
[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70015-70016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28763]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


External Defibrillators; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing the following 
public workshop: FDA Public Workshop on External Defibrillators. The 
purpose of the public workshop is to share FDA's understanding of the 
risks and benefits of external defibrillators, to clarify FDA's current 
expectations for how industry should identify, report, and take action 
on problems observed with these devices, and to promote innovation for 
next-generation devices that will bring safer, more effective external 
defibrillators to market.
    Dates and Time: The public workshop will be held on December 15, 
2010, from 8 a.m. to 5:30 p.m., and on December 16, 2010, from 8 a.m. 
to 2 p.m. Persons interested in attending this public workshop must 
register by 5 p.m. on December 8, 2010.
    Location: The public workshop will be held in the Great Room at the 
Food and Drug Administration, White Oak Campus, Bldg. 31, 10903 New 
Hampshire Ave., Silver Spring, MD 20903.
    Contact: Megan Moynahan, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5404, Silver Spring, MD 20903, 301-796-
5435, FAX: 301-847-8510, or e-mail: Megan.Moynahan@fda.hhs.gov.
    Registration and Requests for Oral Presentations: Registration is 
free and will be on a first-come, first-served basis. To register for 
the public workshop, please visit the following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm232062.htm (or go the FDA Medical Devices New & Events--Workshops & 
Conferences calendar and select this public workshop from the posted 
events list). Please provide complete contact information for each 
attendee, including name, title, affiliation, address, e-mail, and 
telephone number. For those without Internet access, please call the 
contact person to register. Registration requests should be received by 
5 p.m. on December 8, 2010. Early registration is recommended because 
seating is limited and, therefore, FDA may limit the number of 
participants from each organization. If time and space permit, onsite 
registration on the day of the public workshop will be provided 
beginning at 7:30 a.m.
    Registrants requesting to present written material or to make oral 
presentations at the public workshop, please call the contact person by 
November 29, 2010.
    If you need special accommodations due to a disability, please 
contact Susan Monahan (e-mail: Susan.Monahan@fda.hhs.gov) at least 7 
days in advance.

SUPPLEMENTARY INFORMATION: 

I. Background

    External defibrillators (including automated external 
defibrillators (AEDs)) are life-saving devices designed to restore 
normal heart rhythms following sudden cardiac arrest. Each year, nearly 
300,000 Americans collapse from sudden cardiac arrest. In sudden 
cardiac arrest, the heart unexpectedly stops pumping blood to the body. 
When normal heart rhythms are not restored quickly, sudden cardiac 
arrest can cause death.
    External defibrillators are important, life-saving devices. 
However, over the past 5 years we have seen persistent safety problems 
with all types of external defibrillators, across all manufacturers of 
these devices. From January 1, 2005, to July 10, 2010, there were a 
total of 68 recalls, of which 9 occurred in 2005 increasing to 17 in 
2009 (the last complete year for which data are available). During this 
period, FDA received over 28,000 medical device reports (MDRs), of 
which 4,210 occurred in 2005 increasing to 7,807 in 2009 (the last 
complete year for which data are available). FDA conducted multiple 
inspections of all external defibrillator manufacturers throughout this 
time period.
    Many of the types of problems we have identified are preventable, 
correctable, and impact patient safety. As part of a comprehensive 
review, FDA identified several industry practices that have contributed 
to these persistent safety risks including industry practices for 
designing and manufacturing defibrillators, handling user complaints, 
conducting recalls, and communicating with users. In some cases, these 
practices can contribute to device performance problems, place undue 
burden on users, and put patients at risk.
    To date, FDA has addressed individual device problems on a case-by-
case basis. However, our analysis of MDRs, recalls, and inspections 
confirms that common problems persist across all types of external 
defibrillators and all manufacturers. One purpose of the public 
workshop is to share FDA's understanding of the risks and benefits of 
external defibrillators and to clarify FDA's current expectations for 
how industry should identify, report, and take action on problems 
observed with these devices.
    In addition, to promote innovation and to better understand patient 
outcomes, FDA is collaborating with the University of Colorado's 
Department of Emergency Medicine and the Centers for Disease Control 
and Prevention (CDC) to develop a multi-city AED registry that will 
link with the CDC-funded Cardiac Arrest Registry to Enhance Survival 
(CARES). The registry will provide the infrastructure to foster the 
development of innovative AED features such as automated integration 
into local 9-1-1 systems. FDA will work with multiple stakeholders to 
facilitate the development of next-generation defibrillators, enhance 
surveillance of defibrillators in community settings, and improve the 
rapid delivery of treatment for sudden cardiac arrest patients. One 
purpose of the public workshop on December 15 and 16, 2010, is to 
advance these efforts by bringing together government, industry, 
academia, and users, including clinicians and consumers, to share 
perspectives.

II. Topics for Discussion at the Public Workshop

    The public workshop will be organized to allow facilitated 
discussion by industry, academia, clinicians, users, and regulators on 
the following broad topic areas:
    1. What are the nature, scope, and impact of external defibrillator 
problems that have been observed? What are the root causes of these 
problems?
    2. How should problems with external defibrillators be identified, 
reported, and acted upon by industry and users?
    3. What factors or criteria should be considered when designing 
external defibrillators for use in different environments (hospital, 
community, home)?
    4. What features of next generation devices can be defined that 
will increase the diffusion of new technologies, enhance device 
interoperability, and improve ease of use?

[[Page 70016]]

    5. How might device registries improve our ability to identify 
early device performance signals, or enhance the use of external 
defibrillators?

III. Transcripts

    Please be advised that as soon as a transcript is available, it can 
be obtained in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to 
Division of Freedom of Information (HFI-35), Office of Management 
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, 
Rockville, MD 20857. A link to the transcripts will also be available 
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the 
posted events list), approximately 45 days after the public workshop.

    Dated: November 9, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28763 Filed 11-15-10; 8:45 am]
BILLING CODE 4160-01-P


