The purpose of this letter is to request correction of information disseminated by the FDA in accordance FDA guidelines. 1
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).
Relevant Facts
- 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.
Conclusion
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.
Notes
1Guidelines for Ensuring the Quality of Information Disseminated to the Public. VI. Agency Administrative Complaint Procedures Available: http://aspe.hhs.gov/infoguality/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]
3http://www.ftc.gov/bc/index.shtml
Sincerely,
/s/
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
11Strategies for Home Users and Public Access AED Owners to Maintain Readiness of Automated External DefibrillatorsAvailable: http://www.fda.gov/MedicaiDevices/ProductsandMedicaiProcedures/CardiovascularDevices/ExternaiDefibrillators/ucm233450.htm
[Page last Updated: 11/10/2010. Retrieved 12/21/12]
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http:Uwww.heart.org/HEARTORG/CPRAndECC/CPR UCM 001118 SubHomePage.jsp Retrieved 12/21/12
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Accrediting Organizations pt. 1
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Accrediting Organizations pt. 2
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Accrediting Organizations pt. 3
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Accrediting Organizations pt. 4
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Exhibit E
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Last
Revised: 01/10/13