ANSI/AAMI/ISO 11663 & 23500, Quality Requirements and Monitoring of Water Treatment and Dialysis Fluid for Hemodialysis and Related Therapies
ANSI/AAMI has recently adopted several ISO standards which in combination replace ANSI/AAMI RD52. This webinar will discuss ISO 11663:2009 as it relates to the recommendations for dialysis fluid quality and how it differs from ANSI/AAMI RD52. Having two documents can be confusing as U.S. users have relied on all the information residing in a single document. As RD52 was adopted as regulation by CMS, the clinics are left with the question of how to comply with the CMS regulation and the new ISO documents. The webinar provides some strategies for addressing this dilemma. It addresses certain aspects of ISO 23500:2011 (the user guidance document on how to comply with the recommendations of ISO 11663) not covered in the April 3, 2012, AAMI webinar on ISO 23500. Specifically, items related to components of the water treatment system design critical to meeting the requirements of ISO 11663 are discussed.
In addition, monitoring requirements for the water treatment system, bacterial control devices, concentrate preparation and proportioning is covered in detail. Since much of the information previously provided within the body of the RD52 standard is now incorporated into a series of Annexes in both ISO 11663 and 23500, the content of these Annexes is highlighted, and their relationship to the body of the standards explained. Finally, differences between RD52 and the ISO standards in the above areas are described.
| WHO SHOULD PURCHASE |
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| This program is designed for those who are responsible for delivering quality dialysis to ESRD patients, those who maintain the equipment and systems necessary to deliver hemodialysis therapy, and those who are responsible for CMS regulatory compliance. Personnel who design, develop, manufacture, and utilize concentrates, water treatment systems, and systems for reprocessing dialyzers will also benefit from this program. |
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| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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PROGRAM OBJECTIVES
- Describe the minimum chemical and microbiological requirements for dialysis fluids
- Discuss the critical elements of water treatment system design
- List the monitoring requirements for commonly used water treatment components, bacterial control devices and concentrate preparation, distribution and proportioning
- Compare and contrast ISO 23500 and RD52
- Demonstrate how the Annexes complement the standards
SPEAKERS
- Jo-Ann B. Maltais, Independent Consultant, Maltais Consulting, San Ramon, CA
Member AAMI Renal Disease and Detoxification Committee and Sterilization Standards Committee - Glenda Payne, RN, MS, CNN
Director of Clinical Services for Nephrology Clinical Solutions, Lisle, Illinois
Member, AAMI Renal Disease and Detoxification Committee
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD.
- $50 for webinar registrants
- $75 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Click here to order online.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
AAMI Webinar CD
Quality Requirements and Monitoring of Water Treatment and Dialysis Fluid for Hemodialysis
PO Box 0211
Annapolis Junction, MD 20701-0211