Lithium-ion batteries may not fail often, but when they do, the results are catastrophic — critical injuries and death are not uncommon. However, these batteries are an essential part of medical device manufacturing, so they aren’t going anywhere soon. What can information technology (IT) professionals do to help protect patients and providers?
Safety Issues With Lithium-Ion Batteries
There are several ways lithium-ion batteries can catastrophically fail, raising four major safety concerns.
Fires
Thermal runaway happens when lithium-ion batteries generate more heat than they can release. A chemical decomposition process results in self-oxygenation, accelerating and sustaining the reaction. The uncontrollable heat and pressure cause rapid degradation, leading to ignition. Medical devices will seemingly randomly burst into flames.
Leaks
Batteries contain corrosive, toxic chemicals that can cause irritation, burns, blindness and death. For example, regarding hydrofluoric acid, concentrated exposure to as little as 2.5% of the body can be deadly. Due to the sheer size and weight of commercial-sized power banks, leaking medical devices can cause tremendous damage.
Fumes
Off-gassing occurs when a lithium-ion battery releases combustible hydrocarbons like methane, acetylene, hydrogen and propane. These fumes can also contain toxic chemicals like hydrogen cyanide, carbon monoxide and hydrogen fluoride. Hospitals’ commercial-grade power banks can produce enough smoke to force a wing-wide evacuation.
Blasts
Explosions can result from thermal runaway because lithium-ion batteries are highly combustible. While they often cause fires, the burst does enough unique damage to be classified as its own safety concern. The consequences are severe — especially when the reaction happens to someone with an implantable medical device.
Examples of Lithium-Ion Battery Failure in Medical Devices
Unfortunately, safety concerns surrounding lithium-ion batteries are based on real-world events. There have been countless cases of these cells igniting, combusting, leaking or smoking. Usually, the United States Food and Drug Administration (FDA) removes high-risk models from the market as quickly as possible.
For instance, the agency recalled an Abbott glucose monitoring system in 2023 after discovering it could catch fire if users didn’t use the manufacturer-provided charging cable and power adapter. Over 4.2 million devices were affected since the recall came seven years after the initial distribution date.
Some recalls come too late. In May 2022, Muhammedou Tarawally received Abbott’s HeartMate 3 Left Ventricular Assist System. The device — which the FDA has since recalled — failed less than one year after implantation. The battery pack’s cells shorted out internally due to an alleged manufacturing defect, causing an explosion.
While Tarawally likely passed away from the blast, his 3-year-old son died as a result of the subsequent fire, leaving Fatou Nguda Secka, his spouse, as the family’s sole survivor. Cases like this illustrate how serious the safety issues surrounding lithium-ion cells are — critical injuries and fatalities are real possibilities.
Even in cases where no one is hurt, malfunctioning power sources can cause unplanned downtime and impede patient care. In 2023, a children’s hospital in Tampa, Florida, caught fire and 80 people had to be evacuated after a commercial power bank began off-gassing. Two of the 30 lithium-ion batteries — weighing approximately 100 pounds each — had ruptured.
Why Do Medical Devices Still Use Lithium-Ion?
The safety concerns surrounding this power source seem serious enough to necessitate a switch to an alternative. However, as batteries go, lithium-ion is actually relatively safe. Although failures are almost always catastrophic, they are rare as long as users follow the manufacturer’s instructions and best practices.
Besides, these batteries are incredibly long-lasting compared to similar alternatives. A standard model can last 1,000 to 2,000 charge-discharge cycles on average. Lithium-ion batteries retain capacity surprisingly well despite consistent use, making them ideal for powering medical technologies and implantable devices.
These power cells are also one of the most affordable options on the market. Their cost has decreased by about 97% since entering the market. Standardization has driven research and development, resulting in unparalleled levels of optimization. Further, the chemicals and rare earth minerals required for production are relatively common.
How to Address These Safety Issues
While health care IT professionals may not have as much power as original equipment manufacturers, they can still address safety concerns in multiple ways.
1. Validate Suppliers
When designed for medical applications, lithium-ion power sources must comply with IEC 60086-4 — a standard from the International Electrotechnical Commission — to ensure chemical, electrical and mechanical safety standards are met. IT teams should verify that their equipment supply comes from reputable, compliant providers.
2. Replace Batteries
There are multiple signs a battery may soon ignite, combust, leak or smoke. If it swells, is hot to the touch or experiences a drastic capacity change, the IT team should replace it immediately. They cannot put it in the garbage — they must dispose of it at a hazardous waste collection point to prevent it from catching fire or smoking in transit.
3. Have a Plan
Catastrophic issues often happen when least expected. Professionals may be unable to prevent every failure, but they can safeguard patients and providers. Having a plan for a sudden combustion reaction or off-gassing event is essential. They should keep the proper tools — like a chemical extinguisher for a Class B fire — on hand.
4. Post Guidelines
Not everyone knows how lithium-ion batteries should be used, charged and stored. Even fewer know they can produce toxic fumes and are highly combustible. The IT team should post guidelines for patients, providers and team members to ensure everyone works together to follow best practices, preventing failure.
Making Medical Device Batteries Safe to Use
Lithium-ion batteries are necessary parts of medical devices. However, they can be dangerous. Health care professionals can protect their institution by knowing the signs of an impending failure and how to address hazardous situations. Their quick thinking could save their colleagues and patients.
By Zac Amos, ReHack
