New AAMI CN6 – Connectors for liquids and gases

Sometimes human error can be avoided through good design.  In the case of the healthcare industry, many errors caused by connecting patients to the wrong gases or liquids can be avoided by connector design.  So AAMI has been issuing a series of connector standards recently, and the CN6 is the latest.  AAMI CN6, “Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications ,” is available now from Document Center Inc.  You’ll be able to get copies both in paper format and as pdf downloads.

First, the AAMI CN6 is a provisional standard.  It has been developed from a draft of the proposed ISO 80369-6 document.  For all of you who are concerned about whether to purchase this provisional standard now or to wait for the ISO release, you’ll be pleased to know that when the ISO document is published, you’ll get the AAMI adoption at no additional charge.

Also, the AAMI committee is chaired by the head of the FDA’s CDRH Standards Program (Center for Devices and Radiological Health), along with a medical device industry representative.  And, should the ISO 80369-6 not make it through the adoption process and ISO and not be published after all, the AAMI CN6 will be withdrawn.

Also of note is the fact that the ISO 80369 series will eventually consist of 8 Parts.  This will mean that issues of unique connectors for such applications as breathing systems, limb cuff inflations, urinary applications and so on will all be defined.

Now for the AAMI CN6.  The standard addresses connectors used for neuraxial applications.  These are intended to administer medications for anaesthesia procedures, remove cerebro-spinal fluid, and so on.  The 65-page document is a wealth of information.  It covers general requirements, dimensional requirements and performance requirementsin the body of the text.  Then the 10 (count them, 10!) Annexes delve into the details of test procedures, rationale and guidance, small bore and reference connectors, etc.  A 24 item Bibliography completes the document.

Why has AAMI CN6 been published?  Very simply to promote patient safety.  The benefits of standardizing connectors in a hospital or other healthcare setting to avoid errors which can sometimes lead to fatalities are clear.  As a prime proponent for healthcare and medical device safety, AAMI feels compelled to help industry achieve this worthy goal as soon as possible.

How can you get your copy of AAMI CN6?  Since AAMI standards are covered by the laws of copyright, you’ll need to choose an authorized distributor like Document Center Inc. for your purchase.  Use our webstore, www.document-center.com, to order online.  Here is the link directly to the order page for AAMI CN6.  Or feel free to contact our staff by phone (650-591-7600) or email (info@document-center.com).  We work with many companies in the medical device space and have tools available to make your documentation challenges easier.  Make us your Standards Experts!

 

Published by

Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

Leave a Reply

Your email address will not be published. Required fields are marked *