Advising health care facilities nationwide of possible safety defects in battery-operated mobile medical carts, the U.S. Food and Drug Administration recently issued a warning accompanied by guidance from its headquarters in Silver Spring, Maryland.
Affected ambulatory devices include medical crash carts and carriers used for therapeutic purposes, such as allotting medication to or monitoring patients. The FDA considers any medical cart meeting the criteria listed in its regulatory material subject to the warning under section 201(h) of the Federal Food, Drug and Cosmetic Act.
The FDA publicized risks associated with the devices after
receiving reports of adverse events occurring in hospitals from cart batteries.
Consequences included smoke, overheating, fires and explosions, putting health care facilities at risk for damage and putting patient and staff at risk for injuries.
The dangers are magnified by the fact that lithium battery blazes
are difficult to extinguish. Hence, the FDA recommends that health care
practitioners practice preventive maintenance for mobile carts powered by batteries,
including regular inspection, vacuuming, safe storage and more.
In the event of a fire, hospital or office personnel should
report the event as a Class
C electrical fire, following protocol; unplug the cart and/or its charger;
move the cart to a safe area away from patients and visitors, and do not touch
The FDA urges all personnel to report any such incidents through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Questions can be addressed to the Division of Industry and Consumer Education at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.