Some aspects of the current federal legislation are unclear. For example, FDA regulations do not describe the exact nature and scope of medical advice or training required to use AEDs. Some help on the issue of medical surveillance is a statement in a consumer information document published by the FDA`s Center for Devices and Radiological Health (CDRH), which states that “a physician overseeing the Public Access Defibrillation (PAD) program at a facility must write a prescription for the AED in order for the facility to purchase it.” 2 This indicates that an AED prescription is device-specific, not patient-specific. With respect to training matters, the same document states: 1Note: The information in this chapter does not constitute legal advice. While every effort is made to ensure the accuracy of information, AED`s legal and regulatory landscape is changing rapidly. The legal issues surrounding the use of AEDs can be complex. If your community needs specific advice, seek the services of a competent lawyer. 2www.fda.gov/cdrh/consumer/AED_PAD.html. 3Ibid. (emphasis added).
4Public Health Improvement Act, sections 401 to 404. 5Ibid., article 403. 6Ibid., Article 404. 7Public Health Improvement Act, sections 411 to 413. 8Pub. L. 105-170, 49 USC 44701. 9Edition.
1995;92:2740-2747 10W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 53, p. 356 (5th ed. 1984). 11Ibid. 12Restatement (Second) of Torts § 314A. 13Somes v. United Airlines, Inc., 33 F.Supp.2d 78 (US District Court, D. Massachusetts 1999) 14Talit v.
The case for AEDs is clear. What may not be so clear are the legal issues surrounding AEDs. In the case of AEDs, state and federal laws are starting to catch up with recent medical developments. It often seems that AED laws are more complex than equipment. ™Let`s look at some of the key legal issues employers need to be aware of. The simple truth is that the law only protects us when we are trying to save a life! If, like most people, you`re considering implementing an AED program, you probably have questions about the laws and regulations that affect early defibrillation programs and whether or not there are liability risks. Let`s take a look at federal and state laws and the regulatory framework in which early defibrillation programs are conducted, and examine the nature and limited scope of liability risk for negligence associated with community-based early defibrillation programs.1 Defibrillation, administered as soon as possible after the onset of sudden cardiac arrest, has the ability to significantly improve a victim`s chances of survival. Therefore, ordinary freight forwarders, restaurateurs and commercial enterprises that do not purchase and use AEDs are at the greatest risk in terms of proof of causation. However, this relative risk is quite low given the generally low survival associated with sudden cardiac arrest. Then, in order of risk, there are situations where an AED is available but misused.
This scenario is unlikely because the modern generation of AEDs, with proper training, is both easy to use and difficult to abuse. Companies that purchase AEDs and use them correctly have the least risk of causation. The following sections provide an overview of negligence liability issues applied to the concept of early defibrillation. With this general information, individuals, agencies, and businesses considering purchasing and using AEDs should be assured that any actual threat of legal liability is both minor and manageable. It is clear that the benefits associated with widespread early defibrillation far outweigh the liability risks. In the Federal Register of 4. In May 2005, OSHA asked the public for comments on “the usefulness and effectiveness of automatic external defibrillators (AEDs) in professional settings.” Based on the cost of AED equipment, the training and program management requirements associated with it, and the potential value of lives saved, OSHA believes that using this equipment in facilities is cost-effective from a societal perspective. OSHA says it will use the information gathered to “identify professional settings in which AEDs are more cost-effective” and to help develop “outreach programs to encourage facilities to install AEDs.” The cases are likely to provide insight into the company`s current view on relevance to ill or injured customers.