2011 JSDT Standard on the Management of Endotoxin Retentive Filter for Dialysis and Related Therapies

Abstract

The contamination of the fluids for dialysis therapy is an important factor that deteriorates the biocompatibility of HD and related therapies. In particular, microbiological contamination is considered to be an important factor that causes dialysis amyloidosis and malnutrition due to the strong physiological activity of endotoxin (ET) (1). High-performance dialyzers are more frequently used in Japan than in other countries; hence, dialysis facilities in Japan are particularly affected by the bacterial contamination of dialysis fluid when it occurs. Moreover, most of the dialysis facilities in Japan use central dialysis fluid delivery systems (CDDSs), which are considered to be less effective in suppressing microbiological contamination than systems used in other countries, which adopt single-patient dialysis machines. Although ET retentive filters (ETRFs) are indispensable for increasing the microbiological quality of dialysis fluid, they may be a source of contamination if not appropriately handled (2). Therefore, the installation of an ETRF, which is the final safety step in the purification of dialysis fluid, does not always guarantee the purity of the final fluid. Rather, it is important to manage the quality of dialysis fluid that passes through the ETRF. In 2008, the Japanese Society for Dialysis Therapy (JSDT) established the Microbiological Quality Standard for Dialysis Fluid, which merely states that users of ETRFs should handle them according to the manufacturer’s instructions (3). To date, however, no consistent standard for handling ETRFs has been given by the Japan Medical Devices Manufacturers Association. ETRFs from different manufacturers have been deployed in various dialysis facilities using procedures at the discretion of each facility. Considering this situation, the JSDT has recommended that the management of ETRFs should be standardized and has formulated the JSDT original standard for managing ETRFs with the aim of supplying safe and stable dialysis fluid. The Working Group on the Development of the ETRF Management Standard consisted of members of the JSDT Subcommittee of Scientific Academy for the Function and Efficiency of Blood Purification Therapy as well as representatives of the Japan Medical Devices Manufacturers Association and the Japan Association for Clinical Engineers. To the best of our knowledge, there are few reports with high-level evidence regarding ETRF management. Moreover, CDDSs are predominantly used in Japan and rarely used in the US and Europe, so that makes it extremely difficult to refer to overseas evidence and standards on ETRF management. Therefore, we summarized the opinion of experts based on the results of joint research with related societies, including the Japan Association for Clinical Engineers and the Japanese Society for Hemodiafiltration, as well as the standards presented by the Japan Medical Devices Manufacturers Association and the dialysisrelated International Organization for Standardization (ISO) standards. We then formulated the ETRF Management Standard through a Consensus Conference at the 55th Annual Meeting of the JSDT. Received October 2012. Address correspondence and reprint requests to Dr. Ikuto Masakane, Yabuki Hospital, 1-6-17 Honcho, Yamagata City, Yamagata 990-0885, Japan. Email: imasakan.aipod@seieig.or.jp bs_bs_banner