Usability Evaluation for Aseptic Presentation—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
Devices need to enter the sterile field for a medical procedure in a safe and contamination-free way. If they don’t, problems can ensue such as infection or waste. Further, a complicated opening procedure can add to the risk of these problems. As such, the design of a device’s package becomes a critical factor in ensuring its safe delivery to a facility as well as its aseptic presentation to the sterile field.
 
This necessity brings with it an array of questions regarding the best design for the packaging. What features will be required? How will it be opened? Who will be opening it? Is there a single or double barrier in place? The packaging designer must be familiar with the use environment such that the development of the final product will fulfill all needs.
 
Fortunately, Matt TerBush, Director of Packaging Innovations at Packaging Compliance Labs, has responded to several questions involving aseptic presentation, packaging design, and usability evaluation to ensure a successful result. He shares his expertise on the importance of aseptic presentation, standards and guidance that can be referenced, and best practices for the usability evaluation.
 
Sean Fenske: What is aseptic presentation and why is it important?
 
Matt TerBush: Aseptic presentation is defined as the transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination of the product or contents.
 
It’s important for several reasons. We use this process to reduce surgical site infections (SSIs), which occur in 200,000 to 400,000 patients in the U.S. each year. These SSIs add $900 million per year to healthcare costs, whether due to prolonged stays or additional procedures.
 
Further, while this may sound counterintuitive to this effort, aseptic presentation can help reduce waste and contribute to sustainability efforts. Healthcare facilities produce nearly 14,000 tons of waste per day in the U.S.—approximately 20% to 25% is plastic. Since much of medical packaging is plastic, if we can reduce the amount of product that needs to be opened due to contamination or error, it can have a positive impact on the environment.
 
Fenske: What impact does aseptic presentation have on device packaging and its design?
 
TerBush: First is the packaging label. Healthcare staff need to know important information about the contents—product name, size, quantity of devices—which is provided on the label. This is necessary to ensure the healthcare personnel is aseptically opening the package, dispensing the contents safely, and performing the right techniques to do so. Whether the package has a single or double barrier is going to affect the method used to transfer to the sterile field.
 
Speaking of technique, we also need to ensure the peel strength required to open the package is not too strong such that it creates a challenge for the nurse. As packaging engineers, we often look at minimum seal strength, but we don’t want it to be so strong that an accident can occur.
 
Further, aseptic presentation will lead to the proper sizing of the packaging, whether a pouch or tray is used. If a package is not designed as intended for a specific device (i.e., leveraging the same packaging for multiple devices or SKUs), issues may arise.
 
Finally, aseptic presentation can generate options for different design types, such as finger holes, snap features, peel tabs, and other opening feature options for trays, pouches, and other types of flexible packaging.
 
Fenske: Are there ISO standards and/or regulatory guidance regarding aseptic presentation? What do they cover?
 
TerBush: This is the big question within the industry as we all feel like we’re roaming the desert without a North Star. Fortunately, an ASTM working group is currently drafting a guidance document, specific to aseptic presentation and usability for sterile barrier packaging.
 
In the meantime, however, there are four guidance documents or standards I’d recommend as references. They are:

• ISO 11607-1:2019 Section 7—This asks us to vet three things: ensure a user can identify the opening feature of a pouch, the user can aseptically open the package without damaging or contaminating the contents, and the user can transfer the device to the sterile field.
• FDA guidance 1757—States usability evaluations must be conducted on the device as well as the package using actual users of the packaging system.
• IEC-62366-1 2020 & ANSI/AAMI HE75:2009 (R2018)—Provide a means of conducting these evaluations through usability studies, whether it’s a formative or summative study.

 
Fenske: Can you please explain what usability evaluation is?
 
TerBush: Usability evaluation is defined as a method for exploring or evaluating a user interface with intended users within a specified intended-use environment.
 
In layman’s terms, we’re evaluating the task and procedures needed from an intended user (e.g., circulating nurse, scrub tech, sterile nurse, etc.) within the intended use environment. So either in a real or simulated use environment with different characteristics, such as PPE or other factors, to determine if the design is useful or if it has flaws.
 
Fenske: How can a usability evaluation impact the aseptic presentation or the design of the packaging?
 
TerBush: As I mentioned, a usability study will either be formative or summative. Formative studies are used to establish design requirements based on user needs and will inform a company’s DFMEA tool. Summative studies evaluate the efficacy of device and sterile barrier system design for usability and assess risk per the DFMEA. The evaluations detect patterns of design problems and can inform design changes.
 
Fenske: Are there aspects of aseptic presentation the device manufacturer neglects to consider in packaging design? Or can a usability evaluation reveal aspects overlooked?
 
TerBush: As I tell clients, testing early can really help. So we’ll typically do feasibility studies in the lab. Similarly, conducting a formative study before the design freeze is essential to avoid the potential problems that would be revealed in a summative study.
 
From a personal perspective, I have seen sizing issues when using a double barrier system, failure of key design elements (e.g., lift tabs), or other ergonomic features overlooked that would be necessary for aseptic presentation. These are then uncovered during the summative study.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
TerBush: There are three things I share with clients.

1. Design with aseptic presentation in mind.
2. Perform usability evaluations early and retest when design changes are implemented.
3. Connect and interact with the healthcare industry and your potential users.

 
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