Table 1 Stakeholders
From: Medical device registries for breast implants - where to?
Stakeholders | Benefits | Prerequisite |
|---|---|---|
Registry | Reporting function | Independent body |
Patients | Product recall, electronic implant identification | Opt-out (=mandatory entry) |
Surgeons | Product recall, implant failure rate, benchmarking | Minimum dataset |
Hospitals | Maintenance of certification, government accreditation | Implementation of registry data entry forms in hospital IT systems |
Industry | Product recall, market share | Unique identification for implants as industry standard |
Insurance | Product recall, implant failure rate | Acceptance by other stakeholders |
Government | Patient safety, regulatory instrument | Legislative framework, data protection |