This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.