FDA Warns About Risks of Using Home Use Test Strips that are Pre-Owned or Not Authorized for Sale in U.S.
April 8, 2019 -- Today, the U.S. Food and Drug Administration warned against using test strips from a previous owner (pre-owned) or test strips not authorized for sale in the U.S. because they may potentially cause infection or lead to inaccurate test results, which can cause serious harm, including death. The FDA issued a safety communication alerting patients and health care professionals about the risks of using these kinds of test strips.
“Millions of Americans use test strips at home to monitor serious diseases or conditions. We recognize that some people may be choosing to purchase pre-owned or unauthorized test strips because they believe there is a cost savings. However, by doing so they may be putting themselves at risk for serious injury or even death,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s warning is part of our ongoing public health commitment to communicate when we become aware of issues stemming from the use, or misuse, of medical devices. In alerting the public and helping them to recognize the illegal sale of these products, we hope to prevent unnecessary harm to people who rely on testing.”
Test strips are part of many home use tests that allow people to test for or monitor some diseases or health conditions at home. For example, a person with diabetes may apply blood to a test strip to measure their blood glucose (sugar) level or people on warfarin therapy may apply blood to a test strip to obtain their International Normalized Ratio (INR), a measurement used to monitor individuals on warfarin therapy to determine whether or not they are in their therapeutic range.
The FDA is aware that some sellers are marketing test strips previously owned by another user or test strips that are not authorized for sale in the U.S. to consumers. These test strips may be sold through online marketplaces such as Amazon, eBay, and Craigslist, or directly from a seller.
While the FDA is not aware of any deaths or serious injuries specifically associated with pre-owned warfarin INR or glucose test strips or test strips not authorized for sale in the U.S., the agency is warning consumers about the potential for significant injury from using pre-owned or unauthorized products. These test strips may not be safe to use because they may be expired or may have been stored improperly, which could lead to inaccurate results if used. If a user receives an inaccurate result from a 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. It’s also possible the test strips may have small amounts of blood from the previous owner on them, which can put users at risk of infection from potential cross-contamination.
To determine whether or not a test strip is pre-owned or unauthorized, the FDA recommends inspecting the package to check whether it has been opened or altered and to check expiration dates. If someone is able to purchase prescription-only test strips without a prescription, the products may be unauthorized for sale in the U.S. and should not be used. Test strips should only be purchased from a trusted source, such as a local pharmacy or through the test strip manufacturer. Patients who are unsure about where to buy safe test strips or cannot afford to buy unused test strips should talk with their health care provider or pharmacist. There may be patient assistance programs through test strip manufacturers or consumer advocacy organizations that help provide financial assistance to people who cannot afford to buy test strips. Some test strip manufacturers also offer coupons or prescription cards that may help reduce the cost.
As part of the FDA’s Medical Device Safety Action Plan, the FDA is committed to alerting the public when safety issues are identified, such as surgical staplers, duodenoscopes, and breast implant-associated anaplastic large cell lymphoma. The agency is also working with stakeholders to develop patient registries, including the National Evaluation System for Health Technology, to provide more complete evidence in clinical areas to enhance the agency’s ability to identify and act upon safety issues with medical devices.
As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with the use of test strips. We will keep the public informed if new information becomes available. We encourage patients, providers and health care facilities 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.
Posted: April 2019
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