On April 11, 2013, the committee will discuss the potential effects of extreme weather
and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. The committee will further discuss how to optimize the use of FDA’s current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. In a separate Federal Register notice, FDA is seeking additional broad public input about the effects of extreme weather on medical device safety and quality.
In the most recent strange weather events and patterns that the world has experienced (Hurricane Sandy in October 2012; the Tsunami in Japan in March 2011; Hurricane Katrina in August 2005), it is about time that FDA begin to look at the effects that these natural occurring weather patterns may have on the medical device supply chain. When the raw materials or components cannot be obtained by medical device manufacturers, there potentially may be a shortage of medical devices commercially available in America and worldwide.