Office of the Ombudsman
Food and Drug Administration
10903 New Hampshire Avenue
WO Building 32, Room 4260
Silver Spring, MD 20993
The purpose of this letter is to request correction of information disseminated by the FDA in accordance FDA guidelines. 1
Detailed Description of the Specific Material That Needs To Be Corrected
1. Regarding Automated External Defibrillators, the FDA states;"Consider taking American Heart Association training courses in cardiopulmonary resuscitation (CPR) that include the use of AEDs." (EXHIBIT A)
2. The hyperlinked "cardiopulmonary resuscitation" in the FDA statement is designed to send the reader directly to the American Heart Association®,Inc., ("AHA") "Find A Course" web page that promotes the AHA, its products, and network of Instructors and Training Centers - though the link is presently broken (EXHIBIT B).
Specific Reasons for Believing the Information Does Not Meet Applicable OMB, HHS, or FDA Guidelines and Is In Error, and Supporting Documentation
1. The statement suggests an organizational bias and therefore violates the element of presentation objectivity as defined by HHS Guidelines.2
Specific Recommendations for Correcting the Information
1. To promote and protect "free and vigorous competition",3 remove the AHA reference and hyperlink and replace with an organizationally neutral recommendation;i.e., "Consider taking a nationally recognized training course in cardiopulmonary resuscitation (CPR) that includes the use of AEDs."
Description of How the Person Submitting the Complaint Is Affected By the Information Error
- Promotion of a single, private sector training organization and their commercial training products unfairly provides advantage and hinders competition on equal and fair terms.
- As a profit-making, non-tax paying entity, and the dominant competitor in the cardiopulmonary resuscitation ("CPR") and Automated External Defibrillator ("AED") training business,the AHA and their Approved Training Centers,Affiliated Instructors,and Authorized Providers have a vested economic interest in CPR/AED training in corporations,the community and the healthcare industry- particularly where required for regulatory compliance.
- Though corporate structures differ (HSI is a tax-paying corporation), the profit-making business units of HSI, the AHA and other nationally recognized organizations are similar (EXHIBIT C).
- Each organization develops and markets commercially available, proprietary CPR/AED training programs, products, and services to Training Centers and Authorized Providers, either directly or via distributors.
- The fee-for-service business structures of Training Centers and Authorized Providers include sole proprietorships,partnerships, corporations,LLCs,non-profits, as well as government agencies.
- Instructors affiliated with Training Centers are authorized to certify CPR/AED course participants. Certification requires performance and evaluation of hands-on skills to verify skill competency.
- The AHA is not a Recognized Accrediting Organization (EXHIBIT D).
- The AHA is not a recognized regulatory standards developing organization (EXHIBIT E).
- The Health and Safety Institute (HSI) is a large privately held emergency care and response training organization, joining together the training programs of ASHI, MEDIC First Aid, 24-7 EMS, 24-7 Fire, First Safety Institute, GotoAID,and EMP Canada.
- An ASHI and MEDIC First Aid representative participated in the International Committee on Resuscitation 2005 and 2010 International Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations, hosted by the AHA.
- An ASHI and MEDIC First Aid representative was a volunteer member of the AHA and American Red Cross 2005
National and 2010 International First Aid Science Advisory Board and were contributors to the 2005 and 2010 Consensus on First Aid Science and Treatment Recommendations.
- ASHI and MEDIC First Aid training programs conform to the ILCOR 2010 Consensus on Science, the 2010 AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science, and the 2010 AHA and ARC Guidelines for First Aid
- Like the AHA, HSI is a nationally accredited organization of the Continuing Education Coordinating Board for Emergency Medical Services (CECBEMS). CECBEMS is the national accrediting body for Emergency Medical Services (EMS) continuing education courses and course providers. CECBEMS accreditation requires an evidence-based peer-review process for continuing education programs comparable to all healthcare accreditors. ASH! professional level CPR programs are CECBEMS approved.
- ASHI and MEDIC First Aid training programs conform to the recommendations of the Occupational Safety and Health Administration (OSHA) Best Practices Guide: Fundamentals of a Workplace First-Aid Program.
- On whole, ASH! and MEDIC First Aid and CPR training programs are currently endorsed, accepted, approved, or recognized as an meeting the requirements of more than 2600 state and provincial regulatory agencies, occupational licensing boards,national associations,commissions, and councils.
- Nearly 2000 state and federal government agencies currently use ASHI and MEDIC First Aid training programs to train their employees in CPR/AED, including the United States Coast Guard, Veterans Administration, Department of Agriculture, Air Force, Army Corps of Engineers, Army National Guard, Marshals Service, Administration Office of the U.S. Courts, Forest Service, Bureau of Alcohol, Tobacco, Firearms and Explosives, Bureau of land Management, Customs and Border Protection,and the Internal Revenue Service.
- HSI is a member of the American National Standards Institute (ANSI) and ASTM International (ASTM) - both globally recognized leaders in the development and delivery of international voluntary consensus standards.
- HSI is a member of the Council on licensure, Enforcement and Regulation (CLEAR), the premiere international resource for professional regulation stakeholders.
- HSI publishes and administers a set of quality assurance standards designed to monitor and improve the performance of HSI, its approved ASHI and MEDIC First Aid Training Centers and Authorized Instructors so that the products and services provided meet or exceed the requirements of regulatory authorities and other approvers.
The FDA statement regarding AEDs suggests bias toward the private sector commercial products of the AHA. In so doing, it violates elements of objectivity as defined by HHS Guidelines and promotes unfair and discriminatory practices that lessen fair and honest competition without a legitimate purpose or countervailing rationale sufficient to justify its harmful effects. Consequently, we formally request that the FDA amend this and other similar or future statements to
remove the suggestion of organizational bias.
1Guidelines for Ensuring the Quality of Information Disseminated to the Public. VI. Agency Administrative Complaint Procedures Available: http://aspe.hhs.gov/infoquality/Guidelines/fda.shtml#vb [Retrieved 12/21/12)
2 HHS Guidelines for Ensuring and Maximizing the Quality,Objectivity,Utility,and Integrity of Information Disseminated to the Public. D.2.c. . Available: http://aspe.hhs.gov/infoqualitv/Guidelines/part1.shtml#d3 [Retrieved 12/21/12]
Ralph M. Sshenefelt
Vice President, Strategic Compliance
Health & safety Institute
1450 Westec Drive
Eugene, OR 97407
cc:Gregory R. Ciottone,MD,FACEP, Medical Director,Health and Safety Institute
Bill Clendenen,MBA,Chief Executive Officer,Health and Safety Institute
Jeff Jackson, MBA,Chief Financial Officer, SVP Product Development,Health and Safety Institute
Steve Barnett, MBA,VP, Brand Management- Emergency Care, Health and Safety Institute
Kristal Langner, Regulatory Approval Specialist, Health and Safety Institute
|http:Uwww.heart.org/HEARTORG/CPRAndECC/CPR UCM 001118 SubHomePage.jsp Retrieved 12/21/12|