Medical Devices Improve: Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

No Mistakes

Stephen B. Kaufman, a pioneer in home-care technology from Deerfield, Ill., supports device technology that has "simple prompts" and "no possibility of mistakes." He says, "There are just too many opportunities to make bad mistakes." For this reason, CDRH has provided human factors guidance to manufacturers on device design that will reduce the likelihood of user error. This guidance document, titled "Medical Device Use Safety: Incorporating Human Factors Engineering Into Risk Management," can be found on CDRH's Web site at www.fda.gov/cdrh/humfac/1497.html (the document is also available as a PDF).

"Design controls are another new regulatory tool for us that have a lot of potential to avoid use errors and other device quality problems," says Stewart Crumpler, a regulatory operations officer in CDRH. Design controls are a system of checks and balances that increase the likelihood that a device is designed, manufactured, used, and maintained properly, and that the device is appropriate for its intended use. Design controls are the part of a quality system that requires manufacturers to consider both human factors and the intended use environment during device design. The controls, Crumpler says, are intended to "build quality into the device."

Another factor contributing to the increase in user errors is the difficulty that consumers have understanding instructions provided with devices. Most are written for health-care professionals. CDRH has prepared guidance for manufacturers of home-use devices to help them plan and write their manuals for consumer use.

"One of the biggest problems we're finding," adds Herman, "is the inability of systems to be used by people who have not been trained." Because of this, CDRH's guidances also will focus on patient education and training, proper technical standards for manufacturers, and safety issues that new technologies may generate.

A New Paradigm for Health Care

Today, what could be characterized as a return to home health care has much to do with the emergence of the Internet as a conduit of health information to patients. Those who remember huge mainframe computers can appreciate today's technology and the exponential advances in the compilation and distribution of information.

"For some time now, the technology forecasts of CDRH's office of science and technology have projected home- and self-care devices as a high probability area for dramatic growth," says Herman. Other forecasts, he says, are now mirroring those CDRH expectations. This unfolding wing of modern medicine means that 21st century home- and self-care devices could soon revolutionize health-care delivery systems in the United States. And when these potential technological marvels are ready for the market, some may lead to products that we may wonder how we lived without.

Driving Forces Behind the Home Health-Care Push

The primary need for today's home-care population is more frequent and convenient monitoring of chronic diseases and conditions, according to a 1998 workshop on future trends in medical device technologies sponsored by the National Science Foundation and the FDA. A wide range of health and social services gradually are being delivered at home to recovering, disabled, chronically ill, or terminally ill people.

Chronically ill infants and children are receiving sophisticated medical treatment in a familiar and secure home environment. Many younger adults who are disabled or recuperating from acute illnesses are choosing home care, whenever possible. Adults and children diagnosed with terminal illnesses also are being cared for at home.

Audrey Kinsella, a medical research librarian who specializes in home health-care product trends and applications, says that the trend toward earlier discharges from acute care settings to home while people still may need daily care also has been driving the home health-care market. "And some see it as a wonderful adjunct to the care they're already getting," she adds.

According to a study conducted by Kaiser Permanente's Medical Care Program, the greatest users of home-health services are older people — also the most rapidly growing segment of the population. Two-thirds of Americans over 62 have at least one chronic disease, and so may need to use home-monitoring devices daily, such as heart rate monitors. Heart disease, diabetes, and respiratory problems are the top chronic diseases of this age group. And more and more older people, electing to live independent, non-institutionalized lives, also are receiving home-care services as their physical capabilities diminish.

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.