key: cord-0821490-iasgz5id authors: Chaturvedi, Satyam; Gupta, Amartya; Krishnan S, Vimal; Bhat, Anil K. title: Design, usage and review of a cost effective and innovative face shield in a tertiary care teaching hospital during COVID-19 pandemic date: 2020-07-24 journal: J Orthop DOI: 10.1016/j.jor.2020.07.003 sha: 5018d4a6bbb6272dbaad2d4cfd8b977e6af96b8b doc_id: 821490 cord_uid: iasgz5id BACKGROUND: A major challenge of the coronavirus pandemic is personal protective equipment (PPE) shortage. The open source community mobilised solutions to combat this using 3D printing technology. One such solution was the face shield, which protects facial areas from droplet contamination when used by orthopaedic and other front line health care workers (HCWs). OBJECTIVES: To assess the efficacy of an in-house developed face shield based on feedback by HCWs and its usage in triaging zones and operation theatre in a tertiary care hospital. METHODS: A protective face shield was developed and distributed among the orthopaedic surgeons and front line HCWs involved in the ICU in our hospital and neighbouring facilities. Feedback was obtained using a questionnaire utilising a Likert scale. RESULTS: 227 face shields were distributed to the HCWs in our hospital (157) and neighbouring facilities (70). Design modifications were done as per the needs of the HCWs. 37 HCWs provided feedback giving the face shields an overall mean score of 7.92 out of 10. The poly vinyl chloride (PVC) film visors were better for airway management procedures as it can be tucked into PPE suit and visors with overhead projector (OHP) sheets were suitable for ICU and operative procedures. CONCLUSION: A locally developed face shield design by an inter disciplinary team in synchrony with HCWs is found to increase its acceptability and efficacy. Face shields can be made more effective in different triaging and treatment situations by varying the device setup. We would like to thank Kasturba Medical College and Hospial, Manipal, MAHE for their support. We also thank the departments of Orthopaedics, Emergency Medicine, and Critical Care in Kasturba Hospital for their valuable inputs and feedback. We would like to acknowledge "Hastha -Center for Congenital Hand Differences", Kasturba Medical College, Manipal, MAHE for its support in face shield development and 3D printing. Coronavirus disease or COVID-19 as labelled by the World Health Organization (WHO) has spread rapidly affecting more than 5,000,000 people in more than 210 countries . 1 The rapidity of its spread has placed an enormous burden on hospitals and other healthcare facilities. This accompanied with nation-wide lockdowns have hampered the availability and accessibility of required personal protective equipment (PPE). 2 The open source community emerged with cost effective solutions that could be developed locally like face shields, masks, etc. These solutions are being widely propagated in urban areas with large scale 3D printing facilities and Maker labs. However, the disbursement of said products to hospitals and clinics in smaller cities and towns is hindered due to the lockdown imposed and travel restriction within the country. In such cases, innovative design and in-house production becomes crucial to get the best functional outcomes in the production of PPE. The presence of a 3D printing facility at our institution enabled the immediate creation of protective face shields tailored to the needs of the Healthcare Workers (HCWs) at our hospital. At first glance, compared with the field of infectious diseases and emergency medicine, the role of an A face shield is classified as a PPE that provides protection to the facial area and related mucous membranes (ear, nose and mouth) from splashes, sprays and splatter of bodily fluids. 7 It is mostly used in conjunction with level D PPEs , which are commonly utilized by first receivers in hospitals and other facilities. 8 In light of the coronavirus pandemic, which is spread primarily through aerosolized contaminants and droplet and contact infection, 6 there are recommendations to use face shields as part of the PPE by the World Health Organization (WHO) 9 , and many other such organisations. Out of the four PPE for the facial region namely, Full face shield, Full face shield with N95 respirator, Surgical Mask with eye shield, and safety glasses with N95 respirator; the Full-face shield with N95 respirator is the most effective. 10 With technical experts mobilizing to help front line HCWs, face shields are being produced in large numbers as they can be made by readily available materials. Methods of manufacture range from easy Do It Yourself (DIY) options to 3D printed options. Face shields are used as alternatives to goggles as they extend protection to other facial areas apart from the eyes and protect from splashes, sprays and aerosolized contaminants. Lindsley et al. 11 experimented to gauge the efficacy of face shields against coughs using a coughing patient simulator and a breathing worker simulator. They found that, for an influenza laden aerosol with a volume mean diameter (VMD) of 8.5µm, face shields reduced inhalation exposure by 96% and surface contamination of a respirator by 97% immediately after a cough at a distance of 45.7cm. With smaller cough aerosols of VMD 3.4µm, the face shield blocked 68% of the inhalation exposure and 78% surface contamination. If the aerosol is allowed to disperse in a room, the effectiveness of the face shield reduces and it blocks inhalation by 23%. Suboptimal adherence to wearing face shields during aerosol generating procedures was identified by Tak Ching et al. 12 as an independent risk factor associated with the acquisition of an influenza like illness by health care workers. Shmuel Shoham et al. 10 The plastic visor can be any clear plastic sheet. The sheets used in this study were soft 0.125mm Polyvinyl Chloride (PVC) film and stiff A4/A3 Overhead Projector (OHP) sheets. The PVC film was chosen because of its soft and malleable form, allowing it to be inserted into the PPE gown which can provide a greater degree of protection during procedures such as wound care, dressings, traction and those involving the airway at triage area and ICU. The stiff OHP sheet was also an alternative because it can be cleaned easily and can be used by HCWs not utilising the level D PPE gown as it maintains its shape and provides good visibility. This was used in wards and operation theatre predominantly. These are attached to the frame using either paper or binder clips. The use of binder clips is essential to the design as it reduces the manufacturing effort in negating the need for punching holes into the plastic visors. It also allows for quick disassembly and can be disposed off and replaced if contaminated. The steps in the assembly process can be seen in Fig. 2. Additive manufacturing (3D printing) was used for the face shield designed above. The material used was polylactic acid (PLA). The print settings were optimized to achieve the lowest time possible on the given printer: 0.25mm layer height, 20% infill, and 2 shells. The model takes one hour and 59 minutes to print and uses 20.2g of PLA material. The settings can be adjusted on different 3D printers to yield faster prints. The model can also be stacked one on top of the other to maximize overnight printing efficiency. The total cost of production amounts to INR 75/-making this an economical device considering the capacity for reuse. The face shields can be reused and it is important that each healthcare professional using the face shields must be assigned one dedicated device for use, disinfection and reuse. 13 Prior to disinfection, the face shield set-up must be disassembled. Face shields with the PVC film visor need to discard the visor after use and replace it for the next cycle of use. Face shields with the OHP sheet as the visor can have the OHP sheet changed if it is excessively scratched, damaged and it impairs user vision. The disinfection procedures to be followed are as per the recommendations by the CDC with standard disinfection solutions like isopropyl alcohol or sodium hypochlorite and perform proper hand hygiene later 13. It is advised to discard the paper or binder clips after a cycle of use, however in situations requiring reuse they can be disinfected using an EPA registered hospital disinfectant solution. The face shields were distributed to the HCWs in our hospital to a cohort of orthopaedic surgeons, emergency medicine physicians, and nurses. 2. In NON-COVID triage: A3/A4 size OHP sheets was used as the visor of the face shield to provide basic splash and droplet protection. 3. In Orthopaedic Operation Theatre (OT): When using the PPE hood for Covid or Covid suspect patients, the face shield frame was used in conjunction with the hood to provide an offset between the face and the hood visor to accommodate the eye goggles and the N95 mask for greater comfort. A questionnaire (Table 1 ) was designed to gain feedback on the devices. The questionnaire uses a Likert scale to record the responses, with the range: 0-3 indicating a negative response, 3-6 indicating a neutral response, and 6-10 indicating a positive response. Following the use of the face shields after a duration of two weeks, the questionnaire was filled by the end users. A total of 227 face shields were printed of which 157 were distributed to the HCWs in our hospital with the options for using PVC film or the OHP sheet. An additional 70 shields were distributed to other local clinics and hospitals. We obtained a feedback from 37 healthcare professionals of our institute during the design and manufacturing phase of these protective face shields. The results of the feedback can be seen in Table 2 . Thus, the feedback makes it evident that the protective face shield was well received by the end users and hence we could finalise the design and release it for larger use to become an essential part of the PPE. Shortage and ineffective implementation of PPE were the primary reasons behind the high number of infected healthcare workers during the beginning of the pandemic. 15 As per the literature, face shields, while not providing absolute protection from contamination, do significantly mitigate the chances of contracting the virus. 10, 11, 12 Face shields have seen a major upsurge in production by individuals with access to 3D printers and by large companies. 16 infection. In OTs, the use of the face shields with the PPE hood to augment user comfort is shown to work and can be implemented in not just Orthopaedic OTs but other areas as well where the PPE hood has to be used. One of the major issues with face shields and the PPE hood is the fogging of the visor which impairs the end users' ability during procedures and surgery. The discomfort of the end user due to lack of adequate ventilation is also a major area of concern. Although majority of these problems of PPE discomfort can be evaded by using a level C PPE with a Powered Air-Purifying Respirator (PAPR), these devices are expensive and not easily available in Low and Middle Income Countries such as India. We circumvented this problem by making a small opening at the top of the PPE which is not a part of sterile area and has given reasonably good results. However, this is not a permanent solution to the issue. Thus, a major area for innovation in the future would be the development of low cost devices that reduces fogging, improves ventilation and user comfort. The face shield in light of the coronavirus pandemic has become an integral part of the PPE used by HCWs. The collaboration between technical experts and HCWs will play a pivotal role in the success of such endeavours. Through this article, we can summarise that it is an achievable task to design, manufacture and use locally developed 3D printed face shields. The cost effectiveness, ergonomics, reusability and acceptance were assessed among orthopaedic surgeons and emergency medicine personnel and revealed positive feedback on all variables considered. The acceptability of the 3D printed face shield was high and it held preference over the regular hood setup that are donned as part of the level D PPE. Face shields can also be made more effective in different triaging and clinical settings by varying the device setup. Thus, we suggest that economic and innovative local solutions like these may help tide over the current PPE crisis which is unmasked by the COVID-19 pandemic. The present initiative addresses the basic principles of health care delivery in terms of availability, accessibility, acceptability and affordability with an interdisciplinary approach which makes it eligible to upscale for a mass production level. Tables: Table 1 : Questionnaire for feedback on 3D printed Protective Face Shield. Answer on a scale of 0 to 10: 0 1 2 3 4 5 6 7 8 9 10 0-3: negative response, 3-6: neutral response. 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