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Can Repetitive Handling Contaminate Sterile Packaging?

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MD&M East speakers from the Kilmer innovations in Packaging Repetitive Handling Team shared the results from their recent study.

Kilmer innovations in Packaging (KiiP) is at it again. Already setting out to solve wicked problems and address sustainability, KiiP is now examining the impact of repetitive handling of sterile packaged medical devices. Speaking at MD&M East, the Repetitive Handling Team shared results from a study suggesting that such handling can impact surface contamination. The team is part of KiiP’s “Last 100 Hundred Yards Group.”

Speaking during the panel discussion, New Medical Packaging Research - Potential Contamination from Repetitive Handling on Sterile Packaging at Healthcare Facilities, were Hanna Harris, packaging engineer for Healthmark Industries; Austin Liu, a senior project manager in the healthcare packaging industry; Teri Meadow, market manager, APC Healthcare for American Packaging; and Katherine Olson, staff packaging engineer for MicroAire Surgical Instruments.

“Our goal is to understand the potential contamination that can occur on sterile packaging when it’s moving through healthcare facilities,” explained Olson.

The team’s work grew out of a survey conducted in December 2020 by the Last 100 Yards group on the packaging challenges encountered in healthcare facilities. “One of the common threads we saw in the survey results was that products and their packaging are handled quite a bit more than we would expect in healthcare facilities,” Olson told the audience. “So what we are trying to understand is whether multiple handling causes an increase in contamination transfer or contamination spread throughout facilities.” She added that the team hadn’t found much evidence or many studies on the topic.

Olson explained that in healthcare facilities, medical products are often pulled from shelves and added to case carts or procedure kits and transferred to the OR, but they won’t all be used and some will go back to shelves.

She also mentioned CDC data that demonstrate that 1 in 31 patients get a healthcare-associated infection (HAI). “We wonder, ‘Is the packaging part of this?’ ”

So the Repetitive Handling Team developed a study “to provide visual evidence of sterile barrier system contamination through repetitive handling,” Harris told the audience. “As a group we hypothesized that repetitive handling could increase the amount of microbial transfer from hands to sterile barrier system surfaces and in turn increase the risk for device contamination.” She added that the study focused solely on surface contamination and did not focus on microbial ingress.

Harris explained that the study took place in September 2021 at a Michigan hospital with three OR professionals. Each participant was given five bins, each containing a sterile, clean Tyvek-to-film pouch with a device inside. Each bin was lined with parchment paper, and participants were instructed to pick up each pouch and place it back in the bin during each trial. The contaminant was represented by Glitterbug, an invisible lotion that illuminates under UV light, which was placed on participants’ hands. Sharing results from one participant’s trials, Harris told the audience that “there’s definite incremental increase of contaminant transfer . . . this was evident with each of our three participants." For one participant, for instance, "trials one and two show little to no transfer . . . while trials four and five are almost completely soiled in that Glitterbug contaminant,” explained Harris. The team then quantified transfer by further examining the pouches, parchment paper, and contaminant. She said the team is working further to determine the best way to conduct such quantification.

“So in conclusion, this was a qualitative exploratory where we did determine that repetitive handling increases surface contamination,” she concluded. “We also determined that contamination transfer from handled packages to storage bins occurs and handling techniques impact the surface area of contaminant transfer.”

Meadow pointed out that the results are preliminary and the team is still conducting its analysis and finalizing its results, but she said the team wanted to get the word out about potential contamination from repeated handling. Next steps for the team include looking at what devices are repeatedly put into case carts “just in case” and whether that “just in case” is needed; if so, would there be ways to include such items in a way to make them less prone to repetitive touching? The team is also looking at submitting comments on healthcare facility guidances such as AAMI TIR109, External Transport of Medical Devices Processed by Healthcare Facilities.

“And there’s a lot more research we need to do,” Meadow said. “What we did was an initial qualitative study—we wanted to explore whether we could confirm through science that cross contamination really does occur. We confirmed our hypothesis, and now we need to elevate it to a statistical significance by repeating it with a much larger sample size. This will be important for our peer-reviewed articles.” The team has other plans, too, such as measuring the potential cross-contamination that could be occurring from packages to case carts to bins to shelves. The team also wants to look at the implications of healthcare professionals’ placement of medical devices into lab coat pockets as well as the impact of package types and features on contamination. Finally, they want to develop a method for the aseptic presentation guidance for using of Glitterbug. 

In addition to Harris, Liu, Meadow, and Olson, the Repetitive Handling Team also includes Jane Severin, president, MedPack Systems; and Sue Klacik, clinical educator, IAHCSMM. Meadow said that "both Jane and Sue were instrumental to the Repetitive Handling research program but were not able to be at MDM East."

Meadow invited the audience and others to help out with the team’s efforts as well as any of KiiP’s other groups. Austin Liu shared the groups as:

  • Let’s Speed It Up
  • Last 100 Yards Group
  • Aseptic Presentation
  • Sustainability & End of Life
  • KiiPed Education

As Liu said to kick off the session, KiiP’s vision is “to improve patient outcomes and clinician delight through the science and engineering of sustainable packaging.” For more details, check out the Kilmer innovation in Packaging LinkedIn Group.

 

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