Buying Medical Products Online : Medical Devices

by Food and Drug Administration (FDA)

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What are they? Medical devices are pieces of equipment, apparatus, machines, implants, test kits, or other similar articles intended to diagnose, heal, manage, or prevent diseases or conditions.

Problem sites: Examples of unlawful device sales include selling contact lenses or other prescription devices without a prescription or fitting by a qualified health care professional. Or a site may be selling an unapproved device and making fraudulent claims about it, such as promoting magnets to treat carpal tunnel syndrome and arthritis pain.

Some over-the-counter tests, such as pregnancy tests, are approved for consumer use, but most tests should be used by health professionals only, says Harold Pellerite, assistant to the director of the Office of Compliance in the FDA's Center for Devices and Radiological Health (CDRH). "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," Pellerite says. 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 FDA has received reports of sight-threatening corneal ulcers from using non-corrective decorative contact lenses that were distributed without a prescription.

Joyce Iliya, an attorney in the Texas Office of the Attorney General in Austin, recently worked on several lawsuits involving one death and four serious injuries in patients who developed perforated colons as a result of a procedure advertised through the Internet. The companies in the suits 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," Iliya says. "In Internet ads, they claimed to 'cure disease' and 're-energize life,' and people came in to get the procedure." According to the FDA, prescription colonic cleansing systems can be used only for medical purposes such as before a radiological examination.

Pellerite says that, 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.

And 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, Pellerite says. "The FDA has received questions from Internet services about parents wanting to advertise and sell sleep apnea monitors, prescription devices sometimes used to monitor babies at risk for sudden infant death syndrome. 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. The FDA's Center for Biologics Evaluation and Research (CBER) regulates medical devices related to blood collection and processing procedures, such as HIV test kits.

The FTC regulates device advertising. The FDA works with the FTC, the U.S. Department of Justice, and state attorneys general to crack down on devices that violate the FD&C Act. Enforcement activities include cease-and-desist orders that stop the illegal marketing of devices, as well as warning letters and cyber letters. Depending on the outcome of a case, companies may have to pay penalties and consumer refunds.

Enforcement Examples:

In 2003, The FTC and the FDA warned Web site operators, manufacturers, and distributors who suggested their products can protect against SARS that the agencies were aware of no scientific proof for such claims and that any misleading or deceptive claims must be removed from the Internet. They found 48 sites touting SARS treatment and prevention products. Some sites falsely said consumers could ward off SARS with disinfectant sprays, wipes, and respiratory masks. There is no device or drug approved to prevent SARS.

The FTC announced in January 2003 that it had charged a Switzerland-based company and its U.S. counterpart with making unsubstantiated claims on the Internet for a variety of dietary supplements and devices. The products included "The Zapper," a device they claimed could kill disease-causing parasites in the body with electricity, and "The Syncrometer," which the marketers claimed could diagnose disease.

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. "There are so many devices, it's hard for consumers to tell what is a prescription device and what isn't, or what is legitimate and what's not," Pellerite says. "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 [phone].

Legislation

In March 2004, the Federation of State Medical Boards (FSMB) voiced support of federal legislation that would protect consumers from dangerous Internet drug prescribing practices.

"The Internet Pharmacy Consumer Protection Act would remove the veil of secrecy surrounding many rogue Internet pharmacies and the physicians who serve them," FSMB President James Thompson, M.D., told Congress during a hearing.

The bill, which was introduced in early March 2004 by Rep. Tom Davis, R-Va., and Rep. Henry Waxman, D-Calif., targets domestic Internet pharmacies that sell drugs over the Internet without a valid prescription. These are the main provisions of the bill:

• Sites would be required to make specific disclosures of the names of Internet prescribing physicians, dispensing pharmacies, the states in which practitioners are licensed, and contact information.
• Sites would be barred from dispensing prescription drugs solely on the basis of an online questionnaire. An in-person medical evaluation would be required.
• State attorneys general would be allowed to go to federal court to enforce a nationwide injunction against illicit online pharmacies, rather than just in their individual jurisdictions.

A companion bill, The Ryan Haight Act, also has been introduced by Sen. Dianne Feinstein, D-Calif., and Sen. Norm Coleman, R-Minn. The bill is named for a teen-ager who died as a result of obtaining dangerous drugs over the Internet.

The administration has not stated a position on the proposed legislation.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.