Over the past year, emergency cardiac care and related issues have increasingly moved to the forefront of debate in the Congress. Legislators are becoming more sensitized to emergency care issues.
In the May 1991 edition of Circulation, the American Heart Association (AHA) unveiled its “chain of survival” concept. The chain details the sequence of events needed to ensure that more people can survive sudden cardiac arrest. The links of the chain included early access to the emergency system, early cardiopulmonary resuscitation (CPR), early defibrillation, and early advanced cardiac life support.
In the article, the Emergency Cardiac Care Committee of the AHA set forth a series of recommendations to strengthen the chain of survival. Among the suggestions with public policy ramifications are the following: (1) all communities should implement an enhanced 911 system; (2) communities should adopt more widespread and effective targeted CPR programs; (3) communities should implement programs to establish dispatcher-assisted CPR; and (4) all communities should adopt the principle of early defibrillation, including making automatic external defibrillators (AEDs) available to first responders trained in their use.
Chain of Survival Legislation
Legislation will soon be introduced, drafted in large part by the AHA, that would remove barriers to the “chain of survival” to increase the likelihood of people surviving sudden cardiac arrest.
The legislation, sponsored by Gerry E. Studds (D-10-MA), directs the Secretary of Health and Human Services to provide states with recommendations on a variety of issues, including lifesaving first aid and CPR training for 911 dispatchers, firefighters, teachers, and day-care providers. Further, recommendations regarding AEDs would address the placement of the devices in emergency vehicles and large buildings, stadiums, and arenas; the need for removing barriers to expanding the pool of emergency personnel and first responders authorized to use the device; and the modification of tort laws regarding its use.
The placement of AEDs in the hands of large numbers of people appropriately trained in their use is essential for increased survival of cardiac arrest. In light of this, measures need to be taken to facilitate the placement and proper use of defibrillators in all large gathering places. Ambulances should be equipped with defibrillators, and all traditional first responders to emergencies should be trained in the use of the devices.
The current programs to teach CPR have been very successful in many areas. It is clear, however, that these programs have not penetrated large segments of the population and, without change, will have little effect on cardiac mortality in such groups. In the schools, a 1986 study published in the Journal of Emergency Medical Services found that only six states and the District of Columbia required training in secondary schools, and eight had pending legislation. The situation has not dramatically changed since that time.
The legislation calls upon the Secretary of Health and Human Services to establish a program aimed at providing recommendations to the states and the federal government that will increase the likelihood of survival from sudden cardiac arrest. The Secretary will be instructed by Congress to make recommendations to states to ensure proper implementation of the chain of survival, including recommendations relative to first aid, CPR training, and access to emergency medical services through the 911 system. States will evaluate the merits of training in lifesaving first aid for law enforcement officers, firefighters, teachers, athletic coaches, day-care providers, and other potential first responders. As for the use and location of AEDs, states will determine the merits of training additional health professionals and the general public. The bill also requires the development of federal policies relative to federal facilities and employees. Tort reform issues are also addressed in the legislation.
The legislation has already been endorsed by the American Red Cross, the American Association of Critical Care Nurses, and the National Association of EMS Physicians.
Last year, language was placed in the report accompanying the 1995 Department of Transportation and Related Agencies Appropriations bill that directs the National Highway Traffic Safety Administration to encourage states to allocate funding in their highway safety plans for developing first aid and CPR training and certification programs for police and other emergency service personnel. Technical assistance would be provided to states and localities to improve medical service training for police and other service personnel. In 1994, the AHA actively supported the proposal.
The healthcare reform debate has also brought another emergency care issue to the attention of Congress. Legislation has been drafted by the American College of Emergency Physicians (ACEP) that would prohibit managed care plans from requiring preauthorization for emergency medical care. The bill would establish a uniform definition of emergency that will “protect patients by establishing a prudent layman’s definition of emergency medical condition which restricts managed care plans’ ability to retrospectively deny legitimate emergency medical services.” The bill would also require 24-hour access to primary care gatekeepers qualified to authorize coverage for necessary services in a timely fashion. The legislation also requires health plans to educate enrollees about the appropriate use of the 911 system and would prohibit health plans from discouraging patients from calling 911 when the patient believes, on the basis of his or her symptoms, that an emergency medical situation exists.
Anecdotal information from ACEP cites numerous troublesome cases, including a woman who delayed calling 911 for 2 hours while she attempted to contact her primary care doctor, as required by her HMO, while her husband experienced chest pain and vomiting. The woman did not call 911 until her husband collapsed. The husband later died.
Late in 1994, the issue of informed consent in emergency research began to generate quite a bit of attention. Two gatherings of experts in the Washington, DC, area focused on informed consent and waiver of consent in emergency research. First, in October, representatives of the AHA joined others from the ACEP, the Society for Academic Emergency Medicine, and numerous other groups at a coalition conference of acute resuscitation and critical care researchers. The group’s report and recommendations were published in the April 26 edition of JAMA. The report concludes that “there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol” and sets forth recommendations for determining appropriate circumstances for approving the forgoing of informed consent.
As summarized in the document, there are many acute clinical situations for which no effective treatment is available. In these cases, the use of an experimental treatment may be beneficial. Normally, human subjects must give informed consent for either standard or experimental treatments. However, prospective informed consent for standard or experimental treatment in the emergency setting is often impractical and sometimes impossible when patients are suffering from a cardiac arrest, severe head injury, drug overdose, stroke, or other catastrophic medical or traumatic event. Entry of critically ill patients into an emergency research protocol without consent has been shown to be not only acceptable to but also appreciated by the patients’ families, who, in most cases, allowed continued participation in the protocol.
The consensus recommendations include the promulgation of federal regulations that explicitly address the investigation of emergency therapies for patients unable to give informed consent. The Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations that are developed should be complete and compatible. A new risk category, “appropriate incremental risk,” should be defined for studies that propose to forgo consent in emergency research. Appropriate incremental risk is an amount of incremental risk that is acceptable to the vast majority of potential patients.
On January 9 and 10, 1995, the FDA and National Institutes of Health held a Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. Joseph Ornato, MD, chair of the AHA’s Emergency Cardiac Care Committee, spoke on behalf of the AHA. Numerous examples of hardships resulting from the current regulations were presented to participants.
Numerous meetings in the Senate and House and with the FDA have been held since January. Senator Nancy Kassebaum (R-KS) and Senator Edward Kennedy (D-MA) are among legislators showing an interest in the issues. Although legislation has been drafted to address the issue, it now appears likely that DHHS and FDA regulations regarding waivers of consent will soon be forthcoming. Initial reports from DHHS have been very encouraging as to the content of the regulations.
The 104th Congress has begun its series of hearings into possible reform of the federal FDA. In testimony before the House Appropriations Committee Agriculture Subcommittee, the AHA stated, “Is the FDA perfect? No, of course not. Are there ways that drug and medical device approval can be accelerated without sacrificing public health? Probably so. But Congress, in its haste to implement regulatory reform for the sake of reform, should not be throwing the baby out with the bath water. We are opposed to an approach to reform that will bring health and safety agencies to a screeching halt and indefinitely delay much needed standards.
“The AHA believes that like much of what is transpiring in our society, the FDA needs to ensure that it is keeping up with the technological revolution, that it is meeting the needs, challenges, and opportunities of our society. However, it should not forgo its primary responsibilities to the American public to ensure that the foods, drugs, and medical devices the public consumes are safe, effective, and properly manufactured and distributed.”
In April 1995, as Congress was just beginning its public investigatory process, the Clinton Administration submitted an opening salvo in the debate by releasing its Reinventing Drug and Medical Device Regulations recommendations, part of the National Performance Review headed by Vice President Al Gore. The report addressed the financial burdens of FDA device regulations and looked for ways to eliminate those burdens that had created barriers to bringing beneficial new products to market. Among the FDA’s reform recommendations are proposals to expedite product review, eliminate unnecessary requirements that will not adversely affect public health, and use more automated technology.
Biomaterials Shortage Act
The threat of litigation has led US manufacturers of raw materials needed to make implantable medical devices to limit or cease their shipments to device manufacturers. Dow Plastics, Dow Corning, and DuPont have already ceased to supply a number of raw materials. An estimated 700 000 patients each year need some sort of implantable device, including 35 000 artificial heart valves, 140 000 pacemakers, and 35 000 implantable defibrillators. In addition, more than 1 million cardiac catheterizations, 331 000 angioplasties, and 330 000 vascular grafts are performed annually. Without the necessary supply of raw materials for their manufacture, lifesaving procedures and research could be in jeopardy.
A group of legislators, led by Joseph I. Lieberman (D-CT) and George W. Gekas (R-17-PA), introduced the Biomaterials Access Assurance Act. Under the legislation, biomaterials suppliers would not be liable for harm to a claimant caused by an implant unless they furnish raw materials or component parts that fail to meet applicable contractual requirements or specifications. This legislation would establish a procedure to ensure that suppliers can avoid litigation without incurring heavy legal costs, while not diminishing the existing liability of medical device manufacturers. The AHA actively supports this legislation.
The Biomaterials Access Assurance Act language was included in the omnibus product liability legislation being considered by the Congress, the Product Liability Fairness Act of 1995. The legislation has passed both houses and gone to a conference committee.
- Copyright © 1995 by American Heart Association