December 27, 2016
Dear Health Care Professionals, Health Care Facility Administrators
The FDA is warning health care facilities of potential safety risks associated with battery-powered mobile medical carts. The FDA is aware of reports of explosion, fires, smoking, or overheating of equipment that required hospital evacuations associated with the batteries in these carts.
ANALYSIS OF THE PROBLEM
Battery-powered mobile medical carts include crash carts, medication dispensing carts, and carts that carry and power medical devices for point of care, barcode scanners, and patient monitoring. These carts typically have high capacity lithium or lead acid batteries that can power medical devices and workstations (computers) for many hours.
The FDA regulates medical carts that meet the definition of a device under section 201(h) of the Federal Food, Drug and Cosmetic Act. In some cases, the battery-powered cart itself has a therapeutic function (e.g., medication dispensing carts). In other cases, the cart can function as an accessory to medical devices, such as colonoscopes, ultrasound machines, and anesthesia machines.
Battery-powered mobile medical carts are used because of their convenience and utility. FDA has received medical device reports of hospital fires and other health hazards associated with batteries used in mobile medical carts and their chargers. These events, which range from smoke production and overheating to equipment fires and explosion, can occur with lithium, lead acid, and other types of batteries. Such hazards may result in equipment and facility damage, hospital evacuation or patient and staff injury.
In addition, lithium battery fires are very difficult to extinguish. In several reports, firefighters had to bury mobile medical cart batteries to extinguish a fire.
The FDA recommends that health care professionals and health care facilities take the following steps to help reduce the potential for injury to patients, staff and visitors.
Preventative Maintenance of Battery-Powered Mobile Medical Carts:
- Inspect batteries for signs of damage, including bulging, swelling, or cracks.
- Notify the manufacturer of damaged batteries.
- Inspect battery chargers and carts containing chargers for overheating components.
- Vacuum to remove dust and lint around battery chargers and carts containing chargers.
- Do not use batteries that do not charge properly. Ensure that batteries are replaced at the manufacturer recommended replacement intervals.
- Conduct a survey of battery charger locations, and verify that all chargers are located in easily visible, fire retardant locations away from patient care areas and open sources of oxygen.
- Do not install chargers or charging carts in confined spaces.
- Keep flammable and explosive objects away from battery chargers and charging carts.
- Request preventative maintenance documentation from the cart manufacturer for the health care facility to use.
If a fire occurs:
If a battery in a mobile medical cart catches fire while charging or in use:
- Immediately report the fire according to your hospital protocol. Follow hospital protocol for addressing a Class C electrical fire.
- Do not touch the battery.
- Unplug the charger or power off the cart if it is safe to do so.
- Remove the cart from patient and visitor areas, as safely as possible.
General Recommendations for Battery-Powered Mobile Medical Carts:
- Do not block any charging station vents.
- Do not tape or attach any object or material to a battery charger.
- Only operate and store the battery charger and cart with charger outside of patient rooms and in non-patient care areas.
- Contact the manufacturer if there is a problem with any component of this system. This alerts the manufacturer of a potential product concern.
- Request maintenance and user manuals for the carts, chargers, batteries, and all accessories.
- Before purchasing these carts, establish the necessary criteria, that meets your facility needs:
- Meets battery standards for use in a hospital environment
- Preventative and maintenance documents to be supplied to facilities
- Contact manufacturer support with all questions
REPORTING PROBLEMS TO THE FDA
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you experience adverse events we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Please provide the following information, if available:
- How was the cart or battery charger being used at the time of the event
- Any patient, staff, or visitor injuries and or any actions taken by the facility
- What type of event occurred, i.e., explosion, fire, smoke
- Any cart identifiers, i.e., manufacturer name, model number
- Any action taken by the cart system manufacturer and your facility.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
The FDA has collected and analyzed data from medical device reports (MDRs), labeling, medical literature, and information from clinicians and manufacturers. The FDA will continue to monitor this situation.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration