Home Hemodialysis, Acute Hemodialysis & Validation: Special Considerations and How They Link to ANSI/AAMI/ISO 23500
ANSI/AAMI/ISO 23500 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies has recently replaced in part ANSI/AAMI RD52 Dialysate for hemodialysis. As with RD52, the primary ISO 23500 document is focused on requirements and recommendations for in-center hemodialysis systems and processes. The Annexes are used to provide additional information. Home and acute hemodialysis settings present some unique challenges where in-center solutions are not applicable or feasible and require a different approach while still making patient safety a priority. These are addressed in Annexes F and G of ISO 23500 respectively. The details of these annexes will be presented and situations where what the recommendations/requirements are either not clear or revert back to the primary ISO 23500 standard will be clarified. These changes will have an impact on acute services and home hemodialysis programs, particularly those who have struggled with meeting the RD52 action levels and limits. The potential and process for the Centers for Medicare & Medicaid Services and The Joint Commission to adopt this ISO document will be addressed, and suggestions will be provided for making a smooth transition to the new requirements.
In addition, the concept of validation, an important component of the ISO documents’ approach to maintaining quality dialysis fluid preparation and use, will be reviewed as it is a new concept for most U.S. dialysis clinics and programs. The validation approach with process control rather than QC/QA provides flexibility for manufacturers and users but may appear daunting at first. This webinar attempts to demystify the concept with examples applicable to home and acute hemodialysis settings and the importance of the manufacturer’s IFU and the user following those instructions when using a validated system.
| 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 regulation compliance or The Joint Commission Accreditation Standards. Personnel who design, develop, manufacture, and utilize concentrates, water treatment systems, and systems for delivery of ultrapure dialysate and on-line prepared substitution fluid 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
- Discusses special requirements/recommendations for hemodialysis in a home setting especially related to system design, installation and monitoring
- Describes the specific portions of the ISO 23500 standard applicable to acute dialysis services
- Identifies major challenges to patient safety in the provision of acute dialysis services
- Lists the steps in a validation process and how the approach to monitoring changes from the traditional QC/QA approach
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
Home Hemodialysis, Acute Hemodialysis & Validation
PO Box 0211
Annapolis Junction, MD 20701-0211