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

新冠肺炎疫情突显出，有必要保护医护人员和其他弱势群体免受呼吸道感染，并促进企业复苏。个人防护装备(PPE)，特别是一次性、单用户、过滤面罩呼吸器(FFR)的需求量前所未有。由于持续的大流行，医院、初级保健诊所、牙科和住宿疗养院等医疗保健行业正面临中断、成本负担显著增加以及这些防护口罩持续供应不足的问题。因此，护理人员和他们的患者感染和传播新冠肺炎的风险增加。世卫组织估计，应对这一流行病每月需要8900万种FFR，全球产量需要至少增加100倍。世界市场上可用的有限库存正在引发价格上涨和医用级FFR的紧急短缺。此外，大量的“一次使用即丢弃”的FFR正在产生堆积如山的医疗废物，用于焚烧，对环境构成严重且日益严重的威胁。对“单一用户”FFR进行循环消毒，使同一佩戴者能够重复使用，是一个有吸引力的选择，以帮助管理有限的现有库存，并大幅减少丢弃的FFR的数量和随后对环境的破坏。目前的选择使用蒸汽灭菌、过氧化氢蒸汽、伽马照射或紫外线杀菌照射(UVGI)，但都存在重大缺陷，包括FFR变形以及巨大的成本、人员和时间开销。我们提出了一种快速可用的应对危机的方法，即一种低成本的医疗设备，使佩戴者能够快速而轻松地使用靠近使用点的设备来净化他们的“单一用户”FFR。该设备的目的是简化和加快消毒过程，以延长每个口罩的寿命，使用一种高效的过程，而不损害其功能完整性。该设备是一种使用紫外线(UV)-C波段的“翻盖”消毒器，众所周知，紫外线(UV)-C波段可以杀死微生物。它由一个手提式单元组成，在每个治疗周期中，该单元将单个FFR完全封闭在高反射环境中。一旦达到了杀灭任何污染微生物所需的UV-C辐射强度和曝光时间，该设备就会自动关闭并打开。这项创新建立在开发单片选择性金属化聚合物结构的多年经验基础上。每个设备的使用生命周期为1000小时。FFR消毒周期将只需不到10分钟，使每个设备可以节省多达12,000个FFR的使用和处置。这将避免在需要焚烧处理的日益堆积如山的医疗废物中增加12,000个FFR对环境的影响。医护人员和其他“高危”群体可能会被提供这种设备，涉及数百万台的销售。消毒剂的成功开发和商业化将在英国制造(塑料注射、组装等)、销售、分销和产品支持领域创造就业机会。

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.