NYSDA Publications

FDA Issues Guidance on Preparing for Hurricane Season

Jun 10, 2024

Per the notice below, the United States Food and Drug Administration (FDA) has issued guidance for health care providers on preparing for hurricane season.

Take Action to Prepare for Hurricane Season

hurricaneTo help minimize potential disruptions to patient care, the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH),  encourages medical device stakeholders (such as health care providers, medical device manufacturers, and distributors) to prepare for hurricane season, which began on June 1, 2024.  It is important to act now, as shortages of medical devices could directly impact patients’ lives, particularly our most vulnerable populations, and jeopardize our national security.                                                       

As you plan for hurricane season, here are some best practices to consider:

  • Review risk management plans and identify critical suppliers that could be impacted by severe weather.
  • Identify manufacturing and sterilization facilities that are susceptible to hurricane or severe weather disruptions.
  • Forecast demand for products produced in those locations to ensure sufficient production capacity in the event of a storm.
  • Plan for continuity of business operations by ensuring additional production capacity is available and identify alternate sources of materials and delivery methods.
  • Consider stockpiling additional materials to ensure you have sufficient inventory to maintain operations during any potential disruption.
  • Consider shipping finished inventory out of potentially impacted facilities ahead of a forecasted hurricane or other severe weather event.

If you have manufacturing and quality problems, delays, discontinuances, or interruptions of a medical device, notify the FDA.

Questions?

If you have questions about hurricane preparedness and medical devices, contact: Division of All Hazards Preparedness and Response.  If you have questions related to supply chain, contact the Office of Supply Chain Resilience.