ISO 11607 Part 1 requires that sterile barrier packaging systems be subject to a formal usability evaluation with real world end-users to verify human factors considerations. When healthcare professionals are able to open and dispense products aseptically, it reduces the potential for accidental contamination that could impact patient health, as well as reduced risk for damage or loss of product.
Who is Usability Evaluation for?
Medical device manufacturers in the development process of a new product that requires sterile packaging.
Usability Evaluation criteria
We provide Clinical Usability Evaluations to assess the three criteria for usability evaluation listed in ISO 11607:
- 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.
All Usability Evaluations are performed in our simulated surgical suite with real-world clinicians.
What's Included in Clinical Usability Evaluation
Opportunity for study customization
Technical immersion session to document device and packaging system to develop technical questions and acceptance criteria for the study
Clinical assessor profile(s) with the user’s credentials, experience, demographics, and area(s) of expertise
Complete details of the use environment, gowning, and surgical suite simulation
Clinical use photographs of aseptic presentation techniques for the client’s products
Video that captures the entire process of the clinical study
Objective evidence that the three items required by ISO 11607- 1:2019 have been evaluated
Protocol Report with moderator questionnaire, user responses, formal discussion notes, summary content and recommendations