Singular secular Kuznets-like period realized amid industrial transformation in US FDA medical devices: a perspective on growth from 1976 to 2020.

INTRODUCTION: Since inception, the United States (US) Food and Drug Administration (FDA) has kept a robust record of regulated medical devices (MDs). Based on these data, can we gain insight into the innovation dynamics of the industry, including the potential for industrial transformation?. AREAS COVERED: Using premarket notifications (PMNs) and approvals (PMAs) data, it is shown that from 1976 to 2020 the total composite (PMN+PMA) metric follows a single secular period: 20.5 years (applications - peak-to-peak: 1992-2012; trough: 2002) and 26.5 years (registrations - peak-to-peak: 1992-2019; trough: 2003), with a peak-to-trough relative percentage difference of 24% and 28%, respectively. Importantly, PMNs and PMAs independently present as an inverse structure. EXPERT OPINION: The evidence suggests that MD innovation is driven by a singular secular Kuznets-like cyclic phenomenon (independent of economic crises) derived from a fundamental shift from simple (PMNs) to complex (PMAs) MDs. Portentously, while the COVID-19 crisis may not affect the overriding dynamic, the anticipated yet significant (~25%) MD innovation drop may be potentially attenuated with attentive measures by MD stakeholders. Limitations of this approach and further thoughts complete this perspective.

Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety.

Avoidable harm associated with medication is a persistent problem in health systems and the use of preprogrammed infusion devices ('smart pumps') and data monitoring is seen as a core approach to mitigating and reducing the incidence of these harms. However, smart pumps are costly to procure, configure and maintain (in both human and financial terms) and are often poorly implemented. Variation in the manner in which medicines are prepared and used within complex modern healthcare systems exacerbates these challenges, and a strategic human-centred approach is needed to support their implementation. A symposium of 36 clinical and academic medication safety experts met virtually to discuss the current 'state of the art' and to propose strategic recommendations to support the implementation of medication administration technology to improve medication safety. The recommendations were that health systems (1) standardise infusion concentrations to facilitate the development of ready-to-administer formulations of frequently used medicines, and support 'out of the box' programming of infusion devices; (2) develop and implement drug libraries using human-centred approaches and the aforementioned standard concentrations, with a theoretical understanding of how devices are used in practice; (3) develop standardised metrics and outcomes to support the interpretation of data produced by infusion devices; (4) involve all stakeholders in the development of drug libraries and metrics to ensure broad understanding of the devices, their benefits and limitations; and (5) leverage input into device design, working with manufacturers and users. Using this strategic approach, it is then possible to envisage and plan real-world implementation studies using a uniform approach to quantify improvements in safety, efficiency and cost effectiveness.

Measurement of filtration efficiencies of healthcare and consumer materials using modified respirator fit tester setup.

During the current SARS-CoV-2 pandemic there is unprecedented demand for personal protective equipment (PPE), especially N95 respirators and surgical masks. The ability of SARS-CoV-2 to be transmitted via respiratory droplets from asymptomatic individuals has necessitated increased usage of both N95 respirators in the healthcare setting and masks (both surgical and homemade) in public spaces. These precautions rely on two fundamental principles of transmission prevention: particle filtration and droplet containment. The former is the focus of NIOSH N95 testing guidelines, and the latter is an FDA guideline for respirators and surgical masks. While studies have investigated droplet containment to provide guidance for homemade mask production, limited work has been done to characterize the filtration efficiency (FE) of materials used in home mask making. In this work, we demonstrate the low-cost (<$300) conversion of standard equipment used to fit-test respirators in hospital and industrial settings into a setup that measures quantitative FEs of materials based on NIOSH N95 guidelines, and subsequently measure FEs of materials found in healthcare and consumer spaces. These materials demonstrate significant variability in filtration characteristics, even for visually similar materials. We demonstrate a FE of 96.49% and pressure drop of 25.4 mmH20 for a double-layer of sterilization wrap used in surgical suites and a FE of 90.37% for a combination of consumer-grade materials. The excellent filtration characteristics of the former demonstrate potential utility for emergent situations when N95 respirators are not available, while those of the latter demonstrate that a high FE can be achieved using publicly available materials.

Use, Safety Assessment, and Implementation of Two Point-of-Care Tests for COVID-19 Testing.

OBJECTIVES: The Abbot ID NOW COVID-19 assay and Quidel Sofia 2 SARS Antigen FIA are point-of-care assays that offer rapid testing for severe acute respiratory syndrome coronavirus 2 viral RNA and nucleocapsid protein, respectively. Given the utility of these devices in the field, we investigated the feasibility and safety of using the ID NOW and Sofia assays in the public health response to the coronavirus disease 2019 pandemic and in future public health emergencies. METHODS: A combination of utilization and contamination testing in addition to a review of instrument workflows was conducted. RESULTS: Utilization testing demonstrated that both tests are intuitive, associated with high user test success (85%) in our study, and could be implemented by staff after minimal training. Contamination tests revealed potential biosafety concerns due to the open design of the ID NOW instrument and the transfer mechanisms with the Sofia. When comparing the workflow of the ID NOW and the Sofia, we found that the ID NOW was more user-friendly and that the transfer technology reduces the chance of contamination. CONCLUSIONS: The ID NOW, Sofia, and other emerging point-of-care tests should be used only after careful consideration of testing workflow, biosafety risk mitigations, and appropriate staff training.

[How did the private labs fit onto COVID-19 crisis?] / Comment les laboratoires de biologie médicale privés français se sont adaptés à la crise de la COVID-19 ?

Confronted with the COVID-19 crisis, healthcare professionals have had to tackle an epidemic crisis of a huge magnitude for which they were not prepared. Medical laboratories have been on the front line, from collecting samples to performing the analysis required to diagnose this new pathology. Responding to the needs and to the urgency of the situation, the authorities relied on the network of private laboratories. In France, private laboratory medicine represents 70% of overall activity, and with a network of more than 4,000 local laboratories, private laboratory medicine has been the cornerstone of the « screen-trace-isolate ¼ strategy. This article gives feedback from private laboratory medicine professionals, directly involved in the reorganization carried out at the pre-analytical, analytical and post-analytical stages, during the crisis from March to October 2020.

Exploring options for reprocessing of N95 Filtering Facepiece Respirators (N95-FFRs) amidst COVID-19 pandemic: A systematic review.

BACKGROUND: There is global shortage of Personal Protective Equipment due to COVID-19 pandemic. N95 Filtering Facepiece Respirators (N95-FFRs) provide respiratory protection against respiratory pathogens including SARS-CoV-2. There is scant literature on reprocessing methods which can enable reuse of N95-FFRs. AIM: We conducted this study to evaluate research done, prior to COVID-19 pandemic, on various decontamination methods for reprocessing of N95-FFRs. METHODS: We searched 5 electronic databases (Pubmed, Google Scholar, Crossref, Ovid, ScienceDirect) and 1 Grey literature database (OpenGrey). We included original studies, published prior to year 2020, which had evaluated any decontamination method on FFRs. Studies had evaluated a reprocessing method against parameters namely physical changes, user acceptability, respirator fit, filter efficiency, microbicidal efficacy and presence of chemical residues post-reprocessing. FINDINGS AND CONCLUSIONS: Overall, we found 7887 records amongst which 17 original research articles were finally included for qualitative analysis. Overall, 21 different types of decontamination or reprocessing methods for N95-FFRs were evaluated. Most commonly evaluated method for reprocessing of FFRs was Ultraviolet (Type-C) irradiation (UVGI) which was evaluated in 13/17 (76%) studies. We found published literature was scant on this topic despite warning signs of pandemic of a respiratory illness over the years. Promising technologies requiring expeditious evaluation are UVGI, Microwave generated steam (MGS) and based on Hydrogen peroxide vapor. Global presence of technologies, which have been given Emergency use authorisation for N95-FFR reprocessing, is extremely limited. Reprocessing of N95-FFRs by MGS should be considered for emergency implementation in resource limited settings to tackle shortage of N95-FFRs. SYSTEMATIC REVIEW IDENTIFIER: PROSPERO, PROSPERO ID: CRD42020189684, (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020189684).

COVID-19: smoke testing of surgical mask and respirators.

BACKGROUND: Fluid Resistant Surgical Masks have been implemented in UK personal protective equipment (PPE) guidelines for COVID-19 for all care sites that do not include aerosol-generating procedures (AGPs). FFP3 masks are used in AGP areas. Concerns from the ENT and plastic surgery communities out with intensive care units have questioned this policy. Emerging evidence on cough clouds and health care worker deaths has suggested that a review is required. AIMS: To test the efficacy of Fluid Resistant Surgical Mask with and without adaptions for respiratory protection. To test the efficacy of FFP and FFP3 regarding fit testing and usage. METHODS: A smoke chamber test of 5 min to model an 8-h working shift of exposure while wearing UK guideline PPE using an inspiratory breathing mouthpiece under the mask. Photographic data were used for comparison. RESULTS: The Fluid Resistant Surgical Mask gave no protection to inhaled smoke particles. Modifications with tape and three mask layers gave slight benefit but were not considered practical. FFP3 gave complete protection to inhaled smoke but strap tension needs to be 'just right' to prevent facial trauma. Facial barrier creams are an infection risk. CONCLUSIONS: Surgical masks give no protection to respirable particles. Emerging evidence on cough clouds and health care worker deaths suggests the implementation of a precautionary policy of FFP3 for all locations exposed to symptomatic or diagnosed COVID-19 patients. PPE fit testing and usage policy need to improve to include daily buddy checks for FFP3 users.

Safe Slit-lamp Shield: Maintaining a balance between ergonomics and safety.

Since the emergence of COVID pandemic, health workers have been facing major challenges every day. Ophthalmology practice has encountered countless modifications in the practice pattern not to jeopardize patient care and at the same time maintain all safety measures to reduce transmission. One such modification we made was the Safe Slit-Lamp Shield (SSS) which has been found to be extremely protective in differentiation to other available shield. Although SSS has a larger surface area when compared to already available shields, it won't compromise the comfort of the clinician at the same time gives satisfactory protection.

Firearm purchasing and storage during the COVID-19 pandemic.

To better understand motivations behind purchase and storage of firearms during the COVID-19 pandemic, we used Amazon Mechanical Turk to conduct an online survey of individuals who did and did not purchase a firearm since 1 January 2020 in response to COVID-19. The survey was fielded between 1 and 5 May 2020. We asked about motivations for purchase, changes in storage practices and concern for themselves or others due to COVID-19. There were 1105 survey respondents. Most people who purchased a firearm did so to protect themselves from people. Among respondents who had purchased a firearm in response to COVID-19 without prior household firearm ownership, 39.7% reported at least one firearm was stored unlocked. Public health efforts to improve firearm-related safety during COVID-19 should consider increasing access to training and framing messages around the concerns motivating new firearm purchase.

Novel manufacturing of simple masks in response to international shortages: Bacterial and particulate filtration efficiency testing.

Many healthcare systems have been forced to outsource simple mask production due to international shortages caused by the COVID-19 pandemic. Providence created simple masks using surgical wrap and submitted samples to an environmental lab for bacterial filtration efficiency testing. Bacterial filtration efficiency rates ranged from 83.0% to 98.1% depending on specific material and ply, and particular filtration efficiency rates ranged from 92.3% to 97.7%. Based on mask configuration, specific surgical wrap selected, and ply, the recommended filtration efficiency for isolation and surgical masks of 95% and 98%, respectively can be achieved. These alternative masks can allow for similar coverage and safety when hospital-grade isolation masks are in short supply.

Quality Assurance During a Global Pandemic: An Evaluation of Improvised Filter Materials for Healthcare Workers.

OBJECTIVE: The proliferation of improvised masks during the COVID-19 pandemic has raised questions regarding filter effectiveness and safety. We sought to compare the effectiveness of commonly used improvised filter materials against N95 industry standards. METHODS: Six different filter materials commonly used in the community were tested using both single- and multi-layer configurations with the TSI 8130 automated filter tester in accordance with National Institute for Occupational Safety and Health (NIOSH) standards for N95 respirators. RESULTS: Only three of the tested filter material configurations met N95 parameters with regard to filtration efficiency and pressure drop across the filter material-the: True-high-efficiency particulate air (HEPA) filter, four-layer MERV 13 and 14 HVAC filters. CONCLUSIONS: Many proposed filter materials for improvised masks do not meet current industry standards and may pose safety and efficacy concerns. Care should be taken when selecting materials for this critical respirator component, particularly for health care workers or others at high risk for pathogen exposure.

Reprocessing filtering facepiece respirators in primary care using medical autoclave: prospective, bench-to-bedside, single-centre study.

OBJECTIVE: There are widespread shortages of personal protective equipment as a result of the COVID-19 pandemic. Reprocessing filtering facepiece particle (FFP)-type respirators may provide an alternative solution in keeping healthcare professionals safe. DESIGN: Prospective, bench-to-bedside. SETTING: A primary care-based study using FFP-2 respirators without exhalation valve (3M Aura 1862+ (20 samples), Maco Pharma ZZM002 (14 samples)), FFP-2 respirators with valve (3M Aura 9322+ (six samples) and San Huei 2920V (16 samples)) and valved FFP type 3 respirators (Safe Worker 1016 (10 samples)). INTERVENTIONS: All masks were reprocessed using a medical autoclave (17 min at 121°C with 34 min total cycle time) and subsequently tested up to three times whether these respirators retained their integrity (seal check and pressure drop) and ability to filter small particles (0.3-5.0 µm) in the laboratory using a particle penetration test. RESULTS: We tested 33 respirators and 66 samples for filter capacity. All FFP-2 respirators retained their shape, whereas half of the decontaminated FFP-3 respirators showed deformities and failed the seal check. The filtering capacity of the 3M Aura 1862 was best retained after one, two and three decontamination cycles (0.3 µm: 99.3%±0.3% (new) vs 97.0±1.3, 94.2±1.3% or 94.4±1.6; p<0.001). Of the other FFP-2 respirators, the San Huei 2920 V had 95.5%±0.7% at baseline vs 92.3%±1.7% vs 90.0±0.7 after one-time and two-time decontaminations, respectively (p<0.001). The tested FFP-3 respirator (Safe Worker 1016) had a filter capacity of 96.5%±0.7% at baseline and 60.3%±5.7% after one-time decontamination (p<0.001). Breathing and pressure resistance tests indicated no relevant pressure changes between respirators that were used once, twice or thrice. CONCLUSION: This small single-centre study shows that selected FFP-2 respirators may be reprocessed for use in primary care, as the tested masks retain their shape, ability to retain particles and breathing comfort after decontamination using a medical autoclave.

SARS-COV-2 in Ophthalmology: Current Evidence and Standards for Clinical Practice.

INTRODUCTION: COVID-19 is caused by the coronavirus SARS-CoV-2. Ocular manifestations have been reported including conjunctivitis and retinal changes. Therefore, it is of the utmost importance to clarify eye involvement in COVID-19 in order to help with its diagnosis and to further prevent its transmission. The purpose of this review is to describe the structure and transmission of SARS-CoV-2, reported ocular findings and protection strategies for ophthalmologists. MATERIAL AND METHODS: Literature search on PubMed for relevant articles using the keywords 'COVID-19', 'coronavirus', and 'SARS-CoV-2' in conjunction with 'ophthalmology' and 'eye'. Moreover, official recommendations of ophthalmological societies were reviewed. RESULTS: Although the conjunctiva is directly exposed to extraocular pathogens, and the mucosa of the ocular surface and upper respiratory tract are connected by the nasolacrimal duct, the eye is rarely involved in human SARS-CoV-2 infection and the SARS-CoV-2 RNA positive rate by RT-PCR test in tears and conjunctival secretions from patients with COVID-19 is also extremely low. DISCUSSION: The eye can be affected by SARS-CoV-2, which is supported by some reports of conjunctivitis and retinal changes, but its role in the spread of the disease is still unknown. CONCLUSION: Given the current scarce evidence, more research is needed to clarify the relationship between SARS-CoV-2 and the eye.

Introdução: COVID-19 é o nome atribuído à doença causada pelo novo coronavírus - SARS-CoV-2. Esta infeção rapidamente atingiu uma disseminação mundial, face ao aumento da globalização e adaptação do vírus a ambientes distintos. Foram descritas manifestações oftalmológicas em doentes com COVID-19, nomeadamente, conjuntivite e alterações retinianas. Assim, é fundamental esclarecer o envolvimento ocular na COVID-19, contribuindo para o seu diagnóstico precoce e limitando a sua transmissão. O objetivo desta revisão é descrever a estrutura e o modo de transmissão do SARS-CoV-2, assim como manifestações oculares reportadas e estratégias de proteção para oftalmologistas. Material e Métodos: Revisão dos artigos relevantes publicados na PubMed usando as palavras-chave 'COVID-19', 'coronavirus' e 'SARS-CoV-2' em associação com as palavras 'ophthalmology' e 'eye'. Além disso, foi feita uma revisão das recomendações oficiais de várias sociedades oftalmológicas a nível mundial. Resultados: Apesar da conjuntiva estar diretamente exposta a patógenos exógenos, e da mucosa da superfície ocular e do trato respiratório superior estarem conectados pelo canal nasolacrimal, o olho raramente parece ser afetado pelo SARS-CoV-2. A infeção por SARS-CoV-2 e a taxa de positividade para a pesquisa do RNA do SARS-CoV-2 pelo teste de RT-PCR em lágrimas e secreções conjuntivais de pacientes com COVID-19 também são extremamente baixas. Discussão: O olho pode ser afetado pelo SARS-CoV-2, dada a descrição de casos de conjuntivite e alterações retinianas, mas o seu papel na disseminação da doença ainda é desconhecido. Conclusão: Dada a escassa evidência atual, são necessários mais estudos para esclarecer a relação entre o SARS-CoV-2 e o globo ocular.

Chest Radiographs and CTs in the Era of COVID-19: Indications, Operational Safety Considerations and Alternative Imaging Practices.

Coronavirus disease-19 (COVID-19) is a pathogen that has shown an ability for sustained community transmission. To ensure utmost safety, radiology services will need to adapt to this disease in the coming months and possibly years ahead. This will include learning how to perform radiographs and CT in a safe and sustainable manner. Due to the risk of nosocomial spread of disease, the judicious use and implementation of strict infection protocols is paramount to limit healthcare worker and patient transmission. Between 28 January 2020 and 8 June 2020, our institution performed 12,034 radiographs and 178 CT scans for suspected or confirmed COVID-19 patients. As of 8 June 2020, there have been no documented instances of healthcare staff acquiring COVID-19 during the course of work. In this article, we present the indications and operational considerations used by our institution to safely image patients with suspected or confirmed COVID-19. Alternative practices for imaging radiographs are also discussed.

Ventilator management of adult patients in the emergency department.

There are a variety of ventilator options available to the emergency clinician, and decisions on choosing optimal settings will depend on the clinical circumstances. Understanding the latest literature in ventilator management can improve patient outcomes by ensuring optimal oxygenation and ventilation and reducing the potential for ventilator-induced lung injury. This article reviews the most appropriate ventilator settings for a variety of conditions in intubated adult patients presenting to the emergency department, and gives recommendations on monitoring the ventilated patient and making ventilator adjustments. An update on managing COVID-19-associated acute respiratory distress syndrome is also included.

Can the Elastic of Surgical Face Masks Stimulate Ear Protrusion in Children?

In this period of the Covid-19 pandemic, a protective mask has become a common object of use to contain virus transmission. The imminent need for masks has led many governments to produce them, including surgical masks with elastic loops or masks with side cuts at the ears. Among those on the market, surgical masks with elastic loops are the ones most chosen by parents for their children. These elastics cause constant compression on the skin and, consequently, on the cartilage of the auricle, leading to erythematous and painful lesions of the retroauricular skin when the masks are used for many hours a day. Pre-adolescent children have undeveloped auricular cartilage with less resistance to deformation; prolonged pressure from the elastic loops of the mask at the hollow or, even worse, at the anthelix level can influence the correct growth and angulation of the outer ear. In fact, unlike when using conservative methods for the treatment of protruding ears, this prolonged pressure can increase the cephaloauricular angle of the outer auricle. It is important for the authorities supplying the masks to be aware of this potential risk and for alternative solutions to be found while maintaining the possibility of legitimate prevention of the potential spread of the virus.Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the table of contents or the online instructions to authors www.springer.com/00266 .