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Medical Devices Linked to 70,000 ER Visits

According to a study conducted by the FDA’s Center for Devices and Radiological Health, 70,000 kids visit the emergency room each year due to injuries from medical devices.   One of the most common offenders is contact lenses, which can cause eye abrasions and infections, especially if they are kept in the eyes too long between cleanings.

Another culprit is the hypodermic needle, which can break off in the skin while administering medications, followed by ear tubes, which can cause infection.

Some of the more serious problems occur with shunts in the brain used to treat hydrocephalus, or with chest catheters used for giving chemotherapy treatments at home.

The American Academy of Pediatrics has been concerned about safety problems with medical devices used on children for the last several years.  Although children and adults often have the same illnesses and procedures performed on them, medical devices are lacking when it comes to adjusting for size, anatomy and overall physiology.

Additionally, there are devices that are exclusively appropriate for children; such devices have no adult counterpart. 

In 2005, the Institute of Medicine recommended expanding regulation of medical devices for children by the FDA, citing significant flaws in safety monitoring.

Because diseases in children are rarer than they are in adults, the medical device market has little incentive to focus on that particular market.  As a result, doctors must “adjust” by using medical supplies designed for adults.

 The AAP also suggests a comprehensive approach to address the problem by elevating medical device issues at the FDA and the National Institutes of Health.  The agency also believes that innovators should be given support and regulatory processes streamlined in order to improve the quality of medical products available to children. 
 
The current study on medical devices and emergency room visits is being published in the online version of the journal Pediatrics.