FDA Plans Disaster Response Standards to Protect Device Supply Chain

The U.S. Food and Drug Administration (FDA) plans to put a comprehensive standard operating procedure in place for medical device manufacturers in the event of extreme emergencies and natural disasters, so that the supply chain will continue as uninterrupted as possible. The agency will be collecting input from industry players until May 10, first during a meeting of the Device Good Manufacturing Practice Advisory Meeting on April 11, and then through a public docket.

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.

“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. Through the public docket, the agency is requesting comments on the effects of extreme weather in devices in use for patient care; new or unused devices, components or accessories in storage or in the process of being shipped; and damage to medical device manufacturing sites.

The advisory panel meeting and call for comments are part of ongoing FDA and federal disaster preparedness efforts.

Post-Hurricane Sandy that hit the United States’ East Coast last October, the FDA kicked into high gear to ensure minimal effect to the medical device and product supply chain. At the time, FDA Commissioner Margaret A. Hamburg, M.D., wrote: “You may think that the FDA is simply an organization that reviews medical products or works to keep your food safe. But FDA’s broad public health mission includes mobilizing to protect Americans when natural disasters like Hurricane Sandy strike. We often think of major storms like Sandy in terms of the risk of life and damage to property, but at FDA we also have to focus on the effects of natural disasters on the safety of products we regulate and that consumers and patients depend on.”