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ISO 80369: Another one to watch
With all the talk of the MDR and IVDR in the past year, it’s worth noting that many other changes are also afoot in the medical device space. Currently on the books and with a transitionary period due to end on December 31 2019, the ISO 80369 small-bore connector standards, introduced to prevent misconnections, have superceded the existing ISO 594 standards.
Over the years there have been many cases of patient deaths caused by misconnections, when the wrong tubes are connected to the wrong machines. This is because traditional connectors (e.g. intravascular connectors) are very similar and under certain conditions such as fatigue, mistakes are made.
Documented cases have included incidents such as a feeding bag tube being put into a patient’s IV, (described as being like pouring concrete down the drain) resulting in death within hours. In another case, a woman in hospital for routine surgery had her IV mistakenly connected to a blood pressure cuff, pumping air into the vein and killing her instantly with an embolism.
An ISO committee are currently developing ISO 80369 and this includes standards for various sectors of the healthcare industry. As can be seen here:
|ISO 80369-1||General requirements for small bore connectors, which convey liquids or gases in healthcare applications.|
|ISO 80369-2||Breathing systems and driving gases|
|ISO 80369-3||Enteral and gastric|
|ISO 80369-4||Urethral and urinary|
|ISO 80369-5||Limb cuff inflation|
|ISO 80369-6||Neuraxial devices|
|ISO 80369-7||Intravascular (IV) or hypodermic (traditional luer with additional dimensional specifications)|
|ISO 80369-20||Test methods for each application|
ISO 80369-1: General Requirements and Overview
Outlines general requirements for small-bore connectors and the healthcare fields in which these small-bore connectors will be used. Currently, some of the standards are at more advanced stages of development than others.
ISO 80369-2: Respiratory
ISO 80369-2 has been identified by the ISO committee as an area where change will occur for small bore connectors. This will affect connectors for “low-flow equipment” (e.g. anaesthetic and ventilator systems) and connectors for “high-flow equipment” (e.g. flowmeters and nasal cannulae). As mentioned above, these changes are likely to be introduced in the next 3-4 years.
ISO 80369-3: Enteral Feeding
This is the first clinical application to transition to the new connectors. The enteral and gastric connectors are designed to reduce misconnections and in doing so, save lives. The redesign does not allow the male and female connectors under this standard to link with any other connectors from different clinical arenas. They can also lock in place for extra security.
ISO 80369-4: Urinary and Urethral
Primarily includes urinary catheters used in draining the bladder of waste fluid.
ISO 80369-5: Limb Cuff
Limb cuff inflation connectors used in equipment like blood pressure monitors. This standard is currently in the development process.
ISO 80369-6: Neuraxial
Neuraxial connectors are used in devices required for anaesthesia delivery, monitoring/removal of cerebro-spinal fluid, delivery of medications to neuraxial sites and more.
ISO 80369-7: Intravenous
This standard is designed as an update to the current ISO 594-1 and the ISO 594-2 governing intravascular connectors and “hypodermic applications” (formerly described as luers). Changes to the current luer specs are not expected.
ISO 80369-20: Common Test Methods
Due to the similarities of many of the test methods throughout the ISO 80369 series, they have been standardised under this section to avoid duplication.
Of course, each connector itself will have its own unique test requirements. These test methods will be specified in the individual test standards.
It’s still a long way down the road, but just like the changeover to the MDR/IVDR, companies would be best to start preparing now for what will likely be a huge issue in the next 2 years.