Thursday, June 30, 2022
HomeHealthcareInfusion Pumps: What The FDA's New Mandates Mean

Infusion Pumps: What The FDA’s New Mandates Mean

The downloadable guide offers key insights while giving flexibility to front-line workers using the medical technology.

“Patients infected with COVID-19 may require continuous infusion of medications, nutrition, and/or other fluids. As such, FDA recognizes the need to help increase access to an adequate supply of devices to treat patients who need these therapies and to help foster technologies that maintain a safer physical distance between the health care provider and patient affected by COVID-19.” (FDA) 

In early April, the U.S. Food and Drug Administration (FDA) issued a new Emergency Use Authorization (EUA) or mandate and guidance around infusion pumps and accessories due to COVID-19. Created specifically during the pandemic to keep healthcare professionals up-to-date on best practices, the mandate both expanded the availability and capabilities of infusion pumps and helped educate practitioners. Additionally, the FDA has called on pump manufacturers to send information regarding pumps and the EUA mandate to CDRH-COVID19-InfusionPumps@fda.hhs.gov

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Breaking down guidance by classification, device type, product code, and class, the downloadable guide offers key insights while giving flexibility to front-line workers using the medical technology. According to the FDA:

“This policy will create more flexibility for manufacturers that make device modifications to address manufacturing limitations or supply shortages related to the public health emergency. Examples may include: 

  • Changes to the infusion pump motor to allow an alternate supplier to meet the required design specifications, or 
  • Enabling an alternate supplier of infusion pump accessories to meet the established performance of the FDA-cleared device.”
COVID Emergency Relief- What Hospitals And Clinics May Not Know
Photo by Bru-nO via Pixabay

To best understand the mandate, here are three key points to remember:

  • The FDA states, “wherever possible, health care facilities should use FDA-cleared infusion pumps to treat patients who require continuous infusion therapy.” A list of approved devices can be found on the FDA’s Premarket Approval (PMA) site.
  • More information around infusion pumps (including failures and guidance around safety,) can be found at the FDA Infusion Pump Improvement Initiative page.  
  • During the COVID-19 crisis, the FDA has greenlit the ability make modifications to the device including remote monitoring, increases in battery capacity, modifications to hardware and software, and material changes to tubing. 

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Not updated since 2010 when the FDA addressed infusion pump safety by increasing user awareness, facilitating device improvements and publishing new guidelines, the newest mandate offers direction with actionable plans for hospitals and clinics to follow. 

In the fight against COVID-19, the FDA is actively working to be proactive and allow healthcare facilities and workers to have information in a relevant, timely manner. One of many EUA’s put out since late March, the newest rules only apply during the current pandemic. One the situation has passed; the FDA will be issuing more guidance around infusion pumps and their accessories.

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