Evaluating Aseptic Presentation of Different Medical Device Packaging Configurations

Area of Science:

• Medical Device Usability Engineering
• Sterile Packaging Science
• Patient Safety Research

Background:

• European Union Medical Device Regulation (MDR) mandates enhanced usability for infection risk reduction.
• ANSI/AAMI/ISO 11607-1:2019 requires usability evaluation for aseptic presentation of sterile medical devices.
• Limited research exists on sterile barrier system (SBS) usability and aseptic performance in clinical settings.

Purpose of the Study:

• To evaluate the usability and aseptic presentation performance of different sterile barrier system (SBS) configurations.
• To determine how SBS configuration (type, size, number of layers) and user satisfaction affect usability.
• To analyze the effectiveness of a powder contamination method for usability evaluations.

Main Methods:

• Assessed 14 sterile medical devices with five distinct SBS configurations in a simulated operating room.
• 40 experienced clinical nurses conducted 280 trials (20 per configuration).
• Ultraviolet fluorescent powder simulated contamination to evaluate aseptic presentation success.

Main Results:

• Pouch and tray SBS configurations demonstrated superior performance and user acceptability.
• Vent bags performed poorly and were rated less acceptable by users.
• Double SBS configurations outperformed single layers, and appropriate SBS symbols were crucial for usability.

Conclusions:

• SBS configuration significantly impacts aseptic presentation success and usability.
• Pouches, trays, and double-layered SBSs are preferable for maintaining sterility.
• Clear SBS labeling and user-centered design are vital for meeting EU MDR requirements and enhancing patient safety.