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
SETTING UP THE SERVICE
IAS has a simple efficient process for setting up the Implant Analysis Service in hospital trusts
Hospital and IAS liaise to implement the service
Processes and training supported by IAS with procurement, theatres and logistics
IAS provide approved containers for shipping of biohazardous materials
UMD shipped from hospital to lab for decontamination and analysis
Analysis results reviewed by lab, flagged where appropriate and reports completed
Report emailed to surgeon and UMD held in storage
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.
- Hospital pre-purchases explant analysis in units of 10.
- Devices are analysed and surgeon receives a screening report to inform them if the explanted device has performed within expected parameters, or if an issue has been identified.
- In the case of an identified issue the surgeon can purchase the full report for that specific device.
- For hospital analysing all their explanted joints an annual report providing insights and trends on device performance can be purchased.
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