These devices are required to be prescribed by a clinician as per their intended use. If a device is used off-label, the user recognizes that it is not the approved use of the device and that the responsibility for doing so is their own.
Reprocessing of Fisher & Paykel Healthcare RT-series single-use products
F&P Healthcare DO NOT recommend reprocessing of, or reuse on multiple patients, of RT-series single-use products.
Background information on reprocessing
The information provided below may help explain why reprocessing of F&P Healthcare single-use products is not possible.
Effective reprocessing of any medical device involves three key steps to achieve sterilization: Cleaning, disinfection and sterilization. The success of each step is very dependent on the preceding steps achieving their expected level of sporicidal action.
Cleaning: The removal of gross contaminants or visible dirt from the device.
Disinfection: Destruction of the bulk of ‘invisible’ contaminants. For respiratory equipment that contacts mucous membranes, the minimum inactivation level is high-level disinfection (HLD). High-level disinfection destroys all microorganisms except large numbers of bacterial spores.
Sterilization: Destruction of all microbial life. Whenever sterilization is possible it is considered the default best practice.