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| Panel Recommends FDA Approval for Sedasys, with Cautions |
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An advisory panel of outside experts voted 8 to 2 to recommend FDA approval of Ethicon Endo-Surgery's Sedasys machine, a computer-assisted personalized sedation system designed to administer propofol to colonoscopy patients without the need for a clinician trained in general anesthesia.
Most panel members agreed with the manufacturer's findings that the system could potentially increase compliance with colorectal cancer screening by helping to control sedative dosing, speeding recovery times and reducing side effects associated with colonoscopy sedation. However, the panel raised concerns about having a machine rather than clinicians directly administer the powerful sedative.
The Anesthesiology and Respiratory Therapy Devices Advisory Committee ultimately recommended that the FDA approve the device, with a few caveats. It said the agency should require special training on the device for physicians and should require teams of at least 3 clinicians - including 1 doctor or nurse to handle the device - to work on cases in which Sedasys would be used. Experts also said the system should only be used on adults aged 70 or younger and that additional studies were needed.
Officials with Ethicon Endo-Surgery told Reuters they'd be in talks with the FDA over the next few months, as the agency weighs the panel's recommendation and the evidence of Sedasys' safety and efficacy. The day before the advisory panel's decision, the FDA had released a memo in which staff noted "a marked study site effect" with one of the manufacturer's studies on the device that showed "investigator behavior rather than product performance may have favored the Sedasys system."
Irene Tsikitas |
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| Taxing Times for Wisconsin ASCs |
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Wisconsin is planning to tax its 60 ambulatory surgery centers a total of $44 million over 2 years to help bridge the state's $1.6 billion budget shortfall.
Details of the tax remain sketchy, says Eric Ostermann of the Association of Wisconsin Surgery Centers. ASCs are expected to be taxed on their gross patient revenues, but it's not clear at this point how much tax would be assessed and how it would be collected.
The ASC tax is similar to a tax on hospitals that could draw down more federal money to pay back the centers and balance the state budget.
ASCs would be eligible to receive $11.4 million in additional Medicaid reimbursement annually, but ASCs that treat fewer Medicaid patients than acute care hospitals do would see fewer benefits from the proposal.
"We're currently evaluating the impact this would have on all surgery centers in the state," says Mr. Ostermann.
Dan O'Connor |
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| Obesity Linked to Poor Bowel Preps |
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The more overweight a patient is, the more likely is it that his bowels have been inadequately prepped in advance of a colonoscopy, according to a new study.
The study, which examined the cases of 1,588 patients, found that as a patient's body mass index increased, so did the chance that he would present with an inadequate bowel prep. Each BMI unit increased the likelihood of 2.1%, researchers say.
Factoring the patient's weight into the bowel prep prescription and prepping instructions might reduce the likelihood of a poor bowel prep, says Brian Borg, MD, of Washington University in St. Louis, Mo., in a press release. "Our results suggest that the obese patient should at least be subject to more precise instructions and possibly a more rigorous bowel preparation regimen."
Dr. Borg and his colleagues have published the results of their study in the June issue of Clinical Gastroenterology and Hepatology.
Kent Steinriede |
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| News & Notes |
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Tip of the week Since an empty OR loses you money, it's imperative that you confirm that the docs who've reserved a place at the table show up to claim it. Judith A. Pasqualoni of the Hamden Surgery Center in Hamden, Conn., recommends that schedulers call surgeons' offices a week in advance to make sure. "You can also mail printouts of your block-time list to all your physicians and ask that they let you know in advance of any time they won't be using," she says. "If a surgeon doesn't have any scheduled cases, release his block time." And make other surgeons aware of your open hours by fax.
Correction An OR Excellence "Conference Connections" newsletter e-mailed on May 21 incorrectly stated the method of finessing propofol inductions described by Daniel K. O'Neill, MD, the assistant professor of anesthesiology at New York University's Langone Medical Center in New York, N.Y. It should have read as follows: "Propofol offers rapid induction, but its use is not always free of complications. For example, a propofol loading dose of 2mg/kg can be given at 400mcg/kg/min over 5 minutes, 300mcg/kg/min over 7.5 minutes, or 200mcg/kg/min over 10 minutes to avoid hemodynamic instability, respiratory arrest or airway obstruction. Alternatively, minibolus method using 150mcg/kg IV every 20 seconds PRN. After loading dose, administer 50 to 150mcg/kg/min titrated based on clinical criteria. This can help prevent apnea and hypotension, which requires mask ventilation or intubation, fluid boluses and vasopressors. At first glance, the approach may appear inefficient to the observer, but it may save time by preventing a resuscitation circus."
Attitude affects surgical satisfaction? A patient's personality has as much to do with their satisfaction following knee replacement surgery as their clinical outcome does, says Raymond J. Walls, MD, an orthopedic surgeon at Cappagh National Orthopedic Hospital in Dublin, Ireland. Dr. Walls, who presented his findings last week at the American Psychiatric Association's annual meeting, used a brief questionnaire to measure the extroversion, agreeableness, conscientiousness, emotional stability and openness to new experiences of 110 patients who underwent knee replacement surgery between January and June 2007. He discovered that extroverted patients and those who were open to new experiences reported being more satisfied with their surgeries, despite experiencing residual pain and stiffness at 6 months post-op. |
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