By Laurie Reed & Jan Hemmelmann
There are a wide variety of medical devices that utilize sterile barrier packaging systems (SBS), including implants, catheters, procedure kits, and tubing sets, to name just a few. There are also a wide variety of types of SBS systems such as header bags, pouches, reels, pre-formed trays, and wraps. Since the early 2000s, manufacturers have been required to validate that these packaging systems can be used successfully to transfer devices aseptically to a sterile field. In this article LHF provides some background and practical tips for conducting an aseptic presentation study.
EN ISO 11607-1:2020 Packaging for Terminally Sterilized Medical Devices is a European standard initially released in 2019, but then revised and re-released in 2020. It supersedes the same standard from 2017 and replaces the original standard from 2006. The standard specifies requirements about designing SBS and packaging systems for terminally sterilized medical devices (i.e., devices that need to remain sterile up to the point of use) and outlines the design validation requirements of these systems.
Just like user documentation, labeling, and other types of packaging, SBS are considered part of the medical device user interface and are recognized by regulatory authorities as such. All components of a medical device user interface are subject to human factors / usability engineering evaluations per IEC 62366-1:2015/Amd 1:2020. However, the latest version of ISO 11607-1 (2020) explicitly calls for human factors evaluation of sterile barrier systems in order to validate that users can effectively handle and open the packaging as designed without compromising the sterility of the items inside. This new requirement is outlined in Section 7 of ISO 11607-1, dictating that:
This can be done as a simulated use study or an actual use study.
While the standard points only toward performing one validation-type usability assessment, it would be prudent to perform formative usability assessments of the SBS while still under development to ensure that the packaging is not problematic prior to settling on a final design. To be efficient and save money, formative and summative aseptic evaluations of packaging systems can be conducted in conjunction with other formative and summative studies where usability of the device itself is being evaluated, or they can be conducted as standalone studies focused solely on the usability of the packaging.
In designing a usability study for assessing aseptic presentation, the standard specifically calls for evaluation of the following:
The ability to identify where to begin opening;
The ability to recognize and perform the technique required to open the sterile barrier system without contaminating or damaging the contents; and
The ability to subsequently present the contents aseptically into the sterile field.
We’ve learned that when designing such a study, it’s important to pre-determine what potential aseptic presentation techniques may be used because there are often multiple methods of successfully aseptically presenting a device. Since SBS packaging designs vary widely, this will involve researching how your particular type of device is typically presented in the intended use environment(s) and also thinking carefully about which parts of the packaging and contents inside must remain sterile. From this, you will define your success criteria.
For example, let’s imagine that we need to evaluate a chest drain product with packaging configuration as follows: the device itself is packaged within a cardboard tray that is wrapped with blue central supply room (CSR) wrap and then encased in a sealed Tyvek/Nylon sterile pouch.
Depending on the aseptic presentation technique chosen by the user, they may either keep the CSR wrap and everything inside sterile using something we will call the Picking Technique, where they open the outer pouch and present the CSR-wrapped product inside for the sterile person to pick out. Or, they may choose to keep just the contents within the CSR wrap sterile (the tray with device components) using something we will call the Placing Technique, where they place the wrapped device on a prep table and open the CSR wrap to reveal the contents inside for a sterile person to pick up and bring into the sterile field when ready, being sure not to touch the inside of the wrap or device contents.
The success criteria for each of the above may be slightly different depending on the presentation technique chosen by the participant. For example, success criteria for the three assessment items for a chest drain might be as follows:
The ability to identify where to begin opening. Picking Technique: User opens the sterile pouch from the intended opening; Placing Technique: User opens the sterile pouch and CSR wrap from the intended openings.
The ability to recognize and perform the technique required to open the sterile barrier system without contaminating or damaging the contents. Picking Technique: User opens the pouch without contaminating or damaging the contents inside. Placing Technique: User opens the pouch and the CSR wrap without contaminating or damaging the contents inside.
The ability to subsequently present the contents aseptically. Both Techniques: User does not breach sterility when presenting the contents.
We’ve also learned that when executing a simulated use aseptic presentation usability evaluation, it’s critical to introduce as much realism into the study environment as possible to minimize potential study artifacts. Here are some tips to keep in mind:
Clearly delineate which areas of the test environment are considered sterile vs. non-sterile. This can effectively be done with the use of blue drapes and by staging the types of surfaces, equipment, and accessories that healthcare professionals might have on hand in each area.
Wear the appropriate personal protective equipment (PPE). Non-sterile healthcare professionals whose job it is to present devices to the sterile field aseptically may not wear any gloves during the setup process, or they may wear basic nitrile gloves. However, the sterile person receiving the device would be wearing sterile gloves (and possibly a gown, mask, hair net and booties, depending on the intended use environment). In one of our recent studies, an LHF team member acted as the sterile “confederate” and dressed accordingly.
Explicitly communicate the intended job roles and use scenarios to the participant. The success of the evaluation hinges upon the study participant understanding whether they are acting as the non-sterile person (often called a Circulator in the OR setting) or the sterile person (often called the Scrub Nurse in an OR setting) and what the end goal of the task is (i.e., get the device into the hands of the Scrub Nurse without breaching sterility, or open the device onto a prep table without breaching sterility).
If use errors, use difficulties, or close calls are observed during the evaluation, you should use standard root cause probing techniques to determine whether the design of the SBS packaging contributed to any of the issues. If you see patterns of use errors or difficulties related to packaging design, the SBS system may need to be redesigned or additional information may need to be provided to users. The manufacturer is then responsible for conducting a second aseptic presentation usability evaluation to validate that the new design or the new instructions lead to successful results.
If you need help conducting an aseptic presentation usability study, we have additional tips and tricks to share. Connect with us to learn more!