HHS sends dialysis machines to hospitals with high cases of COVID-19; Fresenius ships equipment from Europe
HHS has deployed 50 Tablo portable kidney dialysis machines and supplies to New York City and Long Island ICUs caring for patients with COVID-19 who have also experienced acute kidney injury, according to an agency press release.
The dialysis machines, made by Outset Medical, came from the Strategic National Stockpile, which is managed by the Assistant Secretary for Preparedness and Response of HHS. HHS signed an agreement with Outset Medical in 2019 to provide dialysis machines during disasters.
“Deploying these portable dialysis machines is a sign of the commitment the Trump administration has made to New York and its hard-hit health care system, as well as to deploying the latest technology to help Americans during the COVID-19 pandemic,” Alex Azar, HHS Secretary, said in a release. “We learned from recent disasters that disruptions in kidney care can present serious risks. We responded by working with American innovators to create flexible, reliable solutions like these portable machines, which operate as long as there is tap water and electricity.”
The agency is also looking for other manufacturers that can design and build new dialysis machines rapidly in response to the COVID-19 pandemic. In its request for information, the agency said it wants to identify manufacturers that have current capability to produce portable dialysis and continuous renal replacement therapy (CRRT) devices and that “are able to quickly modify their current capabilities” to make the machines.
Current manufacturers of dialysis equipment and supplies have also increased shipments to areas like New York City. Fresenius Medical Care North America’s (FMCNA) Renal Therapies Group recently announced it has made its first shipment of multibic dialysate solutions for use in CRRT in the United States, beginning with hospitals in the New York metropolitan area.
The FDA has granted emergency use authorization (EUA) to these solutions, as well as to Fresenius’ Multifiltrate PRO System for use in acute care settings during the COVID-19 pandemic. Multifiltrate PRO, which is CE-marked and currently widely available in Europe but not in the United States, will create a stronger supply of critical care machines in the United States able to provide CRRT for patients with AKI, Fresenius said in a statement.
“We appreciate the FDA’s quick action in order to get these needed supplies and equipment into the U.S. for emergency use to provide CRRT to treat more patients with acute kidney injury and to help save more lives,” Bill Valle, CEO of FMCNA, said. “This is just one part of a larger effort to support continuous supply of critical care machines and dialysis solution for our nation's hospitals.”
Last month, the company announced the formation of its national intensive renal care reserve which has been working to deploy available NxStage Medical’s System One S machines across the country to those hospitals most in need, as well as deploying similar portable units typically used for home dialysis or in skilled nursing homes. The company also announced that it had increased production of its tubing and filter sets, along with premixed dialysate fluid. To date, this reserve has helped multiple hospitals along the East Coast and Upper Midwest support patient care during this crisis, according to Fresenius.
“Since we first became aware of the increasing demand for dialysis due to COVID-19, we have been working diligently to support hospitals with the needed critical care equipment and supplies,” Joe Turk, president of home and critical care therapies at FMCNA, said in the release. “While the early experiences in other geographies appears to be less challenging than in the New York metropolitan area, the option to support our nation’s hospitals with these systems brought in under EUA will allow us to even better serve patients during this pandemic.” - by Mark E. Neumann