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Recommendations to FDA on a Path Forward to Prevent Medical Device Shortages in the Face of Sterilization Facility Closures

Today, the Food and Drug Administration (FDA) is hosting a panel to hear from stakeholders on the risks associated with medical device sterilization facility shutdowns due to ethylene oxide (EtO) environmental emissions and potential action steps.

Dr. Kara Mascitti, the Medical Director & President of Healthcare Epidemiology and Infection Prevention President for St. Luke’s Infectious Disease Associates and Chaun Powell, Premier’s Group Vice President of Strategic Supplier Engagement, will be testifying at the FDA meeting. Attached are their statements, which underscore the threat that device shortages pose to the safe, effective delivery of patient care, targeted steps that Premier is taking to prevent disruptions in the supply chain, and recommendations to prevent these shortages while balancing the need to protect public health.

Earlier this week, The Health Care Blog published a byline, “The Untold Reality of Medical Device Shortages in the U.S.," by Chaun Powell and Soumi Saha, Premier’s Senior Director of Advocacy. Chaun and Soumi discuss the root causes of medical device shortages, best practices for navigating these shortages and proactive solutions to solve the problem.

Download full testimonies from Dr. Mascitti and Chaun below.

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