ABSTRACT
The Medical Device Regulation (MDR) of the European Union (EU) places greater emphasis on the usability of medical devices, with the goal of eliminating or reducing the risk of infection to patients. As this goal also is applicable to sterile packaging, ANSI/AAMI/ISO 11607-1:2019 introduced a usability evaluation requirement for aseptic presentation of terminally sterilized medical devices. In an effort to reduce contamination risks, this requirement focuses specifically on the sterile barrier system (SBS). However, research is limited on evaluating the usability of SBSs and their performance, from an aseptic presentation standpoint, in clinical settings. To address this research gap, we assessed 14 sterile medical devices with five different SBS configurations to elucidate how SBS configuration (type, size, and number of SBS layers) and user satisfaction levels affect usability. A total of 40 experienced clinical nurses participated in 280 individual trials (20 per SBS configuration), which were conducted in a simulated operating room. Ultraviolet fluorescent powder was used to simulate the contamination process and to evaluate the success or failure of the aseptic presentation. Pouch and tray configurations exhibited the best overall performance, while vent bags performed poorly and were considered less acceptable. Double SBS configurations outperformed single SBS configurations. The study highlighted the importance of appropriate SBS symbols to identify SBS layers, which is another patient safety-related requirement of the EU MDR. The current work also includes an analysis of the powder contamination method used in conducting the usability evaluation.