Medical Devices Improve: Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

In February 2000, the FDA cleared for marketing one of the latest telemedicine devices that includes a blood pressure cuff, stethoscope, and thermometer, as well as a television monitor and camera. The medical information that Geyer's wife, Jean, helps obtain by maneuvering the stethoscope over her husband's chest and back is transmitted from the devices directly to McRae. New, cheaper devices connecting telephones and televisions to the Web have the potential to expand this technology even further.

"Telemedicine is simply a steppingstone to a more sophisticated home health-care future," says Steve Warren, Ph.D., assistant professor of electrical engineering at Kansas State University. It's a steppingstone that McRae says adds an element of reality to her job as a home-health nurse by allowing her to promptly see what's troubling her patient. She says that systems like the one used by Geyer "give patients confidence and reassurance that we can do more than just talk to them by phone."

But as information technology becomes a more robust resource for people and their health-care providers, the link to home- and self-care products will raise issues such as liability, privacy, financing, and most important, the safety and effectiveness of the products.

The National Association for Home Care in Washington, D.C., conducted several clinical trials of home-distance monitoring of blood glucose levels by computer and found improved outcomes in diabetes care. Similarly, trials of home-distance monitoring of blood pressures showed enhanced efficiency. But failure to improve outcomes of high-risk pregnancies through home-distance monitoring illustrates the difficulties in managing certain clinical applications in the home environment, and the need for further research and regulatory controls.

New FDA policies, guidelines, and regulations may be needed, says the FDA's Herman, especially once it's clear how the Internet will change device regulation. These guidance documents will require special consideration of the capabilities and limitations of people using the devices at home as well as in different types of environments.

User Issues — A Major Concern

Given the newness of various technologies and known problems with some home-use devices, CDRH is going to be skeptical of new medical technologies that are long on promise to consumers, Herman says. As technological developments become more complicated, so do the requirements for their design to ensure that they can be used safely and effectively in the home.

"Human factors" is the science of interactions between people and technology, and involves designing a device with the users' abilities, limitations, and operating environments in mind. Ron Kaye, a human factors specialist in CDRH, says that the possibility of user errors (unintentional mistakes) always is of particular concern.

Medical device design problems can lead to errors when they don't consider that consumers can become easily confused using devices in the home. Distractions, such as children or other family members, variations in lighting and noise levels, and the demands of using the device exceeding the user's capabilities, all can contribute. A patient receiving oxygen, for example, died when a pressure hose loosened from the unit. The alarm was not loud enough to be heard over the drone of the device. Dropping a device or using it in changing temperatures or high humidity (such as a bathroom or shower) also may affect its performance. Kaye says other problems, such as not following procedures precisely or relying on the device too heavily, also are concerns.

"These risky behaviors can involve lifestyle changes, such as changes in diet or physical activity, or less attention to monitoring their health condition due to over-reliance on the device," says Kaye. And, usually once the user becomes accustomed to a device, failing to follow maintenance and calibration procedures, taking shortcuts when a specific technique is critical, or failing to communicate with health-care professionals as often as they should, also could lead to trouble.

The critical question, Kaye says, is whether consumers will be able to use new medical technology without unintentionally making errors that could compromise their health.

The ability of patients to operate a medical device, for example, can depend on medical training and experience, language barriers, literacy, memory, learning ability, dexterity, vision, and hearing. Difficulties using certain devices can be caused by advanced age, medications, or the actual medical condition that requires use of a product. The focus of most of CDRH's guidances will be on ensuring that users are able to safely operate and maintain the device — anything they would need to know about, such as controls, displays, software, labeling, and instructions.

Although new devices give people increasing control and a feeling of security when managing their health, users must remember to keep in regular contact with their health-care providers, Kaye says.

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.