The Coronavirus – 2019 (COVID-19) pandemic is unmasking the shortcomings of in-center hemodialysis for people with kidney failure. Individuals with kidney failure who rely on in-center dialysis do not have the luxury of social distancing during a pandemic. In-center dialysis exposes people with kidney failure and healthcare workers to potential infection. Additionally, in-center hemodialysis patients are exposed to other discomforts and inconveniences associated with strict infection control and isolation policies necessitated by emergencies like pandemics.

The opportunity to receive kidney replacement therapy at home via home hemodialysis (HHD), peritoneal dialysis (PD), or other technology, either during the pandemic or non-emergent times could substantially improve the quality of life for people with kidney failure. Now is the time to accelerate the development of wearable or implantable products that offer patients more options for their treatment.

Home therapies, including future wearable and implantable therapies, offer many benefits to people with kidney failure including:

• Providing freedom and control over treatment;
• Extending capacity for full or part time work, schooling, or other pursuits, and avoiding disability; and
• Enabling longer periods of dialysis to improve blood homeostasis.
   

This pandemic should impel a renewed commitment to accelerating innovation through initiatives such as the July 2019 Presidential Executive order Advancing American Kidney Health, the KHI RRT Technology Roadmap, and the US Department of Health and Human Services (HHS)/ASN’s KidneyX Redesign Dialysis prize competition. This renewed commitment will create technologies that facilitate increased access and use of currently available home hemodialysis and PD therapies, while home wearable and implantable technologies are being developed.

Advancing Patient-Centered Technology for Home Therapies and Other Alternatives to In-Center Dialysis

Currently, several new technologies and innovations with the potential to facilitate wider adoption of home therapies are accelerating development processes. Exciting innovations include easier-to-use HHD machines, updates to PD technologies, advances to vascular access, and enhanced communication tools for physicians, clinics, and patients.  However, advances in number and ambition are needed if more medically eligible individuals are to go home for treatment.

Fortunately, policy makers, innovators, researchers, and healthcare system leaders already have a clear roadmap for making these technology advancements possible. The KHI Technology Roadmap, released in 2018, describes the milestones and minimum design criteria that must be met to deliver novel approaches to kidney replacement therapies, including wearable, portable, and implantable dialysis solutions.

Expanding therapies and creating innovations that will overcome the existing challenges include, but are not limited to:

• Efficient use of water, via purification, sterilization, and reuse technologies;
• Point of care infection detection;
• Miniaturization, especially of energy sources, pumps, filters, and fluids;
• Painless, self-sealing, needle free, and patient operated vascular access;
• Blood filtration, access to a safe, effective, longer-life, easy-to-use filtration system that avoids clotting issues;
• Toxin removal and secretion for reduced presence of harmful toxins in the bloodstream that could lead to uremic toxicity and/or drug toxicity;
• Fluid regulation to allow patients to personalize and optimize the amount and rate of excess fluid removal resulting in stable blood pressure and less thirst and cramping;
• Filtrate transport and drainage processes and equipment that are safe and effective;
• Sensors, especially for fluid status, infection, electrolyte imbalance, and other physiologic status indicators; and
• Remote monitoring and telehealth services.
   

Focus on Individual Patients

KHI has provided tools that innovators can use to integrate patient preferences and patient reported outcomes throughout their product’s lifecycles so that the innovative solutions match what people with kidney disease need.

The COVID-19 pandemic has laid bare the challenges and fears the kidney community has been grappling with for years. Those challenges are heightened in people with kidney diseases who are more vulnerable or who have reduced access to optimal treatment options and, health care. Now is the time to bring technologies to market that have the potential to reduce disparities and improve the lives of all individuals with kidney failure.\

Researchers, innovators, and entrepreneurs must work together with the kidney community to overcome the engineering and scientific barriers that make it hard for some patients to utilize home therapies. This kind of concerted effort will create incremental and transformative technologies to dramatically improve care for those with kidney diseases ahead of the next pandemic or natural disaster.

DISCLAIMER

The views and opinions expressed in this statement are those of the authors and do not necessarily reflect the official policies of any KHI member organization, the U.S. Department of Veterans Affairs, or the U.S. Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

Please see the full position paper for more information.