Healthcare Associated Infections (HAI’s) are infections patients receive while they are receiving treatment in a healthcare environment. Depending on the severity of the infection, or the health of the patient before they undergo the procedure, contracting a HAI could be a life or death situation. Approximately 1 out of 25 patients will get a HAI from receiving healthcare. These infections lead to tens of thousands of deaths and costs the healthcare system billions of dollars annually.
To mitigate the risk of patient infections, the healthcare industry has protocols they follow to minimize the opportunities of those adverse health care outcomes from happening. One of those protocols is aseptic presentation of healthcare devices.
ISO 11607 is a standard for the healthcare packaging industry that specifies requirements and test methods for materials, sterile barrier systems, and packaging systems that are intended to maintain integrity of terminally sterilized medical devices until the point of use. In other words, the medical device must remain sterile until it is removed from its sterile barrier system and transferred into a sterile field to minimize risk of HAI’s.
In the most recent revision to ISO 11607-1 (2019), Section 7.1 states “A documented usability evaluation shall be conducted to demonstrate that the sterile contents can be aseptically removed from the sterile barrier system for presentation.” In other words, usability is now called out as a requirement to address the issue of proper package opening procedures to mitigate the potential for HAI’s.
It is for those reasons that evaluating sterile barrier packaging design for aseptic presentation is required for every sterile barrier packaging system. In this blog, we will explain aseptic presentation further, how it is performed, a few different aseptic presentation techniques, and how it relates to usability evaluations.
What is Aseptic presentation and why is it important?
Aseptic presentation is the process of transferring sterile contents from its sterile barrier packaging system to a sterile field using procedures that minimize the risk of microbial contamination. Sterile barrier systems require an aseptic presentation technique where contact of the sterile contents with the closure and non-sterile entities is avoided to reduce risk of contamination. Being that we are in the healthcare industry, we must ensure the sterile barrier package maintains its integrity until the point of use – think an operating room or an ambulance. Since it is vital that the end user can transfer the device without contamination, the aseptic presentation technique must be feasible, easy, and intuitive.
As a medical device packaging engineering firm, we can design packaging systems all day long that protect the sterile barrier system from microbial ingress through sterilization, distribution, storage, and handling to the point of use for aseptic presentation.
At the end of the day, if the end user cannot aseptically present the sterile barrier system to successfully transfer sterile contents into a sterile filed in an operating room environment, then we have not done our job.
Aseptic Presentation Techniques
Many factors must be considered when designing a sterile barrier package for aseptic presentation. All design decisions should boil down to a manufacturer’s risk management strategy – some of the factors that should be considered are outlined in section 7.2 of ISO 11607-1 (2019).
When healthcare professionals are in action, they typically execute one of two aseptic presentation techniques – Picking or Dumping.
Picking is where a user opens a package in a non-sterile environment towards the sterile field to someone who is in the sterile environment. The sterile person would then reach into the opened sterile barrier package and pick the device from the packaging.
Dumping is where a user will open the package towards a sterile field, invert it, and dispense the medical device from the packaging on to the sterile field.
Healthcare professionals may consider factors like visibility of all device components within a package, the size and weight of a package, the cost of medical devices and much more when considering which aseptic presentation technique to use.
Usability Evaluation for Aseptic Presentation: A Great Addition to ISO 11607-1
Medical device packaging should be intuitive enough to use for someone who has never handled medical device packaging before as well as a seasoned healthcare professional.
In 2019 a major revision of ISO 11607-1 was released for use by the industry. One of the major changes was the addition of section 7 which discusses Usability Evaluation for Aseptic Presentation.
In section 7.2 of the standard, it requires manufacturers to assess the following through a usability evaluation for aseptic presentation:
- The ability to identify where to begin opening a sterile barrier system
- The ability to recognize and perform the technique required to open the sterile barrier systems without contaminating or damaging the contents, and
- The ability to subsequently present the contents aseptically
After the usability evaluation, if a manufacturer determines that their sterile barrier system packaging design does not adequately meet the three considerations for aseptic presentation above, then either the sterile barrier packaging system must be redesigned and/or additional information must be provided to the user. The ability to successfully open and present the contents will then need to be retested in a second usability evaluation.
Consumer products and services consider end users all the time when they are developing their product. In custom software development, there are jobs dedicated to user experience (UX) testing. During this phase, the software development tester will record their screen while they navigate the website as they “think out loud”. This information is then sent the UX developer to make the website/web app easier to navigate for the end user.
This is essentially what happens during a PCL Usability Evaluation. Our panel of OR nurses are asked a series of questions during the usability studies, that information is recorded and then reported back to the customer.