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

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

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