Prepare for Potential Hurricane Disruptions, FDA Tells Devicemakers

Medical device manufacturers should prepare now for the potential disruption in fluctuating power, contaminants or unusual levels of heat or humidity that often occur during hurricane season, the FDA advises.

Preparing now, the agency says, can help mitigate potential disruptions in the supply chain as well as delivery of devices or critical components that could affect patient care, as was the case several years ago when Hurricane Maria devastated the island of Puerto Rico.

The agency recommends manufacturers and distributors engage with supply chain partners and create memoranda of understanding to formalize expectations for sharing resources and assistance during an emergency.

Organizations should identify the potential impact of a hurricane on the supply chain, operations and facilities as well as consider stockpiling materials in the event of a disruption and find alternative methods for ordering, receiving and tracking supplies before and after a storm.

Additional recommendations from the FDA’s Resilient Supply Chain Program for Medical Devices can be found here.

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