No More Tragedies: An Introduction to ISO 80369

That’s what happened to Robin Rogers in 2006.

According to the New York Times, a hospital nurse caring for Rogers during her final weeks of pregnancy inadvertently connected a feeding tube with liquid nutrients to an IV in Rogers’ arm. The Times noted, “Putting such food directly into the bloodstream is like pouring concrete down a drain.” She died shortly after.

Today, a new industry-wide standard defined as ISO 80369 is under development to help eliminate these heartbreaking tragedies. Once completed in the coming years, the international ISO 80369 standard will provide strict guidelines for manufacturers to produce non-interchangeable connectors that only can be used between devices intended for the same clinical application. As the Times noted, the non-interchangeable connectors will be made incompatible “just asdifferent nozzles at gas stations prevent drivers from using the wrong fuel.”

The products at the core of ISO 80369 are small-bore luer connectors (less than 8.5 mm in diameter) that hospital personnel use to link, for example, a medicine bag to an IV. The male and female components of luer connectors join together to create secure, yet detachable, leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Although tiny, these inexpensive connectors play an extremely critical role in any medical device.

ISO 80369 is a package consisting of seven sections of standards. The first section, titled “General Requirements” is the initial governing document that was finalized in April this year. Six additional sections—each meticulously focusing on tube connectors for a specific clinical application and market—must be in place in thecoming years.

The General Requirements document identifies the six market categories, and specifies general design and dimension requirements for connectors that conveyliquids or gases in the specific six healthcare applications. More specifically, ISO 80369-1 provides methodologies manufacturers can use to assess the characteristics of non-interchangeable connectors.

The ISO 80369 Committee

Top-level executives of companies that manufacture tube connectors are committed to creating the safest standards possible. In fact, these executives play an integral role on a joint committee established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) to develop the important standards.

Other participants on the 100-member ISO 80369 committee include well-regarded experts from hospital organizations and industry regulators. This dedicated, focused committee—whose members come from Europe, North America, Asia-Pacific and South America—gather to discuss and develop stringent tube design standards that will reduce the risk for potentially tragic misconnections or tube mix-ups by hospital personnel to happen.

The committee established separate, smaller ISO 80369 workgroups that are developing six written standards for specific healthcare applications or markets (see sections 2-7 below).
The groups are crafting draft recommendations for each that then will carefully be reviewed by the entire committee and other experts:

• ISO 80369-1: General requirements(completed 2011);

• ISO 80369-2: Driving gases and breathing system ancillary ports;

• ISO 80369-3: Enteral feeding;

• ISO 80369-4: Urological;

• ISO 80369-5: Limb cuffs;

• ISO 80369-6: Neuraxial; and

• ISO 80369-7: Luer fittings(will replace ISO 594).

Impact of ISO 80369 on Medical Device Manufacturers

For companies that manufacture such medical devices as blood pressure cuffs, catheters, IVs and ports, compliance with ISO 80369 likely will require changes to their product designs to support connectors that meet the new internationalstandards. In addition, the manufacturers may need to retrofit existing devices. In short, the impact of the new tubing connector standards on medical device manufacturers could be new product designs, new parts, new moldings, and updating orreplacing millions of components.

The ISO 80369 Journey

A Chinese proverb summarizes the unending determination of the ISO committee and workgroups over the course of the past five years:

“To get through the hardest journey, we need take only one step at a time. But we must keep on stepping.”

This hardworking group has remained steadfast in its resolve to undertake each action with vigilance. Every individual knows he or she bears a tremendous responsibility—to ensure patient safety for years to come. Closely analyzing each recommendation, debating and re-debating design specifications and more make this an arduous process.

Yes, the ideal would be to quickly implement standards. But because of the vast number of medical devices—many used in multiple ways—and accompanying tube connectors, it is imperative that the committee continue to take the one-step-at-a-time approach to ensure a positive outcome in the long-term.

The ISO 80369 journey began when an ad hoc group of ISO-related experts met in Paris, France, and agreed that ISO standards specific to luer connectors used in six healthcare applications must be developed. Before that first meeting, several alerts from government and healthcare agencies had been issued to hospitals, while news organizations ran stories about patients who were injured or who had died as aresult of tube misconnections. In October 2010, the ISO Standards committee met in Seattle, Wash., to review and morethoroughly outline connector standards for specific markets.

By February this year, proposed standards for six of the seven different sections were disseminated to the entire committee for careful review. In April, ISO 80369-1—General Requirements—was finalized, while work continued on the remaining six sections. In May, four of the market standards workgroups are meeting in Maryland to continue to discuss—and come closer to adopting—standard connector specifications for their fourrespective applications.

The ISO 80369 committee has made tremendous progress. As the standards are universally adopted, tube misconnection tragedies such as the accident that took the life of Robin Rogers, likely will be eliminated.

Laura Dowling is a freelance writer who has written articles about the biotech, healthcare, and medical device industries for 20 years. Value Plastics Inc. is proud to be a part of the concerned global team developing these strict, detailed connection-device standards. The company manufactures complete lines of quick connect fittings, luer fittings, check valves, tube-to-tube fittings, threaded fittings and blood pressure monitoring components. Several Value Plastics officials are members of the ISO 80369 committee—specifically the limb cuff and luer fitting workgroups. For more information, call (888) 404-5837 or visit www.valueplastics.com.

Editor’s note: To stay current on the progress of ISO 80369, its most up-to-date iterations and how they impact medical device manufacturers, please keep an eye out for periodic installments of this column.