Plana Deborah, Tian Enze, Cramer Avilash K, Yang Helen, Carmack Mary M, Sinha Michael S, Bourgeois Florence T, Yu Sherry H, Masse Peter, Boyer Jon, Kim Minjune, Mo Jinhan, LeBoeuf Nicole R, Li Ju, Sorger Peter K
Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA.
Harvard-MIT Division of Health Sciences & Technology, Cambridge, MA, USA.
medRxiv. 2020 Jul 27:2020.07.25.20161968. doi: 10.1101/2020.07.25.20161968.
During the current COVID-19 pandemic, supply chains for Personal Protective Equipment (PPE) have been severely disrupted and many products, particularly surgical N95 filtering facepiece respirators (FFRs; "masks") are in short supply. As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union.
We conducted a survey of mask in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer. We then assembled a simple apparatus for performing a necessary (but not sufficient) test of filtration performance and tested masks from the inventory; an accompanying website shows how to build and use the testing apparatus.
Our survey showed that, seven months after the start of the COVID-19 pandemic, over 100 different makes and models of N95-type masks are in the inventory of local hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many did not perform to accepted standards and are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers in the FDA EUA and confusing or inconsistent labeling of KN95 masks, it is difficult to distinguish legitimate and counterfeit products.
Many of the FFR masks available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations for end users to assist in acquiring legitimate products. In particular, institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for U.S and Chinese regulatory agencies with regard to labeling and public disclosure aimed at increase pandemic resilience.
在当前的新冠疫情期间，个人防护装备（PPE）的供应链受到严重干扰，许多产品，尤其是外科N95过滤式面罩呼吸器（FFR；“口罩”）供应短缺。因此，美国食品药品监督管理局（FDA）的紧急使用授权（EUA）允许进口符合国际标准生产的N95型口罩；这些包括来自中国的KN95口罩和来自欧盟的FFP2口罩。
我们对马萨诸塞州波士顿主要学术医疗中心库存中的口罩进行了调查，以确定其来源和制造商。然后，我们组装了一个简单的装置来进行过滤性能的必要（但不充分）测试，并对库存中的口罩进行了测试；一个配套网站展示了如何构建和使用测试装置。
我们的调查显示，在新冠疫情开始七个月后，当地医院库存中有100多种不同品牌和型号的N95型口罩，而在正常情况下只有2 - 5种型号。大量不熟悉的口罩来自未知制造商。许多口罩不符合公认标准，很可能是假冒产品。由于FDA EUA中缺乏关于口罩供应商的公开信息，以及KN95口罩标签混乱或不一致，难以区分正品和假冒产品。
在新冠疫情期间可供采购的许多FFR口罩提供的贴合度和过滤水平与N95口罩不同，不适合在医疗环境中使用。基于这些结果，并与职业健康官员协商，我们为终端用户提出六项建议，以帮助获取合法产品。特别是，机构应始终通过将口罩的标记和制造商信息与美国国家职业安全与健康研究所（NIOSH）提供的数据和最新的FDA EUA附录A进行核对，来评估来自非传统供应链的口罩。在缺乏口罩来源合法性的可核实信息时，机构应考虑直接测量口罩的贴合度和过滤效果。我们还就标签和公开披露向美国和中国监管机构提出建议，以增强应对疫情的能力。
