Regulatory Focus™ > News Articles > FDA Says Reforms of Battery Equipment and Labeling Practices Needed

FDA Says Reforms of Battery Equipment and Labeling Practices Needed

Posted 13 May 2013 | By Alexander Gaffney, RAC

As anyone who has ever lost power-be it because of a storm or a blown transformer-can attest, ours is a society that relies heavily on the use of electricity. Everything from our houses to our modes of transportation to our workplaces relies in part on the use of power. To cite the most obvious example: You'd be unable to read this article were it not for the electrically-powered device in front of you (that is so long as you didn't print it out, an act which also would have required power).

That reliance extends to other, more critical areas of society as well, one of which has garnered particular interest from the US Food and Drug Administration (FDA): medical devices.

That's because as society has advanced, so too have medical devices. Whereas electricity-dependent devices were generally once large and tethered to a mostly permanent source of power, such as a wall's power sockets, new devices are increasingly portable and powered (or made redundant) by batteries.

The increasing reliance has left regulators wondering whether they have an adequate understanding of how, in their words, batteries are used, are maintained, fail and "how FDA can work with device manufacturers to improve battery reliability."

One glance at the list of devices they're interested in shows why they're so concerned about the potential impact of batteries in a medical device. At least 11 devices-including ventilators, defibrillators, pacemakers, heart and lung machines, aspirators and feeding pumps-rely on battery technology, and all are considered by the agency to be life support devices. A battery failure could in theory lead to a fatal adverse event.

Manufacturers Give Feedback

But a recent survey conducted by FDA of nine respondents has given the agency greater insight into how the batteries are used and some of the more common problems facing the industry. One of the key takeaways: "Many of these problems, especially those related to large-volume infusion pumps, may be attributed to staff practices," and not the devices themselves.

Respondents said they typically experiences nine problems, of which the majority were related to poor maintenance practices. Those failures include failure to plug a device in when it's not in use, overcharging or undercharging a battery, leakage or swelling of a battery resulting in fires or explosions, confusion regarding the use of a device's on/off switch, a loose connection between a charging cord and a device and incorrect placement of a battery in a device.

In other words, manufacturers aren't too keen to take much blame for device failures in this case.

"All nine respondents report that nursing staff is responsible for charging battery-powered medical devices on the units where they are used," FDA observed. "However, staff either forgets to plug in the devices or outlets/plugs are not available when needed. Although all report providing ongoing training to reinforce the need for plugging in devices, staff often fail to do so even when outlets/plugs are available. This is particularly true after transport devices have been used to move patients from one location to another; staff does not remember to plug in the transport devices in the new locations."

But if problems are related to staff knowledge of how a device works, wouldn't that be a problem rooted in the device's instructions for use (IFU)? Not necessarily, devicemakers told FDA. The agency said six manufacturers said they believed current IFUs are "clear and contribute to proper use and maintenance." A further two manufacturers, however, said current labeling is not adequate because the IFUs do not accompany the device, and are therefore not of any assistance. In other cases, the IFUs are contained on stickers attached to the device, but do not contain all of the relevant information, or fall off due to use.


All manufacturers said they believed a shut off alarm would be helpful to have on the devices. Such a feature would alert staff that a device needs to be plugged in fully. At present, partially plugged-in devices can shut off or exhibit warnings.

  • Ultimately, FDA said it had developed eight takeaways from the survey:
  • FDA needs to provide education and training to users.
  • FDA needs to track and present performance data on battery-related failures.
  • FDA needs to note the specific batteries used in recalled devices where the battery is a root cause of the recall.
  • Manufacturers need to provide stickers, posters and permanent labeling on medical devices to assist proper use.
  • Manufacturers need to provide visual warnings on devices to indicate low battery or end-of-battery status warnings.
  • Manufacturers need to provide standards for battery charging, replacement, service intervals and battery disposal.
  • Manufacturers need to provide access to a battery compartment to allow users to check the status of a battery.
  • Manufacturers must reclassify and provide testing information that is now proprietary.

FDA noted that it continued to work on the project, though no future dates were mentioned as to when it might release new guidance or regulations.

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