A panel of veteran operating room nurses shared their experiences in using packaging designed for aseptic presentation at this year’s thePACKout conference in Coronado, California.
Aseptic presentation is the process of transferring sterile products from sterile barrier packaging systems to a sterile field. The process uses procedures that minimize the risk of microbial contamination, with the aim of reducing surgical site infections (SSIs).
SSIs are a big deal for not only patients but also hospitals’ bottom lines. SSI’s make up about 20% of health care associated infections and 5% or more of surgical patients develop an SSI, according to a published review.
Contamination of an incision with microorganisms from the patient’s microbial flora during surgery is the most common cause of SSIs, which are associated with significant morbidity and extended hospital stays. In fact, the authors report that SSIs extend a hospital length of stay an average 9.7 days and increase the cost of hospitalization by more than $20,000 for each admission.
Since up to 60% of SSIs are thought to be preventable with the use of evidence-based measures, SSIs have become a pay-for-performance metric and a target of quality improvement efforts, according to review authors.
“The Centers for Medicare and Medicaid Services (CMS) will not reimburse hospitals if they can pinpoint the surgical site infection back to the hospital’s [practices],” says Malinda Elammari, a clinical education specialist for Healthmark Industries and co-moderator of thePACKout session “How Aseptic Presentation Impacts Healthcare Workers and How to Incorporate Usability Lessons into Your Packaging Designs.”
Packaging matters.
A growing body of evidence suggests packaging could be a route of contamination for sterile devices during aseptic presentation, according to a paper published in PLOS ONE. And packaging design and opening technique play roles in the success of the process, the authors write.
In 2019 a major revision of International Organization for Standardization (ISO) 11607-1 was released for industry use, with the addition of section 7 addressing Usability Evaluation for Aseptic Presentation, according to session co-moderator Matthew TerBush, director of packaging innovations at Packaging Compliance Labs, which provides medical device packaging testing and design.
Section 7.2 of the standard requires that manufacturers assess the ability to do the following through a usability evaluation for aseptic presentation, according to Packaging Compliance Labs:
• Identify where to begin opening a sterile barrier system.
• Recognize and perform the technique required to open the sterile barrier systems without contaminating or damaging the contents.
• Subsequently present the contents aseptically.
Circulating nurses and scrub technicians typically interact with the packaging during aseptic presentation, according TerBush.
Panelists weigh in.
“Nobody thinks about packaging until we have a problem with it,” says Elammari, who began her medical career as a surgical technologist.
What could go wrong was on display during the session, when an audience member participated in an aseptic presentation on stage, in a mock OR, using mock packaging. She opened the packaging only to have its contents fly out and hit the floor. And one could argue that she wasn’t as stressed as a nurse or tech would be in a real-world operating room (OR).
To be effective, packaging used in aseptic presentation has to be user-friendly, taking into consideration the challenges and obstacles of working in a busy operating room.
Session panelists were: Michele Carson, MSN, CNL, CNS, La Jolla perioperative inpatient director, at UC San Diego Health; Pamela Goss, BSN, RN, CNOR, Gu/ObGyn surgery clinical nurse coordinator at UC San Diego Health; and Elizabeth Hipkins, clinical nurse with Jacobs Medical Center.
Ability to focus and patient care and efficiency are paramount, according to the panel. It’s also important for the hospital’s bottom line to turn over rooms quickly to accommodate more surgeries. To do that, they have to set up and breakdown rooms correctly to preserve sterility and patient safety.
This is where opening packaging really comes into play. The goal is to open packages quickly, get on with the case and move on, according to the panel.
Initial packaging interaction and inspection.
An OR nurse typically first inspects a device’s primary packaging to ensure the contents are sterile. But there are cases in which nurses first encounter secondary packaging because the primary packaging has been removed.
The nurses point to what they need to see on the packaging, including device type, size, expiration date and whether it’s sterile. They also look for such details as device name, lot number, barcode, precautions, any contraindications, and warnings.
What’s on the label can be communicated in a combination of symbols and text.
Nurses also find informational pamphlets within the packaging helpful if, for example, a diagram explains how they have to assemble or insert a device.
The nurses shared that they first visually inspect packaging for damage.
“We’re checking for dents … any cracks or punctures. Any tears or folds within the packaging — anything that gives us a red flag that this item might potentially be contaminated,” Hipkins says.
When asked about identifying the package opening, the nurses expressed the urgency of what they do, with no time to figure out how to open packages. Goss shared that she looks for a place to peel with arrows, and, for ease of use, she prefers packaging that’s firmer, rather than flimsy
A complex or cumbersome opening can be stressful and challenging.
“A lot of the time in the operating room we wear gloves. You have to take into account the dexterity and how [packaging] feels while you’re wearing gloves,” according to Carson.
A note about environmental impact.
The nurses also value package sustainability and efficiency in packaging design, noting current efforts by hospitals to recycle as much as possible.
So, what’s most important?
The nurses agreed that simplifying packaging is key because time is of the essence.
Hipkins added that she leans more toward the importance of sustainability, and “…ensuring that the package is sterile from the manufacturer all the way to our use.”
