Public Workshop – Battery-Powered Medical Devices Workshop: Challenges and Opportunities, July 30

Batteries play a significant role in the overall safety, performance, and reliability of many life-saving and life-sustaining medical devices.  As more medical devices become computerized, compact, and mobile, the number of battery-powered medical devices will continue to increase. While many different components can potentially impact the safety and effectiveness of medical devices, the battery is one of the most critical components.  Unexpected depletion or failure of the battery can cause the device to stop functioning properly, preventing the device from delivering life-sustaining or life-saving therapy.  The Association for the Advancement of Medical Instrumentation (AAMI) has identified battery management as one of the top 10 challenges for hospital’s biomedical departments. 

While the FDA has confidence that medical devices currently being marketed will continue to function appropriately, there are opportunities to further improve their overall performance and safety.  The FDA is organizing a Battery-Powered Medical Devices Workshop on July 30-31, 2013 to create awareness of the potential challenges related to battery-powered medical devices and to collaboratively develop ways of ensuring the continued performance and reliability of these devices.  The participants would include a broad group of stakeholders that are responsible for the design, testing, manufacturing, integration, regulation, selection, purchase, storage, maintenance, and use of batteries throughout the total product life cycle of battery-powered medical devices.

This meeting is a way to better understand and address the potential challenges related to the design/development, selection, purchase, use, and maintenance of battery-powered medical devices. It’s also designed to initiate greater collaboration among stakeholders to develop best practices, training, and industry standards for battery-powered medical devices.

This meeting will be held July 30 and 31, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

• Link for FDA Campus Information

As the agenda is being developed please contact us with suggested topics and speakers.

Day 1

Session 1: User experiences

In this session, participants from Industry, health care, and patients/consumers will voice their experiences with battery powered medical devices. Topics may include: challenges, battery maintenance, evaluating battery capacity, selection and purchase of replacement batteries including counterfeit batteries and third party batteries, human factors considerations, training, and best practices.

Session 2: Design and manufacturing of batteries and battery powered medical devices

In this session, participants will discuss battery/device integration.  Topics may include system integration of batteries, control and selection of suppliers, human factors considerations, good manufacturing practices, signaling and alarm considerations, labeling and maintenance recommendations, transparency between cell manufacturers and pack assemblers, and best practices.

Session 3: Battery and medical device testing by manufacturers and hospitals

In this session, participants will discuss battery and medical device testing that assures continued reliability and performance.  Topics may include battery performance and evaluation, accelerated aging testing, soft and hard short circuits, and battery safety test conditions.

Session 4: Standards

In this session, participants will discuss standardization needs for battery-powered medical devices.  Topics may include: battery performance and evaluation, battery signaling and alarms, battery indicators and status, battery and device labeling, accelerated testing, soft and hard short circuits, computer modeling, battery safety tests, and quality assurance.

Day 2

Session 1: Special considerations

In this session, participants will discuss special considerations for battery-powered medical devices used in the home, during military deployment, and during public health emergencies. Topic may include labeling and instructions for end users and tracking and notification of life-sustaining devices in home use during natural disasters.

Session 2: Evolving needs and emerging technologies

In this session, participants will discuss the challenges and unmet needs presented by new technologies.

Session 3: Innovation lab

In this session, participants will collaboratively identify best practices and innovative solutions to the challenges identified during the workshop.

Session 4: Workshop out come and future activities

In this session, participants will discuss the next steps (e.g. standards, FDA guidance, and user training).

If you wish to attend this Workshop, you must register by close of business on July 19, 2013. 

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.

Food and Beverages will be available for purchase during the breaks.