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Chris Vasquez replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 6 months ago
With respect to medical devices that are used during surgery, lab technicians should be properly trained in aseptic technique, and both surgeons and lab technicians should be aware of how there devices function. I know for one product in the company that I worked in, there were complaints on how to use a particular surgical staple device… surgeons did not know how to use the stapler and as a result delayed surgical completion. A cheat sheet was created and attached to the surgical staple giving surgeons a step by step method to using the device. This cheat sheet was pretty much a small sticker like diagram attached to the device that showed what knobs to press and release on the device.
Chris