OMRC will be hosting their SA National Diabetes Dataregistry Project Initiation Workshop on 2 November 2021. The goal of the workshop is to convene and lead a discussion about the importance of surveillance in diabetes and how a SA National Diabetes Dataregistry project should be initiated and create a working group/approach to take this forward. It is urged that any and all SAMED members involved in diabetes consider attending as this may impact your company/products. Register for the workshop here.
SAMED has a petition paper on Medical Device Registries that should also be consulted and we urge members to ensure that registries you participate in are designed and implemented considering the principles contained therein.
The medical technology industry is committed to the principles of evidence-based medicine. 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. It is anticipated that SAMEDs revised registry principles will help achieve this aim. The principles are intended to provide guidance to medical technology companies (SAMED members) considering registry initiatives and to facilitate the development of registries by sharing the 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 a 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 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 the 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.