Why is the luer standard changing?
“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.”
Peter B. Angood, M.D., Vice President & Chief Patient Safety Officer for The Joint Commission of the FDA.
FDA has participated in an international effort to develop and implement standards for non interchangeable connectors for small bore medical connections. The International Organization for Standardization (ISO) has developed a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, ISO 80369 removes the ability to make inappropriate connections or misconnections in a clinical setting through non-compatible luer connection groups called out in ISO 80369.
Merit’s Plan to Meet the New Requirements
|New with ISO 80369-7||Merit’s Plan to Meet the New Requirements|
|Additional functional testing requirements regarding the elasticity of the material||The new functional testing requirements regarding the luer connection material are being addressed for each resin type.|
|New Dimensional Requirements Include:
|Conditioning prior to functional and dimensional testing is required||Merit will conduct dimensional and functional testing at T=0 and T=life of the product.|
|Inner lumens CANNOT EXCEED 8.3F or 0.114” and be compliant to 80369-7||
ISO 594 to ISO 80369-7:2016
The description below is a basic overview of some dimensional requirements for ISO 80369-7 compared to the previous luer standard ISO 594. This information is describing some changes Merit will make to our luer connection to become compliant. For a full description of this new standard Merit recommends visiting the ISO website. https://www.iso.org/standard/58011.html
In general, Merit will review and update our male luer lock connection to include the tightened tolerances and dimensional requirements specified in the standard. Here are some examples of those updates and requirements.
Some of Merit’s products feature a male luer designed with a chamfer to the inner dimension of the luer as shown below. This chamfer will be removed to allow the affected components to be compliant to 80369-7.
A number of Merit’s female luer lock connections were originally designed with a ANSI style thread, that will be modified to the new ISO 80369-7 style thread as shown below.
Working Towards Compliance
Despite the current status of ISO 80369-7, Merit continues to work on transitioning more of our priority products to be ISO 80369-7:2016 compliant.