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Industry Insights Article

Major ISO Refit: Costly and Quick

Industry InsightsWe've all heard nightmare stories about mistakes made in hospitals that injure or even kill patients. A new standard for tubing connectors, ISO 80369, will impact medical device manufacturers and design decisions as it reduces the risk of such mistakes. The standard will make it more difficult to misconnect small-bore (8.5 mm or smaller) fittings to the wrong mate, by defining which applications may use luers and which ones must use a different connector set.

The change might not seem like a big deal, but in a modern medical facility, a patient in a hospital bed may be connected to multiple systems handling many different tasks. If the luer fittings from the different systems are in close proximity, there is a chance that a tube could be misconnected. For example, an IV tube might be accidentally mated to a urine catheter, or a tube administering one drug might be confused with another, which would be very dangerous.

Value Plastics is excited and honored to be one of only two connector companies worldwide participating on the ISO committees that are creating this new standard.

Industry InsightsSpecifics of ISO 80369

The ISO 80369 standard comprises seven parts and specifies that luers may not be used in a specific group of markets/applications, except as identified.

Part 1 — which identifies the general requirements for small-bore connectors, will be complete and up for review and vote by member countries before long.

The following six sections identify specific requirements for connectors used for these general applications:

Part 2 — breathing systems and driving gases (respiratory)
Part 3 — enteral feeding
Part 4 — urinary collection
Part 5 — limb cuffs (blood pressure monitoring)
Part 6 — neuraxial (e.g., epidural, catheter)
Part 7 — vascular access (IVs); luers are specifically for this market

Changes ahead
The standard will require major changes on the part of medical device manufacturers. Device makers will have to design instruments using parts that meet the specifications in the new standard, or design their own fittings. In addition, manufacturers might have to retrofit existing devices in the marketplace. That means new designs, new parts, new molding and updating or replacing millions of components.

Value Plastics is actively working on the team developing this standard, and we'll be ready with the connectors that meet the new standards once they are defined and approved.

How soon?
The next full meeting of the standards committee is in October in Seattle. It is difficult to determine when each Part section listed above will be approved; however, the first approved sections could happen as early as 2011. California has already passed legislation requiring manufacturers to be in compliance by 2013 with ISO 80369 for connectors used for enteral feeding, neuraxial and vascular applications.

The concern in the marketplace is that other regulatory agencies and governments will also move to enact similar laws before the standard is even finalized. Value Plastics will provide an update about developments that come out of the October meeting. In the meantime we will also work to keep you up to date on significant developments before then.

The Association for the Advancement of Medical Instruments produced a webinar that covers the key elements of ISO 80369. CD copies of the webinar are available for purchase on the AAMI site: http://www.aami.org/meetings/webinars/2010.80369.html

Our customers are free to call us at any time to get a status update, and we're happy to be a resource for you as you make this transition.

To learn more about the new ISO 80369 standard covering luer fittings in medical devices, contact Value Plastics' Technical Support online at http://www.valueplastics.com/contact/contactUs.aspx or by phone at 970-267-5200 or 888-404-5837.

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