Safeguarding medical device connections

Fluids need to move from point A to point B, and while it’s a simple sounding process, media characteristics, pressure requirements, flow rate, and safety issues can complicate every day fluid handling. An industry-wide push to standardize medical device connector and components will help with patient safety.

Because the connector is usually the user’s primary interface with the device, it plays a key role in overall perception of the design and should be considered in the early design process to fulfill aesthetic goals, product performance, and patient safety.

Historically, the luer was a universal design that provided a connection for many applications. However, with today’s large number of medical tube and connector applications, regulatory and reporting groups such as the Food and Drug Administration (FDA), the Institute for Safe Medication Practices (ISMP), and The Joint Commission (TJC) have reported patient injuries and deaths arising from misconnections.

In response to misconnections, a series of new small-bore medical connector standards are being developed by a work group of the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC). The ISO 80369 series of standards will define non-interchangeable connectors and will impact connector selections for a wide range of medical device applications.

Delving deeper to uncover misconnection solutions, Today’s Medical Developments spoke with Jim Brown, medical business unit manager at Minnesota-based Colder Products Co. – a manufacturer of connectors for plastic tubing.
 

TMD: Is it a problem with the design of luers or tubing that has led to this standard, or is it the universal capability that makes them so efficient that issues arise?

JB: Medical misconnections occur when two incompatible medical devices connect to each other, resulting in the wrong fluid going to the wrong part of the body. This occurs when the tubing on these devices all have the same connector – the standard luer fitting. Because these fittings are simple to manufacture and a defined standard, medical device original equipment manufacturer (OEM) engineers have specified them on many different types of devices.
 

TMD: Is there a central repository to collect data on misconnections?

JB: As of now, no. However, there are several resources for medical device OEM engineers to reach out to in order to better understand what ISO80369 seeks to accomplish, including www.stayconnected.org and the United States FDA Guidance documents for Small Bore Connectors.
 

TMD: How long has this new standard been in the works?

JB: This effort began in Europe in the late 1990s but formally began in 2000 when the European Committee for Standardization (CEN) created the framework for the standards being released today. In 2007, the effort became international when ISO took it on. For over 15 years, an international group of regulators, engineers, and medical device OEMs have worked to improve patient safety through a defined set of medical connectors for different applications, rather than a common connector for all devices around a patient.
 

TMD: California has already passed legislation about connectors for patient safety, can you talk on this topic with how it compares to ISO 80369?

JB: California passed legislation saying devices for vascular access, enteral feeding, and neuraxial application could not cross connect, but did not specifically address the connectors themselves. ISO80369 was already underway when this legislation was passed in California. ISO80369 defines connectors that help device OEMs meet the requirement defined in the legislation.
 

TMD: ISO 80369-1 and ISO 80369-3 legislation has been published. Can you talk about what is contained in these two?

JB: ISO80369-1 defines the overall framework for this work. It includes information about the materials used in small-bore connectors; the requirements for small-bore connectors for specific applications, including breathing systems and driving gases, enteral and gastric, urethral and urinary, limb cuff inflation, neuraxial, and intravascular or hypodermic applications; and mechanical tests for verifying non-interconnectable characteristics. ISO80369-3 defines the connector intended for use in enteral feeding applications.
 

TMD: How will this change the design and manufacturing of medical tubes and connectors?

JB: Rather than simply specifying a luer fitting, medical device OEMs now have multiple connector options, depending on their device. The market understands the issue of medical misconnections, so to meet customer requirements and expectations of regulatory agencies, such as the FDA, OEMs need to address the risk related to misconnections of their device application.
 

TMD: What impact will this have on materials used as well?

JB: The standard defines a minimum stiffness for materials used to minimize the chance that different connectors can’t be forced together. A pliable material deforms easily, allowing it to stretch or compress and fit in or over a variety of different styles. Physically keying designs becomes difficult if rigid or semi rigid materials are not used.

Brown believes that although connectors are sometimes thought to be a minor component of medical equipment, they should not be relegated to an afterthought in the design process. A well-designed connector makes the medical device easy to use and enhances the overall satisfaction with the device.”

Colder Products Co.
www.cpcworldwide.com

About the author: Elizabeth Engler Modic is the editor of TMD and can be reached at emodic@gie.net or 216.393.0264