A Transparent Surgical Mask to Improve Patient/Caregiver Communication, Minimize Errors and Increase Patient Satisfaction

透明手术口罩可改善患者/护理人员的沟通，最大限度地减少错误并提高患者满意度

• 批准号: 10390374
• 负责人: Jeanne Hahne
• 金额: $ 38.54万
• 依托单位: FACEVIEW MASK, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-03 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10390374
• 关键词: 5 year old; Acute; Affect; Air; American Sign Language; Anti-Bacterial Agents; Arkansas; Audiology; Bacteria; Biological Assay; Blood; Caregivers; Client satisfaction; Clinical; Communication; Consensus; Development; Engineering; Ensure; Feedback; Filtration; Goals; Health Personnel; Health Professional; Hearing Aids; Hospitals; Infectious Agent; Laboratories; Lead; Legal patent; Life; Lip structure; Lipreading; Masks; Medical Errors; Methods; N95 mask; Operative Surgical Procedures; Participant; Particulate; Patient-Focused Outcomes; Patients; Penetration; Perception; Performance; Personal Communication; Persons; Phase; Process; Production; Regulation; Resistance; Site; Speech; Speech Pathology; Surface; Surveys; Testing; Universities; Viral; Virus; Visual; Visual Aid; Work; age group; antimicrobial; base; biomaterial compatibility; commercialization; comparative; deaf; design; disease transmission; hard of hearing; health care settings; hearing impairment; improved; microbial; normal hearing; pathogenic microbe; personal protective equipment; prevent; prototype; seal; surgical mask; tool; transmission process

PROJECT SUMMARY Approximately 4% of people in the US are either deaf or hard of hearing, equating to more than 13 million people. Of these, approximately 12 million people over the age of 5 years have difficulty hearing normal conversation even when using a hearing aid. Hearing difficulties affect all age groups and present significant challenges in daily life. These challenges are particularly acute in healthcare settings, where miscommunication results in suboptimal treatment and can lead to serious and potentially life-threatening outcomes for patients. Errors in interpersonal communication are an important contributing factor in medical errors, and the wearing of surgical masks by healthcare personnel and patients increases the likelihood of miscommunication. The surgical mask is an essential item of personal protective equipment, preventing the transmission of infectious agents such as bacteria and viruses, but conventional surgical masks can muffle speech and prevent patients and healthcare workers with hearing difficulties from being able to lip read. Lip reading is an important visual aid to communication for everyone but is particularly important for those who are deaf or hard of hearing. Our goal is to complete the development of a transparent surgical N95 respirator mask that prevents infectious disease transmission and improves communication among healthcare personnel and patients with hearing impairment. In Phase I, we successfully developed and tested a prototype surgical N95 respirator mask with a transparent window that enables patients and healthcare workers to see each other’s lips while maintaining the protective barrier function of the mask. A collaborative study with Dr. Sam Atcherson of the Department of Audiology and Speech Pathology at the University of Arkansas at Little Rock validated the mask as a visual aid, showing that groups with either moderate or severe-to-profound hearing loss benefitted from the visual input from the prototype mask. The patented FaceView Mask™ combines the transparent window with both N95 filtration capability and a unique antimicrobial coating to kill bacteria. In Phase II, we propose to optimize the mask design, establish a scalable production process, and conduct further testing to support 510(k) clearance, NIOSH approval, and commercialization of the FaceView Mask™ surgical N95 respirator. Specifically, we will 1) optimize the FaceView Mask™ and conduct a survey study with end users to ensure comfort and an effective seal around the airways; 2) conduct comparative product testing with healthcare professionals, including American Sign Language interpreters to gather their perceptions of the FaceView Mask™ vs. a leading opaque surgical N95 respirator mask; 3) perform testing required for 510(k) clearance and NIOSH approval of the FaceView Mask™; and 4) test its antimicrobial performance both in a standard laboratory test and in use by healthcare workers.

项目摘要 美国大约有4％的人聋或难听，相当于超过1300万人。 其中，大约50岁以上的大约1200万人很难听到正常对话 即使使用助听器。听力困难会影响所有年龄段，并在 日常生活。这些挑战在医疗保健环境中尤为严重，沟通不畅导致 次优治疗，可能会导致患者严重危及生命的结果。错误 人际交往是医疗错误和外科手术的重要因素 医疗保健人员和患者的面具增加了沟通不畅的可能性。手术面具 是个人保护设备的必不可少物品，可防止传染剂的传播 细菌和病毒，但是常规的手术口罩可以消除语音并预防患者和医疗保健 听到难以唇读的工人。唇读是重要的视觉辅助 对于每个人来说，沟通对于那些聋哑人或听力障碍的人尤其重要。我们的目标是 完成透明的手术N95呼吸器面膜的发展，以防止传染病 传播和改善医疗保健人员和听力障碍患者之间的沟通。 在第一阶段，我们成功地开发并测试了具有透明的原型外科N95呼吸器面膜 使患者和医疗保健工人能够看到彼此的嘴唇的窗户，同时保持受保护 面具的屏障功能。与听力学系的Sam Atcherson博士的合作研究 阿肯色大学小石城的语音病理学证明了面具的视觉援助，表明 中度或重度听力损失的组受益于来自的视觉输入 原型面具。获得专利的面具蒙版™将透明窗口与两个N95过滤组合 能力和独特的抗菌涂层可杀死细菌。在第二阶段，我们建议优化面具设计， 建立可扩展的生产过程，并进行进一步的测试以支持510（k）间隙，NIOSH 批准和商业化面罩™手术N95呼吸器。具体来说，我们将1）优化 FaceView Mask™并与最终用户进行调查研究，以确保舒适和有效的密封 气道； 2）与医疗保健专业人员（包括美国标志）进行比较产品测试 语言口译员会收集他们对面罩™与领先不透明手术N95的看法 呼吸器面具； 3）执行510（k）清除率和NIOSH批准面view蒙版所需的测试； 4）在标准实验室测试和医疗保健工人使用中测试其抗菌性能。