Medical Devices: Home Is Where the Heart Monitor Is

by Food and Drug Administration (FDA)

Medical devices, products and technologies are converging to revolutionize home- and self-care health systems in the United States, making it possible for people to play a greater role in maintaining their own health.

These systems are geared toward a prevention-oriented, consumer-driven model for health care that includes innovations such as "smart devices" that can "think" for themselves, customized wearable devices, electronic patient records, and wireless Internet-linked systems — all expected to deliver convenient, user-friendly, intelligent health care in the home.

For consumers, this could mean convenience in time and travel and reduced health-care costs, and — it is hoped — result in home-care systems that teach people to monitor themselves with gizmos that give timely warnings of illness so that they can turn to their physicians early — when intervention will do the most good. For doctors, it could mean more efficient — and effective — health care driven by patients who take greater responsibility for their own health.

William Herman, director of the division of physical sciences in the Food and Drug Administration's Center for Devices and Radiological Health (CDRH), which regulates medical devices, calls home-care systems "the fastest growing segment of the medical device industry." 'If You Build It, They Will Come'

The list of planned and imagined medical devices reads like a work of science fiction. For example, imagine a toothbrush with a biosensing chip that checks your blood sugar and bacteria levels while you're brushing your teeth. Optimally, the brush would come with a holder that would transmit information to a database containing the person's medical file. Other devices on the drawing board include computerized eyeglasses with a tiny embedded display that can help those who wear them to remember people and things, and skin surface mapping, a new imaging technology that can collect images of the skin surface over time and would enable people predisposed to melanoma to detect malignant moles as soon as they begin to develop.

Also in the future, hand-held biosensors resembling the technological gadgets wielded by "Bones" on the TV series Star Trek could eliminate the need for maintaining large laboratories. A "smart" bandage could be made of fiber that could detect bacteria or virus in a wound, and tell the wearer if treatment with antibiotics is warranted and which to use. Using a wide range of advanced technologies such as wireless electronics and digital processing, heart monitors that can be connected to personal computers could make it convenient for people to track their own heart rates and other vital information at home and then transmit it to their health-care providers.

The Defense Advanced Research Projects Agency, within the U.S. Department of Defense, has developed a wearable system called the "smart T-shirt," which successfully monitored the vital signs of climbers on a recent expedition to Mount Everest. Another type of device that allows people with disabilities to operate machines and perform routine tasks is a hands-free instrument that is controlled by small muscle movements, such as a blink of an eye (electromyography), and brain activity (electroencephalography). Other devices include those controlled by tracking eye movements or by speech recognition technology. Devices that offer this kind of assistance show promise for individuals with spinal cord injuries or other nervous system disorders resulting in paralysis.

Products well along in the development pipeline are about to make possible dramatically improved pacemakers, cochlear implants (for hearing), and medicine delivery systems. Some of these devices will incorporate the most advanced product design and manufacturing on a molecular scale (nanotechnology) and other state-of-the-art technologies, such as microprocessors and miniaturization. The ability to bring these kinds of tools into the home adds a dimension of health care that people never had access to in the past.

"Do we know what's going to work?" asks Gilbert Devey, program director for biomedical engineering at the National Science Foundation. "Not yet," he says, "but there are ample precedents for these types of technologies. The focus now is on increasing the level of technological literacy for consumers."

Shifting Responsibilities

With some 76 million Americans born between 1946 and 1964 heading toward retirement, emerging technologies likely will help care for this aging baby-boomer generation. Technology is already being used to help keep tens of millions of older people in assisted living situations a lot safer.

At 9:30 a.m. on a recent Monday, nurse Linda McRae asks her patient: "How's your appetite? What about your bowels? Are you coughing up anything?" The questions sound routine; however, the physical exam is not. Elwin Geyer, a 69-year-old chronic lung disease patient, is at home — some 25 miles away from McRae. But from the video room in Kaiser Permanente's Sacramento, Calif., home health-care facility, the two are virtually connected by the flip of a switch, and McRae can examine Geyer long-distance, thanks to telemedicine.

Telemedicine connections like this one bring high-resolution images and audio through not much more than a telephone line and a computer monitor. A telemedicine device installed in the home allows a nurse to complete an exam without the person ever having to leave the house.

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.