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...
Evaluating Disposable Isolation Gown Liquid Barrier Test Methods for Relevance to Healthcare [0.03%]
评估一次性隔离衣液体屏障测试方法对医疗保健的适用性
Karen Haberland,Julie Miller,James Davis et al.
Karen Haberland et al.
Healthcare staff rely on isolation gowns to provide a degree of protection against cross contamination from blood or body fluids. Gowns that meet standardized liquid barrier penetration test methods provide staff with a presumed assurance o...
Clinical Experience with Disposable Isolation Gown Selection, Strikethrough, and Reporting [0.03%]
一次性隔离衣的选择、破型和报告的临床应用经验
Karen Haberland,Julie Miller,Amanda Sivek et al.
Karen Haberland et al.
Objectives: This study sought to investigate whether and to what extent fluid strikethrough for disposable isolation gowns is underreported and to identify areas for improving healthcare worker (HCW) understanding of gown performance. Metho...
Assessing the Impact of End-of-Life Processing on Reusable Medical Devices [0.03%]
评估终末期处理对可重复使用医用设备的影响
Alpa N Patel,Daniel Olsen
Alpa N Patel
End-of-life (EOL) testing requirements for reusable medical devices continue to cause confusion in the medical device industry. Regulatory expectations from U.S. and European Union authorities differ, particularly regarding whether manufact...
Marie-Ange Janvier,Andrew A M Ibey,Kajal Madhusudan et al.
Marie-Ange Janvier et al.
During a 12-year period (2011-23), the number of staff in the Clinical Engineering (CE) Department at the Children's Hospital of Eastern Ontario (CHEO) increased from five to more than 20 biomedical equipment technicians/technologists. Howe...
Impact of Borescope Inspections on Endoscope Repair Frequency and Costs [0.03%]
内镜孔镜检查对其维修频率和费用的影响分析
Cori L Ofstead,Abigail G Smart,Larry A Lamb et al.
Cori L Ofstead et al.
Background: Infections and injuries have been linked to endoscopes with visible damage or residue. Guidelines recommend visual inspection to identify endoscopes requiring repair or further cleaning. This study sought to evaluate the impact ...
Scott Skinner
Scott Skinner
Objective: The processes of evaluating and selecting health technologies in hospitals have been extensively explored. However, few studies have been specific to U.S. hospitals, and none has approached the subject from the perspective of cli...