Aseptic presentation plays a crucial role in ensuring patient safety and preventing infections in healthcare settings. Proper packaging and presentation of medical devices, such as syringes, IV sets, and catheters, are essential to maintain their sterility until use. Evaluating the usability of aseptic presentation is vital to identify potential risks, challenges, and areas for improvement. This blog will explore the importance of usability evaluation in an aseptic presentation and highlight key factors for enhancing safety and efficiency.
Healthcare-Associated Infections (HAIs) are infections patients receive while 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.
To mitigate the risk of patient infections, the healthcare industry develops protocols to minimize those adverse healthcare outcomes. One of those protocols is the aseptic presentation of medical 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 intended to maintain the 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 the risk of HAIs.
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 HAIs.
For those reasons, evaluating sterile barrier packaging design for aseptic presentation is required for every sterile barrier packaging system. Further, we will explain 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 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.
Why Evaluate Usability in Aseptic Presentation?
1.Patient Safety: Aseptic presentation aims to minimize the risk of contamination, infection, and medical errors. By conducting usability evaluations, healthcare providers can identify potential issues that may compromise patient safety, such as packaging that is difficult to open or results in contamination during device retrieval.
2.User Experience: Healthcare professionals, including nurses and doctors, are responsible for regularly handling and using aseptic medical devices. Evaluating usability allows for identifying design flaws or challenges hindering seamless and efficient device handling, leading to user frustration and potential errors.
3.Regulatory Compliance: Regulatory bodies, such as the FDA and the EU Medical Device Regulation, emphasize the importance of human factors engineering and usability testing for medical devices. Compliance with these regulations is crucial to ensure the safety and effectiveness of aseptic presentations.
Aseptic Presentation Techniques:
When designing a sterile barrier package for aseptic presentation, many factors must be considered. 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.
Section 7.2 of the standard 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 need to be retested in a second usability evaluation.
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 in the sterile environment. The sterile person would then enter the 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 onto the sterile field.
Healthcare professionals may consider factors like the 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.
Factors to Consider in Usability Evaluation:
1.User Testing: Engage representative users, such as nurses or doctors, in the evaluation process. Observe and gather feedback on their experience with aseptic presentation, including device retrieval, unpacking, and preparation. This information can uncover design issues and inform necessary improvements.
2.Packaging Design: Assess the ease of opening the packaging. Evaluate the clarity of instructions for safe and aseptic device retrieval. Packaging should be intuitive and promote proper aseptic technique while minimizing the risk of contamination.
3.Labelling and Instructions: Evaluate labelling and instructions’ clarity, size, and legibility. Ensure critical information is presented, including device name, lot number, and expiration date. Consider incorporating visual aids or colour coding to facilitate quick and accurate identification.
4.Ergonomics and Handling: Assess the physical aspects of device handling, such as grip, weight, and manoeuvrability. Evaluate how well the device aligns with the user’s hand anatomy and the ease of connecting or attaching auxiliary components during an aseptic setup.
5.Sterility Maintenance: Evaluate the packaging’s ability to maintain sterility until device use. Consider factors like particulate contamination, moisture control, and the effectiveness of barrier materials. Assess if the packaging allows for easy inspection of device integrity before opening.
6.Human-Device Interaction: Study the user and device interaction during aseptic presentation. Identify any potential risks of device misuse, such as accidental needle sticks or improper handling during assembly. Ensure that the device is user-friendly and minimizes the risk of errors.
Usability evaluation is essential to optimize aseptic presentation in healthcare settings. By assessing the usability of packaging, labelling, and device handling, healthcare professionals can enhance safety, reduce the risk of contamination and medical errors, and improve overall user experience. Regulatory compliance and adherence to established usability testing standards are paramount to ensure the effectiveness, safety, and user-friendliness of aseptic presentations. Ensure that usability evaluations are carried out iteratively, with continuous improvement efforts to provide healthcare professionals with reliable and efficient aseptic medical device presentation.
