Reiterating The FDA’s Suggestions On How To Best Navigate Medical Supply Shortages

In the wake of the COVID-19 pandemic, medical supply shortages have continued to plague the US healthcare system and other countries around the globe. While the pandemic brought attention to medical supply chain issues in a glaring way, medical supply shortages occurred prior to the COVID-19 crisis. 

Even as the pandemic wanes, medical supply shortages have continued to be a problem. Saline IV bags, nitrile medical gloves, surgical devices, ventilators, and more have continued to appear on the US Food and Drug Administration’s (FDA) device shortage list.

The FDA has provided guidance for how to navigate these medical supply shortages along with recommendations for improving the US medical supply chain in years to come.

FDA Recommendations For Navigating Medical Supply Shortages

When there is a shortage of medical devices, public health and patient care suffers. The three main causes of medical device shortages are unexpected demand, supply chain interruptions, and manufacturing issues. The shortage of medical supplies during COVID-19 tipped off with a surge in demand followed by supply chain disruption and manufacturing issues – the latter two factors still being an issue today.

The FDA’s recommendations to medical facilities for navigating these shortages focuses on inventory management, communication, collaboration, and contingency planning.

Inventory Management

Every hospital and healthcare facility needs to utilize an inventory management system to track their supplies and identify potential shortages. They should monitor usage patterns and identify trends that could lead to shortages. If a shortage is unavoidable, conservation strategies need to be implemented. In this case, supplies should be reserved for the patients with the highest need. 

Communication

Medical facilities should communicate with suppliers if they notice trends that indicate potential shortages. Additionally, healthcare workers and administration should learn about their distributors’ supply chain and manufacturing capabilities. This further insight can help the staff at the medical facility anticipate shortages and prepare contingency plans.

An essential communication should take place between medical device manufacturers and the FDA’s Center for Device and Radiological Health (CDRH) if they foresee an impending medical device shortage. The CDRH can assist manufacturers with resolving, or mitigating, supply chain issues that indicate a potential medical device shortage down the road. 

Contingency Plans

It is critical that every medical facility has a contingency plan that includes identifying alternative sources of medical devices and supplies (such as different distributors or manufacturers). They should also have a plan ready for when product substitution becomes necessary.  

Collaboration

Hospitals and other medical facilities in the same vicinity should collaborate with each other to share resources. They may need to coordinate medical device orders to eliminate competition, redistribute patients to the facilities with the best resources on hand for their needs, and share supplies.

What The FDA Is Doing To Support Medical Supply Chains

Under the CARES Act, in response to the shortage of supplies in hospitals during COVID-19, the CDRH received statutory authority to help mitigate and prevent device shortages during or in advance of a public health emergency. 

This authority required manufacturers to report supply chain disruptions that could impact the availability of supplies needed for the delivery of patient care during a public health emergency. As a result of the FDA’s wider authority over medical devices, the CDRH can now better understand and monitor medical device supply chains. This allows them to be more proactive in resolving supply chain issues. 

The CDRH now publishes their devices shortage list to inform the public and medical community of current and ongoing medical device shortages.They have also built the Resilient Supply Chain Program for Medical Devices (RSCP) to strengthen the medical device supply chains in the US. And they seek to increase the manufacturing of medical devices and supplies here in the US.

Preparing For Future Events That Could Disrupt The Supply Chain

Unfortunately, public health emergencies are not the only scenarios in which a shortage of medical devices can occur.  Device recalls, natural disasters, and disruption of manufacturing or procurement of raw materials needed to create medical devices and supplies are among the various other causes of shortages.

The CDRH would like to attain comprehensive authority over medical device shortages (beyond public health emergencies) to support these other scenarios. In the meantime, it is advised that all hospitals, healthcare and medical facilities follow the recommendations of the FDA to navigate shortages.

How Isikel Is Fortifying The Medical Supply Chain In The US

The FDA recommended that a crucial step to fortifying the US medical device and hospital supply chain is to manufacture more supplies here in the United States. With many essential medical devices, their components, or their raw materials, being imported from China and other countries, the US supply chain is weakened and at risk of further shortages. 

Isikel is responding to this need here in the US by manufacturing critical supplies such as nitrile gloves, saline IV bags, and saline flushes at a new facility in Katy, Texas. It is our hope that we can contribute to the resiliency of the US medical supply chain and be a part of the solution to consistent patient healthcare in any situation.