|
|
|
|
| FDA Recalls Balanced Salt Solution, Issues Benzocaine Spray Warning
|
|
After reports of injuries in more than 300 patients who were given balanced salt solution manufactured by Cytosol Laboratories, the FDA has requested a recall of the product. The FDA has also issued a Public Health Advisory on the use of benzocaine sprays used in the mouth and throat after the Veterans Health Administration suspended their use earlier this month.
The FDA's recall order explains that product lots of BSS were found to have elevated and dangerous levels of endotoxins and that it has been notified of resulting incidents of a "serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome." TASS occurs when a contaminant such as endotoxins enter the anterior segment of the eye during surgery, causing an inflammatory reaction.
The BSS subject to recall was sold under three labels:
AMO Endosol, distributed by Advanced Medical Optics (Santa Ana, Calif.),
Cytosol Ophthalmics, distributed by Cytosol Ophthalmics (Lenoir, N.C.), and
Akorn, distributed by Akorn, Inc. (Buffalo Grove, Ill.).
The benzocaine spray warning was triggered by incidents of methemoglobinemia resulting from incorrect use, such as longer lasting or more frequent doses than recommended. In methemoglobinemia, the hemoglobin in red blood cells becomes unable to bind to and carry oxygen.
The sprays are used to numb mucous membranes of the mouth and throat during intubation or minor surgical procedures and are marketed under several names, including Hurricaine, Topex and Cetacain. The FDA is "reviewing all available safety data, but at this time is not planning action to remove the drugs from the market." Further announcements or action may follow the ongoing review.
|
|
 |
^ Back to Top |
|
|
|
|
| More Regulation for Kansas Surgery Centers?
|
|
A legislative battle over abortion clinics is pulling Kansas's surgery centers into the fray through a recently introduced bill that would require unannounced health inspections at the clinics, the centers and all other standalone outpatient medical facilities.
The legislation would mean an inspection at each of the state's 2,300 outpatient facilities at least once every five years. The annual $837,000 cost of inspections would be paid for out of physicians' fees.
The proposed regulations follow several bills that sought unannounced inspections at the state's abortion clinics, each of which were vetoed by Gov. Kathleen Sebelius. Ms. Sebelius has said she'd support such inspection regulations only if they apply "across the board," according to a report in the Wichita Eagle.
The Kansas Medical Society and other health associations are opposed to the bill, arguing that it duplicates existing regulatory efforts. The Kansas Ambulatory Surgery Association has not yet taken a stand on the bill, but is expected to review the issue at its March meeting, says association president Shelley LeGate.
|
|
|
^ Back to Top |
|
|
|
|
| Study: "Quality Chasm" in Hospital Care
|
|
The odds that a patient will survive a hospital stay at a top-tier U.S. facility are significantly higher than those they'll face at the bulk of the nation's medical facilities, a new study reveals. According to the independent healthcare ratings company HealthGrades, hospitals that ranked in the top five percent in terms of overall quality exhibit on average a 27 percent lower risk of patient death and a 14 percent lower risk of surgical complications than the other 95 percent.
The annual study, based on an examination of nearly 39 million hospitalizations of Medicare recipients between 2002 and 2004 at the nation's 5,122 non-federal, acute care hospitals, noted that 152,966 patient lives could have been saved and 21,896 complications avoided during that period if the quality of care at all American hospitals matched that of the top five percent, or 277 hospitals.
"The data in this year's study indicate a clear and profound divergence between the best hospitals and all others," says Samantha Collier, MD, HealthGrades' vice president of medical affairs. "This growing 'quality chasm' is of concern to healthcare professionals and patients alike."
|
|
|
^ Back to Top |
|
|
|
|
| News and Notes |
|
ANESTHESIA WAS THE CAUSE OF DEATH for two cosmetic surgery patients undergoing procedures in New York City, officials say. According to investigations, a patient who died at the Manhattan Eye, Ear & Throat Hospital in February 2004 was accidentally given an injection of anesthesia in her larynx by a provider trying to infiltrate the fat between her skin and windpipe. Another patient, who died in a Manhattan plastic surgery clinic shortly after a liposuction procedure, suffered complications from general anesthesia. In that incident, prosecutors say, the person performing the surgery was not a licensed physician.
TWO PHARMACEUTICAL COMPANIES have announced positive results in a study of a drug to treat post-operative ileus caused by opiate use after gastrointestinal or abdominal surgery. According to the Adolor Corporation and GlaxoSmithKline, the investigational therapy Entereg (alvimopan) showed statistically significant results across all of the Phase 3 study's time-to-event endpoints. Adolor, which received an initial approvable letter from the FDA for Entereg in June 2005, plans to submit the final study results to the agency as part of its response to a request for further information in June of this year.
HOW MUCH DO SURGICAL COMPLICATIONS INFLUENCE HOSPITAL COSTS? Not much, actually, according to a study in the Annals of Surgery. The study suggests that pre-operative risk factors and surgical complexity are more effective predictors of hospital costs than complications. For a random sample of nearly 6,000 patients on six surgical services, researchers analyzed the National Surgical Quality Improvement Program pre-operative risk factors, surgical complexity and outcomes, along with hospital costs. Fifty-one of 60 pre-op risk factors and 22 of 29 post-operative complications were associated with higher variable direct costs. Risk factors predicted 33 percent of cost variation and complications predicted 20 percent. Risk factors and work RVUs together predicted 49 percent of cost variation or 16 percent more than risk factors alone. Adding complications to this combined model modestly increased prediction of costs by 4 percent for a total of 53 percent. Researchers conclude that pre-operative intervention to reduce risk could lead to significant cost savings. They also urge payers and regulatory agencies to risk-adjust hospital cost assessments using clinical information that integrates costs, preoperative risk, complexity of operation and outcomes. |
|
|
^ Back to Top |
|
|
|
|
|
|
