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.
ISO 80369-7 Connectors for Intravascular or Hypodermic Applications
Since the publication of ISO 80369-7 in 2016, Merit has committed substantial resources towards planning and executing a proactive plan for compliance. Merit’s initial timeline for compliance was to transition all affected products to ISO 80369-7 by the end of 2020, ahead of the original October 2021 date recommended by the International Standards Organization. Merit also identified some products as “priority” with a sooner compliance timeline. As Merit has aggressively pursued this compliance project, the current status of the standard has caused Merit to reevaluate the speed that we accomplish this project. Despite the changes to the status of ISO 80369-7:2016, Merit has successfully transitioned some of our priority products to be ISO 80369-7:2016 compliant.
Current Status of ISO 80369-7:2016
Second Edition of ISO 80369-7
Merit Medical has been in direct communication with ISO about the development of the second edition of ISO 80369-7. The second edition of ISO 80369-7 will replace ISO 80369-7:2016. The revisions include minor clarifications and potential changes to some dimensional tolerances that may change Merit’s path to compliance.
FDA Acceptance of ISO 594-1/-2 & ISO 80369-7:2016
In December 2019, the FDA removed the withdrawal date of ISO 594-1/-2, recognizing that the second edition of ISO 80369-7 was still being developed. Having removed this withdrawal date, the FDA announced the continued acceptance of ISO 594-1/-2 and ISO 80369-7:2016 as consensus standards. Once the second edition of ISO 80369-7 is published, the FDA will start a new transition period concluding with a new compliance deadline.
EU Harmonizing ISO 80369
EN 20594 and EN 1707, the EU versions of ISO 594-1/-2, are harmonized to MDD. ISO 80369 is not harmonized to MDD, nor has a timeline been released for harmonizing ISO 80369 to MDR.
