Outpatient Surgery Magazine

Marking Madness - April 2013 - Subscribe

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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OSM560-April_DIGITAL_Layout 1 4/5/13 2:30 PM Page 78 F L U I D W A S T E M A N A G E M E N T International customers warning labels to apply to their devices. The warning states: "Do not apply high-flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low-vacuum or low-flow suction." Months after the initial recall over the patient injuries, Stryker extended the recall to inform customers that it never obtained 510(k) clearance from the FDA for the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra. Unlike the Neptune 1 Gold, these devices hadn't received pre-market approval from the FDA. Stryker plans to discontinue the Neptune 1 Silver and will withdraw all support for the use of this device by March 1, 2014. After that date, the FDA says you shouldn't use the Neptune 1 Silver. Stryker is working with the FDA to get clearance for the second generation of the Ultra. Ms. Willoughby says she hopes that happens by next March. Post-recall use of the Neptune In the short term, the FDA is giving you the option to continue using the Neptune until next March — but only if you have no alternative systems for collecting and disposing of surgical fluid waste. The FDA "is not currently asking Stryker to remove the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System from the U.S. market due to concerns that removal would likely create immediate market shortages." Considering that individual units range in price from $20,000 to 7 8 | O U T PAT I E N T S U R G E R Y M A G A Z I N E | A P R I L 2 013

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