Telemedicine

by Food and Drug Administration (FDA)

In Hays, Kan., an infant is born with a heart murmur. Because there is a slight chance of severe cardiac problems when this happens, Robert Cox, M.D., a pediatrician and medical director of rural development and telemedicine at Hays Medical Center, seeks the advice of a cardiologist in Kansas City, which is 270 miles away. Yet the infant and Cox never leave the small town of Hays.

Instead, using interactive videoconferencing, the cardiologist in Kansas City examines the infant and listens to the heartbeat as a technician in Hays holds an instrument similar to a stethoscope against the baby's body. The cardiologist also can view the baby's chest x-ray and electrocardiogram. Because of this technology, Cox says, "Today, we refer only 1 percent of infants with heart murmurs to an out-of-town hospital, instead of 100 percent."

An elderly man who has trouble walking is referred to a small hospital in rural West Virginia. "Even after doing a complete physical exam, no one was sure what the problem was," recalls James Brick, M.D., a rheumatologist and medical director of the telemedicine program at the West Virginia University School of Medicine in Morgantown.

So a medical student at the rural hospital used videoconferencing to present the patient's case to the chairman of the university's neurology department. The neurologist examined the patient, put him through various tests, and made a diagnosis of amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease.

These doctors are practicing telemedicine, which involves the use of computers and telecommunications equipment to provide health care over long distances. It is actually an extension of one of the oldest, simplest, and most popular forms of electronic medical consultation: a telephone conversation between doctor and patient or a medical generalist and a specialist. But, unlike the telephone, some aspects of telemedicine are regulated by the Food and Drug Administration.

Telemedicine Technology

Teleradiology is the oldest form of telemedicine referenced in the medical literature and one FDA has been involved in since 1977, according to Melvyn Greberman, M.D., of FDA's Center for Devices and Radiological Health. As now practiced, this technology involves creating and transmitting medical images, such as x-rays or computed tomography scans, electronically in the form of a digital signal from one location to another. An expert at a distant site receives the images, evaluates them, helps make a diagnosis, and suggests additional care as needed. The process is much like sending an x-ray by mail or courier — but with telemedicine, the transmission is almost instantaneous.

FDA and the medical community share responsibility for ensuring the safety and effectiveness of the medical devices used in the telemedicine process. For example, photographs of a suspicious skin lesion can be sent electronically as digital images. The images are then reconstructed for display on a monitor and read by the doctor who receives them.

"The question that the doctor should ask is, 'Is the resulting image adequate for the purposes intended?'" FDA's Greberman says. "If an image will be used for diagnosis, then the clinician must be certain that it has sufficient detail to permit accurate interpretation."

For example, he says, the digitized image, which may be compressed to reduce transmission time and storage requirements, should not have degraded significantly in quality when it is viewed as a reconstructed image. "FDA requires a manufacturer to indicate on-screen when compression that results in the loss of some data is used, but the doctor must determine the impact of this compression on the clinical adequacy of the image," he adds.

Another form of telemedicine is interactive videoconferencing, also known as interactive television and interactive teleconferencing. This technique permits two doctors and a patient to confer simultaneously, even though they are at different sites. For example, a camera in an examining room would enable one doctor to present the patient to the other. The other doctor, usually a consultant, also in front of a video camera, would offer an opinion.

Nurses and other health professionals also can use interactive television to monitor patients at home. For example, in Hays, an older woman receives regular visits from a home health nurse via cable television.

The woman's television emits a beep two minutes before the nurse is scheduled to check on her. The patient switches on the television, which also is equipped with a small videocamera. She can see the nurse, and the nurse can see her. The nurse assesses the patient's overall appearance; reviews her temperature, blood pressure, and other vital signs; and reminds her to take her medication.

"With this technology, we found that one home health nurse could visit nine patients in one morning during a blizzard, simply by working from her base station," Kansas doctor Cox says.

The same technology also is used for educational purposes. For example, the Georgia Telemedicine Network, which is based at the Medical College of Georgia in Augusta, links the medical college with 44 sites throughout the state, including the Eisenhower Army Medical Center and Emory University Medical Center, according to Max Stachura, M.D., the network's executive director. Medical students in remote locations take classes at the university, doctors earn continuing medical education credits, and health information is communicated to the public.

FDA's Role

FDA's primary role with respect to telemedicine is to review the devices, or hardware, before clearing them for marketing and to conduct postmarketing surveillance — that is, to be aware of significant problems that occur after the devices are marketed.

In July 1996, the Center for Devices and Radiological Health issued the report "Telemedicine Related Activities." It reviews current and potential areas of telemedicine of interest to FDA.

Certain medical software products that may be used for diagnostic purposes also fall under FDA's jurisdiction. However, other government agencies — such as the Federal Communications Commission, which regulates some aspects of the communications technologies — are involved in telemedicine, as well. The Federal Joint Working Group on Telemedicine, of which FDA is a participant, includes representatives from various government agencies working together to clarify regulatory issues related to telemedicine.

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.