What do HTM professionals need to know about battery use, battery maintenance, and battery purchasing? A clinical engineer and others weigh in.
By Chris Hayhurst
A few days before the turn of the new year, on Dec. 27, 2016, the U.S. FDA sent a letter to healthcare facilities warning of potential problems with battery-powered medical carts. Such carts, noted William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health, typically feature high-capacity lithium or lead-acid batteries capable of powering medical devices for hours at a time.
The agency, Maisel wrote, had recently received reports of fires and “other health hazards” associated with such batteries, from “smoke production and overheating to equipment fires and explosions.” His letter was intended to serve as a reminder: There were steps facilities could take to reduce the chances that their own battery-powered carts might go up in flames next.
The FDA’s recommendations outlined in the letter were specific to batteries on medical carts, but they also apply equally well to hospital batteries of all kinds. Among other things, Maisel wrote, facilities should inspect batteries for any sign of damage, “including bulging, swelling, or cracks.” Battery chargers and the carts that contain them should be vacuumed to remove any lingering dust or lint, and inspected for overheating components.
Batteries that don’t charge properly should be retired and swapped out, and all batteries should be replaced at manufacturers’ recommended replacement intervals. And when a damaged battery is identified, its manufacturer should be notified of the problem.
Maisel also offered a few suggestions around the storage and use of battery chargers: Facilities should conduct surveys of their current charger locations, and ensure that “all chargers are located” and used “in easily visible, fire retardant locations away from patient care areas and open sources of oxygen.”
And finally, chargers should never be stored in confined spaces or near flammable or explosive objects, and their vents should remain open—never blocked by tape or any other material.
The Importance of Due Diligence
While it’s unclear how many HTM professionals around the country actually read the FDA’s battery letter, one person who did—Joe Padilla, senior national sales manager with Dallas-based Interstate Batteries—was hardly surprised. “It’s about reducing risk and protecting lives,” says Padilla, who served as a consultant for an instructional video on battery management released last summer by AAMI.
Battery maintenance, Padilla notes, “is a big piece of reducing risk.” But putting the right maintenance program in place takes time, and it requires the HTM professional “to commit to a regimen that works for his or her facility.”
In his work with the HTM community, Padilla says, one of the points he tries to convey is that “the majority of medical device problems reported to the FDA have to do with batteries.”
Interstate provides batteries to more than 2,500 hospitals nationwide, he says, and his sales pitch to new customers is quick and simple: “The No.1 message is: ‘It’s not a battery; it’s a life.’ We’ll often hear people say, ‘Ah, it doesn’t matter, I’m going with the cheapest price.’ Well, you can do that and you might save a few bucks upfront, but you also might be putting patients’ lives at risk.” He had this conversation recently with one potential buyer interested in purchasing a defibrillator battery.
“He said he was going to go with one that was $100 cheaper because price was the most important consideration.” Padilla’s response: “You know, when 25% of AED batteries fail, that’s a 25% risk that you’re taking onto the hospital—and that you’re taking onto yourself. That’s a major issue, and it’s the kind of thinking that can get you in trouble.”
Padilla’s admittedly biased, yet wise, recommendation: Instead of just looking for the cheapest vendor, use “due diligence to assure [that vendor] is properly managing the quality-control process.”
Check, for example, that the battery company is insured and indemnified, that they’re following FDA regulations, and that they’ve achieved International Organization for Standardization (ISO) 13485 certification. Find out how long they’ve been in the industry, ask for details about their manufacturing processes, and determine the quality of the components in their products.
“Are you buying the best cells that you can buy?” Padilla posits. “Are the amp hours they advertise really accurate? Does it vent properly so it won’t damage your equipment or harm your patients?” He also encourages HTM professionals to weigh the cost of any battery they’re considering against the downside of having that battery fail at the wrong time.
“If it’s a poorly made battery, its run-time might be an hour less than one of higher quality. Should you really buy that battery if the doctor who depends on it can’t use it when he or she needs it? How is that going to impact the patient?” Padilla continues.
Interstate, he notes, “doesn’t sell the cheapest batteries,” but like other high-quality battery manufacturers and distributors, does focus on delivering “a low total cost” in terms of overall lifecycle and a product that works safely and as expected. “Because the No.1 thing hospitals are concerned about is the quality of care they provide for their patients,” he says. “What they don’t want is to end up on the front page of The Wall Street Journal after they’ve had a battery fire.”
Almost any HTM professional would agree with Padilla that it’s not worth cutting corners at the risk of patient safety, and Brandon Low is no exception. Low, a student in the clinical engineering master’s program at the University of Connecticut, is currently in the middle of a two-year internship with the biomedical engineering department at VA Greater Los Angeles Healthcare System (VAGLAHS).
He has yet to see any battery fires, Low says, but that doesn’t mean batteries haven’t been on his mind. “One of the biggest problems we’ve had with batteries involved the ones we have in our infusion pumps,” he says. “The batteries were dying, and it wasn’t clear why.”
Eventually, Low says, they figured out what was going on. “The nurses who were using the pumps weren’t really aware of how long the batteries lasted. They didn’t realize they were meant to be used for backup and not as the primary source of power.” The clinicians, Low explains, would run the pumps off battery power until the units alarmed. “And then they’d just take them and plug them in.”
For the most part, he says, “that works out fine; we’re in a hospital, it’s not too hard to find an outlet.” But in one particular case, a battery alarm sounded right as the patient needed to be transported. “It was kind of a mess,” Low recalls. “It’s not what you want to happen at a time like that.”
In response to that incident, Low says, department staff determined that the batteries in question were “doing exactly what they were supposed to do,” or lasting as long as might be expected. Now, he says, they’re putting together “some training information” they can give to clinicians to explain how the pumps should be handled going forward. “And that includes information on how to tell if a pump is on battery power or if it’s plugged in,” as well as some advice around proper storage.
“One of the things we found was that not only with our pumps, but with a lot of other devices as well, when they go into clean utility rooms or even into dirty rooms, they’re unplugged,” Low says. “So they’re sitting in there and their batteries are discharging, which means they won’t necessarily be available when they’re actually needed.”
The devices that give his department the most trouble are typically not the ones with batteries that last 10 or 20 minutes, Low says, because those devices alert users right away with an error message indicating that they need to be plugged in. “The problems come up when you have a device that runs on a battery with a much longer life,” he says. “A nurse might think it’s on A/C power and assume it will run indefinitely.”
Another related issue, Low says, is that many batteries only recharge when the devices they’re in are turned on. “You might think, ‘Oh, it’s plugged in; I’m good to go,’ when in reality you’re not charging anything.”
In general, he adds, the VAGLAHS biomedical engineering department follows manufacturers’ guidelines when it comes to battery maintenance and replacement intervals. “I know some departments will develop their own battery maintenance programs. But the thing with batteries is, you really never know—they might go down in three months or they might last for five years, depending on use and how you care for them,” Low says. “For us, it just makes sense to do what they recommend.”
The fact that most batteries eventually wear out raises yet another question for many biomeds: Is it OK to replace that OEM battery with an aftermarket battery from a third-party manufacturer?
The short answer? Yes. “There’s a great deal of information coming from device manufacturers stating that you need to use OEM batteries,” says Rich Springer, chief operating officer with Milwaukee-based Alpha Source, Inc. “There’s also a considerable amount of incorrect information about aftermarket batteries, their quality and performance.”
Alpha Source, he notes, manufactures OEM-quality aftermarket batteries. “In most cases, you can purchase an OEM replacement battery,” Springer says. “But when you’re looking at alternatives, you should make sure that the aftermarket pack is equivalent to or better than what the OEM is offering.”
Springer offers purchasing advice similar to that of Interstate’s Joe Padilla: “There is tons of variability in the quality in the market,” he says. “[So] you have to do your homework and look for all the signs of a quality product and manufacturer,” such as ISO certification.
As part of the quality assurance process at Alpha Source, for instance, every battery is tested before it is shipped to the healthcare facility. Our goal, Springer adds, is to “make it so the biomed doesn’t have to think about the battery at all. [Instead,] they can focus on working with the nurses and care teams to ensure a positive patient experience.”
In the future, however, smart batteries—which encompass a rechargeable battery pack with a built-in battery management system—may prevent HTM professionals from fretting too much about batteries. That’s not to say that such technology will come without challenges, however.
Padilla, for his part, sees a smart-battery future, but he’s concerned that the software might drive up costs and force users to buy replacements only from OEMs. And as lithium batteries become more common, he also worries about the expense of recycling. “A lot of times batteries are just an afterthought when you’re looking at the equipment you need to purchase,” he says. But when you consider what it takes to dispose of that battery when it wears out, “the costs can be astronomical.”
Padilla’s suggestion to any facility under budgetary pressure? “Consider the big picture upfront when you’re buying. It may save you a lot of money.”
Chris Hayhurst is a contributing writer for 24×7. For more information, contact chief editor Keri Forsythe-Stephens at [email protected].