Release Date: Sep. 10, 2004

GOVERNMENT STUDY FINDS NEARLY HALF A MILLION MEDICAL DEVICE INJURIES A YEAR

An estimated 454,383 people suffered injuries from medical devices – ranging from wheelchair accidents to careless toothbrushing – in one 12-month period from 1999-2000, say researchers from two federal regulatory agencies.

The devices were responsible for an estimated 58,000 hospitalizations, but the accidents were fatal in less than one in a thousand cases.

“A majority of the total estimate appeared to reflect incidents where an unintentional traumatic injury occurred, with no explicit malfunction or personal misuse of the device,” says Brockton J. Hefflin, M.D., the lead researcher.

Falls while using wheelchairs, crutches, canes and walkers were the most commonly recorded injuries. The catalogue of more than 50 types of injuries included an estimated 2,489 toothbrush mishaps classified as “oral laceration resulting from accident while using device.”

Researchers from the Food and Drug Administration and the Consumer Product Safety Commission say the large number of injuries may actually be understated because the study counted only patients treated in emergency rooms. The reporting system would have missed cases treated in doctors’ offices or clinics. Even injuries occurring in hospitals—a logical place for medical device injuries—would have likely been treated elsewhere than the emergency room, they say.

About 42 percent of the device injuries occurred in the home, and 60 percent of the cases happened to women. About 13 percent were admitted to the hospital after emergency room evaluation.

The two agencies used records from 100 hospitals statistically selected to represent 5,000 hospitals across the United States. Results from the smaller group of hospitals was then extrapolated to get a national estimate of medical device injuries. There was a 95 percent chance that the true number of injuries was between 371,000 and 538,000.

The authors, writing in the American Journal of Preventive Medicine, say that previous official FDA estimates of device injuries of 100,000 a year were low because that agency depends on public reporting of incidents instead of an examination of medical records.

They say the study “is in concert with the health care community’s concern for patient safety” following the 1999 Institute of Medicine report finding that up to 98,000 patients a year die from medical mistakes in hospitals.

Determining the relation of a device to an injury is not simple, the authors say. “The contribution of a device to an adverse event may be subtle and indirect, and therefore would go unrecognized and unreported,” says Hefflin.

For instance, a fall while using crutches may happen because the patient improperly positions her hands, bumps a chair with a crutch, or is too weak or uncoordinated to use the device properly.

The authors call the estimated 454,383 device injuries “relatively high.” By comparison, the National Center for Health Statistics estimated that in the same time period there were 39 million injuries treated in emergency rooms, ranging from 4.3 million sports injuries to 89,000 for child nursery equipment.

# # #

FOR MORE INFORMATION:
Health Behavior News Service: (202) 387-2829 or www.hbns.org.
Interviews: Contact Brockton J. Hefflin, M.D., at (301) 594-0668 or bjh@cdrh.fda.gov American Journal of Preventive Medicine: Contact the editorial office at
(858) 457-7292.

Center for the Advancement of Health
Contact: Ira R. Allen
Director of Public Affairs
202.387.2829
press@cfah.org