Robo-Anesthesia: ASA Reacts to FDA's Sedasys Approval

The American Society of Anesthesiologists is lobbying for greater input into the use of Sedasys, Ethicon's computer-assisted personalized sedation system, following the FDA's recent pre-market approval of the technology.

The ASA has established an ad hoc committee to review the FDA's restrictions on and conditions of approval for the device's use, and to determine whether the FDA addressed the ASA's previously communicated concerns and recommendations.

During the FDA's review of the technology, the ASA had expressed concerns over the safety of the device, which monitors critical life support functions and determines the delivery rate of intravenous propofol; the limitations of oxygen saturation and end tidal CO2 measurements in detecting respiratory depression in sedated patients; the system's inability to prevent or manage loss of consciousness; the properties and risks of propofol; and necessary safety requirements for closed-loop control devices.

ASA representatives will meet with reps from Johnson & Johnson — Ethicon's parent company — this week to gather information on the FDA's conditions of approval for Sedasys, particularly regarding supervision, training and post-market studies. The ASA will also request the FDA's Center for Devices and Radiological Health conduct an enhanced consultation of the device and future advances.

Sedasys is indicated for the intravenous administration of 1% (10mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal-to-moderate sedation in ASA physical status I and II patients 18 years old or older undergoing colonoscopies and EGDs. It integrates drug delivery and patient monitoring while monitoring and recording 6 patient parameters: oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.

The FDA rejected Sedasys in April 2010, despite studies that demonstrated its safety.

Daniel Cook

3 Steps to Effective Room Disinfection

A disinfection process that includes both manual and automated steps as well as supervisory verification eliminates C. diff from contaminated rooms more effectively, according to a recent study.

The study, published in the May issue of the journal Infection Control and Hospital Epidemiology, follows concerns that healthcare facilities' anti-C. diff efforts are falling short.

Researchers at the Veterans Affairs Medical Center in Cleveland monitored the results of a multi-step room disinfection process for nearly 2 years. The process incorporated the use of fluorescent markers to detect how well high-touch surfaces had been cleaned; an automated, ultraviolet light system; and a team of dedicated disinfection housekeepers with bleach wipes whose work was held to the assessment and clearance of supervisors.

The study's baseline measure was the 67% of rooms which still showed the presence of C. diff after a routine cleaning. While the fluorescent markers reduced that number to 57%, and UV cleaning to 35%, the dedicated team and supervisory follow-up brought it down to 7%.

"With effective monitoring and feedback, motivated environmental services personnel can achieve results that rival or surpass many of the automated devices," noted study co-author Curtis Donskey, MD.

David Bernard

MRIs Can Predict All-Metal Hip Implant Failure

By the time a patient starts to suffer symptoms of wear and inflammation from a metal-on-metal hip implant, the damage is already done. In fact, says a study from New York's Hospital for Special Surgery, even asymptomatic patients show signs of tissue damage when undergoing MRI scans to identify implants that are going to fail.

The researchers analyzed MRIs of patients who had received metal-on-metal implants and found synovitis in 68% of asymptomatic hips, 75% of symptomatic hips with a mechanical cause, and 78% of hips with unexplained pain.

"The study shows that synovitis exists in asymptomatic people in a fairly high prevalence," says Hollis Potter, MD, chief of the hospital's MRI division, in a press release "If that is the case, symptoms alone are insufficient to determine the health of an implant. You can't wait for people to be sore before we evaluate them for this potential problem."

The researchers say that MRIs, rather than CT scans, should be used "to identify patients who need revision surgery before tissue sustains further damage that makes a revision more difficult."

Stephanie Wasek

InstaPoll: How Many Hours Do You Work in an Average Week?

Running a surgical facility is not a 9-to-5 job. Tell us in this week's InstaPoll how many hours you typically work per week.

Nearly 1 in 5 (18%) of the 525 respondents to last week's InstaPoll have a policy against hiring smokers, and another 7% are planning one.

Do you have a policy against hiring smokers?

  • Yes: 18%
  • No: 75%
  • Not yet, but it's in the works: 7%

Curious about the questions and results of past InstaPolls? Browse them all here for free.

Dan O'Connor

News & Notes
  • Michigan hit hardest by fungal meningitis Researchers are trying to determine why, despite having received only 13% of the tainted steroids from New England Compounding Center, Michigan has reported a staggering 261 cases of fungal meningitis and 16 deaths, disproportionately more than any other state. Tennessee is second, with 152 cases and 15 dead. Nationwide, more cases may yet emerge: Some patients didn't develop infections until 200 days after their injections, according to researchers.
  • Blood test predicts implant allergy Nickel has been known to trigger allergies or skin irritation. It's also commonly used in metal hip and knee implants. But some patients who suffer allergic responses to their implants weren't aware of their sensitivity to the metal until after their surgeries. Allergists at National Jewish Health in Denver have developed the first blood test that can detect patients' nickel allergies more quickly and conveniently than a skin patch test, which not every joint replacement surgery patient is able to undergo, preventing the risk of post-op allergic complications and the need for revision surgery.
  • Prolapse surgery's problems Surgery for pelvic organ prolapse provides relief from related symptoms, but anatomic support deteriorates over time, stress urinary incontinence could develop and mesh or suture erosion could be an issue, according to a study in the May 15 issue of JAMA. Physicians should therefore balance the procedure's abdominal benefits against the long-term risks of mesh or suture erosion, say the study's authors.