RenalWEB linked to the FDA document Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis which offers recommendations to industry about submitting a machine for the first steps towards nocturnal home hemodialysis (NHHD) approval. The FDA provides a list of:
"inherent design and operational properties, we recommend the NHHD system include several key design features, associated alarms, and fail-safe responses. We recommend you incorporate the following features:
- disinfection, cleaning, and reprocessing capabilities and cycles;
- dialysate conductivity monitor, if your device contains a dialysate mixing system;
- water conductivity monitor; if your device contains a water treatment system;
- pH sensor;
- ultrafiltration controller;
- air detector system;
- blood leak detector;
- patient disconnect preventers and detectors;
- temperature monitor;
- anticoagulant administration system;
- access port for external remote patient monitoring device;
- integrated remote patient monitor, if a component of your system; and
- fail-safe design features in the event of power failure."
I'm not sure what "patient disconnect preventers and detectors" could be built into a device but the FDA does seem keen on having numerous monitoring systems integrated into the design. I know it is a fear when one first contemplates home hemodialysis but how often does inadvertent disconnect happen (particularly excluding during the processes of cannulation or decannulaiton)? The FDA did introduce me to a new word: exsanguination. I share their desire to avoid exsanguination but where is the FDA's data to justify their fear? Many people are dialyzing over night at home, around the world and in the US - if this was a clinical concern wouldn't there be examples to point to? Wouldn't there be a case history?
The danger is that by requiring expensive and unnecessary features the FDA will make daily home nocturnal less available. Forcing people to stay with conventional dialysis is far more dangerous. Dialysis isn't deadly, kidney disease is deadly. Dialysis is the solution. The FDA should evaluate machines on their merits and the data.