Studying Pouch Size and Contamination

A first concern of nurses is avoiding contaminating the inside of sterile packaging when devices are flipped to a sterile field or handed off to the scrub nurse. At the Healthcare Packaging Immersion Experience (www.msu.edu/~hcpie/) organized by Michigan State University and Oliver-Tolas Healthcare Packaging, Tony Trier, a masters degree candidate at the Michigan State University School of Packaging, presented a study on the effect of pouch size on device contamination and nurses’ hand repositioning when opening a pouch.
 
“The interface between people and packaging is not just an issue of convenience but an integrated part of patient care. In this study, we wanted to observe peoples’ interaction with the pouch, and see if pouch width affects the aseptic presentation,” said Trier, who studies under MSU associate professor Dr. Laura Bix. (Bix is also on PMP News’s editorial advisory board.)
“The nurses were very excited about this when we were recruiting for the study,” Trier added.
 
Few studies have been done on the impact of packaging on nosocomial or hospital acquired infections (HAIs), Trier said.
 
While standard practices prevail at the local or hospital level, there are no overarching universal guidelines for nurses to follow. AORN standards and recommended practices caution against flipping the device as it may puncture the sterile drape or get tossed off the field. Devices should rather be handed to a scrub nurse. A heavily cited recommendation within AORN’s recommended practice for presentation is defined by D.M. Fogg in Alexander’s Care of Patient In Surgery. Fogg defines the line of demarcation in the aseptic opening of packages as the inner part of the seal beyond which is it considered non-sterile, Trier described.
 
The Association of Surgical Technologists says that tossing to the field from a 12-in. distance is acceptable. AST says the device should be balanced within the pack when presenting to avoid contaminated edges.
 
In Trier’s study, 97 practitioners, predominately nurses and surgical technicians, were digitally recorded aseptically presenting tongue depressors to a drape representing a sterile field. Depressors were packaged in small (3 × 5 inch), medium (10 × 9⅝), and large (16 × 10½) Chevron pouches.
 
Glitterbug lotion (Brevis Corp.), commonly used by infection control experts to teach proper hand washing techniques, was used to simulate contamination. The lotion, which fluoresces under black light, was applied to the surface of the gloves except thumb and forefinger areas where the pouch is gripped. Both sides of the pouches were covered except the uppermost portion where the pouch was gripped for opening.
 
The investigation monitored the participants’ hand motions and the transfer of the potion to the tongue depressors, illuminated with the application of a Brevis Corp. glow bar.
Depressors were shown to be marked with the potion in 11.5% of 583 trials performed, with the majority of contaminated product coming from large pouches. Of 65 incidents of contamination, product in large pouches occurred 32 times, medium bags 19 times, small pouches, 14.
 
The results seem to suggest that large pouches may be harder to handle, with an opportunity for package design improvements. But Trier says there is more work to be done.
 
“This is raw data. We can’t draw any conclusions until we analyze the results for statistical significance,” Trier says.
The study related the breadth of peoples’ hands to the pouch sizes, measured against how many times they moved their hands around the pouch. “We had a strict definition as to what constitutes a hand movement. Measuring the hand movements as we watched the videos was a challenge. Analysis is currently underway,” he says.
 
The study had certain limitations, Trier reported.
Further testing could employ the lotion transfer method when devices are presented to a scrub nurse. Also, “it would be worthwhile to continue the study with more realistic conditions of use, including varied products and contexts.” 
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