Buying Medical Devices and Diagnostic Tests Online

Many consumers consider buying medical devices on-line. The medical devices include such products as hearing aids, contact lenses, magnets, and laboratory diagnostic test kits.

What is considered a medical device? The Food, Drug, and Cosmetic Act defines a medical device as an instrument, a machine, an implant, or a diagnostic test used to help diagnose a disease or other condition or to cure, treat, or prevent disease. Types of medical devices range from thermometers to artificial hearts to at-home pregnancy test kits.

Buying online has advantages, but it also can produce pitfalls for some consumers.  Buying on-line offers privacy, convenience and potential cost-savings, but personal data given by the consumer can be misused by unscrupulous dealers. While the Internet offers many quality medical devices from legitimate sites, it also offers medical devices that don't work and some that may even harm you or your family. Some Web sites sell medical devices for unapproved uses, or they sell medical devices that have not been cleared or approved by FDA. Other Web sites sell prescription medical devices without asking for a prescription. Some foreign Web sites sell medical devices to customers in the United States where the medical devices have not been cleared or approved for sale. Below are some examples of problems with Internet purchases.

• Contact lenses are being sold without a doctor's prescription.
• Hearing aids are being sold without selection and fitting by health professionals.
• Magnets are advertised to cure multiple conditions such as carpal tunnel, motion sickness, and back ache.
• Test kits are being sold to consumers to detect serious illnesses, such as cancer and diabetes, or illegal drug use.

The FDA has monitored Internet sales of health products for several years and has sent warnings about illegal practices to more than 50 companies. Even though its resources are limited, the FDA is increasing its monitoring of Internet sales and is working with the Federal Trade Commission (FTC) to stop illegal advertising. The FTC works with both state and Federal consumer protection and public health agencies. It can take legal actions against Internet advertisers of health products that run false or misleading advertisements.

How can you be a wise consumer?

• Pay attention to labels. If the instructions are in many languages or if measurements are in S.I. (metric) units, the product may be intended for sale in another country, not the U.S. This can mean the product does not meet U.S. requirements and may be of inferior quality.
• Beware of cure-alls claims, amazing results, and independent research that the government is supposedly hiding. Unscrupulous merchants have found a new audience for miracle cure-alls on the Internet. Remember, if it seems too good to be true, it probably is.
• Ask the seller, "Has the FDA cleared or approved this product for sale in the United States?"
• Talk to your healthcare professional about medical devices that you plan to buy on the Internet.
• Beware of sites that do not include an address and telephone in the United States.
• Check the FDA's Buying Online Homepage for helpful information about buying medical products on the Internet and to notify the FDA about problem Web sites. You can also report problem Web sites by e-mail to webcomplaints@ora.fda.gov.

The Internet offers many opportunities for consumers to receive new information and new offers of legitimate medical products. Unfortunately, it is difficult to examine an Internet business in the same way as you would a local store. It is easy for a dishonest merchant to set up a professional-looking Web site. However, if you take a few simple precautions, your Internet purchase can be a worthwhile experience.