Medical Devices

Public Workshop - Battery-Powered Medical Devices Workshop: Challenges and Opportunities, July 30-31, 2013

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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 organized 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 included 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. The first day focused on the current and future challenges with batteries and battery-powered medical devices. The second day focused on the opportunities, potential solutions, and next steps. Both days included keynote and introductory presentations in the morning intended to encourage further discussion during the breakout sessions in the afternoon.


Date, Time and Location

This meeting was 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

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Webcast Archive

Day 1

Day 2

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Agenda

 

Agenda-Day 1, July 30, 2013
Challenges

8:00-9:00Registration and Networking
 Morning Presentations
Moderator: Iacovos Kyprianou, Senior Science Health Advisor, CDRH, FDA
9:00-9:15William Maisel, Deputy Center Director for Science, CDRH, FDA
Welcome and opening remarks
9:15-9:35Keynote Presentation
RADM Nicole Lurie, USPHS, Assistant Secretary for Preparedness and Response, HHS
Responding to public health emergencies
9:35-9:55Antoinette Hazlett, Surveys & Research, Medical Product Safety Network (MedSun), CDRH, FDA
MedSun Survey Results Overview
9:55 -10:10Ken Skodacek, Co-Leader CDRH's Battery Working Group, CDRH, FDASetting the Stage for Collaboration
 BREAK
 Challenges: Stakeholder Perspectives
10:20-10:30AAMI perspective, Alan Lipschultz, CEO, HealthCare Technology Consulting LLC
10:30-10:40Health Technology Management Perspective, David Marlow, Certified Biomedical Equipment Technician, University of Michigan Health System
10:40-10:50Challenges of a children’s hospital, David Bradley, Director of Biomedical Engineering, Nationwide Children's
10:50-11:00Healthcare Provider Perspective, CDR Mike Krumlauf, USPHS, NIH Clinical Center
11:00-11:10ECRI Institute Perspective, Chris Lavanchy, Engineering Director, Health Devices Group, ECRI Institute
11:10-11:20FDA Perspective, Hamed Ghods, Engineer, Office of Science and Engineering Laboratories, CDRH, FDA
11:20-11:30Medical Device Manufacturer (Implantable), Michael Root, Scientist, Boston Scientific
11:30-11:40DoD Challenges with Batteries in a Deployed Environment, MSG Curt Straub, US Army, USAMMA
11:40-11:50Battery Manufacturer Perspective, Dominick Frustaci, VP of R&D, Greatbatch
11:50-12:00Transportation of Lithium batteries, Kevin Leary, International Transportation Specialist, Office of Hazardous Materials Safety, US Department of Transportation
12:00-12:20Question and Answer Period / Panel Discussion
Panel: David Bradley, Dominick Frustaci, Hamed Ghods, Kevin Leary, Mike Krumlauf, Chris Lavanchy, Alan Lipschultz, David Marlow, Michael Root, Curt Straub
12:20-12:30Brainstorming for Innovation, Andrew Grebe, Innovation Lab, U.S. Office of Personnel Management
 LUNCH
 Afternoon Breakout Sessions for In-person and Online Participants
What are the goals? What are the challenges?
1:30-3:00Breakout Session 1
 BREAK
3:15-4: 45Breakout Session 2
4:45-5:00Closing Statement and Plans for Day 2
 

 

 

Agenda-Day 2, July 31, 2013
Opportunities

8:00-9:00Registration and Networking
 Morning Presentations
Moderator: Ken Skodacek, Co-Leader CDRH's Battery Working Group, FDA
9:00-9:30Key Note Presentation, Cristin Dorgelo, Assistant Director of Grand Challenges, Office of Science and Technology Policy, Executive Office of the President
Harnessing American Ingenuity through Open Innovation
9:30-10:30Presentation and Discussion of Day 1 Brainstorming Sessions
 BREAK
10:40-10:50Human Factors Considerations, Ron Kaye, Team Leader of Human Factors Evaluation Team, Office of Device Evaluation, CDRH, FDA
10:50-11:00Battery Standards, Rich Byczek, Global Technical Lead of Electric Vehicle & Energy Storage, Intertek
11:00-11:10Battery Testing, Bruce Adams, VP of Sales, Cadex
11:10-11:20Home Use Devices, Mary Weick-Brady, Senior Policy Advisor, Office of Center Director, CDRH, FDA
11:20-11:30Battery/Device integration and technologies that address patient challenges, Alex Fay, Business Development Manager, Quallion
11:30-11:40Requirements flow-down from device-to-battery and the related role of battery modeling, Craig Schmidt, Sr. Director Energy Systems, Medtronic
11:40-11:50Case for Quality & Critical to Quality, CAPT, Kim Lewandowski-Walker, USPHS, National Expert In Medical Devices, ORA, FDA
11:50-12:00Education: how can we make an impact, Ron Charnock, CEO, KwikPoint
12:00-12:15Q/A and panel discussion
Panel: Bruce Adams, Mary Brady, Rich Byczek, Rich Constantineu, Ron Charnock, Alex Fay, Ron Kaye, Craig Schmidt, Kim Lewandowski Walker
 LUNCH
 Afternoon Breakout Sessions for In-person and Online Participants
What are the solutions? What are the next steps?
1:15-2:45Breakout Session 3
 BREAK
 Afternoon Presentations
Moderator: Charles Ho, Co-Leader CDRH's Battery Working Group, FDA
3:15-3:30Highly Resonant Wireless Power Transfer being used to recharge implantable batteries and devices, Colin McCarthy, Product Marketing Specialist, WiTricity
3:30-3:45Designing Battery Powered Medical Devices for public health emergencies, Philip Ferro, Director of Special Projects, office of Assistant Secretary of Preparedness and Response, HHS
3:45-4:00Human Powered Medical Devices, Mike McAlpine, Assistant Professor, Princeton University
4:00-4:45Presentation and Discussion of Day 2 Brainstorming Sessions
4:45-5:00Closing Statement and Next Steps

Breakout session details for in-person participants:
The in-person participants were divided into 8 groups. The CDRH staff worked with the subject matter experts to facilitate the brainstorming sessions.

CDRH Facilitators:
Laura Adam, Patrick Axtel, Kristen Bowsher, Carole Carey, Simon Choi, Dulciana Chan, Charles Ho, Alan Hoffman, Geetha Jayan, Ron Kaye, Alisson Kumar, Iacovos Kyprianou, Kim Lewandoski-Walker, Mimi Nguyen, Katie O'Calahan, Anindita Saha, Hilda Scharen, Pamela Scott, Jennifer Shih, Ken Skodacek, Pavel Takmakov, Victoria Wagman, Cisco Vicenti

Subject matter experts:
Salil Balar (Aramark), David Bradley (Nationwide Childrens), Chaochao Chen (UMD), Ron Charnock (Kwikpoint), Alex Fay (Quallion), Dominic Frustaci (Greatbatch), John Dumas (Hospira), CDR Mike Krumlauf USPHS (NIH), Chris Lavanchy (ECRI), Alan Lipschultz (AAMI), Mohan Misra (ITN), Joe Padilla (Interstate batteries), Michael Root (Boston Scientific), Tom Skowera (UL), William Sovitsky (USAMMA, PMMD), Like Xie (Palladium)

Breakout session details for webcast participants:
During the in-person breakout sessions there was a panel discussion for the benefit of the webcast participants. On each day 5 panelists discussed challenges and opportunities and the webcast participants provided feedback or ask questions to the panel.

Host/Facilitator: Janesia Simmons (CDRH)

Webcast Support staff: Dharmesh Patel (CDRH), Sophie Wang (CDRH), Geri Smith (CDRH), Carol Krueger (CDRH), Amar Laheri (CDRH)

Panelists Day 1: Bruce Adams (Cadex), Kristen Bowsher (CDRH), Rich Constantineu (Anne Arrundel Health), Antoinette Hazlett (CDRH), Craig Schmidt (Medtronic)

Panelists Day 2: Shah Ashish (Greatbatch), Rich Byczek (INTERTEK), Hamed Ghods (CDRH), William McFarland (CDRH), Bhanu Sood (UMD)

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Registration to Attend the Workshop

Registration is closed as of 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.

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Public Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments is by 5 p.m. on August 30, 2013. Regardless of attendance at the meeting, interested persons may submit their comments regarding this workshop at http://www.regulations.gov/#!documentDetail; D=FDA-2013-N-0580-0001 or to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.

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Workshop Details

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Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Susan Monahan, Office of Communications and Education Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, susan.monahan@fda.hhs.gov.

For questions regarding workshop content, please contact Dr. Iacovos (Jake) Kyprianou, Center Science Council, Office of Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3609, Silver Spring, MD 20993-0002, 301-796-2601, CDRHbatteries@fda.hhs.gov.

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