Makers of automatic external defibrillators (AEDs) have a generally common goal: to make AEDs as ever-present as fire extinguishers. One more step toward that goal was taken last month with an order by the Federal Aviation Administration that mandates installation of AEDS on any U.S. passenger flights staffed by at least one flight attendant. The airlines will have three years to install the equipment on all flights, domestic and international, with the order providing guidelines for flight attendants and other crew to be trained in use of the AEDs. And it estimated the total cost to the airline industry to meet the requirements of equipment and training at $16 million.

In issuing the order, Jane Garvey, FAA administrator, reported that nine airlines already have installed AEDS or have committed to doing so, but she said that the rule "will ensure that all airline passengers have access to this potentially life-saving device." The proposed order was issued by the FAA last May, and the agency received 370 comments on the proposal, 321 described as from the general public and supporting the AED installations and only one comment criticizing the proposal. That comment came from someone describing herself as a registered nurse and saying that any advanced medical care should be delivered by "flight nurses and/or flight paramedics." Twenty-five other comments received, the agency said, supported the proposal "generally" but offered detailed comments or requested modifications.

Among these were statements from AED manufacturer Agilent Technologies (Palo Alto, California), the only organization or company in the medical device and instrumentation sector providing comment on the proposal. Agilent offered several suggestions concerning modifications of the final rules, some of which the FAA agreed with, others not. Most of the other comments in this category came from airlines and worker organizations.

The Air Line Pilots Association (ALPA; Washington) recommended that the AEDs be stored in airplane cockpits to "assure that the flight crew is well aware of the presence of an AED" and to make them more secure. The FAA disagreed, saying that storage in cockpits would make the devices less accessible to attendants. Additionally, it noted four cases of AED batteries rupturing, one of those incidents occurring in a hangared jet. Those incidents, it said, were the result of ruptured batteries powered by lithium sulfur dioxide, with the FAA saying that these batteries "are not intrinsically safe."

The new rules require the addition of several items to the in-flight emergency kit, including an oral antihistamine, non-narcotic analgesic, aspirin, atropine, bronchodilator inhaler, licodain and saline, an IV administration kit with connectors, an AMBU bag to assist respiration following defibrillation and CPR masks. Various comments suggested adding other supplies, ranging from some types of catheters and nasal cannulas to EKG machines and glucometers. But the agency disagreed with these additions saying that the intent of the rule was to allow additional options rather than to offer a comprehensive list. And it noted that the American Heart Association (AHA; Dallas, Texas) had cautioned against large expansion of the emergency kit materials so as to avoid "simply making available every drug and medical device ever requested by an in-flight physician."

"According to the AHA, its international guidelines on CPOR and emergency cardiovascular care have recommended far fewer resuscitation medications and medical devices than ever before," the FAA said, adding that it will continue to study the inclusion of other kit materials.

A comment from a Teamsters local representing Northwest Airlines (Minneapolis, Minnesota) flight personnel said that air flight emergency kits "include cheap, disassembled parts, with medical equipment manufacturers taking advantage of the air carriers by placing sub-standard equipment in the kits purchased by the air carriers." This, it said, "must be addressed." The agency countered this, arguing that current regulations warned against "substandard equipment," that quality equipment "is maintained by routine FAA oversight" and that it had not found evidence of inadequate onboard equipment.

David McKenas, MD, medical director at American Airlines (Fort Worth, Texas), said in a statement that "more than a dozen people are walking around today because defibrillators on American Airlines saved their lives ... these machines have more than proved their worth in the air and on the ground."

TFPI gene therapy shows promise

Three Houston, Texas-based institutions – Texas Heart Institute, St. Luke's Episcopal Hospital and the University of Texas Medical School – said researchers are developing a type of gene therapy that could revolutionize treating patients with atherosclerosis.

Physicians involved in the study expect to begin clinical trials this year in patients who have undergone angioplasty or other catheter-based interventions to remove plaque and restore blood flow in their arteries. They will examine whether gene transfer of tissue factor pathway inhibitor (TFPI) reduces patients' risk of redeveloping buildup and blood clots in vessels damaged during the medical procedure.

Successful use of the therapy was reported in the March 27, 2001, issue of the Proceedings of the National Academy of Sciences.

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