FDA Warns About Home-Built Diabetes Management Devices

reported that in the wake of an accidental insulin overdose involving a home-built artificial pancreas system, the Food and Drug Administration issued a warning about the use of similar devices. The agency warned that despite individual components generally being “approved by the FDA, they haven’t been tested or cleared for use together.” The article explains that a large group of people with diabetes have been using “hacked-together, do-it-yourself systems to control their disease” that are “meant to require little effort by the patient” after initial set-up. https://www.bloomberg.com/news/articles/2019-05-17/patient-hurt-by-do-it-yourself-pancreas-prompting-fda-warning?srnd=premium