The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning test strips from a previous owner (pre-owned test strips).
The FDA is warning people who use test strips and their caregivers that using test strips from a previous owner (pre-owned test strips) may lead to inaccurate test results, potentially cause infection, and should not be used. Incorrect results from home use tests may increase the risk of serious patient injury, including death.
The FDA is aware that some sellers are marketing pre-owned test strips. These test strips may be sold through online marketplaces, or directly from the seller.
According to the FDA, pre-owned test strips may not be safe to use because:
- The test strips may not be stored properly. For example, they may have been removed from their original packaging or not stored within the recommended temperature and humidity conditions. This could lead to inaccurate results.
- The expiration dates might have been changed or covered up. The use of expired test strips could lead to inaccurate results.
- The test strips may have been tampered with and could be damaged causing them to not work properly.
- 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 patient injury, including death.
- The test strip vials may have small amounts of blood from the previous owner on them, which can put users at risk for infection.
The FDA is alerting patients and health care providers with recommendations.
Recommendations for People Who Use Test Strips:
- Do not buy or use previously owned test strips. Look for signs that may indicate their test strips are pre-owned, for example:
- Pre-owned test strips are often sold through online marketplaces, or directly from another user.
- The packaging of the test strip (for example the box or vial of test strips) may have been opened or the labels may have been removed. The test strips may have been moved from their original packaging to a different package or vial.
- The expiration dates on the package, box, or vial may appear scratched off, changed, or tampered with.
- The packaging may look pre-owned, discolored, or otherwise second-hand.
- If they typically need a prescription (such as for test strips for use with warfarin INR meters), and the seller does not verify their prescription, beware. The seller could be selling test strips that pre-owned.
- Always buy unopened vials of test strips designed for their test meter through a trusted source such as their local pharmacy or through the test strip manufacturer. If they are unsure about where to buy safe test strips, talk to their health care provider or pharmacist.
- Talk to their health care provider, pharmacist, or test strip manufacturer if they cannot afford to buy the test strips recommended for use with their meter.
- 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.
- Some test meters used with test strips include a quality control check test that the user can run to make sure the test strips and meter are working properly together. If their test meter includes this, the FDA recommends that users regularly evaluate their home use test using the control solution. Read the test meter instructions for use to see how often they should test with control solutions.
- The FDA strongly discourages them from reselling or giving away their unused test strips because this may put the buyer at risk for infection or inaccurate results.
Recommendations for Health Care Providers:
- Talk to their patients about the risks of using pre-owned test strips.
- Talk to patients or caregivers about safe and affordable options such as patient assistance programs through test strip manufacturers or other consumer advocacy organizations
For details, please refer to the following FDA website:
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm635262.htm
Posted on 10 April 2019.