
| collection | DOAJ |
| description | Post-market monitoring of medical devices by manufacturers and regulatory agencies aids the
identification of novel hazards or increasing trends in the risks associated with devices. This narrative
review estimates the rates of under-reporting of medical device adverse events and explores the
reasons and possible solutions. Incident reports may be presented to the manufacturer or the
regulatory agency spontaneously by consumers, patients, clinicians, or distributors of medical
devices. However, it is evident that reporting does not occur to a great extent, with the rate of
reporting estimated to be as low as 0.5% of all occurrences. The programmes and processes to
increase and support the reporting of adverse events need to be reviewed, with consideration given
to the cost-benefit of increased reporting in relation to the regulator, regulated entities, healthcare
facilities, and professionals, as well as the public. |
| first_indexed | 2024-12-21T08:19:35Z |
| format | Article |
| id | doaj.art-d97c9fbf2954457cb7bc2fbd418b6bc5 |
| institution | Directory Open Access Journal |
| issn | 2513-8634 |
| language | English |
| last_indexed | 2024-12-21T08:19:35Z |
| publishDate | 2019-01-01 |
| publisher | European Medical Journal |
| record_format | Article |
| series | European Medical Journal Innovations |
| spelling | doaj.art-d97c9fbf2954457cb7bc2fbd418b6bc52022-12-21T19:10:29ZengEuropean Medical JournalEuropean Medical Journal Innovations2513-86342019-01-01315663The Need for Greater Reporting of Medical Device IncidentsAmanda Craig0Patrick O’Meley1Pamela Carter2Medical Devices Branch, Health Products Regulation Group, Department of Health, Canberra, AustraliaMedical Devices Branch, Health Products Regulation Group, Department of Health, Canberra, AustraliaMedical Devices Branch, Health Products Regulation Group, Department of Health, Canberra, AustraliaPost-market monitoring of medical devices by manufacturers and regulatory agencies aids the identification of novel hazards or increasing trends in the risks associated with devices. This narrative review estimates the rates of under-reporting of medical device adverse events and explores the reasons and possible solutions. Incident reports may be presented to the manufacturer or the regulatory agency spontaneously by consumers, patients, clinicians, or distributors of medical devices. However, it is evident that reporting does not occur to a great extent, with the rate of reporting estimated to be as low as 0.5% of all occurrences. The programmes and processes to increase and support the reporting of adverse events need to be reviewed, with consideration given to the cost-benefit of increased reporting in relation to the regulator, regulated entities, healthcare facilities, and professionals, as well as the public.https://www.emjreviews.com/innovations/article/the-need-for-greater-reporting-of-medical-device-incidents/adverse eventsbreast implantstherapeutic goods administration (tga)under-reportingurogynaecological meshventilatorsvigilance |
| spellingShingle | Amanda Craig Patrick O’Meley Pamela Carter The Need for Greater Reporting of Medical Device Incidents European Medical Journal Innovations adverse events breast implants therapeutic goods administration (tga) under-reporting urogynaecological mesh ventilators vigilance |
| title | The Need for Greater Reporting of Medical Device Incidents |
| title_full | The Need for Greater Reporting of Medical Device Incidents |
| title_fullStr | The Need for Greater Reporting of Medical Device Incidents |
| title_full_unstemmed | The Need for Greater Reporting of Medical Device Incidents |
| title_short | The Need for Greater Reporting of Medical Device Incidents |
| title_sort | need for greater reporting of medical device incidents |
| topic | adverse events breast implants therapeutic goods administration (tga) under-reporting urogynaecological mesh ventilators vigilance |
| url | https://www.emjreviews.com/innovations/article/the-need-for-greater-reporting-of-medical-device-incidents/ |
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