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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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non-prescription use

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Study Status Completed
522 Number / Requirement Number PS060001 / PSS001
Date Current Plan Accepted 03/13/2006
Study Name non-prescription use
Root Document Number K040904 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is designed as an observational postmarket study with no hypothesis. Annual surveys are conducted on a cohort of AED owners, who have owned the device for at least one year. The objective of this study is to monitor and learn about the use of defibrillators in the home. Specifically, the goal is to characterize the usability of the device by persons who purchase the defibrillator over the counter (i.e., without a physician's prescription). This study will examine device use in actual emergency situations.

Study Population Description Child, Adolescent, TransB, Adult
Sample Size This study has no calculated sample size requirement, nor predetermined descriptive statistical analyses.

Data Collection Owners will be asked if they have used the AED during the study period. If an owner indicates he/she used the device, a detailed interview will be conducted to assess if the user of the AED had any difficulty during utilization of the device. The interview includes specific questions regarding utilization of the device, and also includes a description of the user's experience with the device in their own words.

Follow-up Visits and Length of Follow-up A follow-up survey will be sent to home owners of the AED, who have had their AED for at least one year. In addition, a follow-up survey will be sent to owners who have had their device for at least two years, and to owners who have had their device for at least three years. An AED owner may be sent a follow-up survey annually, for a maximum of three years.

Interim or Final Data Summary
Actual Number of Patients Enrolled 13,328 survey respondents

Actual Number of Sites Enrolled No sites were enrolled. Home ADE owners were contacted directly.

Final Safety Findings During the course of this study there were 24 cases involving the use of a HeartStart AED. There were 20 Type 1 (Sudden Cardiac Arrest (SCA) Use) uses, three Type 2 cases (Non-SCA use; Pads placed on patient, but determined to not be in SCA.), and one Type 3 case (Cases where the AED was taken to the scene of a suspected/potential SCA but pads were not applied). There were 20 cases of Type 1 use for suspected cardiac arrest, of which 18 involved adults and 2 involved children. Adult Cases: Responders' sex were almost evenly distributed with 9 males and 1 0 females (one case had two responders), with a median age of 63 years (range 38-74 years).Twelve of 18 responders had no medical or formal training. Regarding the relationship of the responder to the patient, five of 18 responders were the wife of the patient, five were family members, and four were neighbors. Main responders also more frequently had CPR training> 10 years prior to the use of HeartStart AED (n=15), and most obtained their training of the AED through watching a video (n=13). The location of the use of AED was predominantly at home (n=14 of 18), tended to be a witnessed arrest (n=12), resulting more often in shocks being delivered (55% (10/18). Of the 18 cases of Type 1 use, 10 (56%) cases presented in ventricular fibrillation (VF). Between the 10 cases a total of 17 shocks were delivered and terminated VF with each delivery. The median number of shocks per patient was 1.5. Shock efficacy was reported as 100% for termination of VF. Of the eight cases that did not present in VF, seven were in asystole/PEA throughout the AED recording, and the eighth case was in normal sinus rhythm (NSR) with some ectopic beats. Pediatric Cases: Both cases were prescription AED's used in the home by the parents to terminate VF in their child; both cases survived. Question #50 asked "In your opinion were you adequately trained?" Seventeen of 18 (97%) Type 1 responders felt adequately trained. When asked how training could be improved (Question #51) suggestions included increasing awareness of teaching video; include instructions on post-event care of AED device, and stressing placement of AED in a location other than the closet.

Final Effectiveness Findings Early in the study (2007), reports indicated users were confused of the on/off button for the shock button. The Quick Reference Guide (QRG) was modified in December 2008 and corrective action to inform owners of the new ORG begin in May 2010.

Study Strengths and Weaknesses The study met its objective of describing device use in actual emergency situations. The study captured information from a large number of AED owners (n=13,328). However, the overall percent of total survey recipients responding (56.8% (13,328/ 23,480)). Survey respondents may have different characteristics that those who did not.
Recommendations for Labeling Changes None

non-prescription use Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
3-year report 07/01/2009 06/25/2009 On Time
4-year and Final report 09/30/2010 10/05/2010 Overdue/Received

  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140