The authors write counterfeit versions of devices “infringe on patent rights…and infringe on branding of well-recognized, [Food and Drug Administration]-cleared products,” as well as compromising patient safety.
The counterfeit devices are cleared through customs “under false pretenses, only to be sold to potentially unsuspecting (or unscrupulous) buyers,” the authors write.
The authors urge physicians to be alert and aware of such devices. They write marketing, graphics and other materials produced by those selling counterfeit devices can appear similar to materials produced by legitimate manufacturers.
While bogus devices are often offered at a fraction of the cost of legitimate ones, “any apparent economic advantages are grossly outweighed by the real risks and liabilities associated with using technology that is not FDA-approved and has not been proven to be safe and effective,” according to the authors.
More articles on medical devices:
3-D printing quickens medical devices’ time to market
GE Healthcare recalls CO2 detectors
8 recently issued FDA device-related guidelines
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