Propofol in Untrained Hands?
Gastro Docs Petition FDA to Relax Propofol Warning
Can doctors and nurses not specifically trained in general anesthesia safely administer propofol (Diprivan) in the low doses necessary for minimally invasive procedures such as colonoscopy? The American College of Gastroenterology believes so, and has asked the FDA to strike the warning from the drug's label and package insert that says only "persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure" should administer the fast-acting sedative-hypnotic.

The ACG petition says that propofol "is superior to alternative sedation agents for endoscopic procedures," and that restricting propofol administration to anesthesiologists or nurse anesthetists "substantially increases the cost of an endoscopic procedure." In addition, the petition says that "propofol can be administered safely and effectively by medical personnel other than anesthesiologists," and cites 31 studies on administration of the drug by non-anesthesia personnel. "We think that there's a sufficient amount of evidence that non-anesthesia providers can administer propofol safely," says Douglas K. Rex, MD, a past president of the ACG, and the director of endoscopy at Indiana University Hospital in Indianapolis.

Others disagree. "There is a nineteen-fold variation in the metabolism of propofol among patients," says anesthesiologist Barry Friedberg, MD. "The variation is so incredible that, even when you think you're giving a safe dose, you might not be."

ACG is putting financial issues before patient safety and patient outcome, says Marc Koch, MD, president and chief executive officer at Somnia, Inc., an office and ambulatory anesthesia service company in New York. "This is a potent medication to which patients react in a very patient-specific way," he says. "The skills, expertise and knowledge of a trained anesthesia provider ... are really something that should be taken with a high degree of importance."

While Diprivan's label states that the drug should be handled by those trained in the administration of general anesthesia, AstraZeneca, the drug's manufacturer, says this "does not specifically limit use of Diprivan to anesthesiologists or nurse anesthetists." The drug's label also says that patients should be continuously monitored, with emergency resuscitation equipment immediately on hand.

Nursing boards in 13 states prohibit RNs not certified in anesthesia from bolusing propofol. In other states, RNs not specifically trained in anesthesia can administer propofol.

The American Society of Anesthesiologists is developing sedation credentialing guidelines for non-anesthesia physicians who seek privileges to administer drugs like propofol to establish a level of deep sedation, says Rebecca S. Twersky, MD, a professor of anesthesiology at SUNY Downstate, speaking on behalf of the ASA. The ASA has "concerns about this drug's being administered in an environment in which no one is available or qualified to rescue the patient from a deeper level of sedation and general anesthesia if that should be needed, which oftentimes occurs intentionally and unintentionally with propofol sedation," says Dr. Twersky.

- Stephanie Wasek

Anesthesiologist Makes Stimulating Discovery
Spinal Stimulator Treats Orgasm Dysfunction
It's called the Orgasmatron. Really, it's nothing more than a spinal stimulator. But Stuart Meloy, MD, has decided to patent the device for its ability to give pleasure, not ease pain. That's right: a spinal stimulator positioned just so can bring women to orgasm. The Winston-Salem, N.C., anesthesiologist first realized the hidden powers of spinal stimulators when he was treating a female patient for intractable leg pain.

"We turned the electrode on, and the patient let out something between a moan and a yelp, and we turned it off," says Dr. Meloy. "Mind you, we're gowned and gloved and she's draped, and all I can see is 6 square centimeters of skin, so I ask, ?Where did you feel that?' She caught her breath, and her response was, ?You're going to have to teach my husband to do that.'"

After determining it was the placement of the electrode - not a device flaw or some other issue - that had caused her to climax on the table, Dr. Meloy repositioned the device so that she started reporting stimulation in her legs, the initial goal.

It probably would have remained an amusing story, except that soon afterward, he relayed the story to an obstetrician friend, who noted that orgasmic dysfunction is the chief complaint for one-third of his GYN patients. "That's very high in my mind. It really got me thinking," says Dr. Meloy.

Dr. Meloy tells women to see their gynecologists first to try to deal with the root problem of orgasmic dysfunction. He says between one-third and one-half of those women will still have a problem; they are candidates for his technique.

Done first on a trial basis, Dr. Meloy implants the electrode roughly at the bottom of the spinal cord, at the L1 and L2 levels in the open spinal space. Temporary placement of an eight-contact electrode takes about a half-hour and costs about $3,800; the generator is external. Patients keep temporary Orgasmatrons for up to 10 days, and take antibiotics to prevent infection in the epidural space.

With permanent placement, an hour-long procedure, Dr. Meloy implants the spinal stimulator in a subcutaneous pocket, in the upper part of the buttocks (just below the belt line) or in what he calls the anatomic love handle (just above the belt line). Those patients get a remote control that lets them turn the stimulator on and off, and adjust the strength of the stimulation. Cost is about $25,000 to $27,000, depending on the generator model.

Dr. Meloy has done an FDA-approved 11-patient trial, the results of which he says have been accepted for publication in an upcoming edition of the journal Neuromodulation.

- Stephanie Wasek

The Orgasmatron for Men?
Women aren't the only ones who can potentially benefit from the implantation of a spinal stimulator for sexual dysfunction.

Based on a case report of a male who experienced climax from such a device installed for chronic pain, Stuart Meloy, MD, is also interested in exploring use of the Orgasmatron for men with erectile dysfunction.

"For males, the greater applicability there is not so much orgasmic dysfunction, but erectile dysfunction, which is often accompanied by heart disease, which is treated with nitrate therapy," he says. "Of course, nitrate therapy is contraindicated by Viagra. So the Orgasmatron would be potentially applicable to those patients who can't take the drugs."

In addition, he says, while Medicare will reimburse for penile implantation, "the man doesn't really benefit from that because it doesn't enhance stimulation. The beneficiary is his partner," says Dr. Meloy. "With this technique, if the government were to approve and pay for it, we can say ?Here's the beneficiary.'

"And, frankly, I think it might be a lot cheaper and safer than the drug options."

- Stephanie Wasek

Specialty Hospitals
Uncertainty Remains as Moratorium Ends
When the 18-month moratorium on the construction and expansion of physician-owned specialty hospitals expired June 8, it appeared that stalled projects would resume, new projects would begin and a small but burgeoning industry would pick up where it left off.

Not so fast. It's time for another round of one step forward, two steps back. Medicare says it will delay certifying new specialty hospitals until January 2006, effectively extending the moratorium. Additionally, pending legislation would make the moratorium permanent and retroactive to June 8.

While it's uncertain how much planning for new facilities is under way now that the moratorium has expired, a federal study says that as many as 37 grandfathered specialty hospitals could open in the next year or so, even if Congress extends the moratorium. Additionally, market research compiled by Outpatient Surgery Magazine detected a recent surge in applications for surgical hospital construction and expansion projects. The American Hospital Association and Federation of American Hospitals say the moratorium put 52 healthcare construction projects under development on hold; between six and 23 of them were specialty hospitals under development, the GAO estimates.

- David Bernard

Headlines on Deadline
Nebraska Lifts Surgical Prep Ban Nebraska's month-long ban on using alcohol-based surgical prep solutions near or around a flammable source prompted healthcare experts to submit an amendment to the National Fire Protection Association suggesting language for safe use of flammable antiseptic solutions. The amendment suggests including an OR time-out to ensure the surgical site is dry before using an ignition source such as cautery, preventing pooling of solution under surgical drapes and removing solution-soaked materials before proceeding with electrosurgery. The Nebraska Department of Health and Human Services banned the rubs in all hospitals and ambulatory care facilities on March 31 after the death of a patient who caught fire in the OR. The ban, which prohibited use of flammable solutions when use of cautery or electrosurgery was anticipated, sparked debate about balancing the risk of fire against the risk of surgical infection. On May 6, the state acknowledged the infection control value of the rubs and advised facilities they could resume using them so long as they exercise caution.

FDA Moves Toward Silicone Implant OK Silicone gel-filled breast implants moved a step closer to the U.S. market after the Food and Drug Administration last month issued an "approvable" letter to Mentor Corp. for its implants.

Florida Cracking Down on Wrong-site Surgery The Florida Board of Medicine will consider raising fines or even suspending the licenses of doctors who perform wrong-site surgeries when it meets this month. Nearly 40 Florida doctors operated on the wrong body part or wrong patient in each of the past two years despite efforts to combat such mistakes, sparking physician regulators on the state medical board to call for harsher penalties. The issue came to a head in April when the board had to discipline nine doctors for wrong-site errors. Each was fined $10,000 or $20,000. In the year ended July 1, 38 doctors were fined, up from 36 last year. In addition to increased fines, the board will consider making it standard practice to suspend a doctor's license if he commits more than one wrong-site error. "While we're going to be a little bit more severe with first-time offenders and a lot more severe with second-time offenders, we realize that singling out and punishing the doctor may not cure the cause," says Nabil El Sanadi, MD, MBA, an emergency physician at Broward Medical Center and vice chair of the state's board of medicine. Kentucky Extends CON Freeze Kentucky's moratorium on processing CON applications, which expired June 30 after 18 months, has been extended to the end of 2005. "Those who have certificates of need are happy that, for the time being, there's no new competition. For those trying to get them, it's a problem," says Stacy Woodrum, Esq., the executive director of the Kentucky Ambulatory Surgery Center Association.