Compounding the magnitude of the disaster were the lack of coordination between civil and military authorities, and the incompatibility of the luer and Record connectors used on intravenous catheters by the American military and German paramedics. Largely in response to the Ramstein disaster, the luer style became the global standard and the Record connector fell into disuse. However, a single standard wasn't codified until 1995.
|The Ramstein Airbase 1988. Incompatibility of the luer and Record IV connectors contributed to emergency response complications following the disaster.|
Over the next couple of decades, luers became the standard connector in enteral and gastric, urethral and urinary, limb cuff inflation, and neuraxial device applications. Their ease of use and low cost moved the product from clinical settings to home-based care environments. This continued expansion counter intuitively weakened its foundation as a simple solution for a complex world.
The connections were simple and secure — but also potentially very risky. The European Committee for Standardization (CEN) Report CR 13825 in 2000 stated, “In a coronary care unit there are as many as 40 connectors on the devices used with a single patient.”
With the same connector being used simultaneously in vascular, enteral, respiratory, epidural, and intrathecal applications, the possibility of misconnections between these applications has always existed. The probability of misconnections grows exponentially with increased applications and types of users, and the consequences can be deadly. That's why new standards mandating separate, incompatible connectors for different applications are nearing adoption.
Although hundreds of millions of procedures are performed each year without incident, any misconnections are still far too many. And the widespread use of standard luer connectors is the reason for misconnections. Devices, components, and materials that are used within a specific application will continue to come from different suppliers, so standardization within, but not across, applications will be the best solution.
The process of developing new standards for small-bore connectors began in 1996 when the Association for the Advancement of Medical Instrumentation (AAMI), stated that “enteral feeding tubes should not be Luer Lok compatible.” In 1997 the standard designated BS1060-3 stated “Luers should not be used with NIBP [non-invasive blood pressure] systems.”
AAMI, with a broad range of industry, healthcare organization, FDA and academia participants worked to develop two standards. The first disallows compatibility of enteral and parenteral connectors. Specific dimensions, tests, and acceptance criteria for a new enteral connector were to be expressed in a second standard. AAMI/ANSI ID 54 is still in effect today and recognized by the FDA but without any additional FDA action; no second standard has been developed.
In 2000, CEN BTTF 123 was formed in Europe to address the issue. In 2006 it proposed that a joint working group (JWG) be formed for “the development of standards for small-bore connectors for liquids and gases in healthcare applications under the Vienna agreement with ISO TC 210 administrative lead.” Responsibility was officially moved to ISO TC210 JWG4 in 2007.
JWG4 subsequently released ISO 80369-1:2010, which “provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6% Luer connectors, and all other non-Luer (6%) connectors that will be developed under future parts of this series of standards.”