FDA tells providers to prepare for supply chain disruptions

Photo: Emir Memedovski/Getty Images

Healthcare providers can expect supply chain disruptions during the current hurricane season – which runs from June through November – and the Food and Drug Administration is advising them to make the necessary preparations.

The FDA is telling providers to be ready and is encouraging any medical device stakeholders to adequately prepare for the disruptions to minimize any effects to patient care. Adequate preparation, the FDA said, can help ensure that critical supplies can still be delivered in a timely manner.

WHAT'S THE IMPACT?

The FDA's general recommendations include engaging with supply chain partners and other entities who may be able to supply resources and assistance during an emergency; the agency encourages creating Memoranda of Understanding (MOUs) or Memoranda of Agreement (MOA) to formalize expectations for sharing resources during an emergency.

The agency also advises assessing risk by identifying the potential impact of emergencies like hurricanes, wildfires or pandemics on the supply chain and business operations.

Another effective strategy would be to consider stockpiling additional materials to ensure there's sufficient inventory to maintain operations during a potential disruption. Still, it may behoove providers and other stakeholder to identify alternative mechanisms for ordering, receiving and tracking supplies, the FDA said.

It also suggested that providers identify multiple delivery locations for essential supplies and ensure sufficient planning for how to route supplies to point-of-care locations. They should also 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, the FDA said.

Additional guidelines for providers include creating a secondary list of distributors for critical supplies in the event primary distributors are unable to meet demand; and preparing to implement conservation measures, as well as workflow modifications, to reduce excess consumption of devices without compromising quality of care.

THE LARGER TREND

The FDA also provided recommendations for medical device manufacturers and distributors, including ensuring additional production capacity is available, and positioning warehouse inventory strategically in regions susceptible to severe weather disruptions.

For manufacturers specifically, the FDA said it would be best to consider shipping finished inventory out of potentially impacted facilities ahead of a forecasted hurricane or other severe weather event. It's also important to review risk-management plans and identify critical suppliers that could be impacted by severe weather.

Distributors are encouraged to collaborate with state and local authorities on opportunities to ensure an uninterrupted supply of medical devices in the event of disruptions from extreme weather events, including an effective channel for communicating with emergency management personnel.
 

Jeff Lagasse is editor of Healthcare Finance News.
Email: jlagasse@himss.org
Healthcare Finance News is a HIMSS Media publication.