Improving Sterile Processing Operational Efficiency through Organizational Change [0.03%]
通过组织变革改进无菌加工操作效率
Kevin M Bush Jr
Kevin M Bush Jr
Background: Sterile processing departments (SPDs) play a vital role in patient care through the safe and effective cleaning, inspection, sterilization, and distribution of reusable medical devices and surgical instruments. Failure in device...
Jeannine W C Blake,Aniruthan Saravanan,YeEun Lee et al.
Jeannine W C Blake et al.
Although intravenous (IV) smart pumps (IVSPs) are widely used to reduce medication errors, many IVSPs continue to depend on passive methods, such as an adequate hydrostatic head height differential (HHD), for the delivery of secondary medic...
Inactivation of Endotoxin by Moist Heat, Electron Beam, and Gamma Irradiation [0.03%]
湿热、电子束和γ射线灭活内毒素
Nick Brydon,Peter Rubino Jr
Nick Brydon
The current work demonstrated inactivation of bacterial endotoxin by moist heat, electron beam, and gamma irradiation in dry, water, and saline conditions relevant to medical devices and pharmaceuticals. This study was intended to help manu...
Biological Indicators and Process Challenge Devices for Nitrogen Dioxide Sterilization [0.03%]
二氧化氮灭菌用生物指示物和工艺挑战装置
Delaney Lisco,Tiffany Bianchi,Minufar Abdollahi Khabisi et al.
Delaney Lisco et al.
Few data have been published regarding the use of biological indicators (BIs) for nitrogen dioxide (NO2) sterilization. This article presents findings from a comprehensive series of studies conducted to assess BI performance across common c...
Laparoscopic Instrument Defect Detection: A Prospective, Multisite Study [0.03%]
内窥镜器械缺陷检测：一项前瞻性多中心研究
Abigail G Smart,Cori L Ofstead,Larry A Lamb et al.
Abigail G Smart et al.
Objectives: Electrical leakage from laparoscopic instruments with defective insulation places patients, surgeons, and perioperative personnel at risk of shocks or burns. The primary objectives of this multisite study were to determine the p...
Multicenter Study
Biomedical instrumentation & technology. 2026;60(2):9-18. DOI:10.2345/0899-8205-60.2.9 2026
Impact of Leadership Structures on Sterile Processing Performance and Patient Safety [0.03%]
领导结构对灭菌处理性能和患者安全的影响
Kevin M Bush Jr,Brandon M Gantt
Kevin M Bush Jr
Background: Sterile processing departments (SPDs) are foundational to perioperative safety and play a critical role in preventing surgical-site infections and ensuring procedural reliability. Despite this essential function, SPD professiona...
Plate-Counting Techniques for Average Bioburden Below the Limit of Detection [0.03%]
低于检测限的平均生物负载平板计数法
Nick Brydon
Nick Brydon
Current methods for estimating average bioburden on medical device products, following ISO 11737-1:2018 with low bioburden or high limit of detection, present challenges for bioburden-based sterilization methods (e.g., radiation sterilizati...
Terra Kremer,Ralph Basile,Alpa Patel et al.
Terra Kremer et al.
Currently, manufacturers of cleaning agents are not obligated to verify the efficacy of formulations used in detergents. Because of a lack of standards, companies can market cleaning agents to healthcare systems for cleaning purposes withou...
Using a Risk Assessment to Transition to a 14-Day Endoscope Hang Time [0.03%]
基于风险评估的内镜浸泡时间延长至14天过渡计划
Margaret Gilman,Kwame A Gyabaah,Katlyn L Burr et al.
Margaret Gilman et al.
Guidelines for endoscope hang time following device processing do not provide a specific time frame; instead, they recommend conducting a multidisciplinary risk assessment for any changes in protocol. After undertaking a risk assessment, a ...
William Sobieski,Terra Kremer,Andrew Tortora et al.
William Sobieski et al.
Reusable medical devices are intended to be subjected to multiple cycles of clinical processing throughout the life of the device in accordance with manufacturers' instructions for use (IFUs). IFUs should include practical information on th...