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Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

Abstract

Newly emerging mandates in the Medical Device Regulation in Europe and additions to ISO 11607 require medical device manufacturers characterize how package designs facilitate (or hinder) aseptic transfer by perioperative personnel.

The present work utilized a semi-structured interview with clinicians on the topic of aseptic presentation. Methodological decisions related to the interviews and assessment of results were undergirded with affordance and situated learning theories to identify the components of a user experience. QDA Miner software was used post-hoc to code, quantify, and categorize the data into major and minor themes.

The study identifies several components within the user’s experience that influenced aseptic transfer, including: context (e.g. staff availability), coworkers’ input, and variation in individuals' interpretation of acceptable practice related to the transfer of devices to the sterile field and appropriate handling of packaging.

To comply with the changing regulatory landscape surrounding the safety of medical devices, the industry should employ human factors methodologies to better understand how sterile packages will be used by the clinician “aseptically”.

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