A true BUREAUCRATIC shame of American healthcare

****Some years ago,in the early 1990s, Yoda learned of a device called a CardioPump used in emergency CPR and opportunistically had a student import one into Thailand from the manufacturer in Denmark and thence smuggled into the U.S. since the USFDA, in fact, had banned imports. Although the total cost in that one-off situation was close to $1K, the device seemed beyond reproach and was in use outside the U.S. The FDA hadn't approved it at the time and it STILL hasn't approved it.****
http://tinyurl.com/ybxh8vs
"FEEL A HEART ATTACK COMING? GO TO FRANCE" by Alexander Volokh, Competitive Enterprise Institute,August 2, 1994, Wall Street Journal:
...In April 1993, the FDA blocked testing of the cardiopump, a new cardiopulmonary resuscitation device for heart-attack victims. As a result of FDA policy, thousands of people with heart disease are literally being protected to death.
The cardiopump, manufactured by Ambu International of Denmark, is a modest device. It weighs a mere pound and a half and looks like a modified toilet plunger, with a pliable cup that fits onto the heart-attack victim's chest and a combination hand- grip/pressure gauge instead of the wooden handle. Manual CPR exerts downward pressure on the chest, but the chest has to re- expand naturally. The cardiopump can apply pressure in both directions. Says Dr. Jeffrey Shultz of the University of Minnesota: "It turns the chest into a bellows. It allows you to pull blood back into the heart and air back into the lungs."
Just how effective is the cardiopump? In St. Paul, Minn., where tests were carried out, 54% more patients survived long enough to be admitted to intensive care if they were given cardiopump-assisted CPR, and 35% more survived to be discharged from the hospital. (Because of small sample size, the hospital discharge statistics aren't statistically significant.)
U.S. tests for the cardiopump began in 1992 and continued until April 1993, when FDA barred further use of the pumps. According to FDA spokeswoman Sharon Snider, "This product is considered to be a 'significant risk device,' and informed consent is required for any trials of significant risk devices."...****Someone in cardiac arrest is most unlikely to give informed consent and so the situation languishes into the second decade of its possible use in the U.S.**** ... Keith Lurie, a professor of medicine at the University of Minnesota who helped develop the cardiopump, estimates that the device will increase one's chances of survival by about 10-50%. That kind of improvement "has not been reported since the first description of manual CPR more than three decades ago." Since 20,000 CPR patients a year survive to leave the hospital, even a 10% increase would mean 2,000 extra lives saved. In the St. Paul trial, the increase was 35%, which extrapolates nationally to 7,000 lives, or roughly 20 a day....strange as the FDA's actions might seem from a medical standpoint, they are perfectly understandable politically. If the FDA mistakenly approves a device that has adverse side effects, this would result in highly undesirable publicity. On the other hand, if the FDA delays in approving a life-saving device, the people who die are politically invisible. For a regulator, it's easy to err on the side of overcaution, even when the results are deadly....(now)charging device manufacturers "user fees" of up to $50,000 per new-product application...backlog isn't the problem. No amount of staff and funding increases can erase the bureaucratic incentive to impose restrictions as illogical as informed consent from patients with no pulse.
COMPETITIVE ENTERPRISE INSTITUTE, 1001 Connecticut Ave. NW #1250, Washington, DC 20036, 202-331-1010, fax 202-331-0640. It may be even more important than was realized.
http://tinyurl.com/yla3hwc
Vigorous CPR Is Best for Cardiac Arrest Study Shows Survival Rates Rise When More Chest Compressions Are Done By Bill Hendrick WebMD Health News
Sept. 16, 2009 -- Vigorous cardiopulmonary resuscitation (CPR) with more chest compressions on people with sudden cardiac arrest can improve the survival rate, a new study shows.
"Chest compressions move blood with oxygen to the heart and the brain to save the brain and prepare the heart to start up its own rhythm when a shock is delivered with a defibrillator,"..."We found that even short pauses in chest compressions were quite detrimental."...In sudden cardiac arrest, the heart suddenly stops pumping blood effectively to the brain and body, causing a person to collapse....When sudden cardiac arrest occurs, death comes within a few minutes unless the victims' heart muscles are successfully jolted back into a normal rhythm with an electrical shock.
CPR traditionally involves providing chest compressions to help circulate blood around the body and breathing support, such as mouth-to-mouth ventilation. Interruptions to chest compressions are common during CPR, with rescuers typically spending only 50% of their time giving chest compressions...In the new study, published in Circulation: Journal of the American Heart Association, researchers analyzed data...to determine the effect of chest compressions on patient outcome. They specifically looked at something called the "chest compression fraction" (CCF), which refers to the percentage of time spent performing chest compressions relative to the entire time that CPR is performed....a "return to spontaneous circulation" was achieved 58% of the time when the CCF was 0% to 20%, but rose to 79% when CCF was 81% to 100%. Return to spontaneous circulation means that the heart began to beat effectively again on its own. Survival to hospital discharge occurred in 12% of patients with a CCF between 0% and 20%. Survival more than doubled to 29% when CCF increased to 61% to 81%, the researchers say. Survival rates fell slightly to 25% with CCF ratios greater than 81%.
"There was roughly a 10% increase in the chance of survival for every 10% increase in the chest compression fraction,'' Christenson says.