ASA Gives Brain Monitors Lukewarm Endorsement
Awareness Victim Wants Routine Use of Monitors
A woman who has dedicated her life to preventing anesthesia awareness was hoping for better news than she received at the American Society of Anesthesiologists' annual meeting last month in Atlanta. Carol Weihrer, who claims she was awake but unable to speak or move while surgeons removed her diseased right eye in 1998, wanted the ASA to endorse routine use of brain monitors during surgery that requires general anesthesia. What she got was far less. The ASA approved the group's first practice advisory that acknowledges anesthesia awareness as a condition that might occur at a rate of between 1 and 2 in every 1,000 surgeries done under general anesthesia, but stopped short of endorsing the use of brain monitors, instead leaving that decision to individual practitioners.
"This is a big step of acknowledgement and possibly a concession about anesthesia awareness," says Ms. Weihrer, 54. "But the document has no teeth. This is not a mandate. It's only a recommendation."
Ms. Weihrer wants the use of the monitors to be standard practice in every OR; or, at the very least, she wants a monitor available if individual patients request its use for a case. "This is my passion," says Ms. Weihrer. "I won't stop until brain-function monitors are used in every OR."
- Daniel Cook
Massachusetts Bill Targets Single-use Devices
Massachusetts surgeons would have to explain the risks and benefits of using reprocessed SUDs in surgery, and patients would then have the right to approve or reject their use under proposed legislation.
"Devices designed, developed and manufactured with single-use in mind cannot be adequately cleaned and sterilized," says Nigel Wilkinson, the vice president of regulatory affairs and quality assurance for Andover, Ma., manufacturer Smith & Nephew. Representatives from Boston Scientific and Bard Medical joined Smith & Nephew at an Oct. 19 Public Health Committee hearing at the State House.
Don Selvey, the vice president of quality assurance for Alliance Medical Corporation, a Phoenix-based reprocessing company, opposes the bill because of the low level of risk to patients when reprocessed single-use equipment is used in surgery. He says Alliance reprocessed 1.5 million devices last year, with a complaint rate of 0.034 percent, and believes this legislation is profit-driven.
"I've been using reprocessed devices for years and have never had a problem," says Rich Elliott, RN, director of surgical services for the Four Seasons Surgery Centers of Southern California. "How much less than 34 thousandths of a percent do you need to ensure sterility and safety to the patients?"
Mr. Elliott says manufacturers are backing this law to protect higher priced single-use products.
"These are patients' rights and public health issues," says Joe Metzger, a spokesman for Smith & Nephew. "If this were about economics, we'd start a reprocessing division."
- Daniel Cook
NK-1 Receptor Antagonists
Study: New Class of Drugs Very Effective at Reducing Vomiting
A new class of drugs, called NK-1 receptor antagonists, is more effective at reducing vomiting after surgery than the most commonly used 5-HT3-receptor antagonist, say the Duke University Medical Center researchers who led the Phase III clinical trial.
Compared to the 5-HT3-receptor antagonists, the NK-1 receptor antagonist blocks at a different site the cascade of biological signals leading to nausea and vomiting. In the study, 95 percent of patients taking the NK-1 receptor antagonist before surgery did not experience vomiting 24 hours after surgery, compared to 74 percent for the most commonly used drug, ondansetron. The rates at 48 hours post-surgery were 93 and 67 percent, respectively.
"This is the first time that an anti-sickness drug provides a sustained protection against post-operative vomiting in more than 90 percent of patients," says T.J. Gan, MD, the Duke anesthesiologist who led the trial.
While the trial found a significant improvement in the incidence of vomiting, there was little difference between the two drugs in reducing nausea.
- Dan O'Connor
Agencies Define "Adverse Medical Event" in Office-based Surgery
Three accrediting agencies have agreed to a definition of reportable adverse events in office-based surgery: death related to a procedure which takes place in the office setting or within 14 days of discharge; transfer to a hospital or emergency center for a period exceeding 24 hours; unscheduled hospital admission for longer than 24 hours, within 72 hours of an office procedure and which is related to that procedure; or a serious life-threatening event occurring in the office setting that compromises patient safety and results in unanticipated injury. The American Association of Accreditation of Ambulatory Surgery Facilities, Accreditation Association for Ambulatory Health Care and Joint Commission on Accreditation of Healthcare Organizations collaborated on the definition.
Hair Styling Products a Danger in the OR?
Alcohol-based hair styling products could have caused the surgical fire on a woman's face and neck during a lymph node biopsy at Seattle's Swedish Medical Center, says a hospital official. The patient, Jackie Day, 54, is suing the hospital and two attending physicians.
Ms. Day's burns were "perhaps due to the inadvertent ignition of an alcohol-based hair styling product," says hospital spokesman Ed Boyle in a written statement. He doesn't say how the ignition may have occurred. "They never gave us a clear explanation of what happened to cause this," says Seattle lawyer Jane Morrow, who represents Ms. Day and her husband. Their suit cites the hospital as negligent and seeks undisclosed damages. "That's what we're trying to find out in this case."
Since the incident, Swedish has expanded its pre-surgery procedures to include screening for hair-care products, Mr. Boyle says.
"I'm surprised that if they knew this was the problem, that they weren't screening for (alcohol-based products) already," says Ms. Morrow.
Ms. Day, of Poulsbo, Wash., was under sedation for the biopsy in May 2004 when she awoke to find her face and neck in flames. She suffered disfiguring scars from the incident.
- David Bernard