What do you know about the FDA?? You may remember my invention for delivering music during surgery. The final patent is almost in place and I had applied for an award that would provide money for marketing this device. To my shock and dismay, I did not make the final cut because I was told that anything used in surgery must have FDA approval. I was under the impression that because my device is non-invasive that there was no need for FDA approval. Now I know that this is not true. If one makes any sort of medical claim then FDA approval is necessary. Soooo, it’s a bit of a set-back, but also just a little bit more of a challenge, which I’m always up for!! Stay tuned!
Today I was speaking before a group of nearly 100 people. As usual, most of them were shocked and excited to find that when the patient listens to music through headphones during surgery, the amount of anesthesia needed can be decreased by as much as 50%. A valid question is “will the Dr. automatically allow the patient to bring music into the O.R.?” and the answer is “NO.” You must let your doctor know as much in advance as possible so that if persuasion is needed, you’ll have time to provide evidence and documentation of music’s effectiveness. If you are interested in knowing more about this, you can visit my website, www.SurgicalSerenitySolutions.com or just put “music and surgery” into a search engine. You’ll be amazed at how much information is out there!