In the safety communication issued today, the agency noted that the use of unapproved or unauthorized devices could result in inaccurate blood glucose (sugar) measurements or unsafe insulin dosing, which can lead to injury requiring medical intervention or even death.

“Millions of Americans use continuous glucose monitors and insulin delivery devices to monitor and treat their diabetes. 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 they use devices not authorized for sale in the U.S. By using products that have not been reviewed by the agency for safety and effectiveness, patients with diabetes may be putting themselves at risk for serious injury or even death,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s 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.”

There are many types of devices that patients use to manage diabetes. A continuous glucose monitoring system uses a sensor and transmitter to continuously track a patient’s glucose levels at all times. An insulin pump is a small computerized device that delivers insulin through a catheter (a small, flexible tube) placed under a person’s skin throughout the day. An automated insulin dosing system is a system that is intended to automatically deliver insulin doses based on glucose measurements from a continuous glucose monitoring system.

Some of these diabetes management devices may be reviewed by the FDA as a whole system or they may be reviewed to be compatible with other FDA authorized 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.

The FDA is aware of manufacturers illegally marketing unauthorized devices for diabetes management, which have not been reviewed by the agency for safety and effectiveness. Companies are also illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems. Additionally, the FDA is aware of patients combining devices or components that are not intended for use with other devices.

When devices that are not intended for use with other devices are combined or when unauthorized devices are used, new risks are introduced that have not been properly evaluated by the FDA for safety. Patient use of unauthorized diabetes management devices, alone or in conjunction with other devices, 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 (buildup of acids in blood) and death.

The FDA is aware that patients may choose to create these systems or purchase unauthorized or unapproved components or systems because of personal preference or for cost reasons. The agency is concerned that patients may not fully be aware of the risks of using components or systems not reviewed by the FDA. The agency has received a report of a serious adverse event in which a patient’s use of an illegally marketed continuous glucose monitoring system along with an unauthorized automated insulin dosing system resulted in insulin overdose requiring medical attention.

The FDA recommends that patients talk with their doctor about appropriate diabetes management devices for their needs and to only use devices and components that have been reviewed by the agency for safety and effectiveness. Patients who are concerned about the cost or availability of FDA-reviewed systems, should talk with their doctor and insurance provider about coverage and appropriate alternative options.

The FDA recognizes that patients with chronic conditions, such as diabetes, prefer to have multiple treatment and management options that can be tailored to fit their specific needs. The agency has been working to review and authorize diabetes management devices that patients can tailor, such as the first interoperable insulin pump and fully implantable continuous glucose monitor with compatible mobile app, and is committed to continuing to streamline regulatory pathways to promote innovation and patient access to these types of products.

As part of the FDA’s Medical Device Safety Action Plan, the FDA is committed to monitoring the safety of medical devices throughout a product’s total lifecycle and alerting the public when safety issues are identified, such as the agency’s recent communication regarding purchasing pre-owned or unauthorized test strips, including those used for glucose testing.

As part of this critical work, the FDA will continue to closely monitor reports of adverse events associated with the use of unauthorized devices for diabetes management and will keep the public informed if new information becomes available. The agency encourages patients and health care professionals to report adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: Company Press Release.