More than 70,000 kids hurt by medical devices every year


In our daily life we use several types of medical devices such as toothbrush, eye glasses, contact lenses, thermometer and so on. Medical devices are classified in three categories – Class I, class II and class III based on their risk factors.  Some of the devices are extremely complex, but provide extraordinary benefits.  Medical devices are approved or cleared after rigorous substantiation from U.S. Food and Drug Administration (FDA) that requires safety and efficacy data supported by clinical studies, most of the times. Recently FDA researchers have published a study that analyzed patient records from child and teen ER visits in 2004 and 2005.

About the study
It was the first such study to assess device-related injuries in children only. The researchers analyzed medical records from ER visits reported in a national injury surveillance system.  The data which was collected from 100 nationally representative hospitals, estimated 150,000 medical device related injuries occurred during 2004 and 2005, or more than 70,000 yearly.  Contact lens injuries were at the top in the list of devices.

The study is published online in the journal Pediatrics.

Medical devices related injuries
USFDA Researchers found that almost 34,000 problems were linked with contact lenses in the two-year period. The rest were scattered among other categories –

  • About one-fourth of injuries were from contact lenses
  • Puncture wounds from hypodermic needles breaking off in the skin while injecting medicine
  • infections in young children with ear tubes
  • skin tears from pelvic devices used during gynecological exams in teen girls
  • The most serious problems involved implanted devices such...

    as brain shunts for kids with hydrocephalus (water on the brain); chest catheters for cancer patients receiving chemotherapy at home and insulin pumps for diabetics

Researchers mentioned that many injuries were not all that serious. But those that required hospitalization were more likely to have involved implanted devices.

Major reasons for medical device related injuries
The researchers told that they are looking into how and why the injuries occurred and also are assessing the prevalence in adults. They blamed malfunction and misuse as the main factors. They also pointed out that various devices that were prescribed for adults were used in children.

FDA has very strong Medical device reporting system for medical device companies. Consumers and healthcare professional, if they find any problem with the medical device can report to FDA via filling Medwatch online reporting form or via telephone.  Children and health care professionals should pay more attention to proper use of contact lenses. People who are allergic to contact lenses must avoid wearing contact lens as it was the most commonly encountered problem among other injuries.


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