Mar 25, 2022

The US Food and Drug Administration (FDA) has issued a fact sheet aimed at educating stakeholders on how to prevent medical device shortages to protect public health, an issue that is particularly problematic in times of pandemics. Surgical masks, gowns and other medical supplies – known as personal protective equipment or PPE – as well as testing supplies, are in such high demand during times of public health emergency (PHE), that shortages often happen. To help the country cope with these medical device supply scarcities, the FDA’s Center for Devices and Radiologic Health (CDRH) received new statutory authority, under the CARES Act in 2020, to help prevent PPE shortages in advance of or during a PHE.

Although these recommendations are important, there will be situations, such as natural disasters or medical device recalls, where shortages can not be prevented under the authority of the CDRH. If it had more comprehensive statutory authority, the CDRH would be in a better position to prevent and mitigate such shortages and strengthen medical device supply chains. Because we know that PPE shortages can occur even when there is no PHE, the FDA is now creating a new supply chain program to try to prevent shortages before they affect public health.

What did we learn from the pandemic about how to prevent PPE shortages?

During the COVID-19 pandemic, we learned how critical medical devices are in treating and fighting the spread of infectious diseases. The stark shortages that occurred were of not only PPE, but ventilators, test supplies and medical equipment for vaccine administration. COVID-19 uncovered some of the weaknesses in our national supply chain, especially our dependence on devices and components imported from China and other countries.

How does CDRH’s current authority help support the medical device supply chain?

The CARES Act gave the FDA authority to address medical device shortages for the first time. It required certain medical device manufacturers to report product availability and possible supply chain disruptions, before or during a PHE. The CDRH has been better able to monitor the complex medical device supply chain web and be more proactive about preventing problems since being empowered to do so by the CARES Act.

CDRH has been able to work with manufacturers to lessen the severity of some shortages and prevent others. In some instances, CDRH worked with testing and diagnostics manufacturers to help ease raw material shortages, such as those that resulted from a 2021 Texas winter storm. This work to find other sources of resins helped avert shortages of COVID-19 tests.

Won’t medical device shortages stop when the pandemic ends?

New medical device supply chain issues will continue to arise after the pandemic abates. Before COVID-19, a hurricane caused widespread shortages of IV bags. Plastic resin shortages are causing a wide range of medical devices, from tests to PPE, to take longer to produce.

What will help prevent medical device supply scarcities going forward?

At the beginning of the pandemic, the CDRH reached out to 1,000 medical device manufacturers requesting supply chain availability information, but only about one-third responded. Whether or not there is a pandemic in effect, the agency needs the supply chain information in order to protect public health.

What expanded authority will CDRH need?

The CDRH’s statutory authority should be revised to require manufacturers to notify the agency any time there is the potential for a medical device shortage. Without this expansion of CDRH authority, the medical device supply chain and U.S. public health will remain at risk.

How do these authorities help manufacturers?

The highly productive collaboration between the CDRH, manufacturers and other suppliers to tackle supply chain vulnerabilities is a direct result of the empowerment to act in the interest of public health that the CARES Act bestowed. Some examples of these fruitful collaborations include the FDA working with manufacturers to expedite marketing submissions to increase medical device availability, such as those for vaccine administration needed for the COVID-19 response. Those collaborations can be enhanced through more comprehensive CDRH authority to better protect public health into the future. The authorities are good for business, good for patients and good for public health.

Learn more about medical device regulations and compliance from Emergo by UL:

  • US FDA Emergency Use Authorization (EUA) consulting for medical device and IVD companies
  • FDA submission support for medical device and IVD manufacturers
  • Webinar: Medical device market access during public health emergencies

 

Author

  • Kathryn Burke's picture
    Kathryn Burke

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