Originally Published MPMN July/August 2007

PRODUCT UPDATE

IV Component Design Focuses on Safety

Safety, convenience, and user-friendly features are top priorities when selecting filters and IV components.

Shana Leonard

Over the past several years, numerous fatalities in hospitals have been attributed to problems or confusion with luer fittings, connectors, and locks. Because of a luer’s ability to connect functionally dissimilar tubes, accidental disconnects have led to lethal reconnects in some instances, according to the Joint Commission’s 2006 Sentinel Alert on tubing misconnections. Noninvasive blood pressure cuffs have been inadvertently connected to IV lines and enteral feeding tubes have been accidentally connected to IV lines, according to “Luer-lock Misconnects Can Be Deadly,” an article for the Center for Devices and Radiological Health. The result of these seemingly minor mishaps? In many cases, death.

In the healthcare setting, countless things can go wrong. Unfortunately, as the misconnection examples demonstrate, simple mistakes can have catastrophic outcomes. The predisposition to user error of some IV components, such as luer connectors, should be a red flag to OEMs and suppliers alike as to the importance of safety and user-friendly features. For filters and IV components, the safer and easier to use, the better—and convenience can’t hurt either.

From the Hospital to the Home

If mix-ups involving IV components by healthcare professionals are cause for concern, the potential damage that could be incurred by a layperson administering IV treatment seems disastrous. And while this scenario may appear unusual, the throngs of baby boomers now hitting their sexagenarian stride could make it the norm.

The sheer volume of aging baby boomers bodes well for OEMs; each of the estimated 78 million people inching toward senior citizen status represents a potential profit. But while OEMs are eagerly prepping for the anticipated baby boomers boon, hospitals are bracing for a significant burden. Increasingly active lifestyles, spikes in diseases such as diabetes, and poor eating habits may contribute to sending this ample aging population to healthcare facilities in droves. In turn, overcrowding and overextended hospital resources are taking shape as worrisome—and likely—consequences.

As a result, a major shift to in-home care and assistance, as well as nursing homes, may be on the horizon, predicts John Leahey, director of medical products for Filtertek Inc. (Hebron, IL; www.filtertek.com). “What we’re seeing now is that products are being made and marketed so the average person can actually do home care themselves,” he says. “Manufacturers are now trying to make things easier for people because you may not have a trained healthcare professional in every instance. In-home medical care warrants more and better safety products.”

More and better safety features on filters and IV components are necessities if home care is popularized in coming years. With patients or their families dealing with IV treatments at home, user error must be reduced or eliminated for these products as the potential for mistakes increases, according to Leahey.

In addition to being safer, filters and IV components now require increased functionality over their predecessors, especially in the face of home care, says Christine Maar, a marketing specialist for Filtertek. She cites such examples as self-priming IV filters and valves capable of stopping flows as improved iterations of products set for use in home care.

Material Consideration

Mounting safety concerns are swaying filter and IV component material selection, too. Among the most noticeable safety-related material trends is a rising demand for DEHP-free tubing and components, according to Joel Bartholomew, manager of OEM product development, B. Braun Medical Inc. (Allentown, PA; www.bbraun.com). “It seems like every new set we do has that requirement,” he muses.

Commonly used as a plasticizer, DEHP has been at the center of controversy since studies indicated that it caused adverse reactions in animals. Despite the lack of findings about the effects of DEHP on humans, some suppliers are turning to DEHP-free materials for such products as IV bags and tubing due to the stigma attached to the questionable compound. Similarly, Dave Splett, business development for Injectech LLC (Loveland, CO; www.injectech.net), has noticed the filter and IV industry adopting the use of animal-free polypropylene since the outbreak of mad cow disease in order to eliminate risk. When it comes to choosing materials for filters and IV components, caution is the priority.

A further safety-induced development in the field is a step toward antimicrobial materials, Splett says. Antimicrobial dressings and coatings have met with positive feedback in the medical market, and Splett predicts that antimicrobial materials for IV components will follow suit in a matter of time. Acting on this hunch, Injectech is currently collaborating with Bayer on its antimicrobial materials. “There are a lot of companies that are introducing it,” he says. “I think once the tubing market really pushes antimicrobial tubes, then it will hit us as a fittings manufacturer.”

The Convenience Factor

IV system OEMs need to incorporate the latest technologies into their devices while emphasizing safety and convenience in their products, says Bartholomew. With this in mind, B. Braun equips its IV pumps with safety features to ensure that the correct drug is delivered to the correct patient at the correct rate, according to Bartholomew. Elements such as bar coding are incorporated into the pumps for tracking purposes and to further safeguard for quality, he adds.

But safety isn’t the only desirable device quality; convenience and ease of use enable safe and effective patient care while making healthcare professionals’ lives a little easier. “With needleless valves or access ports, a lot of people are requiring that they want access ports that are very easy to use, very intuitive, and still meet their performance needs,” Bartholomew says. “Nobody wants to buy those accessories anymore to access an IV set; they want needleless access ports on the sets and ready to go so they can go into the sets with whatever secondary set or whatever device they need to.”

Like B. Braun, Injectech, which specializes in such injection-molded IV components as luers and check valves, is aiming for convenience in its products. Responding to a customer’s suggestion, Injectech recently developed a hydrophobic filter that enables users to replace the filter media rather than having to discard the entire housing. However, if a user wishes to dispose of the filter and housing, Injectech can spin-weld the product shut. The key is convenience.

“Anything that can improve the ease of use, anything that can improve the quality of the product, is what is going to make the industry thrive,” Bartholomew speculates. “We do have the baby boomers coming, there’s going to be some growth. But the companies that are going to survive in that are the ones that have quality products really looking out above all for patient safety. If you can improve patient safety, you can improve the delivery aspects of your device whether through tubing or new component designs.”

Copyright ©2007 Medical Product Manufacturing News