AAMI News September 2017
Medical Cart Battery Fires Heat Up as Safety Priority
Medical cart battery fires are very difficult to extinguish, according to the FDA.
The healthcare industry needs a better understanding of the troubling issue of fires and explosions in high-capacity batteries used in hospital carts and should turn to standards and education to address the problem, according to a diverse group of experts.
Meeting at AAMI headquarters in Arlington, VA in mid-July, these experts—who came from industry, the Food and Drug Administration (FDA), accreditation agencies, healthcare delivery organizations, and standards development organizations—emphasized the gravity of the issue.
Although there have been no reports of patient injuries or deaths, this doesn’t mean immediate action isn’t necessary, according to meeting participants.
“Surely we’re not going to wait until there’s a patient incident to do something,” said Ram Dhurjaty, president of Dhurjaty Electronics Consulting.
Richard Constantineau, manager of clinical engineering at Washington Adventist Hospital, echoed that sentiment, calling on stakeholders to take a proactive approach to “deal with it now so no one gets hurt.”
According to an FDA MedSun survey conducted last year, half of hospital respondents had experienced a cart battery or electrical-related problem during the previous two years, the majority of which were related to battery issues. This led the FDA to warn healthcare facilities about the potential safety risks of battery-powered mobile medical carts, which include crash carts, medication dispensing carts, and computer 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,” the agency wrote in a letter to healthcare professionals. “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.” Despite heightened concern, medical cart battery fires are still considered rare events.
“It’s a very low likelihood of occurrence, but when it does happen it’s extremely dangerous,” said Pete Segar, CEO of Ergotron, which manufactures hospital computer carts. “Those are the hardest problems to solve because it is difficult to replicate those failure modes and it’s difficult to develop tests. If it’s difficult to develop tests, it’s difficult to put them in standards.”
After a day of diving into the issue and performing a gap analysis of existing standards, guidance, and other resources, the group voted to pursue three action items they believe will help address the issue at both a manufacturer and a hospital level.
These priorities are:
- Encouraging root cause analyses of high-capacity battery failures in the healthcare setting and developing a feedback loop with device and battery manufacturers so this information can be incorporated into future designs.
- Developing new or updating existing battery design standards to reflect the best practices found in UL’s Safety Issues for lithium-Ion Batteries, AdvaMed’s Successful Practices for Battery-Powered Medical Devices, and other published documents.
- Training healthcare technology management professionals about safe battery management practices.
Making the problem of battery fires even more complex is the issue of enforcement and oversight. The FDA only regulates three types of mobile medical carts: crash carts, medication-dispensing carts, and infusion pump stands. Mobile computer workstations and electronic medical record carts are essentially classified as “furniture” and are not under the agency’s purview.
The National Fire Protection Agency (NFPA) could step in to fill this gap. Jonathan Hart, a senior fire protection engineer at NFPA, said risk mitigation strategies could potentially be incorporated into a future edition of NFPA 99, the healthcare facilities code, which could then be enforced through accreditation agencies such as The Joint Commission (TJC).
“Many of our standards are rooted in NFPA 99 and 101, so if something came through 99, I guarantee that we’d look at it,” said Herman McKenzie, who works in TJC’s Standards Interpretation Group.
Although the problem is not yet solved, attendees expressed optimism about the road ahead.
“It is really kind of exciting the way that things work in the U.S. because things can start organically and very quickly you are able to pull together a group of amazing experts,” Segar said. “Here we are, six months from the time the FDA memo came out, convening an amazing group of experts to go attack this problem. It gives me faith that our process works.”
Three work groups are being formed to address the priorities identified during the meeting. Anyone interested in participating should contact Joe Lewelling, AAMI’s vice president of emerging technologies and health IT, at firstname.lastname@example.org.