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  5. Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors
  1. Emergency Situations (Medical Devices)

Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors

During natural disasters and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. There also may be disruptions in the delivery of devices or critical components and impacts on the device supply chain.

The FDA encourages medical device stakeholders to engage in preparation activities to minimize potential disruptions to patient care. Effective preparations can help ensure that critical supplies continue to be delivered in a timely and efficient manner.

For health care providers and systems, manufacturers, and distributors, here are some best practices to consider while preparing for natural disasters and other emergencies:

General Recommendations:

  • Engage with supply chain partners and other entities who may be able to supply resources and assistance during an emergency; create Memoranda of Understanding (MOUs) or Memoranda of Agreement (MOA) 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 your supply chain, business operations, and facilities
  • Consider stockpiling additional materials to ensure you have sufficient inventory to maintain operations during any potential disruption
  • Identify alternative mechanisms for ordering, receiving, and tracking supplies as normal methods may be unavailable during and after a disaster

Recommendations for Health Care Providers:

  • Identify multiple delivery locations for essential supplies and ensure sufficient planning for how to route supplies to point of care locations.
  • Develop a contingency communication plan with key distributors to ensure ongoing communications regarding potential shortages or delivery challenges in case primary methods of communication are unavailable.
  • Create a secondary list of distributors for critical supplies in the event primary distributors are unable to meet demand.
  • Be prepared to implement conservation measures, as well as workflow modifications, to reduce excess consumption of devices without compromising quality of care.

Recommendations for Medical Device Manufacturers:

  • Identify manufacturing sites susceptible to disruptions caused by severe weather and forecast demand for products produced in those locations to ensure sufficient production capacity in the event of a disaster
  • Plan for the continuity of business operations by ensuring additional production capacity is available and identifying alternate sources of materials and delivery methods
  • Review risk management plans and identify critical suppliers that could be impacted by severe weather
  • Identify sterilization facilities that are susceptible to hurricane and/or severe weather disruptions and plan accordingly

Recommendations for Distributors:

  • Identify regions susceptible to disruptions caused by severe weather and pre-position additional inventory in warehouses and customer facilities, where appropriate.
  • Develop a plan for effectively communicating with customers about the availability of products, including product shortages, viable alternatives and/or substitutions, allocation limits, and order confirmations in the event normal ordering processes are unavailable.
  • Collaborate with state and local authorities on opportunities to ensure uninterrupted supply of medical devices in the event of disruptions from extreme weather events, including an effective channel for communicating with emergency management personnel.

If you have feedback or questions related to the medical device supply chain, please contact the Resilient Supply Chain Program for Medical Devices by emailing RSCPshortage@fda.hhs.gov.

If you have questions about emergency preparedness and medical devices, contact the All Hazards Readiness Response & Cybersecurity Program by emailing cdrharc@fda.hhs.gov.

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