Haemodialysis delivery system
Tablo® is a mobile haemodialysis system developed by Outset Medical for the treatment of patients with acute and/or chronic renal failure.
The US Food and Medical Administration (FDA) granted 510(k) clearance to the haemodialysis system in November 2016. It is also the first-of-its-kind system to receive approval from the FDA in April 2020 for use in patients at their home.
Covid-19 virus has been found to hamper kidney function in affected patients, overwhelming the dialysis services in the hospitals during the pandemic.
The Outset Medical, in collaboration with the US Department of Health and Human Services, delivered 50 Tablo haemodialysis systems to the hospitals in the emergency locations in New York City and Long Island in May 2020.
Covid-19 pandemic increased the urgency to provide dialysis patients with options for various care settings including home.
Tablo device is a simple, self-contained, low-cost haemodialysis delivery console comprising fluidic systems and a dialysis delivery system with high-flux dialysers.
The fluidic systems function as a water purification system, while the dialysis delivery system performs the dialysis activities.
The blood flow rate of the system is up to 400ml per minute with an extracorporeal circuit volume of 140ml, maximum ultra-filtration rate of 2,000ml per hour and dialysate flow rate of 100, 200, 300ml per minute.
Tablo sensors automate a larger part of setting, procedure, management and maintenance of the system. The Tablo cartridge requires no manual set up, thus minimises the setting and take-down time. The dialysate on-demand facilitates purification of water and real-time dialysate production.
The haemodialysis system features expanded wireless data transmission capability with two-way cloud communication. This allows users to access treatment data anywhere.
Touchscreen interface provides three-dimensional animations and conversational instructions to navigate the user through the system settings and treatment in a simple way. The regular automated updates improve the system ability with time. The wheels provide mobility to the system, enabling it to work in diverse care settings.
Other features include automated self-cleaning, saline bolus and tracking ability, single touch rinse-back, treatment duration flexibility ranging between 30 minutes and 24 hours with a change in supplies and integrated blood pressure cuff. The system also reduces the training time of the operators to a few hours.
EPA quality drinking water is fed to the system with an incoming temperature between 5oC and 32oC and incoming pressure of 30-80 PSIG.
The filtration system includes integrated sediment, carbon, reverse osmosis (RO) and ultrafilter, while output purified water meets Association for the Advancement of Medical Instrumentation (AAMI) standards.
A total of 30 patients were studied in an eight-week, prospective, multi-centre, home haemodialysis trial for the safety and effectiveness of the system at home.
Patients received four treatment periods, in which dialysis was performed four times in a week for 21 consecutive weeks including one-week run-in, eight-week in-centre, four-week transition and eight-week in-home. The trial showed no device-related adverse events in patients.
The study demonstrated that the system is easy to learn and functions in an in-home setting. It allowed at-home dialysis of the patient while remaining functional during treatment. More than 500,000 people in the US currently need dialysis treatment thrice or more in a week, which takes about four hours per treatment. Every year, approximately 100,000 new patients start taking dialysis treatment.
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