AAMI, the Association for the Advancement of Medical Devices, has two main roles in standardization here in the U.S. First, it acts as the Technical Advisory Group (TAG) for medical device standardization at the international level. And secondly, it provides guidance for U.S. companies when international standardization has not yet taken place. One of these AAMI Technical Reports, AAMI TIR34, has just been updated. Document Center has the new 2014 Edition now so you can purchase it in paper format or for pdf download.
Titled “Water for the reprocessing of medical devices,” AAMI TIR34 covers the complete range of issues involved in what is basically sterilization of medical devices using water. You’ll learn why water quality is important, the categories of both medical devices and of water for the reprocessing function, what types of water treatment you’ll need to consider, and the stages of medical device reprocessing where water quality is a factor.
Of course, in order to set up an effective water treatment process you’ll need to know about the various water treatment systems available and what will work best in your situation. The standard covers this, down to the issues of the physical layout of the water purification system to distribution and storage. You’ll also get complete guidance on how to monitor the water quality in your system, both in clause 7 and in Annex B. Concluding sections cover strategies for bacterial control, personnel considerations, and quality concerns.
You’ll also be pleased to know that there are 7 Annexes that review the various issues in detail — from the monitoring issues noted above to thermal disinfection, water treatment using filtration and the typical presentation of quality issues during reprocessing.
What’s new in this edition? Of course, there are many updates and organization enhancements throughout the document. But the committee also brings the fact that the water categories have been reduced to two from the previous four that were specified in the 2007 Edition.
How do you get a copy? Due to copyright considerations, you’ll want to make sure you purchase your copy from an authorized dealer. Document Center Inc. is such a source. You can order any standards you need at our web store, www.document-center.com. Or feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (firstname.lastname@example.org). Interested in multi-user online subscription access? We have that too! Remember, Document Center has been providing standards to folks like you since 1982. Make us your Standards Experts!