Regulations and Guidelines

The Association for the Advancement of Medical Instrumentation (AAMI) is a professional organization in which committees are composed of representatives that include health care professionals, patients, medical device manufacturers, and representatives of federal agencies.   These committees have developed voluntary guidelines for medical products and procedures. The Renal Disease and Detoxification Committee (RDD) has developed standards for dialysis equipment manufacturers and recommended practices for end users.

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Ever since 1976, water treatment systems for dialysis have been classified as Class II medical devices by the FDA.  High flux dialyzers and hemodialysis machines fall into this same category.  Since then many documents have been published including one back in 1989 from the FDA titled, A Manual on Water Treatment for Hemodialysis. Per the FDA, water treatment equipment, devices, and systems used for hemodialysis and related therapies must comply with ANSI/AAMI Standards.

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More commonly known as the CMS, this agency is under the US Department of Health and Human Services and is responsible for the administration of the End-Stage Renal Disease (ESRD) program.  The latest Conditions for Coverage for ESRD facilities were published on April 15, 2008 and went into effect six months later.  The CMS rule established the latest conditions for coverage that dialysis facilities must meet to be certified under the Medicare programs in order to receive reimbursements and remain in operation.

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