This article is more than 5 years old. Information may no longer be current.
FDA warns of health risks with 'pre-owned' glucose test strips
Click Here to Manage Email Alerts
The FDA on Monday issued a warning against the use of test strips from a previous owner or test strips not authorized for sale in the U.S. because they may potentially cause infection or lead to inaccurate test results, according to a press release from the agency.
In a safety communication, the FDA alerted patients and health care professionals about the risks of using these kinds of test strips, which it said could cause serious harm, including death. The agency noted 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, often through online marketplaces such as Amazon, eBay, and Craigslist, or directly from a seller.
“We recognize that some people may be choosing to purchase pre-owned or unauthorized test strips because they believe there is a cost savings,” Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “However, by doing so they may be putting themselves at risk for serious injury or even death. 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.”
In addition to test strips used for blood glucose testing, people prescribed 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 the therapeutic range.
Although 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.
Health dangers
The FDA cited several safety concerns with unauthorized or pre-owned test strips. Such products 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 insulin dosing, the person could make an insulin dosing error, 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,” the agency noted in the release.
Purchase from a trusted source
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 be purchased only 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 who 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 Endocrine Today previously reported, patient advocacy groups and diabetes organizations have noted that diabetes supply choices were previously limited for Medicare beneficiaries who bought blood glucose testing supplies through the National Mail-Order Competitive Bidding Program (CBP), likely influencing patient health outcomes. A congressional budget deal announced in February 2018 included several changes to Medicare’s CBP, among them a strengthening of the so-called 50% and anti-switching rules that affect patient access to diabetes testing supplies. The changes also bolstered consumer protections that prohibit suppliers from encouraging beneficiaries to switch from one testing system to another.
After the changes, the American Association of Diabetes Educators called the legislation a “big win for people in the diabetes community.” – by Regina Schaffer
Disclosure: Stenzel is director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.