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Making the Change: Advancements in Single-Use Tube Connections

Thu, 10/27/2011 - 12:38pm
Chuck Philipp

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Single-use tubing connectors are an important component in a multitude of medical devices and often the primary connection interface between the patient and the healthcare equipment providing the treatment. But as the popularity of single-use tubing sets continues to rise, so does the number of issues that design engineers must overcome in making the connections both easy for end users and safe for their patients.

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While luer connectors provide medical device manufacturers with an inexpensive, reliable solution, Value Plastics’ SBL Series (top connector) and MQC Series (bottom connector) provide end-users with large ergonomic buttons that they can quickly grasp. These fittings help prevent misconnections through their large offering of colors and unique, proprietary designs.

There has been a considerable increase in the popularity of plastic tubing connectors in recent years, particularly across the healthcare spectrum as more medical device manufacturers readily integrate them into patient care products. While tubing connectors are often not a focal point of the system design process, they can be regarded as one of the key components of single-use systems as they represent one of the primary user interfaces. Designers, healthcare providers, and patients can all benefit from single-use fittings that are intuitive, cost effective, and safe to use.

Issues Encountered by Medical Device Manufacturers
Ergonomics and Patient SafetyWhether the nurse or practitioner is just out of school or has years of experience, being responsible for the health of multiple patients while keeping late nights and long hours is a tough job. Now imagine having to put on ill-fitting latex gloves and fumbling with miniature tube fittings that are not only difficult to handle in a cramped area, but if misconnected, can potentially cause harm to patients. End users need tubing connectors that are intuitive and easy to handle, while also alleviating the risk of mating with other fittings that can endanger the well-being of their patients.

ConnectivityOver many years of design and implementation, the simplicity and reliability of the luer connection has triggered its adoption as the primary connector in patient suites. Since there are so many different medical device applications using the luer connector, the risk of misconnection is possible. Design engineers should give serious consideration to what other connectors may be used in nearby applications and how their design may reduce the potential for these issues.

To provide guidance on some of the applications where luers are used, the International Organization for Standardization (ISO), in conjunction with AAMI (Association for the Advancement of Medical Instrumentation), recently formed the ISO 80369 committee dedicated to reducing the risks associated with misconnections. Medical devices that fall within specific applications identified in this standard will have certain connectors specified for use, assuring OEMs that their device cannot be accidentally misconnected to devices within other applications also outlined within the standard. However, these specifications have not yet been fully delineated, currently leaving OEMs to their own strategies to prevent these potential misconnections.

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Due to the expansive use of single-use disposables across the medical device industry, the variation across plastic tubing components has multiplied. Y connectors are just one of many different configurations frequently requested by manufacturers.
Regulatory Compliance—As demonstrated by the emergent ISO 80369 standard, the number and intensity of industry regulations continues to rise. Compliance with legislation such as ROHS and REACH and the need to be free of elements like Bisphenol A (BPA), latex, and phthalates have become common requirements among many medical device manufacturers. This has added to the complexity of component qualification for a number of companies, and acquisition of required documentation can be unduly difficult if not aligned with the appropriate medical component manufacturers. Designers must also consider the material properties of the connector and how they will be sterilized and used to ensure that product performance and safety are not compromised.

Advancements Made
In response to these challenges, tubing connector manufacturers within the healthcare industry have made an effort to make their products more user and application friendly. Improvements seen in recent product launches include the following.

Intuitive and Easy to Use Designs—Single-use technology continues to make notable progress in its evolution, particularly with regard to patient safety and ease of use. Greater attention to how users interact with healthcare instrumentation and the implementation of human factors engineering principles in single-use systems not only improves ergonomics and how users respond to systems, but is greatly helping to drive out risk by simultaneously invoking operational and environmental, or “field,” considerations. Through this kind of innovative design process and by empowering users with intuitive product designs, the advantages of single-use continue to manifest themselves in big and undeniable ways.

One of the many component usability challenges to be considered is that of gloved nurses who must make multiple connections in low-light environments. With human factors engineering, component designers take these common situations into consideration when developing a new connector to offer to the market. For example, new designs such as the Value Plastics MQC, SBL, and BPF Series connectors feature ergonomic shapes and large, accessible buttons that are easy to push to minimize physical effort and discomfort, maximizing efficiency. Adding special gripping or keying features to the fitting design are also elements that can be incorporated to make connections safer and easier. These types of intuitive features give end users greater confidence in the connections they are making, mitigating the challenges incurred as a result of a weak user interface—such as small, poorly placed buttons—in the midst of urgent situations that require quick and instinctual reactions.

Preventing Misconnections—Until the ISO 80369 standards are solidified, tubing connector manufacturers are attempting to provide other ways to reduce the risk of tubing misconnections. One method is to give medical device manufacturers the ability to specify components in unique colors not commonly available in the setting where the device will be used. Mixing unique color combinations into standard resins is very common and easy for most component manufacturers to accomplish.

Another design feature that has gained popularity among tube fitting manufacturers is having a proprietary design with unique or sometimes “keyed” connections. Luer alternatives do not connect with luer fittings, nor do they mate up with other connector designs due to their unique, often patented, connection features. A recent example encompassing the above strategies is Value Plastics’ MQC Series. With a selection of ten different colors and a unique patented design, end users have less to fear with accidental misconnections.

Consumer Research—In order to truly understand how a medical device is used, the manufacturer is strongly benefited by consulting a large number of end users. As a service to the medical device manufacturers, many connector companies do the same and speak with their end users in an attempt to discover anything from behavioral patterns to common frustrations. Ken Davis, marketing manager at Value Plastics states, “We spend a great deal of time looking at how connectors are used, and we use that information to define connectors that meet all aspects of usability while balancing a cost target. Key specifications, such as pressure rates, durability, connection forces, and insertion counts, are balanced against tight cost goals.”

Easily Accessible Material Data—With increasing regulations comes an increased need for information. Online material data and prompt technical support has resulted in a significant trend for more support from medical component manufacturers. Tube connector websites should not only include part drawings but regulatory information, material data, and product change notifications as well. Simplification of the component qualification process through easily accessible information saves time and money in the product development cycle, helping OEMs get consumables to market faster.

Tips for Medical Device Manufacturers
When selecting tubing connectors for a medical device, manufacturers must be assured they are incorporating the latest components available and that the connectors chosen will address their particular needs. Recommended applications and issues to take under consideration are listed in the table.

Conclusion
Medical device OEMs have the ability to choose from a number of plastic tube fitting manufacturers when integrating tubing connectors into their products. Yet when making these critical decisions, designers should be sure to consider how the end user will make connections between the device and the patient and confirm that the connector will provide at least the same level of performance as expected from other aspects of the device design.

Chuck Philipp is vice president of Value Plastics. He is responsible for educating customers on the capabilities and expertise that Value Plastics’ fittings bring to the medical device marketplace. Philipp can be reached at 970-267-5222 or chuckp@valueplastics.com.

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