A fast, cost effective, NHS led service providing independent analysis of explanted medical devices.
Explant analysis available at a previously unattainable price point.
Developments in automation, processes innovation and creation of validated, peer reviewed analysis methods have enabled us to now make explant analysis available at a previously unattainable price point.
Our service enables surgeons and hospitals to access a fast, cost effective analysis service that can provide expert explant reports and even provide completed MHRA Yellow Cards for adverse event submission to national reporting authorities.
‘The Medicines Healthcare products Regulatory Agency (MHRA) is actively involved in discussions and supports the development of implant explant centres. Benefits of implant explant centres include the potential for earlier detection of safety signals relating to medical devices which contributes to improving patient safety. We are keen to ensure that all adverse events identified are reported to the MHRA via the Yellow Card scheme for England and Wales or through national reporting authorities in Scotland and Northern Ireland. Manufacturers hold responsibilities to monitor the safety and performance of their devices. The information in the generated reports can hold rich information to support this. The MHRA would support manufacturers having access to this information and the device post explant for further investigation
SERVICE OPTIONS
The IAS provides two service options:
Single Device Service
Suitable for explants where an issue has been clearly identified. Surgeon can order analysis and full report for single explanted device and hospital is charged for each individual analysis and report.
High Volume Service
Highly cost-effective service that enables analysis and screening of all explanted devices and detailed reporting only on those explanted devices with identified issues.