FDA aims to thwart infusion pump shortage with new industrywide emergency use authorization
Featuring George Gray, CTO Ivenix: MedTechDive, May 15, 2020
FDA said Thursday it issued an emergency use authorization to spur availability of infusion pumps as the lifesaving machines and accessories are in short supply for COVID-19 patients.
The agency in early April issued guidance targeted at increasing access to breathing devices for patients who may require continuous infusion of medications, nutrition, and other fluids. But this week’s EUA takes the effort a step farther by allowing the manufacture, distribution, and use of pumps and accessories not otherwise cleared or approved for sale, or that require a modification that would ordinarily prompt a new premarket notification to FDA.
The EUA in part covers infusion pumps with remote monitoring, remote manual control features, administration sets, and other accessories with increased length designed to help maintain a “safe physical distance” between healthcare professionals and COVID-19 patients.
FDA said it’s concerned there are not sufficient quantities of infusion pumps and accessories available to meet America’s needs during the public health emergency. The EUA letter says the supply chain for products that meet the agency’s regulatory requirements has been “substantially stressed, with shortages already being observed in United States healthcare institutions, with demand exceeding the available supply.”
That assessment tracks with a warning last month by the Institute for Safe Medication Practices, an affiliate of the nonprofit ECRI Institute, that some healthcare organizations are “already experiencing unprecedented shortages of smart infusion pumps and dedicated administration sets, while others are still anticipating such shortages.”