Presentation
PS4 - Evaluation of Sterile Barrier Systems Aseptic Presentation: A Usability Study
DescriptionIntroduction
Healthcare-associated infections remain a significant cause of illness and death.1 in 31 US patients contract at least one infection in association with their healthcare every day, according to the CDC. The contamination of medical devices poses a particular risk for infection, specifically during package opening and presentation. Regulators across the Europe and the United States are working to establish performance requirement for sterile barrier systems (SBS) intended to maintain terminally sterilized medical devices until the point of use. The Medical Device Regulation (MDR) of the European Union places greater emphasis on the usability of medical devices, to eliminate or reduce the risk of infection to the patient. As a result, usability evaluation requirement was introduced in the 2019 update to the ANSI/AAMI/ISO 11607-1:2019 Packaging for terminally sterilized medical devices. To this day, few research is available on usability evaluation of SBS aseptic presentation and their performance in clinical environment.
Method
14 sterile medical devices with five different SBS configurations were evaluated to decide how SBS configuration (type, size, and number of SBS layers) and user satisfaction levels affect usability. A total of 40 experienced clinical nurses were recruited to participate in the study, resulting in 280 individual trials (20 per SBS configuration), which were conducted in a simulated operating room. Ultraviolet fluorescent powder was used for simulation to detect contamination and to decide pass/fail of the aseptic presentation process.
Result
Pouch and tray configurations presented 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.
Healthcare-associated infections remain a significant cause of illness and death.1 in 31 US patients contract at least one infection in association with their healthcare every day, according to the CDC. The contamination of medical devices poses a particular risk for infection, specifically during package opening and presentation. Regulators across the Europe and the United States are working to establish performance requirement for sterile barrier systems (SBS) intended to maintain terminally sterilized medical devices until the point of use. The Medical Device Regulation (MDR) of the European Union places greater emphasis on the usability of medical devices, to eliminate or reduce the risk of infection to the patient. As a result, usability evaluation requirement was introduced in the 2019 update to the ANSI/AAMI/ISO 11607-1:2019 Packaging for terminally sterilized medical devices. To this day, few research is available on usability evaluation of SBS aseptic presentation and their performance in clinical environment.
Method
14 sterile medical devices with five different SBS configurations were evaluated to decide how SBS configuration (type, size, and number of SBS layers) and user satisfaction levels affect usability. A total of 40 experienced clinical nurses were recruited to participate in the study, resulting in 280 individual trials (20 per SBS configuration), which were conducted in a simulated operating room. Ultraviolet fluorescent powder was used for simulation to detect contamination and to decide pass/fail of the aseptic presentation process.
Result
Pouch and tray configurations presented 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.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives