Devices

Emergency Preparedness Supply Chain

FDA has published a statement, Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Healthcare Providers, Device Manufacturers, and Distributors, with best practices for healthcare providers and systems, medical device manufacturers, and distributors to consider while preparing for natural disasters and other emergencies.

In addition to specific recommendations for providers, manufacturers, and distributors, the statement contains these general recommendations:

engage with supply chain partners and other entities who may be able to supply resources and assistance during an emergency, and create memoranda of understanding or memoranda of agreement to formalize expectations for sharing resources and assistance during an emergency;
assess risk by identifying the potential impact of emergencies like hurricanes, wildfires, or pandemics on the supply chain, business operations, and facilities;
consider stockpiling additional materials to ensure there is sufficient inventory to maintain operations during any potential disruption; and
identify alternative mechanisms for ordering, receiving, and tracking supplies as normal methods may be unavailable during and after a disaster.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome