FDA: Healthcare supply chain troubles existed before COVID-19, and they could get worse

While COVID-19 caused the largest disruption to supply chains across industries, officials at the FDA's Center for Devices and Radiological Health said some of the issues within the healthcare supply chain existed before the pandemic. Now, experts say, is the time to proactively correct issues into the future, the Regulatory Affairs Professionals Society reported May 2.

At the 2023 MedCon conference, Tammy Beckham, associate director for the CDRH's Resilient Supply Chain Program, said she is concerned that many of the issues with healthcare and medical device supply chain issues will continue. 

"We've seen these before COVID, and we're continuing to see these moving into the future," she said. "Many of the issues we're facing are becoming much more complex and more systemic."

Issues ranging from shortages of raw materials used in many medical devices to sole source suppliers, market concentration, labor issues and geopolitical unrest — even natural disasters — all contributed before and will likely continue to affect healthcare supply.

The CDHR's role is to create "reports of shortages and supply chain disruptions through 506J notifications and other communications and create patient impact assessments that are used across the government to evaluate mitigation strategies, including regulatory guidance and enforcement discretion," according to the Regulatory Affairs Professionals Society article. 

Ms. Beckham said there's more that can be done "proactively" to help.

Here are three things the CDRH is prioritizing to mitigate these impacts: 

  1. Working with trade organizations, health systems, distributors and stakeholders to create a list of the devices that are most critical to public health.
  2. Encouraging the increased collaboration between supply chain and product development.
  3. Identifying vulnerabilities or interdependencies from a "bird's eye view" to curb issues before they become larger. 

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