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FDA Calls for Connector Standardization

Click to view the video on SunTech's Cuff Standardization ProgramTubing misconnections, wrong route errors, catheter misconnections or Luer misconnections: the FDA isn't picky about what you call them – they want them eliminated. Multiple and sometimes fatal connection errors between various medical devices, including blood pressure cuffs, have led to the need for standards designed to eliminate this potential. The intent is to achieve this by designating specific connectors for defined types of devices. Blood pressure cuffs are one of the device groups identified by the FDA for standardization1.

The FDA has asked for help from medical device manufacturers – represented by AAMI – and the international standards group ISO in creating these new standards. Not an easy task by any means, as manufacturers have validated their devices with specific connectors and agreeing to a common design involves compromise from all parties. However, a dedicated group of individuals from an array of companies, countries, and institutions have achieved just that. It's time to provide final feedback and incorporate the changes into medical device design2

Now all we have to do is wait for the end users – health care institutions – to change over all of their internal systems to the designated connectors. Yes, the health care industry acknowledges the need to improve and enhance patient safety in all areas, but they have to prioritize changes that allow them to keep the doors open and provide the means to care for patients. Changes are expensive, requiring both staff time and equipment expenditures, both of which are very limited and controlled. So why make the changes to the standardized small bore connectors a priority?

Simple. Standardizing on connectors saves money. Reducing the number of connectors on BP cuffs means fewer SKUs to order. Eliminating SKUs also means less inventory, less storage space required, and a reduction in time spent on purchasing items. Does this mean giving up flexibility in purchasing? Absolutely not. Since the connectors chosen are designs available to all manufacturers, the hospital or health care system can negotiate with multiple vendors for an item that they know will fit the connections and lines currently in use at their facilities.

Bottom line – we need to help our health care customers connect the lines between these new standards and their operations. Improving patient safety and reducing costs is a win-win situation.





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