The pair of research advocacy groups conducted a joint review of systems in place to evaluate the safety of insulin pumps and “found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner.” In the letter, the advocacy groups offer a list of recommendations to improve safety for the devices. They also call for harmonization of standards for pump manufacturing between U.S. and EU regulatory agencies. The statement recommends a single, publicly accessible, international adverse event reporting database, as well as requiring insulin pump manufacturers to disclose data on how many people are using their products as well as the results of studies to test additional pump design features. The groups also call for more funding for independent observational studies and clinical trials to assess “clinically important questions in relation to pump therapy.”
“Technology is evolving rapidly for treating diabetes. While that’s certainly a good thing, we don’t have very good post-marketing surveillance for devices such as insulin pumps, particularly in Europe where manufacturers often introduce products prior to releasing them in the United States,” Dr. Anne Peters, director of the University of Southern California Clinical Diabetes Program and one of the lead authors, said in a statement. “We need to make sure we have sufficient data about how the devices are working once they hit the market, so that we can support patients by helping them understand how to prevent errors in using them,” Peters concluded.
She cited patient difficulties with insulin pump breakage–that can then require a few days to obtain a replacement. Peters suggested that patients have a “pump failure plan” that includes documentation of the current pump settings and having long-acting insulin available.
About 1 million people use insulin pumps for continuous subcutaneous insulin infusion, mostly Type 1 diabetics but also some Type 2 patients.
REFERENCE: Fierce Medical Devices; 18 MAR 2015; Stacy Lawrence