FRIDAY, Sept. 10, 2004 (HealthDayNews) -- At least 450,000 Americans are injured every year by medical devices as large as wheelchairs and as small as toothbrushes.

A new study counted that many injuries by such devices, which also include crutches and canes, but the researchers say the figure is only the tip of the iceberg.

"Medical device-associated adverse events is an under-recognized public health problem," said lead researcher Dr. Brockton J. Hefflin, a medical officer from the U.S. Food and Drug Administration's Center for Devices and Radiological Health.

In their study, Hefflin and his colleagues collected data on injuries from medical devices from 100 hospital emergency departments around the country in 1999-2000. They then expanded their findings to estimate the number of cases of injuries received from medical devices in 5,000 U.S. hospitals, according to the report in the September issue of the American Journal of Preventive Medicine.

"There are nearly 500,000 medical device-associated adverse events, just from emergency departments," Hefflin said. "That estimate is over four times greater than the annual number of adverse reports received by all medical device-regulating agencies."

However, because these cases were only those reported to emergency rooms, Hefflin believes the number of injuries his team found is low, and many more unreported cases happen each year.

There were more than 50 kinds of injuries studied. For example, there were some 2,489 toothbrush injuries called "oral laceration resulting from accident while using device."

There were 98,820 injuries -- such as lacerations, bruises and sprains -- due to falls from wheelchairs and scooters. Similar injuries from falls while using crutches, canes, and walkers accounted for 69,044 injuries.

Most of these injuries (42 percent) happened in the home, and 60 percent happened to women. Of the people who were injured, 58,000 were hospitalized; fewer than 1,000 of the injuries were fatal.

The reasons for these injuries are not clear. "Most of them were unintentional injuries from use error or device malfunction," Hefflin said.

Hefflin's group, from the U.S. Food and Drug Administration and the Consumer Product Safety Commission, is collecting more data to see if they can find out if there are particular devices that don't function properly, and to determine the most common ways injuries occur from each device studied.

"This helps us to better understand if this [injury] was a purely unintentional injury due to an accident, or was caused by some use error, or by a malfunction of the device," Hefflin said.

Hefflin believes many of these injuries can be avoided. "It is important to use medical devices cautiously," Hefflin said. "It is important to understand how to use them properly, to listen to instructions from health-care providers, and to read information associated with the device so it is used properly."

Dr. Matthew Rice, a member of the board of directors of the National Patient Safety Foundation, said the research wasn't surprising, but he wasn't sure what it means. "The number of injuries is a large number, but it doesn't necessarily reflect the seriousness of quality of the ability of companies to produce good devices that are safe," he said.

Rice believes the important part of the study is the collection of data. "When it comes to safety issues there is lots of speculation, but always data," he said, noting the survey included everything from torn rubber gloves to respirators and even devices that are not usually thought of as medical devices, such as vibrators.

There was also no indication from the data of the cause of injury. For example, sterilizer burns were listed as a cause of injuries, but Rice noted that anyone working around a hot stove, sterilizer or even a match is bound to get burned occasionally. "So I'm not sure that's anything more than a usual problem," he said.

"I 'm not surprised that someone in crutches may trip and fall," Rice said. "It's hard to walk on crutches."

However, Rice said the results underscore the need for better education and more caution in the use of medical devices. People need to be aware of problems that can happen to prevent injury, he said.

"Patients need to work closely with their health-care providers to understand the implications of any device that they are using," Rice said. "Informed consumers and informed providers have a joint responsibility to look at all medical care and prevent further medical problems."

More information

The U.S. Food and Drug Administration's Center for Devices and Radiological Health can tell you about of problems with medical devices.

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