FDA Plans Workshop on Battery-Powered Medical Devices
Batteries play a huge role in the performance of many life-saving and life-sustaining medical devices. However, there are a number of challenges posed by the use of such devices, including unexpected failure due to an improperly charged battery. To better understand the design, development, selection, purchase, use, and maintenance of these devices, the U.S. Food and Drug Administration (FDA) has scheduled a two-day public workshop titled “Battery-Powered Medical Devices Workshop: Challenges and Opportunities."
During the workshop, which is scheduled for July 30 and 31 at the FDA’s White Oak campus in Silver Spring, MD, interested parties will work together to develop best practices and industry standards for battery-powered medical devices. In addition, attendees will examine the difficulties faced by hospitals, healthcare providers, and patients when using and maintaining these devices.
When a device fails to function properly, the cause of the problem is sometimes identified as “battery failure,” even when the battery is not the root cause of the problem, according to a June 5 notice about the upcoming workshop, published in the Federal Register. On the other hand, improper charging and inconsistent maintenance can cause unexpected failure of devices at crucial times, such as emergency situations in which electrical power is unavailable or intermittent. Participants will look into these issues and discuss possible solutions for healthcare delivery organizations and patients.
Other topics slated for discussion include human factors; labeling; user training; special considerations under extreme conditions; and emerging technologies and innovation, according to the Federal Register notice.
Those interested in attending the workshop either in person or via webcast must register online by 5:00 pm, July 19. A preliminary agenda is available here. The agency is accepting comments on all aspects of the public workshop topics until Aug. 30. Interested parties can learn more about submitting comments by clicking here.
AAMI has identified battery management as one of the top 10 challenges for healthcare technology management (HTM) professionals in an annual survey. Last year, survey respondents included HTM professionals from 1,900 different hospitals in the United States.
Posted: 06.10.13