A need for reorganization of the Food and Drug Administration.

The associate director for science and medicine in the Office of Drug Safety at the Food and Drug Administration (FDA), Dr. David Graham, reported that the FDA was incapable of protecting Americans from unsafe drugs. In testimony to the Senate Finance Committee, he stated that the FDA has let the American people down and betrayed public trust. Drastic changes and measures within the FDA must be made to ensure the safety of American consumers of drugs, products, and medical devices. Efforts such as the introduction of the Grassley-Dodd Bill, allowing the FDA to order immediate drug recall or increased risk warnings, followed by the FDA Safety Act of 2007, are still not enough to ensure the safety and efficacy of drugs, biological products, and medical devices that the American public use every day. In this report, we describe past and present efforts by congressional leaders, FDA representatives, and American citizens to effect changes within the FDA in order to protect America from unsafe drugs and medical devices. We describe our own struggles in passing a citizen’s petition to ban cornstarch in medical gloves, and the lack of response and responsibility that the FDA has displayed.

Revolutionary advances in the diagnosis of vitamin D deficiency.

Vitamin D deficiency has bee associated with bone diseases, cardiovascular diseases, cancer, and multiple sclerosis. Recent clinical studies have pointed out that these diseases could be prevented by either adequate sun exposure or oral vitamin D3 supplementation. In an effort to prevent these illnesses, emergency physicians and other clinicians must be aware of technological advances in the measurement of serum concentrations of 25-hydroxyvitamin D. Realizing the importance of diagnosing vitamin D deficiency, we reviewed the following advanced diagnostic techniques: liquid chromatography tandem mass spectrometry, radioimmunoassay, and DiaSorin's immunochemiluminometric automated analyzer LIASION®. On the basis of this review, we have found that each of these diagnostic tests has documented limitations, and therefore we recommend an international standardization of these assays to accurately diagnose vitamin D deficiency.

Scientific basis for the selection of vascular closure techniques.

If this educational program heightens the surgeon's, resident's, and student's interest in the biology of vascular wound closure and infection, the long years occupied in our search for improved methods of wound management would more than fulfill our expectations. As with any master surgeon, he/she must understand the tools of his/her profession. This linkage between a surgeon and surgical equipment is a closed kinematic chain in which the surgeon's power is converted into finely coordinated movements that result in vascular wound closure with the least possible scar and without infection. The description of wound repair of blood vessels will be confined to arterial surgery in which the surgeon attempts to establish a new non-wettable intima and to reestablish a strong elastic muscular media. Repair of vessel wall wounds is encountered in arteriotomy for vascular access as well as in artery-to-artery anastomoses. In both circumstances, wound repair is primarily at the suture line. The surgical needles of Syneture™ are produced from stainless steel alloys, which have excellent resistance to corrosion. A new high-nickel stainless steel, SURGALLOY ™, has been used recently by Syneture™ to manufacture surgical needles. We prefer a polybutester monofilament suture whose surface is coated with an absorbable polymer. This absorbable coating of the VASCUFIL™ monofilament sutures markedly reduces its drag forces in vascular tissue. The surgeon can practice using these sutures in femoral arteriotomies in animals.

Scientific basis for the selection of emergency medical examination gloves for emergency medical technicians, paramedics, firefighters, and emergency department personnel. An update.

The use of powder-free natural rubber or latex-free emergency medical examination gloves is especially important to emergency medical technicians, paramedics, firefighters, and emergency department personnel to avoid eliciting an allergic reaction in the latex sensitized patient. The majority of our emergency medical technicians, paramedics, and firefighters are now wearing powder-free emergency medical examination gloves that comply with the stringent codes and standards established by the National Fire Protection Association (NFPA), while very few hospital emergency department personnel have been provided with NFPA-approved gloves. There are four well-defined goals of this report that will assist emergency medical services, fire departments, and hospitals in the selection and purchase of emergency medical examination gloves. First, we will review again the stringent regulations for emergency medical examination gloves that are outlined by the NFPA. This design and performance standard was devised by the NFPA to address protective clothing for emergency medical operations. The design and performance requirement of the emergency medical examination gloves were described in the NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations, 1997 Edition. As of September 2003, the emergency medical examination glove must meet the new design and performance requirements of emergency medical examination gloves discussed in NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations, 2003 Edition.