Design, implementation, and management of an international medical device registry.

ABSTRACT:

Background

Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success.

Methods

We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants.

Results

We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in

SUBMITTER: Mauch H 

PROVIDER: S-EPMC8613936 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature