FDA Update

As June Is Upon Us the FDA Recommends Planning Ahead As… and sending out notices to all medical device companies.

Hurricane Season Can Affect the Medical Device Community and Patients Too

When we think of hurricanes we think of structural disasters with people losing their lives and their homes, and most often we hear of travel interruptions in hurricane prone areas. It is not often that we think of the trickle down effects that hurricanes can have including our national security.

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) encourages medical device manufacturers to prepare for hurricane season, beginning 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.

For more recommendations, please visit Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors | FDA

Questions?

mdi will continue to monitor the FDA’s recommendations and warnings regarding weather emergency preparedness. For more information on this FDA policy please contact mdi at: info@mdiconsultants.com and ref: Risk management plans, hurricane interruptions and medical devices, and supply chain.