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ANSI COVID-19 News: FDA Resilience Supply Chain Program Builds on Lessons from a Global Health Crisis, and More

11/09/2022

The ANSI Federation and standardization community are stepping up with guidance, resources, and initiatives to support public health and safety and the nation’s recovery. Suggestions for news items may be submitted to [email protected]. All submissions are published at ANSI’s discretion.

FDA Expert Reveals How New Supply Chain Program Leverages “Lessons Learned” for Proactive Solutions

Vulnerabilities across the supply chain are still prevalent nearly three years after the onset of the pandemic, but the Food and Drug Administration (FDA) is taking a proactive approach to reduce future disruptions across the medical device ecosystem through a new program. In a recent webcast with AAMI News, Tammy Beckham, associate director of the Resilience Supply Chain Program (RSCP), part of the FDA’s Centers for Devices and Radiological Health (CDRH), reflected on how the COVID-19 pandemic has exposed major challenges across the supply chain that impact patients, such as shortages in raw materials, medical devices, PPE, and ventilators.

Through its newly instituted RSCP, the FDA will leverage lessons learned from COVID-19 and take a proactive approach by working with industry, patients, hospital systems, providers, manufacturers, and suppliers to understand what vulnerabilities exist for critical medical devices that are essential to have at hand at all times to treat patients. Ultimately, the goal is to build resiliency across the supply chain and prevent issues before they occur. Beckham acknowledged that by zoning in on some of the leading supply chain issues linked to the pandemic, the FDA was also able to identify supply chain issues that were present for years before the global health crisis emerged.

“FDA has a unique role in the supply chains. What we are looking to do is prevent issues, and with that unique birds-eye view of the supply chain, we can see across that and help prevent those disruptions before they occur.”

Access the interview with AAMI’s Robert Burroughs, chief learning and development officer, and Joe Lewelling, senior advisor for industry via AAMI.

Mayo Clinic Doctor Talks COVID-19, RSV, and Flu: A Season of Respiratory Infections

A Mayo Clinic infectious disease specialist shares tips to stay safe during respiratory infection season in a new video posted on Mayo News Network.

"It's impossible to distinguish based on symptoms from a regular cold to RSV to COVID-19 or flu—especially if you have a mild case. But you can still transmit all of these to others," warns Dr. John O'Horo.

The doctor shares some key health tips: “Staying up to date on your vaccines, COVID-19 and the flu; wearing a mask in the appropriate settings; or if you're a person who's had exceptional risk, hand-washing and doing everything you can if you do get sick to prevent spreading to others. That includes trying to stay home from work if you can, wearing a mask consistently if you have any kind of symptoms and being extraordinarily diligent about measures like hand-washing."

Dr. O’Horo notes that that omicron subvariants are transmissible and found across the world. He explains that COVID-19 and other respiratory infections will be on the uptick—and likely linked to colder months and the holiday season.

"We've always thought there would be some seasonality to COVID-19. And coming into the holidays, especially, we can expect that we're going to see an increase in cases. We will probably see an increase in hospitalizations as well—in part to the natural surge that we're seeing and in part to seeing low uptake of the bivalent booster vaccines," he says. "Hopefully, we'll see that increase with the vaccinations and blunt some of that, but this is a respiratory infection season. And it's not just COVID-19 that we have to worry about this time. Influenza levels are likely to increase as well. And this is expected to be a more severe flu season because we've had two years without a flu season."

See the video for additional tips and information.

See more ANSI member efforts in the ANSI COVID-19 Resource Webpage Highlighting the Standardization Community’s Response.

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