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FDA Issues Safety Alerts for Some At-Home Tests

July 8, 2019

The Food and Drug Administration (FDA) recently issued safety warnings on home testing equipment that has not been approved by the FDA, including devices to manage diabetes and home-use test strips. Millions of Americans use home testing systems to help manage serious conditions on a daily basis. The concern, according to the agency, is that use of unapproved equipment could result in injuries to patients and even death.
Diabetes Management Devices
Individuals with diabetes may use devices, including continuous glucose monitoring (CGM) devices, insulin pumps, and automated insulin dosing systems, alone or in combination, to manage their condition. The FDA must evaluate the safety and effectiveness of these devices before they can be approved for sale in the U.S. The agency also evaluates and approves specific configurations or combinations of these devices together as systems.
In May 2019, the agency issued an alert about risks associated with the use of unapproved CGM devices, insulin pumps, and automated insulin dosing systems. Some manufacturers are illegally marketing these devices that have not been reviewed by the FDA for safety and effectiveness. Additionally, some patients are combining devices or components that are not intended for use with other devices (e.g., combining an unapproved CGM device with an unapproved automated insulin dosing system).
The FDA sent out the alert in response to a serious adverse event requiring medical attention that occurred when an individual used two unapproved devices to test their glucose and deliver their dose of insulin.
"Because of the complexity of these devices and the lifesaving 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.," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in the alert. "[This] 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 has recommendations for people who use diabetes management devices, including:
· Talk to your healthcare practitioner about the devices you use to monitor your glucose and how to use them correctly.
· Only use devices that the FDA approved for marketing in the U.S. and follow the manufacturer instructions.
· Contact the FDA at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100 if you have questions about whether the FDA has approved a particular product or system.
· Be aware that the FDA has not evaluated the safety and effectiveness of unapproved diabetes management devices or of systems that combine devices in ways that the manufacturers did not intend.
· Using unapproved devices or combining devices in unapproved ways may give you inaccurate results and have unknown risks.
For additional precautions, read the full FDA alert for diabetes management devices.
Home Test Strips
In April 2019, the FDA warned against using test strips from a previous owner or test strips not approved for sale in the U.S. because they may potentially cause blood-borne infections (e.g., hepatitis) or lead to inaccurate test results, which can cause serious harm, including death.
Test strips are part of many home-testing kits that people use to test for or monitor treatment of some conditions or diseases. For example, an individual being treated with warfarin to lower the risk of blood clots may use test strips with a testing device to monitor their INR (international normalized ratio). Monitoring the INR helps to ensure the warfarin dose is sufficient in preventing clots without causing excessive bleeding.
The FDA has not had any specific reports of adverse effects related to tests strips but has several concerns about their use, including:
· Tests strips sold or provided by a previous owner could be expired or may have been stored improperly, which could lead to inaccurate results if used.
· Even if previously owned test strips have not been used for testing, they may have small amounts of blood on them if the previous owner handled them while they had blood on their hands. This can put users at risk of blood-borne infections from potential cross-contamination.
· Test strips not approved to be sold in the U.S. may be of poor quality or not work properly.
· If a user receives an inaccurate result from an unapproved test strip and uses this result as a basis for their treatment, they could take too much medication or not enough medication, potentially leading to serious injury, including death.
According to the FDA, pre-owned or unapproved test strips are often sold through online marketplaces. However, test strips should only be purchased from a trusted source, such as a local pharmacy or through the test strip manufacturer. Furthermore, testing devices should only be used with their specific test strips. The devices should not be used with less expensive or alternative strips marketed by other manufacturers because those combinations have not been approved by the FDA.
The FDA advises people to check to see if products they have could be unapproved or previously owned by inspecting test strip packages to see if they have been tampered with or opened or if the test strips are past their expiration dates.
For additional safety tips, read the full FDA alert for home testing strips.