Use Caution Buying Medical Devices Online
What are they?
Medical devices are:
Medical devices include all other similar articles intended to diagnose, heal, manage, or prevent diseases or conditions.
Problem sites
Examples of unlawful device sales include:
Some over-the-counter tests, such as pregnancy tests, are approved for consumer use, but most tests should be used by health professionals only.
And some companies claim you can rely on in-home results when results should be confirmed in a doctor's office.
Other Web sites advertise services on the Internet that entice consumers to come into a storefront to have questionable procedures. It could be that the use of the device is unapproved or the device itself is unapproved. For example:
Some companies promote full-body computed tomography (CT) scans as a way to detect early disease in people who have no symptoms of a problem. But the FDA has approved them only as a tool to diagnose disease when someone is experiencing symptoms or there is some reason for testing.
Risks
Consumers risk missing out on necessary medical treatment or being harmed if they use devices illegally marketed or sold through the Internet.
The companies were performing what they called "colonic hydrotherapy" without physician involvement. They claimed to be able to use a device to clean the colon as a way to prevent serious diseases. People came in to get the procedure. In Internet ads, they claimed to:
According to the FDA, prescription colonic cleansing systems can be used only for medical purposes such as before a radiological examination.
Because of the nature of the Internet, it can be hard to know who is promoting a device. Someone can claim to be a health professional, but that's no guarantee of device safety.
In the case of classified ads in which people are selling items over the Internet, consumers should consider the risks that may come with used devices.
But you can't sell a prescription device without a prescription and without physician involvement.
Regulation
CDRH regulates the safety and effectiveness of medical devices. Medical devices are categorized into Class I, II, and III, with the degree of regulatory control increasing with each ascending level.
Enforcement activities include:
Depending on the outcome of a case, companies may have to pay penalties and consumer refunds.
Tips
The FDA recommends checking with your health care provider before buying a medical device or before obtaining services that have been promoted on the Internet.
But just like a prescription drug, if a device requires a prescription, it's because it should only be used under the supervision of a physician.
Be wary if a device claims to diagnose more than one illness or promises a miracle cure.
Consumers who want to find out if a medical device has been cleared by the FDA, cleared for home use, or cleared for use in the United States can visit the FDA's device databases at www.fda.gov/cdrh/ or call CDRH at (800) 638-2041.
