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End-User Woes Spur Development of Hybrid Sterile Packaging

BREAKTHROUGHS

End-User Woes Spur Development of Hybrid Sterile Packaging
Shana Leonard
The Duet pouch is designed using features of both header bags and chevron pouches to facilitate easy access to devices for operating room personnel.

Time is of the essence in an operating room (OR). Wasting precious minutes--or even seconds--fumbling with complicated device packaging can mean the difference between life and death.

These concerns were driven home to Rollprint Packaging Products Inc. when it assembled OR physicians and nurses for a focus group earlier this year dedicated to evaluating current sterile medical packaging. End-users voiced complaints that sterile device packaging often lacks an intuitive design and, consequently, attempting to open such a package incorrectly could compromise device sterility. Moreover, a single opening option is just not enough.

In an effort to directly address these grievances, Rollprint has developed the Duet peelable chevron header pouch. "We sat down and said, 'Why don't we take a look and see how we can develop a package that meets the needs of the operating room professionals but also meets the needs of OEMs in terms of package cost reduction?'" says Craig Livingston, Rollprint vice president of business development.

Borrowing design elements from both header bags and chevron pouches, Duet is engineered to meet those criteria. The hybrid product features one side constructed from a strip of Tyvek that is heat-sealed to a polyester extrusion-coated layer. By incorporating a header design, the pouch requires less Tyvek--and thus costs less--than is used for a typical chevron pouch, according to Livingston.

Three sides of the combination package are heat-sealed to a layer of polyester/poly first, and the top Tyvek section is sealed later, after loading of the device. Extending the polyester extrusion-coated layer slightly beyond the polyester/poly film side creates a dual-chevron opening feature. Multiple access points and a user-friendly design are intended to enable OR staff to get lifesaving devices into the hands of surgeons without packaging-induced delay.

Access tabs at the outer edges of the package also facilitate the opening of 3-D structures such as trays, tubing, and kits without compromising sterility, according to the company. Rollprint also maintains that the aseptic presentation made possible by Duet could eliminate the need for a central supply room wrap, which is often applied to procedural kits and trays.

Duet packaging can withstand EtO and gamma sterilization; however, it cannot undergo steam sterilization methods.

"It seems so simplistic when you sit down and look at it, but it really took us sitting down and meeting with some of the professionals who are using the packaging to really see clearly what their needs and wishes were," Livingston says. "I think that this [product] in some cases fulfills that."

Rollprint Packaging Products Inc., Addison, IL
www.rollprint.com

Copyright ©2007 Medical Product Manufacturing News
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