Hokanson whose range of vascular instruments, cuffs and accessories are distributed in the UK and Ireland by PMS Instruments recently announced some changes to their cuffs. All cuffs manufactured after 31st August 2017 will now be supplied with male bayonet connectors.
Hokanson vascular cuffs have been the standard in vascular laboratories and clinics throughout the world for over 40 years and as they have been using “leur” type connectors for many years why the change now?
As ever the idea is to make medical devices safer and in the case of “small bore connectors” which includes blood pressure and vascular cuffs minimize medical device tubing misconnections.
Small-bore connectors are parts used to connect medical devices such as tubing, syringes, IV lines and other accessories that deliver fluids and gases for patient care. Although thankfully rare, tubes using standard luer connectors but with different functions have in the past been mismatched and connected incorrectly.
In the USA the FDA provide several examples of this happening on their website including the case of a blood pressure cuff which was accidentally connected to an IV catheter.
The FDA, and the International Organization for Standardization (ISO), decided to take action and IEC 80369-5:2016 was published in March 2016 to provide specifications for the small-bore connectors used with blood pressure cuffs. Hokanson have standardised on a male bayonet connector.
The following cuffs will be affected.
Hokanson UDC/UPC cuffs, the DP and SC cuffs that currently come with a Luer connector will be changed to a bayonet connector. This includes the SC10, SC12, TMC7 and SC5.
Hokanson cuffs with D rapid version hoses (SC12D, SC12LD, etc.) will remain unchanged. CC thigh cuffs will come with the bayonet connectors, and that connector can be cut off for use with an E20 rapid cuff inflator Y-connector (as with the Luer).
We will be providing Permanent Conversion Kits as well as Adaptor Kits to ensure compatibility and allow you to use legacy leur connector cuffs. Conversion kits are for permanent conversion of cuffs already being used that will change them to the new standard bayonet connector. Adapter kits are for customers who want to use both Luer and bayonet connectors, until all cuffs in use have bayonet connectors.
There is no requirement requiring customers to remove or stop using products currently in use from the market.