Standards Development

Scope

A home high flow therapy (HFT) device blows air at a controlled flowrate, humidifies and conducts the air through a heated tube. The heated tube connects to a respiratory high-flow nasal cannula.

Room air is drawn into the device by a blower such as a turbine.

Supplemental oxygen is commonly sourced from equipment for long term oxygen therapy such as a home cylinder or stationary oxygen concentrator.

Home HFT is predominantly used in home healthcare facilities. It is suitable for use in professional healthcare environment to assist patient setup and trial.

Home HFT is used by spontaneously breathing patients to relieve respiratory symptoms that interfere with daily living and to reduce the incidence of acute exacerbations requiring hospital care The blower, humidifier and heated tube have integrated control. A single fault in one of these can be responded by deactivating the other two to reach a safe state of inactivity.

One category of home HFT is described for devices that incorporate alarms to alert a patient or carer to incorrect device operation. A second category is described for devices that serve patient groups at lower risk.

Purpose

Home HFT has growing recognition in clinical practice for the treatment of respiratory insufficiency, respiratory impairment, bronchiectasis and interstitial lung disease. Equipment configured for this application has different requirements than the particular standards ISO 80601-2-90 for high flow therapy and ISO 80601-2-74 for humidifiers. Home use for the management of chronic conditions is served by an integration of equipment for safety and coordinated control.