Enabling multiple reprocessing of filtering face-piece respirator (FFR) masks as personal protective equipment (PPE) using a high intensity UV-C radiation portable medical device

COVID-19疫情凸显了保护医护人员及其他弱势群体免受呼吸道感染及促进业务复苏的必要性。个人防护设备（PPE），特别是一次性、单用户、过滤式面罩呼吸器（FFR）的需求量前所未有。由于疫情持续，医院、基层医疗机构、牙科及安老院等医疗保健业务正面临中断、成本负担大幅增加及该等防护口罩供应持续不足。因此，护理人员及其患者感染和传播COVID-19的风险增加。世卫组织估计，每月需要8900万个FFRs来应对大流行，全球产量需要增加至少100倍。世界市场上有限的库存正在引发价格上涨和医用级FFR的紧急短缺。此外，本发明还提供了一种方法，大量的“一次性使用并扔掉”的FFR被丢弃，造成了大量的医疗废物用于焚烧，这对环境造成了严重和日益严重的威胁。由同一佩戴者使用是一个有吸引力的选择，以帮助管理有限的现有库存，并大大减少被丢弃的FFR的数量和随后的损坏，环境保护目前的选择利用蒸汽灭菌、过氧化氢蒸汽、伽马辐照或紫外线杀菌辐照（UVGI），但所有这些都具有显著的缺点，包括FFR变形以及显著的成本，我们提出了一个快速可用的应对危机的形式，低成本的医疗设备，将使佩戴者能够净化他们的“单一的，使用位于使用点附近的设备快速轻松地测量用户的FFR。其目的是简化和加快消毒过程，以延长每个口罩的使用寿命，使用高效的过程，而不损害其功能的完整性。该设备是一个“翻盖式”消毒器，使用紫外线（UV）-C波段，这是已知的杀死微生物。它由一个便携式装置组成，在每个治疗周期中，该装置将单个FFR完全封闭在高反射环境中。一旦达到杀死任何污染微生物所需的UV-C辐射强度和暴露时间，该设备就会自动关闭并打开。这项创新建立在多年开发单片选择性金属化聚合物结构的经验基础上。每个设备的使用寿命为1000小时。FFR消毒周期将花费不到10分钟的时间，使每台器械能够节省多达12，000个FFR的使用和处置。这将避免增加12，000个FFRs对日益增加的医疗废物的环境影响，这些废物需要通过焚烧处理。医疗工作者和其他“高危”群体可以获得该设备，涉及数百万单位的销售。消毒剂的成功开发和商业化将为英国制造业（塑料注射、组装等）创造就业机会，销售、分销和产品支持。

The COVID-19 pandemic has highlighted the need to protect healthcare staff and other vulnerable groups from respiratory infection and to promote business recovery. Personal protective equipment (PPE), notably disposable, single-user, filtering face-piece respirators (FFRs) are required in unprecedented quantities. Due to the ongoing pandemic, healthcare businesses such as hospitals, primary care practices, dental and residential care homes, are facing disruption, a significantly increased cost burden and a sustained inadequate supply of these protective face masks. As a result, care givers and their patients are at increased risk of contracting and spreading COVID-19\.The WHO has estimated that 89 million FFRs are needed every month in response to the pandemic and worldwide production needs to increase by at least 100 fold. The limited stocks available on the world market are provoking price-inflation and an emergent shortage of medical grade FFRs. In addition, the substantial quantity of 'use once and throw away' FFRs being discarded is creating a mountain of medical waste for incineration that presents a serious and growing threat to the environment.The cyclic sanitisation of 'single-user' FFRs to enable re-use by the same wearer is an attractive option to help manage the limited existing stock and dramatically reduce the quantity of FFRs being discarded and the subsequent damage to the environment. Current options utilise steam-sterilisation, hydrogen peroxide vapour, gamma irradiation or ultraviolet germicidal irradiation (UVGI), but all have significant shortfalls including FFR deformation alongside significant cost, personnel and time overheads.We propose a rapidly available response to the crisis in the form of a low-cost medical device that will enable the wearer to decontaminate their 'single-user' FFRs quickly and easily using a device situated in close proximity to the point-of-use. The purpose is to simplify and speed up the sanitisation process to prolong the lifespan of each facemask using a highly effective process that does not damage their functional integrity.The device is a 'clamshell' sanitiser that uses the ultraviolet (UV)-C waveband, which is known to kill microbes. It consists of a hand-transportable unit that fully encloses a single FFR in a highly reflective environment during each treatment cycle. Once the intensity of UV-C radiation and exposure time required to kill any contaminating microbes has been achieved, the device automatically switches off and opens. The innovation builds on many years of experience developing monolithic selectively metallised polymer structures.Each device will have an in-use lifecycle of 1000 hours. The FFR sanitisation cycle will take less than 10 minutes enabling each device to save the use and disposal of up to 12,000 FFRs per device. This will avoid the environmental impact of adding 12,000 FFRs to the growing mountain of medical waste that requires disposal by incineration. Healthcare workers and other 'at risk' groups could be supplied with the device, involving the sale of multiple millions of units. The successful development and commercialisation of the sanitiser would generate UK employment in manufacturing (plastic injection, assembly etc.), sales, distribution and product support.