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!
