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| FDA Clears Confusion Surrounding Steris System 1 |
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 Even though the FDA considers the Steris System 1 to be "adulterated and misbranded," you may continue to use the SS1 for another 3 to 6 months — the time FDA expects it will take for you to purchase "another legally marketed" sterilizer.
FDA officials said that and more during a teleconference last week to clear up the confusion surrounding the agency's recent SS1 safety alert.
"We have not directed that the use of the Steris System 1 stop immediately," says an FDA official. "We want you to have suitable alternatives in place, staff trained and other necessaryÊlogistics attended to in a seamless process. Do not interrupt diagnostic and therapeutic procedures using devices reprocessed in the [SS1] until these suitable alternatives are in place."
Among the points FDA clarified:
FDA's notice applies to all SS1s, regardless of the model or how long you've had it.
FDA is not recalling the SS1, but rather recommending that you voluntarily transition to another sterilizer.
FDA may grant exceptions to healthcare facilities that are unable to complete the transition within the 3- to 6-month timeframe. Dan O'Connor |
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| Lidocaine Shows Analgesic Promise After Ambulatory Surgery |
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 Injecting small doses of lidocaine during common outpatient procedures is a safe and inexpensive way to ease patient discomfort, researchers suggest in the first study to investigate the local anesthetic's pain-control potential after ambulatory surgery.
Post-op pain is largely due to tissue inflammatory response following surgery, and the researchers believed lidocaine's inflammatory modulating properties would reduce pain and allow for more a rapid discharge. They observed 67 patients undergoing general laparoscopic and open procedures, endocrine and breast procedures, laparoscopic gynecologic surgery, urologic procedures, plastic surgery and minor orthopedic and ENT surgery. Patients received either a lidocaine or saline placebo infusion, which began at anesthesia induction and continued until 1 hour after arrival in recovery.
The patients who received lidocaine reported lower average post-op pain scores compared to those in the placebo group (3 vs. 4.5, respectively, on a scale of 0 to 10), according to results published in the journal Anesthesia & Analgesia. Opioid use to control post-op pain was reduced by approximately 40% in the lidocaine cohort. However, there was no significant difference in length of stay before discharge between the 2 groups.
Danja S. Groves, MD, PhD, who led the research team from the University of Virginia's department of anesthesiology, hesitates to apply the results universally but believes they offer hope for a new and cost-effective pain-control regimen. "Lidocaine is really inexpensive," she explains. "Since it's so cheap and lessens case costs, it has some potential" for widespread use in combating post-op pain, which the study's authors say is the most common reason for delay in discharge and unplanned hospital admission after ambulatory surgery.
In an editorial on the study, anesthesiologists Christopher L. Wu, MD, of Johns Hopkins University in Baltimore and Spencer S. Liu, MD, of the Hospital for Special Surgery in New York City note that opioid-related side effects persisted, post-op pain scores were reduced only for a few hours and length of stay in PACU was not affected by the use of lidocaine. "Future studies examining interventions in ambulatory anesthesia should consider assessing both patient-reported outcomes and post-discharge symptoms," they suggest.
Daniel Cook |
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| OSM Announces Stocking Stuffer Contest Winners |
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 Congratulations to Marjorie Blouin, RN, the director of surgical services at Mount Airy Surgical Center in Mount Airy, Md., for winning an Apple iPhone 3GS, the grand prize in Outpatient Surgery Magazine's 2009 Stocking Stuffer contest. Nearly 400 readers participated in this year's contest.
Second-prize winner Ronald Smith, MD, the medical director at the Surgery Center at Wellington in Wellington, Fla., won a Barnes & Noble Nook eReader. A Nintendo Wii is headed to our third-place finisher, Pam Moss, RN, the OR/outpatient supervisor at Alleghany Memorial Hospital in Sparta, N.C. Fourth-place finisher Tara Cruz-McKinley, RN, BS, CASC, the clinical director of the Peoria Ambulatory Surgery Center in Peoria, Ill., won a Garmin nuvi 205 Portable GPS.
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| InstaPoll: Are Anesthesia Providers Pressuring You for an Ultrasound? |
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More and more anesthesia providers who administer regional anesthesia believe that ultrasound improves the accuracy of their blocks. Are your providers asking you to buy them an ultrasound device? Tell us in this week's InstaPoll. We'll report the results in this space next week.
Last week, we asked if your staff was getting a holiday bonus. We got back a bit of a bah-humbug reply. Slightly more than half (51%) of our 191 respondents said yes, more than one-third (36%) said no, and 13% said no to a bonus but yes to a nice holiday party for staff. Dan O'Connor |
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| News & Notes |
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Tip of the week Some drugs have names that look and sound a lot like other drugs, though they bear no resemblance in indication, ingredients or strength. To eliminate confusion and prevent medication errors, Laurie Cornell, RN, at the North Haven Pain Center in Connecticut recommends you place a red tab with a warning written in large letters on the bins where you store these look-alike, sound-alike drugs. For example, the tab on the bin for epinephrine should read, "ALERT!! Do you mean ephedrine or epinephrine?"
AAAHC goes international The Accreditation Association for Ambulatory Health Care will begin accrediting outpatient centers in Costa Rica next year as it expands its services internationally for the first time. AAAHC Executive Director and CEO John Burke says the move will help provide medical tourists and "the significant number of Americans living abroad" with "assurances that ambulatory medical services in other countries operate at a level consistent with U.S." centers accredited by AAAHC. The organization will start by offering voluntary accreditation in Costa Rica in early 2010 and later expand services to other countries.
Post-op clot risk The risk of developing a blood clot is up to 70 times greater for surgical inpatients and 10 times greater for surgical outpatients than it is for people who have not undergone surgery, according to a study by British researchers. The findings, published in the journal BMJ, suggest the risk of post-operative venous thromboembolism is higher than previously thought. Vascular surgeon Alexander T. Cohen, MD, of King's College Hospital in London says the results are a "wake-up call to all surgeons" and a reminder that providers should assess patients' VTE risk and take steps to prevent it. |
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