HeartStart Home OTC Defibrillator FDA Panel Presentation

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HeartStart Home OTC DefibrillatorFDA Panel
Presentation
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Introduction

• Carl Morgan
• Company Co-Founder and Scientist

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We propose to remove the prescription requirement
for the Philips HeartStart Home Defibrillator.
Introduction to todays discussion

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HeartStart Home Rx cleared in 2002
Rx requirement
CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A PHYSICIAN.

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Improving access to help save lives

• Mission
• Prevent unnecessary deaths due to sudden cardiac
  arrest.
• Focus
• Improving access by developing and deploying
  automated external defibrillators (AEDs) that can
  be used by virtually anyone to help save a life.

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Timeline

• Heartstream founded 1992
• ForeRunner launched 1996
• First save on American Airlines 1998
• Initial discussions with the FDA re OTC 1999
• FR2 launched 2000
• Filed pre-IDE 2001
• HeartStart Home Defibrillator launched 2002
• Filed 510(k) for OTC clearance 2004

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Medical device labeling
The Food, Drug and Cosmetic Act requires that
medical device labeling must bear adequate
directions for use (502 (f)(1))
directions under which the layman can use a
device safely and for the purposes for which it
is intended. (21CFR801.5)

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The prescription caution
A prescription caution must be included in
labeling if a device is not safe except under
the supervision of a practitioner licensed by law
to direct the use of such device, and hence for
which adequate directions for use cannot be
prepared. (21CFR801.109)

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Basis for removing the Rx requirement for the
HeartStart Home Defibrillator

• Demonstrate established history of safe use.
• Demonstrate that the HeartStart Home
  Defibrillator can be used safely and for its
  intended purpose based upon its labeling alone.

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Presenters

• David Snyder
• Director of Research, Philips
• Dr. Lance Becker
• Professor of Medicine
• Director, Emergency Resuscitation Center,
  University of Chicago
• Dr. Jeremy Ruskin
• Founder and Director, Cardiac Arrhythmia Service
  and Clinical Electrophysiology Laboratory,
  Massachusetts General Hospital
• Arrhythmia research

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Product overview

• David Snyder
• Director of Research, Philips

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Philips HeartStart Home Defibrillator

• Received FDA clearance in November 2002.
• Indications for use
• Unresponsive or not breathing normally.
• If in doubt, apply pads.
• Safety and effectiveness already established.

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Demonstration

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Designed as safety equipment

• If you have concerns about your health or an
  existing medical condition, talk to your doctor.
  A defibrillator is not a replacement for seeking
  medical care.
• Cannot predict who might need it, or when.
• Equipment may be used once in a lifetime.
• Key characteristics
• Safe for all
• Ready when needed
• Easy in the moment

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History of Philips AED technology
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Sophisticated arrhythmia detection

• No single parameter can lead to shock
  advised.
• Multiple parameters required.

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Field-demonstrated sensitivity/specificity

• Biphasic waveform study
• 1st generation AED--ForeRunner
• 286 out-of-hospital patients (1st 100 VF)
• 100 sensitivity, 100 specificity
• American Airlines study
• 1st generation AED--ForeRunner
• 200 consecutive uses 15 VF patients
• 100 sensitivity, 100 specificity
• Includes use as a rhythm monitor
• Tens of thousands of analyses
• One known inappropriate shock.
• Successful defibrillation, followed by AF with no
  ventricular activity indistinguishable from fine
  VF. Patient survived with normal neurological
  function.

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Gliner et al., Biomed Instrum Technol.
199832(6)631-643. Page et al., N Eng J Med.
20003431210-1216.
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Philips AED use estimates Through 12/31/2003

• Over 150,000 AEDs deployed since 1996.
• gt 1,000,000 total patient applications.
• 200,000 patients required shocks.
• 800,000 patients did not require shocks.
• Non-random sampling based on ForeRunner AEDs.

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Field performance

• Six confirmed AED emergency use failures across
  Philips installed base (gt 1,000,000 patient
  applications).
• 4 no patient impact
• 1 patient impact indeterminate
• 1 possible patient impact
• No complaints about shock effectiveness.

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MDR summaryForeRunner and FR2 Top 3 issues
and predominant causes, confirmed unconfirmed
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HeartStart Home DefibrillatorDesign features
relevant to top 3 ForeRunner and FR2 MDR issues
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First-year annualized failure rate for Philips
defibrillators (all causes)

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Automated self-test
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Iterative design process

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HeartStart Home life-cycle support
Storage Maintenance
Post-Use
Use
Set-Up
Training
Purchase
Product Packaging
HeartStart Home Defibrillator Primary
labelingVoice Prompts, Device Icons, Self-Test
Sales Materials
HeartStart Home Defibrillator Secondary
labelingQuick Reference, Owners Manual,
Training Video, Quick Start, Training Coupons,
Product Registration Card

• Product Website
• Resources
• FAQs

Philips Customer Service Product Information,
Training Resources, Consumables, Data Retrieval,
Grief Counseling, Physician Access
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Philips HeartStart Home Defibrillator

• Designed as safety equipment.
• History of safety and readiness.
• Designed for ease of use.

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Clinical overview Safety and usability study

• Dr. Lance Becker
• Professor of Medicine, University of Chicago
• Disclosures

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Sudden Cardiac Arrest A leading killer in the
United States

• Majority have no prior symptoms.
• Nearly 80 happen in the home.
• More than 50 of home arrests witnessed.

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American Heart Association. Heart Disease and
Stroke Statistics 2004 Update. Dallas, Tex.
American Heart Association 2003. Litwin et al.,
Ann Emerg Med. 198716787-791.
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American Heart Association. Guidelines 2000 for
Cardiopulmonary Resuscitation and Emergency
Cardiovascular Care. Dallas, Texas American
Heart Association, 2000. Cummins et al.,
Circulation. 1991831832-1847.

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Time is key to survival
Response curve (exponential decay rate) is after
De Maio et al., Ann Emerg Med. 200342242-250.
Time intervals after Herlitz et al., Eur Heart J
2003241750-5. Blackwell et al., Academic Emerg
Med. 20029288-295., Braun et al., Ann Emerg
Med. 1990191058-64., White et al.,
Resuscitation. 2002Oct55(1)17-23., Myerburg et
al., Circulation. 20021061058-1064.
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Early access can help save more lives
Response curve (exponential decay rate) after De
Maio, et al. Ann Emerg Med. 200342242-250.

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Early defibrillation programs
Page et al., N Eng J Med. 20003431210-1216. Caff
rey et al., N Eng J Med. 20023471242-1247. Val
enzuela et al., N Eng J Med. 20003431206-1209.
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NHLBI-sponsored Public Access Defibrillation
(PAD) trial Will AEDs improve survival?

• Study objective Will AEDs improve cardiac
  arrest survival compared with CPR alone?
• 20,000 lay responders in facilities with a
  pre-defined risk of an event.
• Results
• Survival in CPRAED group doubled (n29) compared
  with CPR alone (n15).
• No serious adverse events associated with AED
  use.
• 89.3 of evaluated responders (n 3,671)
  demonstrated adequate AED skills 3 months after
  training.
• Conclusion
• Laypersons can use AEDs safely to provide early
  defibrillation.
• Ornato J. AHA Scientific Sessions 2003.
• Sehra et al., (Abstract 2002)Suppl to
  Circulation, Vol 106, No 19, pg II-403.

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Rapid response saves lives

• Time is critical Early defibrillation is highly
  effective.
• Primary question Can the HeartStart Home
  Defibrillator be used safely by lay people?

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Safety and usability study

• Hypothesis 1
• The Philips HeartStart Home Defibrillator and FR2
  are safe even in the absence of training.
• Hypothesis 2
• The HeartStart Home and FR2 have high usability
  when used with primary labeling components (voice
  prompts, product graphics) plus training video.
• Study method
• Mock cardiac arrest scenario with a fully dressed
  manikin and AED.

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Enrollment and randomization
FR2
HeartStart Home
HeartStart Naïve n 62
Simulated Use Test
Simulated Use Test
Powered to detect a 20 difference between naïve
and video trained for each device with power
0.80 and alpha 0.05 (approx. 62 per group).

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Primary and secondary endpoints

• Primary endpoints
• Safe no touching of patient in a manner that
  could result in a shock across the rescuers
  chest.
• Successful shock delivered with pads positioned
  in a manner likely to defibrillate (includes
  power on, attach pads with appropriate pad
  placement, analyze, and defibrillate within 5
  min).
• Secondary endpoints (based on starting time from
  when participant entered the room).
• Time-to-pads on
• Time-to-shock

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FR2 results Simulated-use test

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FR2 results Time-to-shock

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HeartStart Home results Simulated-use test

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HeartStart Home results Time-to-shock

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Study limitations

• Simulated use vs. reality
• Demographics
• Human anatomy more varied

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Conclusions

• The HeartStart Home Defibrillator and the FR2
  were used safely in all cases (n 132, 124
  respectively).
• FR2 success rate significantly improved by video
  training from 48 to 86 (p lt 0.001).
• HeartStart Home Defibrillator successfully used
  by both naïve and video trained volunteers at 87
  (79 LCL, n 61) and 89 (81 LCL, n 63) with
  no difference detected between naïve and video
  trained.

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Labeling evaluation and simulated use Lay user
surveyPost-market study

• David Snyder
• Director of Research, Philips

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Labeling evaluation and simulated usePurpose

• Labeling evaluation Test comprehension of
  secondary labeling materials for the Philips
  HeartStart Home OTC Defibrillator.
• Owners Manual
• Quick Reference
• Training Video
• Quick Start Poster
• Simulated use Demonstrate safe and successful
  use after review of only one component of
  labeling.
• Owners Manual
• Quick Reference

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Secondary labeling materials

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Methods

• Recruitment in 3 geographically diverse shopping
  malls.
• No medical or defibrillator training, no CPR
  training within 2 years.
• Age range 21-74.

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Methods

• Hypothesis for comprehension test
• The written labeling materials are well
  understood.
• Approximately 90 passing grade (LCL gt 80).
• Hypotheses for simulated use
• The HeartStart Home Defibrillator is safe.
• The HeartStart Home Defibrillator can be
  successfully used by laypersons to deliver a
  defibrillation shock.
• Non-inferiority vs. 90 (10 margin).
• Study method
• Mock cardiac arrest scenario with a fully dressed
  manikin and AED

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Enrollment and randomization
30 min
15 min
Simulated use powered for a non-inferiority delta
of 10 versus presumed success rate of 90 with
power 0.80 and alpha 0.05.
Comprehension sample size determined to establish
95 LCL of 80 for presumed success rate
(C grade or better) of 90.
Simulated Use Test

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Primary and secondary endpoints

• Primary endpoints
• Safe no touching of patient in a manner that
  could result in a shock across the rescuers
  chest.
• Successful shock delivered with pads positioned
  in a manner likely to defibrillate (includes
  power on, attach pads with appropriate pad
  placement, analyze, and defibrillate within 5
  min).
• Secondary endpoints (based on starting time from
  when participant entered the room).
• Time-to-pads on
• Time-to-shock

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Comprehension test

• Written labeling materials at a 6th grade reading
  level or lower (Flesch-Kincaid).
• Test topics included
• Definition of SCA (vs. MI, stroke, etc.)
• Set-up
• Training
• Storage
• Maintenance
• When to use defibrillator
• Rescue steps
• Post-shock care
• Infant/child use

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Results Median comprehension scores

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Results Simulated-use test
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Results Median time-to-shock
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Limitations and conclusions

• Study limitations same as safety and usability
  study.
• All labeling well understood with at least 90
  receiving a passing grade. Passing grade LCL
  88 for all tests.
• Defibrillator used safely in all cases (n 178).
• Successful use 97 (92 LCL, n 89) with Quick
  Reference.
• Recommended labeling for emergency response.

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Follow-up

• Added information to training video and Quick
  Start poster regarding intended use of various
  labeling materials.
• Cover of Owners Manual modified to clarify its
  purpose as a guide to set up, maintenance, and
  accessories.

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Lay user surveyPurpose

• Determine if lay use of Philips AEDs results in
  any previously unreported problems.

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Jorgenson et al., Resuscitation. 200359225-233.
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Lay user surveyMethods
Owned AED at least 1 year Medical professionals
excluded
Lay users identified 145 homes
2,683 businesses and
public facilities
Initial contact by phone center
(at least 7 contact attempts)
Brief interview
Use by layperson?
YesUse by a layperson Detailed interview with
medical professional

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Lay user surveyResults

• Surveyed 78 homes and 1,645 businesses.
• No problems reported.
• 209 businesses (13) had used an AED at least
  once.
• 9 uses in homes/home offices.
• Conducted 11 detailed interviews regarding pads
  applied to unresponsive patients.
• EMS called in all cases.
• 3 patients appropriately received no shocks.
• 8 patients received shocks.
• 6 survived to hospital admission.
• 4 received shocks solely from lay responders, and
  all survived to hospital admission.

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Lay user surveyLimitations and conclusions

• LimitationsSurvey and interview participation
  was voluntary.
• Conclusions
• No harm or injury to users, bystanders or
  patients.
• No malfunctions or problems.
• All users willing to use defibrillator again.
• No safety or effectiveness issues reported.

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Ongoing HeartStart Home post-market studyPurpose

• Evaluate lay uses of HeartStart Home
  Defibrillator for safe and appropriate
  application.

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Methods
Contact lists generated HeartStart Home owned gt
1 year or 1 year since last surveyed
Pads re-ordered or use reported to Philips
AEDused?
Contact owner
Detailed interviewwith medical professional
Yes
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Proposed extension to HeartStart Home post-market
study

• Extend ongoing post-market study to 200 home uses
  total or 4 years from HeartStart Home OTC
  Defibrillator clearance.
• Results to be reviewed by DSMB and reported
  annually to FDA.

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Clinical perspective

• Dr. Jeremy Ruskin
• Director, Cardiac Arrhythmia Service,
  Massachusetts General Hospital
• Disclosures

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Sudden death - Risk stratification
"High-Risk" Pts
VT-VF
Survivors
Prior MI LV Dysfxn CHF VEA EPS
50 65 50 50 65

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Ruskin et al., NEJM. 1980303607-613. Wilber et
al., NEJM. 198831819-24.
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Sudden deathRisk stratification
"High Risk" Pts
VT-VF
Survivors
Prior MI LV Dysfxn CHF VEA EPS
50 65 50 50 65

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Ruskin et al., NEJM. 1980303607-613. Wilber et
al., NEJM. 198831819-24.
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Evolving role of defibrillation

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Safety equipment
Smoke alarm
Fire extinguisher

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Benefits and limitations
Ahrens, M. U.S. experience with smoke alarms and
other alarm devices, Nov 2003, National Fire
Protection Association, Fire Analysis and
Research Division, 1 Batterymarch Park, Quincy,
MA 02169-7471  National Highway Safety
Administration, Air Bag Facts, Safety Fact Sheet,
11/02/1999 http//www.nhtsa.dot.gov/airbags/factsh
eets/numbers.html

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SCA and motor vehicle injury deaths in US (1999)

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State-Specific Mortality from Sudden Cardiac
Death--- United States, 1999. CDC, MMWR,
February 15, 2002/ 51(06) 123-6 10 Leading
Causes of Unintentional Injury Deaths, United
States, 1999, All Races, Both Sexes. CDC Website
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10-year expectations for emergency events

• U.S. Experience with Smoke Alarms and other Fire
  Alarms, Ahrens, Fire Analysis and Research
  Division, National Fire Protection Association,
  Nov 2003.
• Projections of the Number of Households and
  Families in the United States 1995 to 2010,
  P25-1129, US Dept of Commerce, Bureau of the
  Census, April 1996.
• How Many Homes Are There? US Census Bureau,
  American Housing Survey, http//www.census.gov/hh
  es/www/housing/ahs/01dtchrt/tab2-1.html.
• Safety Fact Sheet, National Highway Traffic
  Safety Administration, 11/2/99,
  http//www.nhtsa.dot.gov/airbags/factsheets/number
  s.html.
• ZJ Zheng, et al, State-Specific Mortality from
  Sudden Cardiac Death-- United States, 1999.
  MMWR Weekly, CDC, Feb 15, 2002/ 51(06) 123-6.

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Benefits of removing the Rx requirement

• Broader access to a safe and effective technology
  that is the only definitive treatment for SCA.
• Provide an opportunity to save some of the lives
  that would otherwise be lost to SCA.

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RisksCan the AED cause harm?

• HeartStart Home OTC is the same intended user and
  patient population as Rx.
• Robust safety features.
• ECG analysis system
• Artifact detection
• No manual override

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Philips AED field performance

• gt 1,000,000 total patient applications.
• 200,000 patients required shocks.
• 800,000 patients did not require shocks.
• One known inappropriate shock.
• No complaints about shock effectiveness.

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Summary

• Safe design and established history of safe use.
• The HeartStart Home Defibrillator can be used
  safely and for its intended purpose based upon
  its labeling alone.

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Theoretical risks

• Will OTC AEDs interfere with medical care?
• Not a substitute for medical care.
• Risk factors still need to be addressed.
• Care and prescribed therapies for pre-existing
  conditions need to continue.
• Physicians retain option to prescribe AEDs in
  cases of medical necessity.
• Target populations are different.
• Will OTC defibrillators interfere with EMS
  response?
• SCA survival rate is lt5 because defibrillators
  do not arrive in time.
• Philips supports calling EMS in labeling.
• Early defibrillation one part of emergency
  response.
• Rx requirement does not enhance EMS response.

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HeartStart Home Defibrillator Realistic
expectations

• SCA is an epidemic and a major public health
  problem the most common cause of death in
  adults.
• Survival rates are abysmally low (lt5).
• A defibrillator is not a cure for the problem
  of SCA.
• Unwitnessed arrests, devices used incorrectly,
  device failure, other human and logistical
  factors.

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HeartStart Home Defibrillator Realistic
expectations

• OTC defibrillators represent a paradigm shift and
  a step toward wider access.
• Potential to save some lives that would otherwise
  be lost.
• Long term even a small impact could double
  current survival rates.

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Strategies for addressing SCA

• Prevention of coronary artery disease.
• Revascularization and ICDs in high-risk patients.
• Availability of on-site rapid defibrillation.

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Successful defibrillation depends on immediate
recognition of the emergency and prompt
application of the external defibrillator. Paul
M. Zoll, M.D. 1956
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