The Advanced Medical Technology Association (AdvaMed) announced today the release of revised principles for the creation and maintenance of medical device registries.
Approved by AdvaMed’s Board of Directors, 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. The revised principles include a series of “threshold questions” and provide greater detail on the key principles that should guide the development of device registries.
“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,” said Stephen J. Ubl, president and CEO of AdvaMed. “But to realize these benefits, it is important that medical device registries be carefully designed, implemented and maintained.”
A key component of the revised AdvaMed principles are a series of “threshold questions” intended to assure that 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?
In addition, the principles outline several key elements that should guide the development of any medical device registry, including: establishment of a data governance committee to oversee issues on ownership, access and use of any data collected; prospective registry design, to establish clear objectives and data analysis plans; policies for sharing of data collected with qualified scientific or medical researchers; and policies for the use and publication of registry data.
“The medical technology industry is committed to the principles of evidence-based medicine,” Ubl said. “Registries can be an important tool for gathering useful information about the safety and effectiveness of interventions involving medical devices and diagnostics, but only if they are designed and executed properly. AdvaMed’s revised registry principles will help achieve this aim.”
A copy of AdvaMed’s revised Registry Principles can be obtained here.