FDA Faces Challenge of Online Medical Device Sales

Over the last 20 years, the Internet has become the world’s largest retailer.

Virtually anything can be sold online these days, from designer clothing and cars to Victorian mansions and vacation packages. Medical devices and equipment are available for sale as well, though this sales genus presents a growing challenge to the U.S. Food and Drug Administration (FDA), industry experts said.

With the Internet having morphed into a formidable sales force, the FDA faces the arduous task of creating better guidance for consumers (not to mention hospitals and medical professionals) who purchase medical devices online. The agency’s job is further complicated by the growing home healthcare sector and consumers’ more recent desire to save money.

“Sometimes a person goes on eBay or another Website and just buys [his or her] prescription device on the Internet, typically without good instructions for use, without accessories that are compatible and without cleaning instructions,” warned Mary Brady, associate director of home use initiatives at the FDA’s Center for Devices and Radiological Health.

Besides buying a device that lacks instructions and compatible accessories, consumers also tend to purchase older products that either are close to the end of their usable life or already obsolete, Brady noted.

“There are newer devices that are marketed toward the home environment, however, we have a lot of legacy devices out there,” she said. “Guess what usually goes home because we tend to sell our newer products to the hospitals? The older products, the legacy products, things that are out there that aren’t supported so well anymore.”

Though eBay has characterized its role as one of a “marketplace” rather than a business that oversees the sales of devices, the company nonetheless has specific guidelines about the sale of medical products. EBay’s guidelines allow the sale of over-the-counter devices but not products that require a prescription (pulse oximeters, defibrillators and oxygen concentrators, for example) or implantable devices (pacemakers, heart valves, vascular grafts, infusion pumps). The site restricts the sale of devices that require government authorization, but allows people to sell vintage products as long as the listing clearly states the item should not be used.

Manufacturers of single-use medical devices claim they cannot vouch for the safety of their products if they are reconditioned. And those who sell reconditioned devices contend there is no credible evidence that their product is more risky than a new device. Such a conundrum leaves consumers vulnerable to purchasing potentially dangerous products from unscrupulous dealers, the FDA charges.

In guidelines it posts on its Website, the FDA warns consumers about the pitfalls of online device purchases. The guidelines state: “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 Websites sell medical devices for unapproved uses, or they sell medical devices that have not been cleared or approved by the FDA. Other Websites sell prescription medical devices without asking for a prescription. Even though its resources are limited, the FDA is increasing its monitoring of Internet sales and is working with the Federal Trade Commission to stop illegal advertising.”

The FDA provides several tips on its Website to help consumers make smart device purchases online. They include:

•Paying attention to labels. If the instructions are in many languages or if measurements are in metric units, the product may be intended for sale in another country. This could mean the product does not meet U.S. requirements and may be of inferior quality.
•Being aware of cure-all claims, “amazing results” and independent research that the government is allegedly hiding. If it seems too good to be true, it probably is.
•Asking the seller, “Has the FDA cleared or approved this product for sale in the United States?”
•Talking to a healthcare professional about purchasing a medical device on the Internet.
•Being wary of sites that do not include a U.S. address and telephone number.