Harvard Radiation Oncology Program, Brigham and Women's Hospital, Boston, Massachusetts, USA.
David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
BMJ Open. 2020 Jul 7;10(7):e039120. doi: 10.1136/bmjopen-2020-039120.
To develop and test a new reusable, sterilisable N95 filtering facepiece respirator (FFR)-comparable face mask, known as the Injection Molded Autoclavable, Scalable, Conformable (iMASC) system, given the dire need for personal protective equipment within healthcare settings during the COVID-19 pandemic.
Single-arm feasibility study.
Emergency department and outpatient oncology clinic.
Healthcare workers who have previously undergone N95 fit testing.
Fit testing of new iMASC system.
Primary outcome is success of fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method, and secondary outcomes are user experience with fit, breathability and filter replacement.
Twenty-four subjects were recruited to undergo fit testing, and the average age of subjects was 41 years (range of 21-65 years) with an average body mass index of 26.5 kg/m. The breakdown of participants by profession was 46% nurses (n=11), 21% attending physicians (n=5), 21% resident physicians (n=5) and 12% technicians (n=3). Of these participants, four did not perform the fit testing due to the inability to detect saccharin solution on premask placement sensitivity test, lack of time and inability to place mask over hair. All participants (n=20) who performed the fit test were successfully fitted for the iMASC system using an OSHA-approved testing method. User experience with the iMASC system, as evaluated using a Likert scale with a score of 1 indicating excellent and a score of 5 indicating very poor, demonstrated an average fit score of 1.75, breathability of 1.6, and ease of replacing the filter on the mask was scored on average as 2.05.
The iMASC system was shown to successfully fit multiple different face sizes and shapes using an OSHA-approved testing method. These data support further certification testing needed for use in the healthcare setting.
鉴于在 COVID-19 大流行期间医疗环境中对个人防护设备的迫切需求，开发并测试一种新型可重复使用、可消毒的 N95 过滤式面罩（FFR）相当的面罩，称为注塑可消毒、可扩展、贴合（iMASC）系统。
单臂可行性研究。
急诊室和门诊肿瘤诊所。
以前接受过 N95 适配测试的医护人员。
新 iMASC 系统的适配测试。
主要结果是使用职业安全与健康管理局（OSHA）批准的测试方法进行适配测试的成功率，次要结果是用户对适配性、透气性和过滤器更换的体验。
共招募了 24 名受试者进行适配测试，受试者的平均年龄为 41 岁（21-65 岁），平均体重指数为 26.5kg/m。按专业划分的参与者分布为 46%的护士（n=11）、21%的主治医生（n=5）、21%的住院医生（n=5）和 12%的技术员（n=3）。在这些参与者中，由于无法在预面罩放置敏感性测试中检测到糖精溶液、缺乏时间和无法将面罩放在头发上，有 4 人未进行适配测试。所有进行适配测试的参与者（n=20）均成功使用 OSHA 批准的测试方法适配 iMASC 系统。使用李克特量表（分数 1 表示极好，分数 5 表示极差）评估 iMASC 系统的用户体验，平均适配分数为 1.75，透气性为 1.6，更换口罩上的过滤器的易用性平均评分为 2.05。
iMASC 系统使用 OSHA 批准的测试方法成功适配了多种不同的脸型和尺寸。这些数据支持在医疗环境中使用所需的进一步认证测试。
