Essay #4: Going Above and Beyond: Why FDA Approval Doesn’t Mean Equipment is Safe for Low Resource...
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Essay #4: Going Above and Beyond: Why FDA Approval Doesn’t Mean Equipment is Safe for Low Resource Settings This Design that Matters series is made possible with support from The Lemelson Foundation in celebration of 20 years of improving lives through invention.
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Please feel free to download and use these slides to present this case study under the terms of the attribution share-alike creative commons license. For more background on these slides, please see the full essay online at bit.ly/FireflyEssay4 Summary Does United States FDA regulatory approval mean a medical device is safe and effective in low resource settings? The short answer is no. In developing countries, 95% of donated western medical equipment is broken within 5 years. In fact, only 30% of this donated equipment is ever even turned on. We had to develop a novel cooling solution and a more robust electrical system to enable Firefly phototherapy to work well in remote hospitals. Sustainable Cooling Solution - In order to keep the electronics from overheating, most medical electrical equipment use fans that quickly break and vent holes that quickly clog with dust and bugs. These systems meet with FDA approval. Firefly uses a unique fully-sealed design with no moving parts to keep cool and use less energy in hot climates. Robust Electrical System - Many hospitals in low resource settings do have power, but it varies up and down during the course of the day, blowing fuses on typical FDA-approved medical equipment. Firefly uses an external power supply to successfully ride these waves.
Transcript of Essay #4: Going Above and Beyond: Why FDA Approval Doesn’t Mean Equipment is Safe for Low Resource...
Essay #4: Going Above and Beyond: Why FDA Approval Doesn’t Mean Equipment is Safe for
Low Resource Settings This Design that Matters series is made
possible with support from The Lemelson Foundation in celebration of 20 years of
improving lives through invention.
