The Food and Drug Administration is warning the public against using medical strips not authorized for sale in the United States.
Some sellers have started offering medical test strips through online marketplaces such as Amazon, eBay, and Craigslist. While many of these products claim to have the same efficacy as those available in pharmacies and other drug stores, they do not necessarily have the same safe-to-use guarantee.
Pre-Owned Or Unauthorized Test Strips
In fact, the FDA even discourages consumers from patronizing test strips sold by unauthorized sellers since they might not have undergone proper safety testings.
This could lead to inaccurate home test results, which are dangerous for people with serious medical conditions such as blood clots and diabetes.
The federal agency also cautioned patients and healthcare providers about using pre-owned test strips as they may potentially cause infections.
Tim Stenzel, a representative from the Center for Devices and Radiological Health, explained that the FDA is aware that some consumers choose to buy pre-owned or unauthorized test strips to save money. However, they may also be placing themselves at risk for serious injury or death by doing so.
"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," Stenzel said.
"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."
Home Use Tests
Millions of people in the United States depend on home use medical tests to closely monitor their health conditions.
Diabetes patients use test strips to check their blood if its sugar levels are still within regular range. Meanwhile, people undergoing warfarin therapy rely on such home use tests to measure their International Normalized Ratio.
The FDA has been keeping an eye on pre-owned test strips and those offered by unauthorized sellers, many of which are currently being made available online.
There are no reported cases of any serious injuries or deaths related to the use of such products. However, the agency has already taken steps to warn consumers about the potential of pre-owned or unauthorized home use tests to cause significant injury.
The FDA said test strips bought online may be expired or not properly stored, making them unsafe to use by patients. They may not produce an accurate test result, which is crucial for disease sufferers to receive the correct dosage for their treatment.
Some pre-owned home use test strips may be contaminated with blood from the previous owner, increasing the risk for infection for the next user.
To find out whether home use test strips are pre-owned or unauthorized, consumers are advised to check whether the packaging has been altered or already opened. They should also look for the expiration dates on the box.
If a person is able to buy prescription-only test strips even without a prescription, chances are the product is not authorized for sale in the United Sates. The FDA said such medical test strips should not be used.
Consumers should only buy test strips from trusted sources, such as pharmacies or product makers themselves.
Patients should consult their local pharmacist or healthcare provider if they are not sure whether the home use test they bought are unsafe, or if they cannot afford to buy products that are not pre-owned.