Introduction - What is ISO 80369, and How Does It Affect You
-U.S. Food and Drug Administration

Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems. These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care.

Unfortunately, because Luer connectors are ubiquitous, easy-to-use and compatible between different delivery systems, clinicians can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Such errors have occurred in diverse clinical settings, causing serious patient injuries and deaths. The Food and Drug Administration (FDA), The Joint Commission (TJC), the Institute for Safe Medication Practices (ISMP), the United States Pharmacopeia (USP), the ECRI Institute and others have all received reports of misconnection errors. The problem is well-known and well documented. Yet despite efforts on the part of FDA and other organizations to reduce misconnections through education, protocol and monitoring, the use of Luer connectors in incompatible medical delivery systems continues to create situations where dangerous misconnections can, and do, occur.

To further reduce the occurrence of these misconnections, FDA is actively participating in an international effort to develop and implement standards for noninterchangeable connectors for small bore medical connectors. A joint working group established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) leads this effort to develop a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, these connectors will facilitate correct connections and eliminate incompatible tubing misconnections.

Until standards are completed and manufacturers design and produce products that can’t be misconnected, all interested parties must continue their efforts to keep these dangerous misconnections from happening. "Actions must be taken at the patient bedside, within all levels of health care organizations and throughout the channels of regulation, manufacturing and distribution of these devices in order to eradicate the serious problem of tubing misconnections," said Peter B. Angood, M.D., Vice President and Chief Patient Safety Officer for The Joint Commission (TJC).

"The information is solely provided by Value Plastics based on participation in the standards committees. These notes have not been endorsed or approved by AAMI or ISO, and should not be used to make specific business decisions."

May 2011 Update

The joint working group, and four of the standards committees met in Washington DC during the week of May 16-20, to make progress on defining the connector standards for each market specific segment. Here is a summary of the meeting:

Joint Working Group meeting – Initially, all the standards members met as a join group to discuss items that should be discussed in a group setting. The group reviewed the progress of the CAD Task Force. A CAD library has been established so each group has access to the other groups designs. The CAD experts are utilizing a macro driven spreadsheet to conduct initial screenings for misconnections followed by detailed 3D analysis of possible misconnections.

The group also decided that PG 7 must thoroughly define all undefined dimensions of luer connectors in order for the other groups to avoid possible misconnections when finalizing their own designs.

PG3, Enteral committee: To improve on the committees progress, attendees to the committee meeting were narrowed to a few delegates from each region of the world. With a smaller group of people, this committee spent the meeting focused on more definition of the proposed connectors. At the nutrition source, three connector options remain in the standard. These connector designs have been proposed with dimensional details, but are still in review by the committee, and are not available to the general market. The Enteral committee is seeking to have one connector design for the patient connection, but this design is not yet finalized.

PG5, Limb Cuff committee: There continues to be three connector sets in the standard, as described previously. Further evaluation will be necessary to confirm that each of the connectors defined do not mate with a luer. This group defined those dimensions that were previously undefined and specified and area on each of the connector designs to accommodate the elastomeric seal.

PG6, Neuraxial committee: There are three different connector sets proposed for this standard. Further discussion and evaluation will be necessary to confirm that these connectors do not mate with luers or other connector sets proposed in other committees.

PG7, Vascular access committee: This group resolved to define in the standard all the relevant dimensions that exist today so that the remaining PG’s can avoid misconnections. Toward this end much discussion took place regarding which dimensions are controlled by the standard and which are not. Finally, the group defined most of the undefined dimensions by ranging the dimensions to those in the marketplace today. The group agreed to survey manufacturers with the intent to narrow the range on the internal diameter of the male luer and the external diameter of the male luer collar.

CAD group meeting: The CAD experts for each committee continue to meet and evaluate proposed connector designs to ensure that the proposed designs do not mate with luers, and will not mate with proposed designs from other standards committees. This work is ongoing, as connector designs in the committees are adjusted and changed.

Joint Working Group meeting: At the end of the week, the joint working group members met again to review progress and discuss next steps. Much of the discussion centered on usability testing, which will be necessary to be completed, once each connector design is completed. It will be important to evaluate these new connectors in each standard to make sure that device performance and usability are not compromised in a real clinical setting.

Note: The PG2 Respiratory standards committee did not meet. Two connector designs are still proposed, as described previously. The PG4 Urinary standards committee has not begun to meet yet, and there is no timetable for this committee to begin meeting.

April 2011 Update:

The initial governing document for small bore connectors has been finalized and is available on the AAMI website. http://www.aami.org/publications/aaminews/Jan2011/80369.html

As explained separately on this site, the 80369-1 document identifies the market categories that should attempt to use connectors that will not mate with a luer connector. The standards for these markets will be provided in separate ISO80369 documents numbered from -2 to -7. These documents are still in process and are being actively developed by separate committees. The 80369-1 document is broken down into the following sections:

1. Scope of the document
2. References
3. Terms and definitions
4. Types of materials used in small bore connectors
5. Requirements, including a description of each market application covered
6. Additional applications, alternate design allowance
7. Procedure to assess a new design, including review, verification and validation

• Annex A – Rationale for the standard
• Annex B – Mechanical tests for verification of a design
• Annex C – Applications covered by the standard and subsequent standards
• Annex D – References

Value Plastics, A Nordson Company is not aware of a specific timetable with regards to an expectation of adherence to any 80369 standard. However, some regulatory agencies may evaluate future connector designs in specified markets as to whether the design interconnects with a luer. Specific standards for connectors in markets listed in 80369-1 have not been completed.

A separate computer aided design (CAD) committee has been formed as a part of the process of developing the individual connector standards to analyze proposed standard connectors for possible connection to a luer, and also to connectors defined in 80369 parts 2 to 6. Connector usability evaluations are also under consideration.

Each separate market standards committee continues to work toward adopting standard connector specifications as described in the Seattle meeting overview below. These committees were scheduled to meet in Tokyo, the week of April 10th, however the tragic events in Japan caused the cancellation of this meeting. The meeting has been rescheduled for the week of May 16 in Silver Spring, MD.

Value Plastics continues to be an active member of the 80369 committees.

February 2011 Update:

As described further below, an outcome of the October meetings was to revise the standard and send it back out for the next round in the review process. This is being done by several different committees:

ISO/IEC JWG4/PG2 - Breathing Systems and Driving Gases: Final revisions are being made to the standard and drawings of the connectors proposed. A new draft standard will go out for circulation, likely before the end of February.

ISO/IEC JWG4/PG3 – Enteral Feeding: Final revisions are being made to the standard and drawings of the connectors proposed. A new draft standard will go out for circulation, within the next two months.

ISO/IEC JWG4/PG5 – Limb Cuffs: A revised standard is in circulation with comments due by February 15.

ISO/IEC JWG4/PG6 – Neuraxial: Final revisions are being made to the standard and drawings of the connectors proposed. A new draft standard will go out for circulation, but a timeframe was not available.

ISO/IEC JWG4/PG7 – Vascular Access: A revised standard is in circulation with comments due by February 15.

In addition, a committee has been formed and is meeting to analyze the potential interconnections between the proposed connectors in each committee standard. This is to ensure that there are no potential mating issues between the connectors that are approved. Value Plastics is an active participant in this committee and has completed a model to show these connections. Further meetings are taking place and revisions to some connectors within the standards above are possible.

October 6-14, 2010 - ISO Standards Meeting Summary

The ISO Standards committees met in Seattle, Washington, October 6-14 to review and set the connector standards for specific markets. In attendance representing Value Plastics were Chuck Philipp (Vice President, Business Development) and Bruce Williams (CEO). The major outcome of this meeting was that the initial Part 1 document (ISODIS 80369-1) was completed and will be sent out for vote in the next couple of months. Besides completing the Part 1 document, sub-committees (Sub-Parts 2, 3, 5, 6 & 7) met to attempt to define connectors for the markets identified in the Part 1 document.

This standard is truly a worldwide document with representation by consultants and manufacturers in Europe, North America, Asia Pacific and South America. The next official meeting will be in Silver Springs, Maryland May 16-20, 2011. Some of the sub-committees may meet prior to the April meeting, to move their standards forward.

A summary of the current status of the standards is listed below.

ISODIS 80369-1 - Governing Standard for sub-parts

• Part 1 standard that specifies that Luers may not be used in specific medical markets, with the exception of PG 7 (Vascular/IV):
  • Breathing systems and driving gases (ISO/IEC JWG4/PG2)
  • Enteral feeding (ISO/IEC JWG4/PG3)
  • Urinary collection (ISO/IEC JWG4/PG4) - did not meet in Seattle.
  • Limb Cuffs, blood pressure (ISO/IEC JWG4 PG 5)
  • Neuraxial (ISO/IEC JWG4 PG 6)
  • Vascular access, intravenous (ISO/IEC JWG4 PG 7) - will use Luers

• Each of the above markets will specify approved connectors for this market. Manufacturers may use the approved connectors, or design their own custom. Custom connectors may not mate with luer connectors, or with the specified standard connector set(s) that will be approved for the markets listed above.
• During the meeting in Seattle, the following items were discussed:
  • That an oversight committee (comprised of PG leaders) be appointed to review high level issues that may arise and that they create an implementation guide.
  • That a task group be established to provide the identified critical dimensions to develop a single CAD analysis and establish a document control structure and ensure consistency in tables and figures between each connector specification.
  • That a joint task group be established between PG3 and PG6 to come to a decision on critical dimensions causing potential inter-connectability and the outcomes be reported to the oversight committee
  • That a task group be established to formulate a protocol to meet the requirements of ISO 80369-1 Section 7.3.4
  • That the 3D solid model designs that are contained in the published standards be placed in a repository where they are made commercially available
  • That at the JWG4 meetings, the PG conveners give a brief update on timelines of the systematic review of their respective ISO 80369 part
• This document is in distribution to members as an FDIS.
• It is important to note that if this standard passes, it does NOT mean that luers can no longer be used in the referenced markets. Until connectors are defined and approved for each market, no definitive action can be taken. Some companies may attempt to design a unique connector instead (as defined in the -1 standard), however, this connector shall not mate with the standard connectors, as yet to be approved, for the other markets. See details below, with regards to the progress in each market standard.

ISO/IEC JWG4/PG2 - Breathing Systems and Driving Gases;

• Since the meeting in Paris, earlier this year, the committee chair completed a table in the standard which identifies approximately 60 unique connection applications. This was important to confirm that two connector sets would be appropriate to handle the majority of these connections.
  • Two initial connector sets are proposed. Both of these connectors are based on the 6% taper seal, but the diameters are larger than a luer and therefore will not connect to a luer.:
  • RESP-125 for pressures less then 15kPa, Value Plastics, TSC2 connector set
  • RESP-6000 for pressures between 15kPa and 600 kPa, Value Plastics, Large Bore connector set
  • Value Plastics has agreed to offer these connectors for this standard, and therefore, drawings and dimensions for these connectors are provided in detail in the draft standard, for other companies to use.
• There was significant discussion about the two connector sets:
  • RESP-125 - two changes are requested by the committee: 1) increase the bore size slightly to remove any potential to force the male luer bore to mate with a female standard luer 2) reduce the dead space when the connectors are mated, so that the space in the cavity between the end of the male bore and the end of the female bore is no more than 25% greater than the current luer connectors. Value Plastics will review these changes and update accordingly.;
  • RESP-6000 - Value Plastics has corrected the drawing specification and all dimensions should now be correct. No further changes were requested for these parts.
• The performance requirements were reviewed to make sure that these requirements are correct. A few minor changes will be made.;
• The table with the unique connections described was reviewed for correctness. There will be some changes made to the table and columns that define each connection. A recommendation on which connector set to use will also be added, as a column.
• Value Plastics will update drawings and also attempt to complete Annex E of the document which provides design verification and validation versus the test requirements and specifications.
• This sub-part will be revised and sent out for the next round of review prior to the meeting in Maryland;

ISO/IEC JWG4/PG3 - Enteral Feeding

• A draft of the connector standard has been completed and posted on the AAMI website for initial review;
• The standards committee determined that there needs to be two connections that must not mate with luer connectors:
  • Feeding source - whether this is a bag or a bottle, the tubing connection at the feeding source must be unique and may not mate with a luer;
  • Patient connection - the connection from tubing to patient must be unique and may not mate with a luer;
• Three unique connectors were proposed for the connection at the Feeding source. This includes a bag/bottle port and a unique connector that mates with this port. Consideration must be given to filling the bag/bottle at the port in production. The three unique connections included one from Japan, and two separate connections for the majority of other countries. It was the feeling of the standards committee that all three connections will be a part of the standard, and manufacturers may then choose which one they want to use in their products.
• Two unique connectors were proposed for the Patient connection. The desire of the committee is to narrow the options to one unique connector, but two connector sets may remain in the standards document when it is sent out for the next review.
• It is recognized by the standards committee that the new law in California, goes into effect 2013, which states that luers may not be used in enteral feeding applications in the state. It was the feeling of some of the manufacturers within the committee that there is very little time left to choose connector standards and make all the necessary changes to meet this date.
• A new draft for this connector standard will be completed and circulated for comment.

ISO/IEC JWG4/PG4 - Urinary products

• This sub-part committee did not meet in Seattle;
• It is not certain when this committee will meet or work on a standard set of connectors for this market.
• It is possible that a standard for this market will be significantly delayed, as it is considered less risk for harm in misconnection, than other markets.

ISO/IEC JWG4 PG 5 - Limb Cuffs (blood pressure);

• The majority of healthcare in this market has already moved away from Luers;
• Connector designs proposed continue to be:
  • Bayonet style connections
  • Quarter turn connector, currently with a male part with an o-ring and female connection that turns and snaps into place with male part;
  • Threaded connection;
• Another connector set may be proposed for neo-natal. Philips has a design on the market that they will offer to the standard.
• The committee discussed user needs at length to compare to connectors proposed;
• This standard will incorporate the current connector designs on the market, as listed above, and then be sent out for comment and vote;

ISO/IEC JWG4 PG 6 - Neuraxial

• Reviewed proposed connector designs (two) but have not selected the final design yet;
• Further work on the standard and proposed connectors is required;
• This sub-part will be sent out for comment and vote in a few months;
• Similar to Enteral, this market has the law in California that connections may not be luers in 2013.

ISO/IEC JWG4 PG 7 - Vascular Access (IV fluids);

• This market will review, make necessary changes and finalize a new luer standard as the standard connector set;
• Listed critical dimensions in ISO 594 that need to be revisited and updated to make current;
  • Developing a work list and priority list for moving forward
  • Review different requirements of semi-rigid vs. rigid materials
  • Apparently semi-rigid materials don’t have to meet the dimensional requirements; instead, they only have to meet the functional testing requirements
• Development of an editing committee
• "User Profile" for luer connectors
• PG7 is going to submit a NWIP to combine 594-1 & 594-2 into 80369-7
  • Working draft created by Terumo that combined the two will be attached
  • The two parts (slip & lock) will be addressed as separate features
  • The group wants to get it out and voted on before the April meetings
• Proposed Critical Luer Dimensions
  • Lumen Diameter
    • 2.95mm (.116") maximum
• Taper Length
  • Male
    • 7.5mm (.295") minimum
    • 9.0mm (.354") maximum
  • Female
    • 7.5mm (.295") minimum
    • 9.0mm (.354") maximum
• Outer Diameter of Collar
  • 9.0mm (.354") minimum
• The above proposed changes may affect current luers that are on the market, and place many of these luers outside the dimensions of this new standard.

General Opinion from this Meeting

• Most of the standards committees have significant work left to do to finalize connectors for their given market;
• There remains the potential that connectors defined in different committees may mate to each other. A separate independent analysis will have to be done to check all connections proposed with solid models and user tests.
• Usability testing needs to be completed by each committee before the connectors in the standard can be finalized. It is unclear how this testing will be done and who will pay for it.
• The law passed in California means there is only about 2 years left for Enteral and Neuraxial to get their connector standards approved and products incorporating these connectors completed. This may not be enough time.
• Process to approve a standard includes: 1) completing a CD and sending out for review and feedback; 2) addressing and incorporating feedback, in committee. Conduct usability testing with actual molded connectors; 3) send another revision out as a DIS for final review and vote; 4) if approved, submit the standard to the members as an FDIS. 5) Finally, send the standard to ISO for review and approval; Each of these steps takes considerable time for review, comment and incorporation into the final standard. The above steps likely take 12 to 18 months, if not longer.
• Implementation of a connector set (or multiple sets) will be difficult and take significant time. The full joint working group will need to meet and determine how to implement these new standards, taking into account that luer connections are in thousands of different products throughout the world.
• The FDA continues to provide good feedback and support, in addition to being a co-chair to the overall standards group.

Previously Published Information on ISO 80369

From Value Plastics

ISO 80369 - It's Coming to a Device Maker Near You - March 3, 2009 - Value Plastics Newsletter

Major ISO Refit: Costly and Quick - April, 2010 - Value Plastics Newsletter

Act Now to Avoid the Tangles Later - June, 2010 - Value Plastics Article

External Resources

JCAHO Sentinal Alert 36 - April 3, 2006

2009 FDA Calendar of Misconnection Hazards

Thinking Outside the Tube - June 28, 2010 - Cheryl Powell, Beacon Journal medical writer

FDA-Enteral Feeding Tube Letter - July 9, 2010 - Sent to Manufacturers of Enteral Feeding Tubes, Healthcare Professionals, and Hospital Purchasing Departments

Association for the Advancement of Medical Instruments (AAMI) Webinar

Small-Bore Connectors Find Their Perfect Mates - April 27, 2011 - Shana Leonard, MPMN writer

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