A Medical Device Daily
The FDA is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy (BSE).
The agency said that this is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle. These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.
The proposed rule would cover medical devices, drugs (prescription, over-the-counter, and homeopathic) and biologics (such as vaccines) intended for use in humans, as well as drugs intended for use in ruminant animals such as cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.
“These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE,” said Andrew von Eschenbach, MD, commissioner of the FDA.
The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include: the brain, skull, eyes and spinal cords from cattle 30 months and older; the tonsils and a portion of the small intestines from all cattle regardless of their age or health; any material from “downer” cattle — those that cannot walk; any material from cattle not inspected and passed for human consumption.
The FDA proposes to require that records be kept to demonstrate that any cattle material used as an ingredient in these medical products or as part of their manufacturing process meet the rule’s requirements.
Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; however the specific products associated with this transmission are unknown.
About 200 cases of vCJD have been identified worldwide, including three cases in the U.S. However, there is no evidence that those three patients contracted the BSE agent in the U.S.
Obesity surgeries on the rise
Obesity surgeries for patients between the ages of 55 and 64 in the U.S. soared from 772 procedures in 1998 to 15,086 surgeries in 2004 — a nearly 2,000% increase, according to a new report by the Agency for Healthcare Research and Quality (Rockville, Maryland). The report also found a 726% increase in surgeries among patients age 18 to 54. A total of 121,055 surgeries were performed on patients of all ages in 2004.
AHRQ said that among the reasons for the dramatic increase is that mortality outcomes from obesity surgery have sharply declined. It said that the national death rate for patients hospitalized for bariatric surgery declined 78%, from 0.9% in 1998 to 0.2% in 2004. Collectively known as bariatric surgery, these procedures include gastric bypass operations, vertical-banded gastroplasty, and gastric banding or “lapband.”
Doctors may recommend bariatric surgery for patients who have a Body Mass Index of 40 or greater — a person who is 5 feet 2 inches tall and weighs 276 pounds, for example — or a BMI of 35 or more for patients who have serious, obesity-related medical conditions such as Type 2 diabetes or severe sleep apnea.
The report also found that:
- Patients ages 18 to 54 still account for the highest number of surgeries: 103,097 bariatric surgeries, 85% of the total.
- Adolescents ages 12 to 17 accounted for 349 bariatric procedures in 2004.
- Women have bariatric surgery more often than men. They accounted for more than 99,000 operations, 82% of the total.
- The in-hospital death rate for men in 2004 was only 0.4%, but it was 2.8 times higher than that of women. In 1998, the in-hospital death rate for men was six times higher than that of women.
- Gastric bypass surgery — which reduces the size of the stomach and bypasses a section of the intestines to decrease food absorption — accounted for 94% of bariatric procedures.
- The average hospital cost for a bariatric surgery patient stay, excluding physician fees, was $10,395 in 2004 as compared with $10,970 in 1998, adjusted for inflation.
- The vast majority (78%) of bariatric surgery patients were privately insured. Only 5% of patients were uninsured, but their numbers increased by 810 percent over the period.
- The overall hospital costs for bariatric surgery patients increased more than eightfold — from $147 million in 1998 to $1.3 billion in 2004. However, the average cost per patient decreased by 5%.