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Healthcare professionals face a multitude of challenges when trying to provide care for children with kidney problems or kidney failure. The blood is filled with waste products and toxic fluids that wouldn’t otherwise be present. Continuous renal replacement therapy (CRRT) requires specialized devices to clean blood. However, the issues arise when children need this kind of therapy and have no other option but to use machines designed for bodies larger than their own.
New Device for Pediatric Patients
Most dialysis devices are only designed for people who are over 22 pounds. When they are used for those who weigh less, the error factor increases significantly, which can place patients at risk even as they use these life-saving machines.
But now, the American Food and Drug Administration (FDA) has approved a new dialysis device for pediatric patients.
Some Italian healthcare professionals who specialize in pediatric care, focusing on the kidneys, have invented the new machine that could solve the problem. They call it CARPEDIEM, which is short for Cardio-Renal Pediatric Dialysis Emergency Machine. This device has been designed for those weighing between 5.5 and 22 pounds, and it’s already showing fantastic signs of success.
Current Data
So far, the data taken from the cases where the new device has been implemented shows a 97% survival rate—an impressive and needed improvement from the 48% chance given to pediatric patients using previous systems.
Many of the technological features that the CARPEDIEM uses were already in use in most CRRT devices. The challenge has been to scale them down enough so that they work just as effectively on people with lower blood volume, especially babies up to 15 months old.
The healthcare industry is fraught with many challenges no other industry faces. As ever, with new technology, there’s always a risk of complications. However, thankfully, the rate of complications with the new CARPEDIEM device has been low. The few complications that have arisen were shown to be caused by air entering into the dialysis circuit, which then caused high pressure in the dialyzer and, consequently, the transducer alarm.
Post-Approval for CARPEDIEM
The new device is in a post-approval stage, meaning it has been approved for US marketing but must continue to monitor results. To this end, studies will continue to be done to monitor patients and maintain or increase the survival rate to satisfactory standing. The research will also study patients post-CRRT care and analyze how long it takes for a patient in the Intensive Care Unit (ICU) to be discharged after being on the device, as well as ongoing health effects.
The director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, MD, said on the subject, “In line with the U.S. Department of Health and Human Services’ focus on improving the lives of Americans suffering from kidney disease and expanding options for these patients, this medical device will advance kidney health, providing a first-of-its-kind option and meeting an unmet need for these critically ill patients who need continuous renal replacement therapy to survive.”
The prospect of future use of this specialized device for pediatric patients in the US is an exciting and encouraging step for young patients with renal failure.
