A method for quantifying key components of the opening process for opening pouch-style packages containing medical devices.

Healthcare-associated infections are a serious worldwide health concern. Although contaminated medical devices are an avenue for infection, little research has evaluated the techniques used to open sterile packages. The goal of this study was to develop a method to quantify aspects of the package opening process in accordance with opening guidelines and then to demonstrate this methodology through a small sample of clinicians opening two sizes of pouch-style packages. Using motion capture techniques, a method was designed to quantify 11 parameters associated with the opening process. The method was then tested with nine healthcare professionals. Results indicated that all participants crossed the sterile field when opening packages. When opening large packages, participants spent significantly more time over the simulated sterile field and there was a trend towards more manipulations as compared to opening smaller packages. This methodology can be used to quantify the opening process, compare opening practices, and for assessment during the learning process.