scope:

This recommended practice describes the essential elements of good practice for reprocessing hemodialyzers to help ensure device safety and effectiveness. These practices embrace considerations of the device and the patient, as well as attention to equipment, facilities, cleaning and disinfection methods, labeling, preparation for multiple use, and quality control of the reuse process. This document does not endorse either single use or reuse of dialyzers.

Regardless of the labeling recommendations, prescription to reuse remains the sole responsibility of the patient's physicians. Therefore, this recommended practice is addressed to the physician responsible for the hemodialyzer reprocessing program. Users, however, should be aware that dialyzers intended for reuse shall be labeled for reuse in accordance with the Food and Drug Administration (FDA) document "Guidance for Hemodialyzer Reuse Labeling" (6 October 1995).

The committee recognizes that reuse may affect such dialyzer characteristics as biocompatibility and clearance of larger molecules. Changes in dialyzer performance and biocompatibility vary with the materials of construction and the reuse method employed. Detailed analysis of these factors is beyond the scope of this document. Specific information on the effects of reuse on dialyzer performance and biocompatibility may be obtained from the dialyzer manufacturer and the scientific literature (Cheung, et al., 1999). This recommended practice does not address every risk or benefit that may be associated with reuse.

Inclusions

This recommended practice is directed to the physician in charge of hemodialyzer reprocessing by either the manual or the automated method. Subjects included within the scope of this recommended practice are recordkeeping, personnel considerations, patient considerations, equipment considerations, physical plant and environmental safety, reprocessing material considerations, patient identification and hemodialyzer labeling, reprocessing and storage procedures, disposition of rejected dialyzers, preparation for subsequent use, patient monitoring, quality assurance, and quality control.

Exclusions

This recommended practice does not cover the reprocessing of blood tubing sets, nor does it address labeling and performance requirements for single-use hemodialyzers.