How widely has ANTT been adopted in NHS hospitals and community care organisations in England and Scotland?

BACKGROUND: To the detriment of patient safety, the important clinical competency of aseptic technique has been notoriously variable in practice, and described ambiguously in the literature, internationally. From a UK perspective, attempts have been made to improve patient safety by reducing variability and improving education and practice through standardisation. The Welsh Government mandated Aseptic Non Touch Technique (ANTT®) as a specific national standard in 2015. All healthcare organisations in England are required by the Health and Social Care Act 2008 to have a single standard aseptic technique, demonstrable by the clinical governance indicators of education, training, competency assessment and compliance audit. In Scotland, an education-based initiative was launched by NHS Education for Scotland in 2012. To review the impact of these and other initiatives on the current status of aseptic technique, all NHS trusts in England and NHS health boards in Scotland were assessed under the Freedom of Information procedure. FINDINGS: 93% of NHS trusts in England use a single standard for aseptic technique. In 88% of these trusts the single standard was stipulated as being ANTT. In Scotland, 62% of NHS acute and community care hospitals within health boards use a single standard. In 56% of these, the single standard was ANTT. When including those that use ANTT in combination with other techniques ANTT usage is 73%. CONCLUSION: These data demonstrate significant progress in standardising aseptic technique education, assessment and governance, and confirms ANTT as the de facto aseptic technique used in NHS trusts in England and health boards in Scotland.

Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment.

Objectives: To design and execute a comprehensive microbiological validation protocol to assess a brand-new sterile compounding robot in a hospital pharmacy environment, according to ISO and EU GMP standards. Methods: Qualification of the Class-A inner environment of the robot was performed through microbial air and surface quality assessment utilising contact plates, swabs and particulate matter monitoring. To evaluate the effectiveness of the microbial decontamination process (UV rays) challenge test against Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis spores and Candida albicans was used. The challenge Media Fill test was used to validate the aseptic processing. Results: After 3 hours, no microorganisms retained viability. Monitoring inside the equipment evidenced complete absence of microorganisms. The Media Fill test was always negative. Conclusions: According to our results, the APOTECAunit meets the requirements for advanced aseptic processing in the hospital pharmacies and the pharmaceutical industry in general, providing advantages in terms of safety for patients compared with conventional procedures of parenteral preparation production. The protocol has demonstrated to be a comprehensive and valuable tool in validating, from a microbial point of view, a sterile-compounding technology. This study might represent an important benchmark in developing a contamination control strategy, as required, for example, in the Performance Qualification of the GMP in the case of drug manufacturing.

Manejo seguro de la ropa e higiene de la piel en pacientes y profesionales sanitarios frente al Covid-19: scoping review / Safe handling of clothing and hygiene of patients and health professionals: Scoping Review

INTRODUCCIÓN: En enero de 2020 aparece en China un brote de neumonía causada por un virus zoonótico (SARS-CoV-2). Se considera que la ruta principal de transmisión es por inhalación de grandes gotas respiratorias, por deposición en las mucosas y las manos o los fómites contaminados. El objetivo es identificar las intervenciones a realizar durante la hospitalización para un manejo correcto y seguro de la ropa e higiene de los pacientes y profesionales sanitarios. MÉTODO: Scoping review realizada sin delimitación cronológica ni de idioma en las bases de datos PUBMED y Cochrane. Rastreo de normas y recomendaciones de entidades gubernamentales nacionales e internacionales para responder a la pregunta de investigación sobre el manejo seguro de la ropa y la higiene de la piel en pacientes y en profesionales sanitarios para evitar el contagio por Covid-19. El análisis de los datos fue realizado en dos etapas: en la primera, identificación y categorización de los estudios, y en la segunda, análisis de contenido como criterio informativo y clasificatorio. RESULTADOS: Se han seleccionado 14 documentos, principalmente de entidades gubernamentales. Las recomendaciones se estructuran en 5 epígrafes sobre manejo de ropa e higiene de la piel de pacientes infectados y profesionales sanitarios en el ámbito hospitalario. CONCLUSIÓN: La ropa de los pacientes y del personal sanitario son vehículos transmisores de la enfermedad. Su correcto tratamiento ayuda a mejorar el control de la misma y a una correcta utilización de los recursos disponibles en estos momentos. La adecuada higiene de la piel, en especial la limpieza de las manos, constituye uno de los pilares básicos para la prevención y el control de la infección. Destacamos la semejanza de algunas de las pautas recogidas y proporcionadas por los diferentes organismos consultados

INTRODUCTION: In January 2020, an outbreak of pneumonia caused by a zoonotic virus (SARS-CoV-2) appeared in China. The main route of transmission is considered to be the inhalation of large respiratory drops, by deposition in the mucosa and hands or contaminated fomites. The objective is to identify the interventions to be performed during hospitalization for the correct and safe handling of clothing and hygiene of patients and health professionals. METHOD: Scoping review carried out without chronological or language delimitation in the PUBMED and Cochrane databases. Tracking standards and recommendations of national and international government entities to answer the research question on the safe handling of clothing and skin hygiene in patients and in health professionals to avoid Covid-19 infection. The data analysis was carried out in two stages: in the first, identification and categorization of the studies, and in the second, content analysis as an informative and classifying criterion. RESULTS: 14 documents have been selected, mainly from government entities. The recommendations are structured in 5 sections on the management of clothing and skin hygiene of infected patients and health professionals in the hospital setting. CONCLUSION: The clothing of patients and healthcare personnel are transmitting vehicles of the disease. Its correct treatment helps to improve the control of the same and the correct use of the resources available at the moment. Proper skin hygiene, especially hand cleansing, is one of the basic pillars for infection prevention and control.We highlight the similarity of some of the guidelines collected and provided by the different agencies consulted

Antisépticos en la práctica clínica. Guía de uso basada en la evidencia / No disponible

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Practising asepsis during dressing changes in community settings.

Community nurses often face challenges when going into a patient's home to change a dressing, particularly if the surroundings are likely to be contaminated by multiple strains of bacteria or viruses. For housebound patients, cleaning the house can be an extremely difficult task due to physical or mental illness. They may also experience a large amount of exudate as a result of possibly debilitating painful wounds, for example, leg ulcers, and may be prone to infection as a result of the difficulties posed in keeping a dressing covering a heavily exuding wound in a possibly unclean environment. Therefore, it is of the utmost importance that a community nurse or healthcare worker be able to change the wound dressing in the cleanest and most supportive manner. This article covers the most recent guidance and research relevant to the practice of aseptic or clean technique when changing dressings in the community.

Acute surgical wound-dressing procedure: Description of the steps involved in the development and validation of an observational metric.

The aim of this study was to develop an observational metric that could be used to assess the performance of a practitioner in completing an acute surgical wound-dressing procedure using aseptic non-touch technique (ANTT). A team of clinicians, academics, and researchers came together to develop an observational metric using an iterative six-stage process, culminating in a Delphi panel meeting. A scoping review of the literature provided a background empirical perspective relating to wound-dressing procedure performance. Video recordings of acute surgical wound-dressing procedures performed by nurses in clinical (n = 11) and simulated (n = 3) settings were viewed repeatedly and were iteratively deconstructed by the metric development group. This facilitated the identification of the discrete component steps, potential errors, and sentinel (serious) errors, which characterise a wound dressing procedure and formed part of the observational metric. The ANTT wound-dressing observational metric was stress tested for clarity, the ability to be scored, and interrater reliability, calculated during a further phase of video analysis. The metric was then subjected to a process of cyclical evaluation by a Delphi panel (n = 21) to obtain face and content validity of the metric. The Delphi panel deliberation verified the face and content validity of the metric. The final metric has three phases, 31 individual steps, 18 errors, and 27 sentinel errors. The metric is a tool that identifies the standard to be attained in the performance of acute surgical wound dressings. It can be used as both an adjunct to an educational programme and as a tool to assess a practitioner's performance of a wound-dressing procedure in both simulated and clinical practice contexts.

Antisepsia en la colocación y mantenimiento de los catéteres endovasculares / Antiseptic measures during the insertion and manipulation of vascular catheters

Se ha propuesto la aplicación de diferentes medidas relacionadas con la asepsia para la prevención de bacteriemia relacionada con catéter endovascular. Entre estas medidas de asepsia recomendadas por diferentes sociedades científicas se encuentra la higiene de manos de la persona que canaliza o manipula el catéter, la aplicación de unas máximas medidas de barrera durante la canalización del catéter, la desinfección de las llaves de 3pasos y los puntos de inyección, la no utilización de cremas antibióticas (salvo en los catéteres de hemodiálisis), el cambio del apósito si se encuentra manchado, húmedo o despegado, y el uso de una técnica aséptica durante el cambio de apósito. Otras medidas recomendadas solo en las pautas publicadas más recientemente (es posible que por la publicación de recientes estudios que objetivan su efecto beneficioso) son la utilización de apósitos impregnados en antimicrobianos, el cambio de apósitos transparentes cada 7 días y los baños del paciente con clorhexidina

Several measures related to asepsis for preventing catheter-related bloodstream infection have been proposed. The aseptic measures recommended by scientific societies include hand hygiene of the person who is inserting or manipulating the catheter; maximum sterile barrier precautions during catheter insertion; disinfection of catheter hubs; the use of needle-less connectors and injection ports; the avoidance of antibiotic ointments (except in hemodialysis catheters); change the dressing if it is soiled, loose or damp; and aseptic technique during dressing changes. Other measures only recommended by the most recently published guides (possibly due to the publication of recent studies reporting their beneficial effects) are the use of antimicrobial-impregnated dressings, changing transparent dressings every 7 days, and bathing of the patient with chlorhexidine

Evaluation du respect des mesures d'asepsie en salle d'opération et antibioprophylaxie en milieu rural. A propos d'une cohorte de 42 interventions chirurgicales réalisées à Moba (République Démocratique du Congo)

Introduction : La prévention des infections du site opératoire demeure une préoccupation pour tout système de santé. Cette étude avait pour objectif d'évaluer le niveau de respect des mesures d'asepsie au bloc opératoire et la pratique d'antibioprophylaxie chez les opérés. Méthode : Il s'agit d'une étude observationnelle de cohorte prospective. Elle a été effectuée au service de chirurgie de l'hôpital général de référence de Moba d'avril à juin 2018. Les variables d'étude concernaient les opérés et les chirurgiens. Dans le but de supprimer tout jugement a priori pouvant entraîner les biais de suivi, l'observation était en double aveugle. Résultats : Quarante-deux interventions chirurgicales avaient été retenues et évaluées chez les patients en majorité de sexe féminin (n = 36 ; 85,7 %), avec un âge moyen de 27 ans. La chirurgie pelvienne a été la plus pratiquée (n = 30 ; 71,4%). Les résultats montrent un écart considérable entre ce qui est fait et ce qui devrait être fait. Il en va de la disposition du bloc opératoire aux fautes d'asepsie (présence des téléphones portables et radiocassette dans la salle d'opération pendant l'intervention chirurgicale ; ports incorrects des bonnets, masques et gants ; gestes non-aseptiques dans l'exécution des actes ; discussions non-utiles, etc…) et à l'antibioprophylaxie à des doses usuelles et uniquement en post-opératoire. La conséquence a été que les infections du site opératoire représentaient 40,5% (n = 17). Néanmoins, pour être complet dans l'amélioration des conditions de travail et de satisfaire nos attentes, ces résultats devraient être corrélés par une étude similaire au service de chirurgie (soins post-opératoires et qualité de stérilité du matériel, hygiène des opérés). Conclusion : Le risque infectieux en milieu chirurgical constitue une préoccupation à laquelle il faudrait rapidement trouver solution pour inverser la tendance des infections du site opératoire. La solution passe obligatoirement par le respect strict des mesures d'asepsie, l'antibioprophylaxie en pré-opératoire et à double dose lors de son initiation, et les études épidémiologiques sur les infections en chirurgie

Brote de bacteriemia por Serratia marcescens en hemodiálisis. Comentario a «Brote de bacteriemia por Serratia marcescens en pacientes portadores de catéteres tunelizados en hemodiálisis secundario a colonización de la solución antiséptica. Experiencia en 4 centros» / Serratia marcescens bacteraemia outbreak in hemodialysis. Comment on «Serratia marcescensbacteraemia outbreak in haemodialysis patients with tunnelled catheters due to colonisation of antiseptic solution. Experience from 4 hospitals»

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Survey to explore understanding of the principles of aseptic technique: Qualitative content analysis with descriptive analysis of confidence and training.

BACKGROUND: In many countries, aseptic procedures are undertaken by nurses in the general ward setting, but variation in practice has been reported, and evidence indicates that the principles underpinning aseptic technique are not well understood. METHODS: A survey was conducted, employing a brief, purpose-designed, self-reported questionnaire. RESULTS: The response rate was 72%. Of those responding, 65% of nurses described aseptic technique in terms of the procedure used to undertake it, and 46% understood the principles of asepsis. The related concepts of cleanliness and sterilization were frequently confused with one another. Additionally, 72% reported that they not had received training for at least 5 years; 92% were confident of their ability to apply aseptic technique; and 90% reported that they had not been reassessed since their initial training. Qualitative analysis confirmed a lack of clarity about the meaning of aseptic technique. CONCLUSION: Nurses' understanding of aseptic technique and the concepts of sterility and cleanliness is inadequate, a finding in line with results of previous studies. This knowledge gap potentially places patients at risk. Nurses' understanding of the principles of asepsis could be improved. Further studies should establish the generalizability of the study findings. Possible improvements include renewed emphasis during initial nurse education, greater opportunity for updating knowledge and skills post-qualification, and audit of practice.

Management of an infected temporomandibular joint prosthesis and the use of bone cement with antibiotics / Manejo de la infección de una prótesis a medida de articulación temporomandibular y el uso de cemento óseo con antibiótico

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U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies.

The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently. To achieve a successful outcome, communicating clearly and effectively with inspectors and having ready access to the information they request are as critical as proving compliance. This article describes the author's experience with an unannounced United States Food and Drug Administration inspection of his 503A compounding facility and his response to the findings. Readers will learn what to expect during such an inspection, how to prepare for that event, and how to achieve an excellent outcome. Those who would like more information about any of the topics presented are invited to contact the author at the address provided at the close of this article.

Aseptic technique for accessing central venous catheters: applying a standardised tool to audit 'scrub the hub' practices.

BACKGROUND: To reduce the risk of infections associated with indwelling central venous catheters (CVCs), practices for hub disinfection have been widely promoted. The objective of this study was to design and implement a standardised tool to monitor compliance with 'scrub the hub' practices at an Australian centre. METHODS: Review of existing literature and recommendations regarding scrub the hub practices was performed to identify nine key components that could be audited by direct observation of staff in clinical areas. The tool was reviewed by stakeholders in infection prevention, infectious diseases and senior nursing roles prior to pilot evaluation. RESULTS: Twenty attempts to access a CVC were audited. In all instances, scrub the hub practices were commenced. However, a 15-second scrub was performed in only 60% of cases, and the hub was permitted to dry in only 65% of instances. With respect to maintaining an aseptic field, the overall compliance was 40%, and compliance was lowest for maintenance of a non-touch technique for key parts and sites, and hand hygiene practices following CVC access. CONCLUSIONS: A standardised clinical audit tool for monitoring aseptic access of CVCs enabled identification of practices amendable to targeted intervention and education, such as duration of hub disinfection. This tool would be readily utilised to facilitate quality improvement initiatives in a range of healthcare contexts, including high-risk inpatient and ambulatory care settings.

Características y calidad de la sangre autóloga recuperada del campo quirúrgico durante cirugía de escoliosis en pediatría / Characteristics and quality of intra-operative cell salvage in paediatric scoliosis surgery

Objetivos. Determinar las características hematológicas y microbiológicas de la sangre recuperada mediante el uso de un recuperador celular con campana centrifugadora pediátrica rígida (100 ml) en cirugía de escoliosis en pediatría y comprobar si se ajusta al estándar esperado en el paciente adulto. Material y método. Estudio de cohorte transversal, descriptivo, sobre 24 unidades consecutivas de sangre recuperada del campo quirúrgico procesadas mediante un recuperador de sangre modelo Haemolite® 2+ (Haemonetics Corp., Braintree, MA, EE. UU.). Se recogieron los datos referentes a edad, peso, abordaje (anterior o posterior) de la cirugía de escoliosis, volumen procesado y volumen de concentrado de hematíes (CH) autógeno recuperado, hemograma y hemocultivo del concentrado obtenido y la incidencia de fiebre tras la reinfusión. Resultados. El volumen procesado fue muy escaso (939 ± 569 ml) con gran variabilidad (coeficiente de variación = 0,6), a diferencia del volumen recuperado 129 ± 50 ml (coeficiente de variación = 0,38). Se estableció correlación estadísticamente significativa entre el volumen procesado y el hematocrito del CH recuperado (Pearson, r = 0,659; p = 0,001) que fue menor del esperado. Los parámetros hematológicos más relevantes de los concentrados recuperados fueron: Hb 11 ± 5,3 g dl−1; HTO: 32,1 ± 15,4%; leucocitos 5,34 ± 4,22 × 103 μl−1; plaquetas 37,88 ± 23,5 × 103 μl−1 (media ± DE). El hemocultivo del CH recuperado fue positivo en 13 casos (54,2%) en los que se aisló Staphylococcus coagulasa (−). Conclusiones. Los recuperadores celulares con campana centrifugadora de volumen fijo (incluso pediátrica) no obtienen la concentración esperada si se procesan bajos volúmenes, por lo que no son la mejor opción en el niño (AU)

Objective. To determine the haematological and microbiological characteristics of blood recovered by using a cell saver with a rigid centrifuge bowl (100 ml) in paediatric scoliosis surgery and to determine whether it conforms to the standard expected in adult patients. Material and methods. A cross-sectional, descriptive cohort study was performed on 24 consecutive red blood cell (RBC) units recovered from the surgical field and processed by a Haemolite® 2+ (Haemonetics Corp., Braintree, MA, EE. UU.) cell saver. Data were collected regarding age, weight, surgical approach (anterior or posterior), processed shed volume and volume of autologous RBC recovered, full blood count, and blood culture obtained from the RBC concentrate, and incidence of fever after reinfusion. Results. The processed shed volume was very low (939 ± 569 ml) with high variability (coefficient of variation = 0.6), unlike the recovered volume 129 ± 50 ml (coefficient of variation = 0.38). A statistically significant correlation between the processed shed volume and recovered RBC concentrate haematocrit was found (Pearson, r=.659, P=.001). Haematological parameters in the recovered concentrate were: Hb 11 ± 5.3 g dl−1; haematocrit: 32.1 ± 15.4% (lower than expected); white cells 5.34 ± 4.22 × 103 ul−1; platelets 37.88 ± 23.5 × 103 ul−1 (mean ± SD). Blood culture was positive in the RBC concentrate recovered in 13 cases (54.2%) in which Staphylococcus coagulase (−) was isolated. Conclusions. Cell salvage machines with rigid centrifuge bowls (including paediatric small volume) do not obtain the expected haematocrit if low volumes are processed, and therefore they are not the best choice in paediatric surgery (AU)

Choosing a Vial Processing Line for Aseptic Compounding: Part 1.

Equipment systems that enable compliance with stringent state and federal compounding requirements are a topic of increasing interest to U.S. pharmacists. Of those equipment types, an aseptic vial processing line offers unique benefits (especially to 503B compounding pharmacies and small contract manufacturers of aseptic pilot-size batches) if the volume of sterile preparations dispensed offsets the cost of purchase, installation, and maintenance. In this article, the reasons for and the process of selecting an aseptic vial processing line for use in 2 independent 503B compounding pharmacies are presented, the operation of our choice of equipment is described, and specifications for the components of that line are listed. In part 2 of this series, the success of our choice and its effect on sterile compounding in our facilities will be reported.

Basics of Sterile Compounding: Personnel Requirements for Sterile Compounding.

The risk of microbial contamination during sterile product preparation would be practically non-existent were people not involved in the preparatory process. This article discusses why people are the main source of microbial contamination and what safeguards need to be present to minimize this source.

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes.

OBJECTIVE: The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system. METHODS: The aseptic preparation of patient individual ready-to-use injection solutions was simulated by using double concentrated tryptic soy broth as growth medium, water for injection and plastic syringes as primary packaging materials. Media fills were either prepared automated (500 units) in the robot or manually (500 units) in cytotoxic workbenches in the same cleanroom over a period of 18 working days. The test solutions were incubated at room temperature (22℃) over 4 weeks. Products were visually inspected for turbidity after a 2-week and 4-week period. Following incubation, growth promotion tests were performed with Staphylococcus epidermidis. During the media-fill procedures, passive air monitoring was performed with settle plates and surface monitoring with contact plates on predefined locations as well as fingerprints. The plates got incubated for 5-7 days at room temperature, followed by 2-3 days at 30-35℃ and the colony forming units (cfu) counted after both periods. The robot was cleaned and disinfected according to the established standard operating procedure on two working days prior to the media-fill session, while on six other working days only six critical components were sanitized at the end of the media-fill sessions. Every day UV irradiation was operated for 4 h after finishing work. RESULTS: None of the 1000 media-fill products prepared in the two different settings showed turbidity after the incubation period thereby indicating no contamination with microorganisms. All products remained uniform, clear, and light-amber solutions. In addition, the reliability of the nutrient medium and the process was demonstrated by positive growth promotion tests with S. epidermidis. During automated preparation the recommended limits < 1 cfu per settle/contact plate set for cleanroom Grade A zones were not succeeded in the carousel and working area, but in the loading area of the robot. During manual preparation, the number of cfus detected on settle/contact plates inside the workbenches lay far below the limits. The number of cfus detected on fingertips succeeded several times the limit during manual preparation but not during automated preparation. There was no difference in the microbial contamination rate depending on the extent of cleaning and disinfection of the robot. CONCLUSION: Extensive media-fill tests simulating manual and automated preparation of ready-to-use cytotoxic injection solutions revealed the same level of sterility for both procedures. The results of supplemental environmental controls confirmed that the aseptic procedures are well controlled. As there was no difference in the microbial contamination rates of the media preparations depending on the extent of cleaning and disinfection of the robot, the results were used to adapt the respective standard operating procedures.

Quality Assurance and Quality Control, Part 2.

The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.