Outpatient Surgery Magazine

Backbreaker - April 2019 - Subscribe to Outpatient Surgery Magazine

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

Issue link: http://magazine.outpatientsurgery.net/i/1101250

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Page 30 of 146

ing of internal tissues and organs, increased risk of cancer recurrence and even death. "If you look at the most commonly reported problems in the adverse event reports (in the FDA letter), opening of the staple line or malfor- mation of staples, misfiring or difficulty in firing, most of those could be attributed to the wrong height of the staple," says David Renton, MD, MPH, FACS, chief of surgery at Ohio State University East Hospital. Dr. Renton believes the FDA recommendations will urge health- care providers to rethink what staplers they use. For example, if a motor-driven or electric stapler determines that the staple car- tridge and the anvil are too far apart — meaning the tissue is too thick for that height of staple — it will not fire. It will stop you from doing it and give you feedback like, "tissue too thick, choose another cartridge." "That may be a benefit of this — it will lead to an earlier adoption of staplers that offer feedback," says Dr. Renton. "Stapling has been around for a long time. It's not like we're suddenly doing it wrong. A lot of this is that we've used the same stapler since training, so that's what we're going to use. Surgeons are nothing if not creatures of habit. It can be difficult for us to accept new things." The FDA's letter also states that the agency will consider reclassify- ing surgical staplers for internal use as Class II medical devices — which would subject them to premarket notification and let the FDA establish mandatory special controls to help mitigate known risks of the device. Safe stapler strategies The FDA offered the following recommendations: • Read and carefully follow the stapler manufacturer's instructions for use. A P R I L 2 0 1 9 • O U T PA T I E N T S U R G E R Y. N E T • 3 1

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