In 2019, Section 7 of ISO 11607-01 was added to include Usability Evaluations for Aseptic Presentation. In the 5 years since its introduction, an ATSM standard guide is currently being authored to provide considerations for the evaluation of usability for terminally sterilized medical packaging in their packaging validations. Considering current and future standards, it’s important to gain an understanding of the purpose of Usability Evaluations and how they aim to improve the medical device and packaging industries.

Matt TerBush, Director of Packaging and Innovations at Packaging Compliance Labs, explains what usability evaluations are, what their purpose is, and then gives an overview of the different options available for conducting a Usability Evaluation.

What is a Usability Evaluation?

As an important part of packaging validations, Usability Evaluations for sterile packaging establish design requirements with end-user inputs so medical devices can be presented aseptically in the healthcare environment. The goal of the evaluation is to ensure that the packaging user interface has been designed such that use errors that occur during aseptic presentation that could contaminate or cause damage to the device are either eliminated or reduced to the extent possible.”

Usability Evaluations for sterile packaging assess three criteria per ISO 11607-01:2019:

1. The ability to identify where to begin opening
2. The ability to recognize and perform the technique required to open the sterile barrier system without contaminating or damaging the contents, and
3. The ability to subsequently present the contents aseptically.

Why Are Usability Evaluations for Aseptic Presentation Important?

Patient safety is the primary reason why usability evaluations are required of ISO 11607. Usability Evaluations also support sustainability initiatives and unnecessary healthcare costs.

• In the United States, between 200,000 to 400,000 patients are affected by surgical site infections (SSI’s) annually. Performing usability evaluations on sterile packaging reduces the number of SSIs by ensuring the package can safely and effectively be opened and the medical device presented aseptically to the sterile field without contamination or damage.
• In addition to the patient risks, SSI’s can cost healthcare systems an additional $900 Million each year.
• And finally, Currently, healthcare facilities produce nearly 14,000 tons of medical waste. While only 25% of that waste is plastic, 91% of plastics are not recycled. Usability Evaluations help decrease wasted materials and reduce unnecessary expenses by limiting the amount of packages opened and contaminated devices discarded.

What are the Different Kinds of Usability Evaluations?

There are two types of Usability Evaluations: Formative and Summative, and they occur at separate times during your packaging validations.

• Formative Usability Evaluations can be performed early in the design process as a tool to compare packaging types, sizes, unique features, etc. By incorporating qualitative and observational feedback, formative evaluations provide medical device manufacturers (MDMs) with end-user inputs on their packaging design before purchasing packaging materials and pushing forward with the rest of your packaging validations.
• Summative Usability Evaluations fulfill ISO 11607 Requirement and are performed after your sealing validation and utilize commercially representative product-packaging systems. A summative evaluation assesses the overall usability of the sterile packaging as it pertains to aseptic presentation against predefined metrics.

Patient safety is paramount in medical procedures. Proper Usability Evaluations ensure that medical devices are presented aseptically, reducing the risk of contamination.

To learn more about Usability Evaluations and how PCL can help you meet the ISO 11607:2019 Section 7 requirements, visit https://pkgcompliance.com/services/packaging-engineering/usability-evaluation/