Supply Chain News / Risk & Compliance

FDA Seeks Input Regarding Med Device Supply Chain

As of Feb. 20, 2013, 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 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. Through the public docket, the agency is requesting comments on the effects of extreme weather in the following scenarios:

  • 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.

During and after extreme weather and natural disasters, the FDA offers the following recommendations for medical devices:

  • Keep your device and supplies clean, dry and secure.
  • If you have a life-sustaining device that requires electricity, discuss with your physician what you should do in the event of a loss of power, water, or phone service—before severe weather happens. Notify your local public health authority to request evacuation prior to adverse weather events.
  • Always use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use (to minimize the risk of fire).
  • If your device appears to be damaged or if you need a back-up device, contact your distributor or device manufacturer.
  • Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power in your home at the main breaker.
  • Maintain your device in a well-lit area so you can assess your device's performance (e.g., refilling your insulin pump, checking your glucose meter).
  • Always make sure your device is clean before you use it (e.g., syringes, mechanical devices).
  • Store the backup equipment for your device (such as spare batteries and accessories) in the same location as the rest of your emergency gear.
  • Keep backup batteries for your cellular phone. If there’s a problem with your medical device during an emergency, your phone might be your lifeline to let someone know that your device is not working, and more importantly, that you need help.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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