SAMED has updated its position paper on medical device registries. The medtech industry is committed to the principles of evidence-based medicine, and as such registries play an important role in gathering useful information about the safety and effectiveness of interventions involving medical devices and diagnostics if designed and executed correctly.
SAMEDs revised registry principles will help achieve this aim. To précis, the principles are intended to provide guidance to medical technology companies considering registry initiatives and to facilitate the development of registries by sharing industry’s perspective with other stakeholders involved in registry development. Registries can help improve patient outcomes by providing greater understanding of the effects of products in the real world and can facilitate patient access to new therapies by efficiently collecting accurate data to support expanded device use and indications, but to realize these benefits, it is important that medical device registries be carefully designed, implemented and maintained.
A key component of the SAMED principles are a series of “threshold questions” intended to assure the creation of a registry is the appropriate mechanism for meeting the defined objective:
- Are there reliable data collection instruments available to collect the data needed to achieve the objectives?
- Will the registry have a stable and diverse source of funding to promote long-term sustainability?
- Is using a registry the least-burdensome means to collect the necessary data to achieve the scientific objectives?
- Do the objectives warrant the level of investment required to develop and maintain a registry?
Other key elements include the establishment of a data governance committee to oversee issues on ownership, access and use of any data collected; prospective registry design, objectives and data analysis plans; policies for sharing of data with scientific or medical researchers and policies for the use and publication of registry data.