Amazingly, since the 1990’s the risk of misconnection of fittings for medical device and drug delivery systems has been evident and of great concern to healthcare workers, patients and regulators alike.  However, it was not before 2007 that work finally began on standardizing fittings and connectors for various procedures and applications.   Finally, by the end of 2016, a full gamut of specifications and performance test methods were published by ISO to reduce the risk of misconnecting fitting in procedures. Through the design of connectors for specific procedures and applications, it is now very difficult for healthcare providers to physically connect delivery devices for one procedure to a different one. The updated table below describes the current series of ISO 80369 Series of standards and when they came online:

ISO Standard

Description

Expected Publication Date

ISO 80369-1
  • General requirements for small bore connectors, which convey liquids or gases in healthcare applications.
  • Misconnection test methods
  • Published
  • Second edition Q1 or Q2 2017
ISO 80369-2 Breathing systems and driving gases Project deleted–12-04-2015
ISO 80369-3 Enteral and gastric Published—07-01-2016
ISO 80369-4 Urethral and urinary TBD—not currently active
ISO 80369-5 Limb cuff inflation Published—03-07-2016
ISO 80369-6 Neuraxial devices Published—03-14-2016
ISO 80369-7 Intravascular (IV) or hypodermic (traditional luer with additional dimensional specifications) Published—10-14-2016
ISO 80369-20 Test methods for each application Published—05-11-2016

Much has been written and published on the objectives and intent of this series of standards, and they have no doubt already been widely accepted and used by manufacturers…. both through regulatory mandate (FDA recognized standards) and through good engineering and product development practices. Obviously, the most apparent change in fittings and connector standards is the mere existence of different designs for different applications (ex. Enteral and gastric versus Intravascular).

However, with the publication of the Part 7 standard (ISO 80369-7) for intravascular (IV) it may not be well known that this standard replaces the ISO 594-1 and 594-2 standards. But not to be alarmed…the standards replacement was essential a clerical change with only a few exceptions. Simply put, the ISO 80369-7 standard is a consolidation and technical revision of the ISO 594 standards. The interchangeability of the standards is clearly stated in the Forward of the ISO 80369-7 standard.

Here are some of the details to be recognized:

  1. All existing ISO 594 connectors will be understood to meet the requirements of ISO 80369-7.
  2. ISO 594 gages and reference connectors are identical to ISO 80369-7 gage and connector specifications with a few exceptions:
    • ISO 594-1 gages in Figure 3 were not included in the ISO 80369-7 standard.
    • Reference connectors in ISO 594-1, Figures 4 and 5 have been replaced by reference connector in ISO 80369-7 Figures C.5 and C.2 respectively, whereby the new reference connectors have a longer minimum length than the reference connectors specified in ISO 594-1. However, this is not critical since the reference connectors are used to test non-interconnectivity, and is a test rarely performed.

Whitehouse Labs’ new Drug Delivery System lab is equipped with all the gages and reference connectors required to perform the full gamut of ISO 80369 series of tests.  Stay tuned for more details on the ISO 80369-7 and ISO 80369-20 standards in future blogs.

Sources of Information:

  • Jamie Hartford; “ISO 80369 is Coming-Will you be Ready”, MD&DI; Device Talk, 2-18-2016
  • Ring and Thread Plug Gages website:   http://www.ring-plug-thread-gages.com
  • Clare Naden; “Reducing risk in intravenous delivery is the aim of new standard”, 20 October 2016, https://www.iso.org/news/2016/10/Ref2131.html.
  • Nic Abraham; “Evaluating the Risk of Device Misconnections: Designing for Medical Devices with ISO 80369 in Mind, www.medicaldesignandoutsourcing.com, June 26, 2015