• Brockton J Hefflin, Thomas P Gross, and Thomas J Schroeder.
• U.S. Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland 20850, USA. bjh@cdrh.fda.gov <bjh@cdrh.fda.gov>
• Am J Prev Med. 2004 Oct 1; 27 (3): 246-53.

BackgroundThe true public health burden of adverse events associated with medical devices is unknown. The purpose of this study, therefore, was to produce the first-ever national estimates of medical device-associated adverse events resulting in emergency department (ED) visits.MethodsFrom July 1999 through June 2000, reports of 10,395 medical device-associated adverse events were accumulated using the National Electronic Injury Surveillance System (NEISS), which collects information on product-related injuries from the ED records of a national stratified probability sample of hospitals. The reports were used to estimate annual total number of medical device-associated adverse events as well as number of adverse events associated with specific devices, injury diagnoses, demographic characteristics, and patient disposition status.ResultsThe total estimated number of adverse events was 454,383 (95% confidence interval [CI]=371,156-537,610), involving a broad range of devices from 15 medical specialty groups. Unintentional traumatic events associated with a particular device appeared to be the most common mechanism of injury. The most prevalent types of injuries included contusions/abrasions, punctures, and lacerations; 13% of total estimated cases resulted in patient hospitalization. Adverse events occurred within healthcare facilities, and some were occupationally related, although they occurred at home more frequently than any other location (about 42%).ConclusionsThe magnitude of the total estimate, which is over four times greater than the annual number of adverse event reports received by medical device-regulating surveillance systems, emphasizes medical device-associated adverse events as an under-recognized public health problem. Planned collection of more detailed NEISS data will allow for appropriate public health interventions.

20 keywords...

hide…