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

Herbert Mauch,Jasmin Kaur,Colin Irwin,Josie Wyss

doi:10.1186/s13063-021-05821-5

Abstract

BackgroundRegistries 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.MethodsWe summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants.ResultsWe 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 design and implementation and make recommendations for future registries.ConclusionsData collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine.Trial registrationClinicalTrials.gov NCT02004353. 9th December 2013.

Highlights

A registry has been defined as ‘an organized system that uses observational methods to collect defined clinical data under normal conditions of use relating to one or more medical devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical or policy purpose(s)’ [20]
There are many types of medical registries, most of which are concerned with drug safety and efficacy, or are disease-specific registries, including rare diseases, or based on medical devices focused on safety and effectiveness
The registry would have the advantage over clinical trials involving cross-culturally adapted patient-reported outcome measures allowing broader participation by clinics, and their treatment groups, which are representative of less biased target populations [35, 38]

Summary

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. We report the challenges and successes in design and implementation and make recommendations for future registries

Conclusions

Introduction

Design

Availability of data and materials Not applicable