Insulin Pumps Need Greater Safety Review

Alexandria, Virginia
March16,2015

Not enough is known about the safety and efficacy of insulin pumps, and a comprehensive safety overhaul including greater access to data from pump manufacturers and public funding of research on the use of insulin pumps is needed to allow health care teams to educate and support those using the devices, according to a joint statement by the American Diabetes Association and the European Association for the Study of Diabetes, being published concurrently online on March 16 and it will appear in the April issue of Diabetes Care.

The statement includes a list of recommendations intended to stimulate the adoption of a more rigorous, standardized and transparent approach to safety. Currently, the U.S. Food and Drug Administration (FDA) conducts more rigorous reviews of devices such as pumps than the European Union. The statement therefore calls upon the FDA and EU to harmonize standards for pump manufacturing companies. It also recommends providing a single, publicly accessible, international database for reporting adverse events, including both technical and human errors; requiring pump manufacturers to provide access to information, such as how many people use their products and the results of studies testing new features of pump design; and providing greater funding for independent clinical trials of safety, efficacy, outcomes and adherence under real world conditions, among other suggestions. A full list of recommendations can be seen http://dx.doi.org/10.2337/dc15-0168.