The First Recall of a Diabetes Device Because of Cybersecurity Risks

摘要

On June 27, 2019, the U.S. Food and Drug Administration (FDA) announced that they are warning patients and healthcare providers that certain Medtronic MiniMed insulin pumps are being recalled because of potential cybersecurity risks.1 This is a historic decision because it represents the first time that a connected diabetes device has been voluntarily recalled by a manufacturer because of cybersecurity vulnerabilities. Prior to that date, FDA has issued device cybersecurity safety communications only for infusion pumps and implanted cardiac device along with their controllers.2