Tag: AAMI-ST79

New Amendment 4 released for AAMI ST79 on Steam Sterilization

When it comes to sterility in health care facilities, the best guide is the AAMI ST79, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities.”  It has just been updated by the release of the new Amendment 4 and can be purchased from Document Center in both the consolidated version (ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013) or as the Amendment 4 only.  Since the Amendment itself is 36 pages in length, the changes are extensive.

The bulk of the update is centered on the addition of a new Section P, Moisture Assessment and a corresponding checklist added to the various tables in the guide.  You’ll also see a series of 4 new figures:  2 for simultaneous double-wrapping (envelope fold and square fold) and 2 for sequential double-wrapping (again envelope and square fold).  And a moisture assessment flow chart has been added to the figures presented as well.

If you choose to get the consolidated edition, the various updates are integrated into the body of the text.  With the Amendment 4 itself, on the other hand, the changes are highlighted for your convenience.  You may want to get both copies — The consolidated issue for replacing the previous edition in your collection so that all usage in the future is based on the new material, and the amendment for gap analysis.

If you’re currently using the AAMI ST79, you’ll also want to confirm that you have all of the material that’s been issued since it’s original release in 2010.  FYI: The original release included the 1st Amendment, so you don’t have to worry about that.  The second amendment was released in October 2011 and the Amendment 3 was issued in October 2012.  Please review the material you have on file to confirm that you have all of the amending material in order to be sure that your copy is complete and correct.

Of course, Document Center customers have an edge when it comes to confirming the status of their documentation.  They receive our superior notification service, so they are always alerted by email when one of the standards they’ve purchased from us changes.  But we have several features on our website that our customers can use to verify their conformance documents.

When you’ve purchased standards from Document Center, you can register at our website, www.document-center.com, and see the list of the standards you own.  They’re displayed with the most recently released standards first, and any items that have changed in our database after the day the item was bought are highlighted.

Customers also rely on Document Center’s reporting services to review their collection on a periodic basis.  The report is generated once every quarter.  Customers have documentation to confirm that they are monitoring the status of the publications applicable for quality and conformance reviews.

If you have any further questions about the changes to AAMI ST79 or any of Document Center’s services, please get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are here to assist you with all your conformance documentation requirements.  We’re your Standards Experts!

New Amendment 2 for AAMI-ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities

AAMI ST79, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities,” has just been modified by Amendment 2.  This is a 134 page amendment that makes corrections to the original text.

You have a choice when purchasing the document.  You can get the whole document as a corrected reprint with the corrections interfiled (included).  Or you can purchase the amendment 2 as a standalone item, making the pen and ink changes to your original copy manually.

The document itself covers steam sterilization in health care facilities. The recommendations are intended to promote assurance of sterility and to guide health care personnel in the proper use of processing equipment.

Included within the scope of AAMI-ST79 are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas), staff qualifications, education, and other personnel considerations, processing procedures, installation, care, and maintenance of steam sterilizers, quality control, and quality process improvement.

Document Center provides AAMI standards via our website, www.document-center.com.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) to order copies.  Most AAMI standards are available in both paper and electronic format.

AAMI-ST79 – The new 2010 Edition is available for preorder now

The AAMI recommended practice ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is now approved in a new 2010 Edition and public distribution is pending.

The standard consolidates 5 previous AAMI steam sterilization standards, the AAMI ST33, AAMI ST35, AAMI ST37, AAMI ST42 and AAMI ST46.  It was the first AAMI standard to be released in a binder edition, since the material covered is extensive.  The binder format facilitates easy access to the various topics, like lowering and limiting bioburden before sterilization, properly preparing items for sterilization, selecting the appropriate sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used.

Users of this standard will find guidance to promote assurance of sterility and to guide health care personnel in the proper use of processing equipment.  The document includes functional and physical design criteria for a number of sterilization processing areas  including decontamination, preparation, sterilization, and sterile storage areas.  There are sections to assist with staff qualifications, education and other personnel considerations.  Also covered are  processing procedures,  installation, care and maintenance of steam sterilizers, quality control and, of course, quality process improvement.

The new ANSI/AAMI-ST79:2010 replaces the previous 2006 Edition with both Amendments 1 and 2, which is no longer available.  Because the new ANSI/AAMI-ST79 was only recently approved (9/3/2010), there will be a delay until the new edition is available.  Normal lag time can be from 1 to 3 months for the formatting and publishing functions to take place and the standard to become publicly available.

To purchase your copy of ANSI/AAMI-ST79, use our website at www.document-center.com, or call us at 650-591-7600, fax 650-591-7617, or email to info@document-center.com.

Your order can be placed now and shipped as soon as it is released.