Tag: Small-bore connectors for liquids and gases in healthcare applications

What ever happened to ISO 594?

In any industry, standards that have been in place for many years sometimes get replaced by entirely new documents as technology or requirements change.  That’s the case with the ISO 594 series on Luer Connectors for Medical Devices.  Over the years, industry realized that existing standards were not meeting current risk management benchmarks.  So the ISO 80369 standards (ISO 80369-7 specifically) for small-bore connectors for liquids and gases in healthcare applications are being developed.  Let’s take a look at the new documents and discuss the rationale for the new publications.

Medical Device manufacturers and health care professionals have committed to the principles of identifying hazards and risks posed by both intended use and foreseeable misuse, and to eliminate or reduce such risks by safe design and construction.  So for small bore connectors used in healthcare, the ISO 80369 provides guidance using this new concept.

The overview standard, ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements, replaces the EN 15546-1.  It contains general requirements to be used with the other parts.  It explains that the series is being produced to avoid mis-connection between small bore connectors used in different applications.  In the introduction, the committee points out that in some coronary care units, there can be as many as 40 luer connections used on medical devices for just 1 patient!  No wonder the industry decided to find a systemic solution for the problem.

It is the intention of the joint working group that has oversight of these publications to deliver a total of 8 standards for the series.  So far an additional 4 have been released. Let’s take a look.

ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications.  This publication was developed to help avoid catastrophic mistakes involving either medication errors into the alimentary canal, or administration of enteral solutions via incorrect routes.  There was no previous standard on this.

ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications.  Issued for similar reasons to the Part 3 — With the errors involving vincristine in this case.

ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications.  This is the part of the series that specifically replaces both the ISO 574-1 and the ISO 574-2.  The material in the older standards is consolidated and technically revised.  There are 4 major technical updates identified by the authoring committee:

  • New terms and definitions better define various luer connections,
  • Requirements are included for new dimensions, developed specifically to reduce the mis-connection risks the series aims to mitigate,
  • Older gauging requirements have been replaced by dimensional ones.  Again, this results in more precision (necessary for risk reduction), and
  • Division of requirements for semi-rigid material connectors and those made from rigid materials is now part of the standard.

The more rigorous design requirements are specifically included to make sure that the increased number of connectors, each for a specific use, cannot mate incorrectly.   And these new specifications will also insure that correct connections will be safe and secure.

ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods.  This was the second standard in the series to be issued.  It specifies the test methods you should use in order to evaluate the performance of any ISO 80369 connectors.  Validating performance through the use of appropriate test methods is essential to confirming your design choices.  Failure to do so may result in non-conformance, which in the case of these connectors can lead to catastrophic results.

What other standards are expected in this series?  Here are the Parts which are not completed at this time:

Part 2:  Connectors for breathing systems and driving gases applications

Part 4:  Connectors for urethral and urinary applications

Part 5:  Connectors for limb cuff inflation applications

If you need one or more of these standards, please head to the Document Center Inc. webstore at www.document-center.com.  You’ll be able to search and order from our catalog of over 1 million publications.  Many obsolete editions are available should you need to reference a historical document.

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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!