Per the notice below, the United States Food and Drug Administration (FDA) has issued guidance on preparing for hurricane season.
Take Action to Prepare for Hurricane Season beginning June 1
To minimize potential disruptions to patient care, the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) encourages medical/dental device stakeholders (such as health care providers, medical/dental device manufacturers, and distributors) to prepare for hurricane season, beginning June 1, 2023. It is important to act now, as shortages of medical/dental 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.
If you have manufacturing and quality problems, delays, discontinuances, or interruptions of a medical/dental device, Notify the FDA About a Medical Device Supply Issue.
Questions?
If you have questions about hurricane preparedness and medical/dental devices, contact the
All Hazards Readiness Response & Cybersecurity Program. If you have questions related to supply chain, contact the
Resilient Supply Chain Program.