Batteries are ubiquitous in the healthcare delivery system, powering everything from infusion pumps, to patient beds, to ultrasound machines. The new issue of AAMI’s peer-reviewed journal BI&T (Biomedical Instrumentation & Technology) looks at the challenges associated with battery management and what solutions exist for healthcare delivery organizations.
The cover story of the March/April 2014 issue of BI&T investigates a topic that came to the forefront last year, when the U.S. Food and Drug Administration (FDA) convened a workshop on battery-powered medical devices. The perspectives of several of the experts who spoke at the event are presented in the article.
Healthcare technology management (HTM) professionals cite battery management as a top medical device challenge. In AAMI surveys of HTM professionals, battery management has often outranked alarm management, infusion pumps, and cybersecurity in terms of challenges. Furthermore, reports to the FDA’s Manufacturing and User Facility Device Experience (MAUDE) database indicate that battery-related issues are on the rise.
“It’s hard to think of a medical device component that is more important than a battery,” says the FDA’s William Maisel, deputy center director for science at the FDA’s Center for Devices and Radiological Health. “It’s easier to generate a list of devices that don’t rely on batteries.”
The article quotes a number of other experts, including David Marlow, a certified biomedical equipment technician at the University of Michigan Health System, who listed a “mixed bag of challenges” associated with battery management:
- Different battery technologies
- Manufacturers with different approaches
- Different applications
- Different levels of criticality
- Medical facilities with different capabilities
- User training and experience differences
One expert even questioned whether all of these batteries are necessary—for example in operating room tables. “There is a tradeoff between the convenience of battery power and the burden to maintain them,” according to Chris Lavanchy, an engineering director at ECRI Institute. “Maybe it is a bit of a luxury factor in having all these devices with batteries. Maybe we’re putting batteries in devices just because we can.”
As the article notes, the battery management problem is moving to nonclinical settings as well. In these environments, there are a lot of variables, with caregivers confused about how to address battery issues. Mary Weick-Brady, a senior policy advisor at the CDRH, points out that what may seem innocuous to healthcare professionals, “may be an emergency” to lay users.
The article details a number of proposed solutions to the maintenance challenge, including the standardizing of practices for battery design, development, testing, certification, and transportation. Another solution offered was to adopt human factors and systems approaches to the design of battery-powered medical devices.
For more information, visit the Association for the Advancement of Medical Instrumentation.
