Value Plastics has set up an online resource to help keep medical device OEMs informed of the changes and updates to the ISO 80369 standard. The manufacturer of plastic tube fittings is one of only a few connector companies worldwide actively participating on ISO 80369 committees.

According to the company, while connectors may have once been one of the most overlooked components of a medical device, the number of patient injuries associated with medical tubing misconnections has caught the attention of the International Standards Organization (ISO),” says the company. In conjunction with a number of other driving forces (AAMI, FDA, EN, JCAHO, WHO, and even states such as California), ISO has deemed it necessary to develop standards intended to reduce future tubing misconnections in healthcare/hospital environments.

“Compliance with the ISO 80369 standard may require major changes on the part of medical device manufacturers. They may have to design their instruments using tubing connectors that comply with the new standards, and manufacturers may have to retrofit existing devices in the marketplace,” says Chuck Philipp, Value Plastics’ vice president of business development, and active ISO 80369 participant. “In the next few years, if these standards are approved it could mean new designs, new parts, new moldings and updating or replacing millions of components,” he says.  

To read the latest updates, subscribe to alerts, and view related resources, go to the company’s online resource.

Value Plastics, Inc makes and markets fluid management components designed specifically for flexible tubing. Products designed and manufactured include quick connect fittings, luer fittings, check valves, tube-to-tube fittings, threaded fittings, and blood pressure monitoring components. Value Plastics products find global application in demanding healthcare OEM, research, and specialty industrial applications.