Today the U.S. Food and Drug Administration is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public can take to prepare for such events.
Extreme weather and natural disasters can interrupt the manufacturing and distribution of medical devices and affect their safety, quality and availability. For example, flooding and fire can damage facilities where sterile products are stored; electricity outages or lack of access to filtered water can stop or slow down medical device production; or large storms can disrupt the shipping and distribution of medical devices or the materials and components used to make them.
The FDA will collect input during a meeting of the Device Good Manufacturing Practice Advisory Committee on April 11, 2013 and through a public docket announced today in the Federal Register. The docket will remain open until May 10, 2013.
“In protecting public health, it is important that the FDA and industry be prepared for extreme weather,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Anticipating and planning for the challenges of extreme weather can help the FDA and medical device manufacturers minimize potentially dangerous effects on the safety, effectiveness, and availability of medical devices.”
The advisory panel meeting will focus on the impact of extreme weather on the medical device manufacturing chain processes and marketed medical device safety and quality.