Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing.

The Bacterial Endotoxins Test (BET) is a critical safety test that is used to detect bacterial endotoxins, which are the major contributor to fever-inducing contamination risks known as pyrogens. All parenteral therapies, including every lot of injected drugs, vaccines, medical devices, must be tested for pyrogens to ensure patient safety. Bacterial endotoxins test methods were developed as a highly sensitive detection method for bacterial endotoxins, after the discovery of a clotting cascade in horseshoe crab blood. However, horseshoe crab species are limited to some inshore coastal habitats along the Atlantic coast of the USA and others throughout Asia. Fully functional horseshoe crab clotting factors can be manufactured via recombinant protein production, and several BET methods featuring recombinant horseshoe crab proteins have now been developed for commercial use. Recombinant Bacterial Endotoxins Test (rBET) methods based on the use of recombinant Factor C (rFC) were established in the European Pharmacopoeia - however, these methods have not yet been granted compendial status in the United States Pharmacopoeia (USP). In order to facilitate dialogue between stakeholders, the Physicians Committee for Responsible Medicine hosted two virtual roundtable discussions on the perceived barriers to the use of rBET methods for US FDA requirements. Stakeholders agreed that multiple rFC-based methods have been demonstrated to have suitable analytical performance, as described in ICH Q2 on the Validation of Analytical Procedures and USP <1225> on the Validation of Compendial Procedures. United States Pharmacopoeia compendial inclusion of the rFC-based and other rBET methods was favoured, in order to reduce the additional burdens created by a lack of global harmonisation on BET testing requirements.

Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy.

INTRODUCTION: The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model. METHODS: Computed tomography (CT)-guided RAB MWA was performed in the peripheral lung parenchyma of 17 Yorkshire swine (40-50 kg) and procedural adverse events (AEs) documented. The acute group (day 0, n = 5) received 4 MWAs at 100 W for 1, 3, 5, and 10 min in 4 different lung lobes. Subacute and chronic groups (days 3 and 30, n = 6 each) received one MWA (100 W, 10 min) per animal. RESULTS: The study was completed without major procedural complications. No postprocedural AEs including death, pneumothorax, bronchopleural fistula, hemothorax, or pleural effusions were observed. No gross or histological findings suggestive of thromboembolism were found in any organ. One 3-Day and one 30-Day swine exhibited coughing that required no medication (minor AEs), and one 30-Day animal required antibiotic medication (major AE) for a suspected lower respiratory tract infection that subsided after two weeks. CT-based volumetric estimates of ablation zones in the acute group increased in an ablation time-dependent (1-10 min) manner, whereas macroscopy-based estimates showed an increasing trend in ablation zone size. CONCLUSION: The NEUWAVE FLEX and MONARCH devices were safely used to perform single or multiple RAB MWAs. The preclinical procedural safety profile of RAB MWA supports clinical research of both devices to investigate efficacy in select patients with oligometastatic disease or primary NSCLC.

[Analysis of Radio Frequency Identification Immunity Standard for Medical Equipment].

Aiming at the increasing application of RFID technology in the medical environment, this study introduces the foreign requirements for RFID immunity test of medical devices, compares them with the current immunity test requirements of medical devices in China, and puts forward the necessity of establishing relevant test specifications in China.

Brain responsive neurostimulation device safety and effectiveness in patients with drug-resistant autoimmune-associated epilepsy.

PURPOSE: This study examines the safety and effectiveness of brain-responsive neurostimulation (RNS System) therapy in patients with refractory autoimmune-associated epilepsy (AAE). METHODS: We retrospectively reviewed 85 medical records of patients who were treated with the RNS System at the three Mayo Clinic sites to identify patients with AAE. We collected clinical data including demographics, epilepsy history, prior evaluations and treatment, RNS implantation and lead information, long term ambulatory electrocorticography (ECoG) data, and patient-reported seizure details. Inclusion criteria included: (1) confirmed neural antibodies, or absent/negative autoimmune panel with Antibody Prevalence in Epilepsy (APE2) score ≥ 4 and (2) at least 6 months of follow up after RNS implantation. The primary outcomes measured were patient-reported seizure frequencies at last follow-up as compared to baseline, ECoG long-episode frequencies, and adverse events following RNS implantation. RESULTS: Of the 85 patients reviewed, nine (11 %) met the inclusion criteria. Three patients had GAD65 antibodies (mean serum titer = 816 ug/dl), one had Rasmussen's encephalitis (biopsy proven), and five had absent/negative neuronal antibody panel but APE scores were ≥ 4. Six out of nine patients (67 %) reported improvement in clinical seizure frequency, all reported improvements in seizure duration and intensity. Four of 9 patients (44 %) showed trends of decreasing frequency of prolonged periods of epileptiform activity over time. One patient (11 %) developed a superficial wound infection at the implant site. CONCLUSION: The findings from our study suggest that adjunctive treatment with the RNS System may be a safe option for patients with refractory AAE.

Left Atrial Appendage Ligation Using the AtriClip Device: Single-Center Study of Device Safety and Efficacy.

Objective: Left atrial appendage (LAA) occlusion at the time of cardiac surgery in patients with atrial fibrillation has been shown to reduce the incidence of postoperative embolic stroke. However, the optimal method for LAA occlusion is not universally accepted. We sought to examine the safety and effectiveness of LAA occlusion with the AtriClip epicardial occlusion device. Methods: Cardiac surgical patients with atrial fibrillation who underwent LAA AtriClip placement were evaluated prospectively. Clip placement and clinical outcomes were examined after 1 year of follow-up with transesophageal echocardiography (TEE). The presence of a 10 mm or greater residual pouch, presence of flow into the LAA, or device-related thrombus (DRT) were considered failures. Results: Ninety-seven patients were analyzed. The mean CHA2DS2-VASc score was 2.4 ± 1.4. The postoperative follow-up period ranged from 366 to 1,693 days (mean 685 days or 1.87 years). Seventy-four AtriClips were placed with video-assisted thoracic surgery, whereas 23 were placed via sternotomy or thoracotomy. Successful closure was found in 96% (93 of 97) of patients at follow-up. Failure occurred in 4 patients. No clip migration or DRT was seen on 3-dimensional imaging. Of all 97 patients, 76 (78%) were on presurgical oral anticoagulation, whereas 5 (5.1%) were on postprocedure oral anticoagulation. There were no postoperative thromboembolic events at the time of the study TEE. Conclusions: The AtriClip epicardial surgical occlusion device can provide an excellent rate of successful closure of the LAA during surgical ablation procedures without DRT.

Cleanability of Metal Surface Finishes Found in Medical Devices and the Environment of Care.

The surface finish of reusable medical devices often is a consideration during design, with attention paid to utility, aesthetics, and cost. To study the cleanability of metal surfaces of varying roughness and finish, soil made of bovine blood and egg yolk was placed on nickel alloy surface of varying average roughness (Ra) values (nominal values of 2-500 µin) and finishes (lapped, ground, milled, profiled, and shape turned). A commercially available wipe consisting of quaternary ammonium compound and less than 20% alcohol was applied for a total of eight wipe cycles to remove the soil. The wipe was applied in both horizontal and vertical directions. Evaluation methods for cleanliness include visual inspection and adenosine triphosphate (ATP) measurement. Rougher surfaces above nominal Ra of 250 were found to have higher ATP readings when wiped in both horizontal and vertical directions. In addition, different surface finishes have different cleanabilities despite similar nominal Ra. To ensure optimal cleaning, surfaces should be cleaned in multiple directions. In the future, similar studies will be coupled with efficacy studies and surfaces made with other materials will be investigated.

Speed of sound in the IEC tissue-mimicking material and its maintenance solution as a function of temperature.

Tissue-Mimicking Material (TMM) is defined on IEC International Standards and applied in assessing ultrasonic diagnostic and therapeutic equipment's basic safety and essential performance. One of the TMM that fits IEC standards specification has its recipe described at IEC 60601-2-37, and it is fabricated using glycerol (11.21 %), deionized water (82.95%), benzalkonium chloride (0.47 %), silicon carbide (0.53 %), aluminum oxide 0.3 µm (0.88%), aluminum oxide 3.0 µm (0.94 %), and agar (3.08 %). Glycerol is the component responsible for adjusting the TMM's speed of sound. Moreover, it is recommended to store TMM in a closed container immersed in a mixture of water (88.1 %)/glycerol (11.9 %) to prevent it from drying out and avoiding air contact. The literature points out TMM measurements underwater can alter the speed of sound property as TMM tends to lose glycerol. Herein, the authors proposed to assess the viability of measuring the TMM speed of sound in the water/glycerol maintenance solution. First, the authors characterized the maintenance solution's speed of sound for a temperature range of 20 °C to 45 °C. Then, the group velocity of a set of TMM was measured underwater and in the maintenance solution for the same temperature range. The respective group velocity expanded uncertainty was calculated. The results indicate it is feasible to measure TMM in the maintenance solution, achieving group velocity values with no statistical difference from the ones measured underwater in the temperature range of 20 °C to 40 °C.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

OBJECTIVE: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.

Secondary Medication Administration and IV Smart Pump Setup.

ABSTRACT: Secondary infusion by large-volume IV smart pump is used extensively in the acute care setting for one-time or intermittent administration of medications such as antibiotics, electrolyte replacements, and some oncology drugs. Consistent and accurate delivery of secondary medications requires a full understanding of the system and setup requirements. Unfortunately, it is not uncommon for nurses to find a secondary medication only partially administered when their programming should have resulted in a complete infusion. This article discusses the technical requirements that every nurse should know when administering secondary medications using an IV smart pump.

Nail gun injuries: not just an occupational hazard.

INTRODUCTION: Nail guns are commonly used in the construction industry. They represent an occupational hazard, and in the context of mental illness can pose a threat to life. AIM: To determine the number of patients admitted to Auckland City Hospital (ACH) with a nail gun injury, and to review the current New Zealand legislation surrounding nail guns. METHODS: A 25-year retrospective review of patients admitted to ACH with a nail gun injury was performed by searching the ACH Trauma Registry. New Zealand legislation was reviewed. RESULTS: Between 1994 and 2019, 45 patients were admitted to ACH with a nail gun injury. Two subgroups were identified: 31% with an intentional injury; 69% with an unintentional injury. All patients were male. The mean age was 36.3. Patients with an intentional injury had a higher mortality rate (21.4% vs 9.5%), Injury Severity Scores (24.2 vs 3.4) and ICU admission rate (50% vs 3%) and required more intensive post-injury care when compared to unintentional injuries. There is currently no legislation in New Zealand specifically governing the use of nail guns. Only powder-actuated nail guns require certification. CONCLUSION: The continued occurrence of unintentional nail gun injuries and the high lethality of intentional injuries represent two distinct areas of concern. The Government should publish guidance aimed at improving safety and reducing the rate of intentional injury.

The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.

A Multicenter Randomized Controlled Trial Comparing Safety, Efficacy, and Cost-effectiveness of the Surgisis Anal Fistula Plug Versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial.

OBJECTIVE: To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano. SUMMARY BACKGROUND DATA: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. METHODS: Participants were randomized to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and reintervention rates. RESULTS: Between May 2011 and March 2016, 304 participants were randomized to fistula plug or surgeon's preference. No differences were seen in FIQoL between the 2 groups at 12 months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon's preference groups at 12 months. Fecal incontinence rates improved marginally in both the groups. Complications and reinterventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs 25/137, 18%; P=0.002). The mean total costs were £2738 (s.d. £1151) for the fistula plug and £2308 (s.d. £1228) for the surgeon's preference group (mean difference +£430, P=0.0174). The average total quality adjusted life years (QALYs) gained was marginally higher in the fistula plug group. The fistula plug was 35% to 45% likely to be cost-effective across a willingness to pay threshold of £20,000 to £30,000 / QALY. CONCLUSIONS: The Biodesign Surgisis anal fistula plug is associated with similar FIQoL and healing rates to surgeon's preference at 12 months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.

MeVO SAVE technique: initial experience with the 167 cm long NeuroSlider 17 for a combined approach in medium vessel occlusions (MeVOs).

Goyal et al described occlusions in M2/3, A2/3 and P2/3 as medium vessel occlusions (MeVOs); the only available controlled data of mechanical thrombectomy (MT) in MeVOs is limited to the middle cerebral artery M2 segment, suggesting that MT may be effective and safe with high functional independence and recanalization rates. The Stent retriever Assisted Vacuum-locked Extraction (SAVE) technique in mechanical thrombectomy consists of the simultaneous use of a stent retriever and a distal aspiration catheter (DAC), with the removal of both as a unit when performing the thrombectomy pass; however, so far the low-profile (0.035 inch distal inner diameter) DACs were longer (160 cm) than conventional 0.017 inch microcatheters for MeVOs. We present a case of a combined approach MT in MeVO with the use of the new 167 cm long NeuroSlider 17 (Acandis, Pforzheim, Germany) 0.0165 inch microcatheter and 3MAX (Penumbra, Alameda, CA) through the SAVE technique-the MeVO SAVE technique. (video 1). neurintsurg;13/8/768/V1F1V1video 1.

Enseñanzas de la actividad otorrinolaringológica durante el pico de la pandemia por COVID-19 en España / Lessons learned from ENT activity during the peak of the COVID-19 pandemic in Spain

Introducción: la infección por el coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2) tiene una elevada incidencia entre profesionales sanitarios, especialmente otorrinolaringólogos (ORL). El objetivo de este estudio fue recoger aspectos organizativos, de seguridad y de protección de los ORL durante el pico de la pandemia por la enfermedad por coronavirus de 2019 (COVID-19) en España. Material y métodos: estudio transversal con una encuesta por correo electrónico a los socios ORL de la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello (SEORL-CCC). Resultados: respondieron 408 profesionales. La atención a pacientes con COVID-19 representó más del 25 % de la actividad asistencial para el 24,4 % de los encuestados. 213 encuestados (52,6 %) respondieron que algún compañero había guardado cuarentena o dado positivo en la prueba. La cantidad de facultativos diagnosticados con COVID-19 o que guardó cuarentena por síntomas compatibles osciló entre 1 y 12 por hospital (media 2,2; mediana 2) y se encontró una mayor incidencia en las regiones con mayor incidencia de coronavirus (62,1 % frente a 41,8 %; p < 0,001), atención directa a pacientes con COVID-19 (81 % frente a 46,4 %; p = 0,001) y actividad de guardias (p = 0,01). El 61,5 % de los especialistas en hospitalización y el 40,4 % en consultas no contaron siempre con la protección personal aconsejada. Conclusiones: la pandemia por COVID-19 ha alterado la organización y la actividad asistencial de los servicios de otorrinolaringología. Importancia clínica: los especialistas ORL no han contado siempre con los equipos de protección aconsejados por los protocolos y una cantidad relevante se ha visto afectada por la COVID-19.

Introduction: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has a high incidence among healthcare professionals, especially otorhinolaryngologists (ENT). Study objective: The objective of this study was to collect organizational, safety and protection aspects of otorhinolaryngologists during the peak of the coronavirus disease 2019 (COVID-19) pandemic in Spain. Material and methods: Cross-sectional study with an e-mail survey to the ENT partners of the Spanish Society of Otorhinolaryngology and Head and Neck Surgery (SEORL-CCC). Results: 408 professionals completed the survey. Care of patients with COVID-19 represented more than 25% of healthcare activity for 24.4% of respondents. 213 respondents (52.6%) answered that a colleague tested positive or had been quarantined. The number of ENT surgeons diagnosed with COVID-19 or who were quarantined for compatible symptoms ranged between 1 and 12 per hospital (mean 2.2; median 2) and was related to regions with the highest incidence of coronavirus (62.1% vs. 41,8%; p <0.001), direct care for patients with COVID-19 (81% vs. 46.4%; p = 0.001) and on call activity (p = 0.01). 61.5% of the specialists attending inpatients and 40.4% attending outpatients did not always have the recommended personal protective equipment (PPE). Conclusions: The COVID-19 pandemic has altered the organization and care activity of the otorhinolaryngology departments. Clinical importance: ENT specialists have not always had the protective equipment recommended by the protocols and a significant number have been affected by COVID-19.

Medical-device-related pressure injury on adults: an integrative review / Lesión por presión relacionada a dispositivos médicos en adultos: una revisión integradora / Lesão por pressão relacionada a dispositivo médico em adultos: revisão integrativa

ABSTRACT Objective: to identify factors associated with medical-device-related pressure injury. Method: an integrative review of published articles on the subject related to the adult population in the databases of PUBMED, Scopus, MEDLINE, Latin American and Caribbean Health Sciences Literature (Literatura Latino-Americana e do Caribe em Ciências da Saúde, LILACS), Web of Science and Nursing Database (Banco de Dados em Enfermagem, BDENF), between 2013 and 2018. Results: medical-device-related pressure injuries were common in adults, especially in the elderly, due to capillary fragility, among other changes. Other observed factors were length of stay, critically ill patients or those requiring any type of medical device. Numerous medical devices have been associated with skin lesions; among the most frequent were breathing, feeding, and orthopedic devices, tubes, oximeters, neck collars, patches and nasogastric tubes. Conclusion: the first step towards prevention is exploration in terms of identifying the types of injury-causing devices and evidence-based interventions, and disseminating information to the entire multidisciplinary team.

RESUMEN Objetivo: identificar factores asociados con las lesiones por presión relacionadas a dispositivos médicos. Método: revisión integradora de artículos publicados sobre el tema relacionado a la población adultas en las siguientes bases de datos: PUBMED, Scopus, MEDLINE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Web of Science y Banco de Dados em Enfermagem (BDENF), entre 2013 y 2018. Resultados: las lesiones por presión relacionadas con dispositivos médicos fueron comunes en adultos, principalmente en ancianos, debido a la fragilidad capilar, entre otras alteraciones. También se observaron otros factores como tiempo de permanencia, pacientes críticos o que necesitaban cualquier tipo de dispositivo médico. Se asoció un sinnúmero de dispositivos médicos a las lesiones de piel; entre los más frecuentes se pueden mencionar los dispositivos respiratorios, de alimentación y ortopédicos, los tubos, los oxímetros, los collares cervicales, los adhesivos y las sondas nasogástricas. Conclusión: el primer paso para la prevención es la exploración, en términos de identificar los tipos de dispositivos que causan la lesión y las intervenciones basadas en evidencias científicas, además de divulgar la información a todo el equipo multiprofesional.

RESUMO Objetivo: identificar fatores associados à lesão por pressão relacionada a dispositivo médico. Método: revisão integrativa de artigos publicados sobre o tema relacionado à população adulta nas bases de dados da PUBMED, Scopus, MEDLINE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Web of Science e Banco de Dados em Enfermagem (BDENF), entre 2013 e 2018. Resultados: lesões por pressão relacionadas a dispositivo médico foram comuns em adultos, principalmente em idosos, devido à fragilidade capilar, entre outras alterações. Outros fatores observados foram tempo de permanência, pacientes críticos ou que necessitassem de qualquer tipo de dispositivo médico. Inúmeros dispositivos médicos foram associados às lesões de pele; entre os mais frequentes estiveram dispositivos respiratórios, de alimentação, ortopédicos, tubos, oxímetros, colares cervicais, adesivos e sondas nasogástricas. Conclusão: o primeiro passo para a prevenção é a exploração, em termos de identificação dos tipos de dispositivos que causam a lesão e intervenções baseadas em evidências científicas, além da divulgação das informações para toda a equipe multiprofissional.

Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

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.

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).