Reducing Medical Device Injuries

by Food and Drug Administration (FDA)

Medical devices help to alleviate pain, overcome disability, and sustain life. They also, on occasion, fail to operate properly or are misused in ways that are associated with injuries and deaths. Betty Davis' wheelchair, for example, caught fire, badly burning over 25 percent of her body in January 1999. A quadriplegic confined to a wheelchair since 1976, the 65-year-old Tucson, Ariz., resident knows the importance of a well-maintained machine that works as intended. "I'm a very active quad," she says, but when the fire started, "all I could do was sit there and watch my arms and legs burn." Faulty wiring short-circuited the battery charger in Davis' wheelchair. Davis says she put the chair on charge after a blinking light indicated the battery was running low. But Davis detected a spark, and immediately disconnected the charger. The spark, however, turned into a flame. Though authorities don't know why, Davis' attempt to reach 911 through her emergency medical pendant failed. Fortunately, a neighbor was nearby at the time and threw water on her to extinguish the fire.

"My legs and arms were on fire and my hair was burning," Davis recalls. "And from the burns, my skin is so thin you can rub it off."

According to the Institute of Medicine (IOM), about 1.3 million Americans are seriously injured each year by adverse events involving medical products. More people die in any given year due to medical errors occurring in hospitals (between 44,000 and 98,000) than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516).

Inadequate device design, poor manufacturing quality, improper device maintenance, and user error all contribute to adverse events associated with medical devices. In 2002 alone, the FDA received reports of more than 111,000 adverse events, including serious injuries and deaths, related to medical devices.

Whether it's failure of a device to operate properly or failure of the user to operate the device correctly, the Food and Drug Administration says that many of the adverse events associated with product problems are preventable. In Davis' case, for example, a $5 fuse would have prevented the short that occurred between the charger and the wheelchair's battery. Davis' wheelchair should have been designed with one.

Nearly 1,800 categories of medical devices exist, and they vary in both complexity and risk potential. That means that the problems associated with medical devices are as diverse as the number of medical devices on the market. Moreover, as health care and the system that delivers it become more complex, opportunities for errors increase.

While it's unlikely that product-related problems and patient injuries can be eliminated, the FDA believes that many adverse events can be prevented by designing systems that make it hard for people to do the wrong things and easy for them to do the right things. "In many cases," says Mary Weick-Brady, deputy director of the FDA's Division of Surveillance Systems, "a device may have been designed properly but the user may have used it wrong." In short, manufacturers can design errors out of the system and build checking and monitoring functions into the system.

For example, because breathing tubes used in ventilators often pop out of place, manufacturers have alarms built into the ventilators to alert health care workers when a tube becomes disconnected. Future designs featuring networking systems could recognize that health care workers are not always present when an alarm goes off. Built-in networking systems would allow the appropriate health care providers to be notified of an alarm wherever they may be.

FDA guidelines now call for manufacturers to consider the needs of the users and patients when designing equipment. Well-designed devices are consistent with the user's experience, and they are logical and not confusing. Also, they minimize the need for depending on the user's memory and making mental calculations; do not overtax the user's strength, dexterity, visual ability, or auditory capacity; alert the user to device-related problems; prevent users from making fatal errors that could otherwise occur easily; and are supported by readable and understandable labeling.

And the FDA wants products to be tested under actual or simulated use conditions to demonstrate that the potential for user error has been minimized.

The agency currently guides the development of new devices, evaluates the results of clinical trials and new products before they are marketed, ensures quality systems are in place in manufacturing plants, and continues to identify and respond to adverse events that are reported in the United States. The FDA plans to expand its knowledge of medical device errors by linking with new sources of data, perhaps from other government and outside organizations. In addition, the agency will focus on educating patients and health care professionals on how to avoid potential threats posed by medical devices.

Improved patient safety through reducing preventable adverse health events is one of five agency priorities set by Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. Other priorities include science-based risk management, better information for consumers, counterterrorism, and a strong FDA at the forefront of biomedical science and technology.

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.