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Background The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; “masks”). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. Methods We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. Results Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2–5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. Conclusions Many FFRs 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 to assist end users in acquiring legitimate products. 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 regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.

Background In response to supply shortages caused by the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or “masks”), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under “reuse” and “extended use” policies. However, the reusability of N95 masks is limited by degradation of fit. Possible substitutes, such as KN95 masks meeting Chinese standards, frequently fail fit testing even when new. The purpose of this study was to develop an inexpensive frame for damaged and poorly fitting masks using readily available materials and 3D printing. Results An iterative design process yielded a mask frame consisting of two 3D printed side pieces, malleable wire links that users press against their face, and cut lengths of elastic material that go around the head to hold the frame and mask in place. Volunteers (n = 45; average BMI = 25.4), underwent qualitative fit testing with and without mask frames wearing one or more of four different brands of FFRs conforming to US N95 or Chinese KN95 standards. Masks passed qualitative fit testing in the absence of a frame at rates varying from 48 to 94 % (depending on mask model). For individuals who underwent testing using respirators with broken or defective straps, 80–100 % (average 85 %) passed fit testing with mask frames. Among individuals who failed fit testing with a KN95, ~ 50 % passed testing by using a frame. Conclusions Our study suggests that mask frames can prolong the lifespan of N95 and KN95 masks by serving as a substitute for broken or defective bands without adversely affecting fit. Use of frames made it possible for ~ 73 % of the test population to achieve a good fit based on qualitative and quantitative testing criteria, approaching the 85–90 % success rate observed for intact N95 masks. Frames therefore represent a simple and inexpensive way of expanding access to PPE and extending their useful life. For clinicians and institutions interested in mask frames, designs and specifications are provided without restriction for use or modification. To ensure adequate performance in clinical settings, fit testing with user-specific masks and PanFab frames is required.

The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.

The disruption of conventional manufacturing, supply, and distribution channels for medical supplies during the COVID-19 pandemic has caused widespread shortages and catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework utilizes extensive stakeholder engagement, comprehensive and dynamic needs assessment, local manufacturing, and product testing for the accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing and discuss relevant regulatory policies. We highlight the applicability of the crisis-responsive framework to a successful local program that designed and supplied face shields for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing and changes in regulatory policy that strike a balance between rigidity and uncontrolled innovation.

Proper disinfection using adequate disinfecting agents will be necessary for infection control strategies against coronavirus disease 2019 (COVID-19). However, limited guidance exists on effective surface disinfectants or best practices for their use against severe acute respiratory coronavirus 2. We outlined a process of fully characterizing over 350 products on the Environmental Protection Agency List N, including pH, method of delivery, indication for equipment sterilization, and purchase availability. We then developed a streamlined set of guidelines to help rapidly evaluate and select suitable disinfectants from List N, including practicality, efficacy, safety, and cost/availability. This resource guides the evaluation of ideal disinfectants amidst practical considerations posed by the COVID-19 pandemic.

ObjectiveThe COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including filtering facepiece respirators (FFRs) such as N95 masks. These masks are normally intended for single use, but their sterilization and subsequent reuse could substantially mitigate a world-wide shortage.DesignQuality assurance.SettingA sealed environment chamber installed in the animal facility of an academic medical center.InterventionsOne to five sterilization cycles using ionized hydrogen peroxide (iHP), generated by SteraMist® equipment (TOMI; Frederick, MD).Main outcome measuresPersonal protective equipment, including five N95 mask models from three manufacturers, were evaluated for efficacy of sterilization following iHP treatment (measured with bacterial spores in standard biological indicator assemblies). Additionally, N95 masks were assessed for their ability to efficiently filter particles down to 0.3µm and for their ability to form an airtight seal using a quantitative fit test. Filtration efficiency was measured using ambient particulate matter at a university lab and an aerosolized NaCl challenge at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory.ResultsThe data demonstrate that N95 masks sterilized using SteraMist iHP technology retain function up to five cycles, the maximum number tested to date. Some but not all PPE could also be sterilized using an iHP environmental chamber, but pre-treatment with a handheld iHP generator was required for semi-enclosed surfaces such as respirator hoses.ConclusionsA typical iHP environment chamber with a volume of ~80 m3 can treat ~7000 masks per day, as well as other items of PPE, making this an effective approach for a busy medical center.

Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment (PPE) for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of simple products such as protective face shields. As a consequence, many public domain designs for face shields have become available. No clear path exists, however, for introducing a locally fabricated and unapproved product into a clinical setting. In a US health care setting, face shields are regulated by the Food and Drug Administration (FDA); similar policies exist in other countries. We describe a research protocol under which rapid iteration on an existing design, coupled with clinical feedback and real-world testing in an emergency department, allowed a face shield to be implemented by the members of the incident command team at a major academic medical center. We describe our design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of face shields and related products. All designs, materials used, testing protocols, and survey results are reported in full to facilitate the execution of similar face shield efforts in other clinical settings. Our work serves as a case study for development of a robust local response to pandemics and other health care emergencies, with implications for healthcare professionals, hospital administrators, regulatory agencies and concerned citizens.

The current COVID-19 pandemic has led to a dramatic shortage of masks and other personal protective equipment (PPE) in hospitals around the globe [1]. One component of PPE that is in particular demand are disposable N95 face masks. To alleviate this, many methods of N95 mask sterilization have been studied and proposed with the hope of being able to safely reuse masks [2]. Two major considerations must be made when re-sterilizing masks: (1) the sterilization method effectively kills pathogens, penetrating into the fibers of the mask, and (2) the method does not degrade the operational integrity of the N95 filters.We studied Cobalt-60 (60Co) gamma irradiation as a method of effective sterilization without inducing mask degradation. Significant literature exists supporting the use of gamma radiation as a sterilization method, with viral inactivation of SARS-CoV reported at doses of at most 10 kGy [3], with other studies supporting 5 kGy for many types of viruses [4]. However, concerns have been raised about the radiation damaging the fiber material within the mask, specifically by causing cross-linking of polymers, leading to cracking and degradation during fitting and/or deployment [5, 6].A set of 3M 8210 and 9105 masks were irradiated using MIT’s 60Co irradiator. Three masks of each type received 0 kiloGray (kGy), 10 kGy and 50 kGy of approximately 1.3 MeV gamma radiation from the circular cobalt sources, at a dose rate of 2.2kGy per hour.Following this sterilization procedure, the irradiated masks passed a OSHA Gerson Qualitative Fit Test QLFT 50 (saccharin apparatus) [7] when donned correctly, performed at the Brigham and Women’s Hospital, in a blinded study repeated in triplicate. However, the masks’ filtration of 0.3 µm particles was significantly degraded, even at 10 kGy.These results suggest against gamma, and possibly all ionizing radiation, as a method of disposable N95 sterilization. Even more importantly, they argue against using the qualitative fit test alone to assess mask integrity.

Treatment of keratinocyte carcinomas requires an assessment of the extent of tumor spread. Visual delineation of tumor margins is error-prone owing to the limited contrast between cancerous and normal skin. In this contribution, we introduce spectrally-encoded optical polarization imaging and evaluate its performance for preoperative demarcation of keratinocyte carcinomas. Subjects with basal or squamous cell carcinoma, scheduled for Mohs surgery, were enrolled. The surgeon outlined the clinical boundary of each lesion preoperatively. Optical images of the lesions were then acquired at 440 and 640 nm. Spectral encoding of the experimental images minimized the impact of background pigmentation and vascularization. The surgeon was blinded to the imaging results. Margin assessments by imaging and by the surgeon were recorded and compared with the intraoperative histopathology. In total, 53 lesions were imaged in vivo. Thirteen cases required more than one Mohs stage. In all these cases, images accurately visualized the tumor. For cases negative following the first Mohs stage, margin assessments correlated with histopathology in 39 out of 40 cases. Imaging demonstrated 100% sensitivity and 98% specificity. Spectrally-encoded optical polarization imaging may prove valuable for real-time noninvasive preoperative delineation of skin cancer.

Background Traditionally, Mohs layers are excised using a beveled incision to facilitate tissue flattening for tangential sectioning. Some surgeons perform non-beveled incisions; however, these specimens may be harder for the histotechnician to process. Limited data exist comparing slide quality between these techniques. Methods Retrospective review of cases performed by two Mohs surgeons (surgeon 1 = non-beveled incision; surgeon 2 = beveled incision) using different incision angles between June 2014 and December 2016. Daily histopathologic slide quality assessment scores (maximum score = 5, minimum score = 1) of the day's first case were compared. Results About 536 slides (surgeon 1 = 277, surgeon 2 = 259) were evaluated from 2,825 cases. Mean quality assessment scores were similar between surgeons (4.89 and 4.86; P = 0.31) with missing or folded epidermis being the most commonly reported issue for both surgeons. Conclusion Similar slide quality can be achieved via both beveled and non-beveled Mohs cutting angles. While more relaxing incisions may be necessary to optimize tissue flattening with non-beveled incisions, there is no associated increased loss of epidermal margins. The potential benefits of non-beveled incisions, such as minimizing tangentially cut adnexal structures and creating vertical wound edges optimized for repair, may offer an alternative technique with positive clinical implications.

Background Intense itch associated with atopic dermatitis (AD) can negatively impact sleep. However, the nature of sleep disturbance and fatigue in AD has not been fully elucidated. Objectives The aim of this study was to determine the burden of sleep disturbance and fatigue in US adults with AD. Methods This study used a cross-sectional, questionnaire-based survey using a nationally representative sample of 5563 adults from the 2005 to 2006 National Health and Nutrition Examination Survey. Respondents were asked about history of AD, sleep disturbance, and fatigue-related instrumental activity of daily living (IADL) impairment. Results There was no significant association between having AD and having a diagnosed sleep disorder (10.44% vs 7.27%; odds ratio [OR] [95% confidence interval (CI)], 1.49 [0.84-2.64]; P = 0.23); however, respondents were more likely to report sleep disturbances to clinicians (33.38% vs 23.67%; OR [95% CI], 1.62 [1.10-2.38]; P = 0.04). In multivariate regression models controlling for sociodemographic and lifestyle factors, adults with AD had higher odds of sleep disturbances, including shorter sleep duration (adjusted OR [95% CI], 1.61 [1.16-2.25]), trouble falling asleep (adjusted OR [95% CI], 1.57 [1.10-2.24]), and early morning awakenings (adjusted OR [95% CI], 1.86 [1.24-22.78]). Those with AD also had significantly higher odds of feeling unrested and feeling too tired to perform IADLs. Conclusions United States adults with AD have significantly impaired sleep and fatigue affecting IADLs, and sleep disturbances may be underdiagnosed in this population.

In the present study, we demonstrate that adult atopic dermatitis is associated with decreased moderate-vigorous and overall physical activity as judged by actigraphy. Such decreased activity may place atopic dermatitis patients at higher risk for cardiovascular disease.

Background Systemic corticosteroids are often used to treat atopic dermatitis (AD). However, few studies have assessed the safety and efficacy of systemic corticosteroids in AD. Objective To systematically review the literature on efficacy and safety of systemic corticosteroid use (oral, intramuscular, and intravenous) in AD. Methods PubMed, Embase, Medline, Scopus, Web of Science, and Cochrane Library were searched. We included systematic reviews, guidelines, and treatment reviews of systemic corticosteroid use among patients of all ages with a diagnosis of AD (52 reviews and 12 studies). Results There was general consensus in the literature to limit the use of systemic steroids to short courses as a bridge to steroid-sparing therapies. Systemic side effects include growth suppression in children, osteoporosis, osteonecrosis, adrenal insufficiency, Cushing syndrome, hypertension, glucose intolerance, diabetes, gastritis, gastroesophageal reflux, peptic ulcer disease, weight gain, emotional lability, behavioral changes, opportunistic infections, cataracts, glaucoma, myopathy, myalgia, dysaesthesia, pseudotumor cerebri, hyperlipidemia, malignancy, thrombosis, skin atrophy, sleep disturbance, and rebound flaring. Limitations Baseline clinical severity, corticosteroid delivery and dose, and treatment response were reported incompletely and heterogeneously across studies. Conclusions Evidence is not strong enough to determine optimal delivery or duration of systemic corticosteroids in AD.

Carcinogenesis involves multiple mechanisms that disturb genomic integrity and encourage abnormal proliferation. The immune system plays an integral role in maintaining homeostasis and these mechanisms may arrest or enhance dysplasia. There exists a large body of evidence from organ transplantation literature supporting the significance of the immune suppression in the development of skin cancer. Nonmelanoma skin cancers are the most frequent neoplasms after organ transplantation, with organ transplant recipients having a 65-fold increase in squamous cell carcinoma incidence and 10-fold increase in basal cell carcinoma incidence. Similarly, UV-radiation (UVR) induced immunosuppression is correlated with the development of cutaneous malignancies in a dose-dependent manner. This was first shown several decades ago by Margaret Kripke, when transplanted tumors were rejected in mice with competent immune systems, but grew unchecked in immunosuppressed specimens. After UV exposure, chromophores initiate a cascade that leads to immunosuppression via derangement of Langerhans cells' antigen-presenting capacity. UV-irradiated Langerhans cells present antigens to Th2 cells, but fail to stimulate Th1 cells. A subset of T regulatory cells, specific for the antigen encountered after UVR, is also stimulated to proliferate. In general UV irradiation leads to a greater number of T regulatory cells and fewer effector T cells in the skin, shiftingthe balance from T-cell-mediated immunity to immunosuppression. These regulatory cells have the phenotype CD4+, CD25+, Foxp3+, CTLA-4+. These and many other changes in local immunity lead to a suppressed immune state, which allow for skin cancer development.

Carcinogenesis involves multiple mechanisms that disturb genomic integrity and encourage abnormal proliferation. The immune system plays an integral rxole in maintaining homeostasis and these mechanisms may arrest or enhance dysplasia. There exists a large body of evidence from organ transplantation literature supporting the significance of the immune suppression in the development of skin cancer. Nonmelanoma skin cancers are the most frequent neoplasms after organ transplantation, with organ transplant recipients having a 65-fold increase in squamous cell carcinoma incidence and 10-fold increase in basai cell carcinoma incidence. Similarly, UV-radiation (UVR) induced immunosuppression is correlated with the development of cutaneous malignancies in a dose-dependent manner. This was flrst shown several decades ago by Margaret Kripke, when transplanted tumors were rejected in mice with competent immune systems, but grew unchecked in immunosuppressed specimens. After UV exposure, chromophores initiate a cascade that leads to immunosuppression via derangement of Langerhans cells' antigen-presenting capacity. UV-irradiated Langerhans cells present antigens to Th2 cells, but fail to stimulate Thl cells. A subset of T regulatory cells, speciflc for the antigen encountered after UVR, is also stimulated to proliferate. In general UV irradiation leads to a greater number of T regulatory cells and fewer effector T cells in the skin, shiftingthe balance from T-cell-mediated immunity to immunosuppression. These regulatory cells have the phenotype CD4+, CD25+, Foxp3+, CTLA-4+. These and many other changes in local immunity lead to a suppressed immune state, which allow for skin cancer development.

The assessment of photoaging is a huge component not only in clinical practice, but also in human research studies geared towards anti-aging therapies, photoprotection or mechanistic studies to understand the effects of ultraviolet light on the skin. However, evaluation remains difficult to standardize. Photonumeric scales are superior to descriptive evaluations, and have been used with some validity and reproducibility. Newer techniques that employ more sophisticated imaging modalities may be necessary. In addition, consideration of skin color, ethnicity, gender, and specific anatomic regions of the face play a role in the evaluation.

Importance Contact allergy to methylisothiazolinone (MI) or to the combined formulation of methylchloroisothiazolinone and MI (MCI-MI) has increased significantly, with a frequency of as much as 11.1% in patients with dermatitis; however, few cohort studies in the US population have been reported. Objective To investigate the prevalence of contact allergies to MI and MCI-MI and the outcomes of patients with positive patch test reactions to MI and MCI-MI. Design, Setting, and Participants Retrospective medical record review of all consecutive patients (n = 703) presenting with possible allergic contact dermatitis and subsequently undergoing patch testing at a tertiary referral center from January 1, 2012, through November 30, 2014. Patch testing used the North American Contact Dermatitis Group standard series. The MCI-MI concentration was 100 ppm; the MI concentration in the screening series increased from 200 to 2000 ppm in January 2013. Demographic data, exposures, and outcomes were reported for patients with positive patch test reactions to MI and/or MCI-MI. Data were analyzed from December 1, 2014, through January 31, 2015. Main Outcomes and Measures Positive patch test reaction to MI and/or MCI-MI and identification of the relevance of contact allergy to these preservatives. Follow-up after allergen avoidance was determined when available. Results Of the 703 patients who underwent patch testing, contact allergy to MI and/or MCI-MI occurred in 57 patients (8.1%), with 35 reactions to MI only, 5 reactions to MCI-MI only, and 17 reactions to both. Prevalence of contact allergy to MI increased from 6 of 236 patients (2.5%) in 2012 to 16 of 235 patients (6.8%) in 2014. The most commonly affected sites were the hands and face. Contact allergy to MI and/or MCI-MI was occupationally related in 4 cases. Cosmetics, soaps and cleansers (including wet wipes), and hair care products accounted for all identified sources. Twenty-three patients had follow-up data, and 17 of these (74%) improved with allergen avoidance. Conclusions and Relevance The increasing prevalence of contact allergy to MI alone supports its addition to the standard series to identify cases missed by testing only for MCI-MI. Recent regulations by the European Commission have banned MCI-MI in all leave-on body products as of July 16, 2015. Currently recommended US regulations are less stringent; however, US regulatory agencies must act to ensure patient safety.