This latest AAMI Standard (a revision of RD62) provides guidance for water treatment equipment for hemodialysis and related therapies. It is specifically directed to any manufacturer and/or supplier of water treatment systems and/or devices that are expressly used for hemodialysis or related therapies. This Standard not only includes all areas of use for dialysis water, but it also includes all devices, components, piping systems and fittings that connect potable water lines to product water lines along with water quality monitoring instrumentation. Water quality itself is not covered within this Standard, merely the method to achieve the desired outcome with reference to Standard 13959.
Water treatment equipment requirements are listed and explained not only as singular devices but also in context within the framework of the entire system. Two such areas are materials compatibility and disinfection protection. Using the correct system materials is essential to avoid leeching contaminants into the product stream but also to prevent damaging components by using incompatible disinfection products or unsafe practices. Lastly, since ongoing preventative maintenance is required, there needs to be a way to ensure the system can be restored to a safe condition prior to any therapy or product preparation.
The Standard contains specific equipment requirements associated with three separate areas. The first, Pre-treatment, includes but not limited to, tempering valves, sediment filters, water softeners, carbon media, and chemical injection systems. The second, Purification, is identified as reverse osmosis (RO), deionization (DI), and endotoxin filters. The third and final, Post-Treatment components, consist of the storage (if applicable) and distribution of dialysis water. Here items like piping systems, storage tanks, and ultraviolet irradiators (UV) are listed along with two disinfection methods; hot water and ozone.
The testing section details compliance with dialysis water quality requirements. All water quality parameters point to the 13959 Standard. Information on sampling collection and analysis is provided in order to monitor microbials and chemical contaminates. Charts are found in Annex B as reference. The same US deviation for approved culture methods as listed in 13959 is also detailed in this Standard.
The water manufacturer and/or supplier must ensure that the installed water treatment system can reliably and effectively remove contaminates in a safe manner. As a result, testing for materials compatibility, disinfection techniques, regenerated devices and every individual component or device within the system, must be compliant. Typically this is accomplished by a supplier gaining FDA 510(k) clearance based on rigorous testing and validation efforts. Of course ongoing monitoring is required by the end user to ensure the system is preforming as intended.
To assist the end user, the manufacturer and/or supplier should provide written materials that are attached to the device along with complete instructions for use (i.e., operating manual) and any other directions or conditions for operation. This specifically details device markings and product literature. Not only should each device be labeled explaining purpose, function, quality checks, and action required, but there also needs to be a schematic diagram of the water treatment system that shows equipment, flow path, valves, monitoring devices, and sampling ports. Safety features and warnings should be displayed and also found within instructions for use. This should also include recommended preventive maintenance and service practices.
Finally, it includes a section that explains the rationale for the development and the provision of the Standard itself. Here microbial, chemical contaminates and the entire water treatment system requirements are discussed further so as to explain in greater detail a particular topic or reason for established practices. Ultimately, the medical director is responsible for the selection and use of water treatment devices as recommended by the supplier.