A Novel Technique of Aseptic Manufacture of Autologous Serum Eye Drops (ASEDs) and Sterility Analysis of the Bottled Ophtioles.

PURPOSE: To introduce a novel technique of the aseptic manufacture of autologous serum eye drops (ASEDs) with a prefiltered closed system and to analyze the sterility of the produced ophtioles between 2018 and 2022. METHODS: This is a prospective single-center study conducted at the Department of Ophthalmology at a Swiss University Hospital between 2018 and 2022. For regulatory reasons, closed systems for manufacturing ASEDs are strongly recommended. We attached an upstream sterile filter (Sterivex PES0.22 µm Burlington, USA) to a commercially available closed system (COL System Modena, Italy) for manufacturing ASEDs. The goal of this novel approach was to reduce the microbiological contamination of the donated autologous blood. Using the presented manufacturing method, we are able to produce, on average, 56 ophtioles per batch, containing either 1.45 mL or 2.5 mL of autologous serum per ophtiole. For each batch of ASEDs, we performed a microbiological analysis by automated blood culture testing (BACTEC). This system examines the presence of bacteria and fungi. RESULTS: We analyzed all manufactured batches between 2018 and 2022. None of the 2297 batches and the resulting 129 060 ophtioles showed bacterial or mycotic contamination. During the analyzed period, two batches were discarded: one due to fibrin-lipid aggregations, further microbiological and histological work-up excluded any contamination; another due to false-positive HIV in serological testing. Overall, the contamination rate was 0%, and the batch discharge rate was 0.09%. CONCLUSIONS: The combination of upstream sterile filtration with a commercial closed system for manufacturing ASEDs proved to be effective in ensuring sterility without any contamination over the past 4 years. This is becoming crucial, as the demand for autologous blood products for treating ocular surface disorders, such as refractory dry eyes or nonhealing defects of the corneal epithelium, is on the rise.

Preoperative skin asepsis protocols using chlorhexidine versus povidone-iodine in veterinary surgery: A systematic review and meta-analysis.

OBJECTIVE: To provide a systematic assessment of the efficacy of preoperative skin asepsis using chlorhexidine versus povidone-iodine based protocols for surgical site infection (SSI) prevention in veterinary surgery. STUDY DESIGN: Systematic meta-analytical review according to PRISMA-P guidelines. SAMPLE POPULATION: Studies comparing preoperative skin asepsis protocols using chlorhexidine versus povidone-iodine in veterinary surgery identified by systematic search between 1990 and 2020. METHODS: A search using MEDLINE/Pubmed, Web of Science and CAB Abstracts was performed, followed by secondary searches of Google Scholar, Proquest Dissertation and Theses, and relevant bibliographic articles. Primary and secondary outcome measures were the efficacy of skin asepsis protocols using chlorhexidine versus povidone-iodine on SSI incidence and skin bacterial colonization, respectively. A meta-analysis was performed with a random-effect model, with effect size calculated as risk ratio (RR) or mean standard deviation (MSD) with 95% CI. Statistical significance was set at P < .05. RESULTS: Among 1067 publications that met the initial search criteria, 9 relevant studies were eligible for analysis. No difference in the incidence of postoperative SSI or skin bacterial colonization between preoperative asepsis protocols using chlorhexidine versus povidone-iodine was found. Insufficient information and detail were frequent among studies and precluded a clear assessment of bias. CONCLUSION: This study showed that asepsis protocols using chlorhexidine were comparable to povidone-iodine in preventing postoperative SSI and reducing skin bacterial colonization. CLINICAL SIGNIFICANCE: Given the limitations of the studies that were included in terms of both quality and quantity, more high-quality randomized controlled trials are needed to confirm these conclusions.

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.

Augmentative antirotational plating provided a significantly higher union rate than exchanging reamed nailing in treatment for femoral shaft aseptic atrophic nonunion - retrospective cohort study.

BACKGROUND: Atrophic nonunion of femoral shaft fracture after intramedullary (IM) nailing is uncommon. The treatment for femoral shaft aseptic atrophic non-union remained controversial. The aim of this study was to compare the surgical results between exchanging reamed nailing (ERN) and augmentative antirotational plating (AAP) for femoral shaft aseptic atrophic nonunion. METHODS: We retrospectively reviewed the patients with femoral shaft nonunion between the year of 2014 and 2015. The patients with nonunion after plate osteosynthesis, septic nonunion, hypertrophic nonunion, additional surgery during revision surgery were excluded. All the patients were followed up at least 12 months. RESULTS: Overall, the union rate after revision surgery was 70.8%. The union rate was significantly higher in the AAP group than in the ERN group. Operating time was also significantly shorter in the AAP group. Regarding the location of nonunion, the union rate was comparable between groups for isthmic nonunions. However, for non-isthmic nonunions, the union rate was significantly higher and operating time was significantly shorter in the AAP group. CONCLUSION: AAP showed an overall higher union rate for management of femoral shaft aseptic atrophic nonunion compared with ERN. Especially for non-isthmic femoral shaft atrophic nonunions, AAP provided a significantly higher union rate and significantly shorter operating time.

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.

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.

Iterative co-creation for improved hand hygiene and aseptic techniques in the operating room: experiences from the safe hands study.

BACKGROUND: Hand hygiene and aseptic techniques are essential preventives in combating hospital-acquired infections. However, implementation of these strategies in the operating room remains suboptimal. There is a paucity of intervention studies providing detailed information on effective methods for change. This study aimed to evaluate the process of implementing a theory-driven knowledge translation program for improved use of hand hygiene and aseptic techniques in the operating room. METHODS: The study was set in an operating department of a university hospital. The intervention was underpinned by theories on organizational learning, culture and person centeredness. Qualitative process data were collected via participant observations and analyzed using a thematic approach. RESULTS: Doubts that hand-hygiene practices are effective in preventing hospital acquired infections, strong boundaries and distrust between professional groups and a lack of psychological safety were identified as barriers towards change. Facilitated interprofessional dialogue and learning in "safe spaces" worked as mechanisms for motivation and engagement. Allowing for the free expression of different opinions, doubts and viewing resistance as a natural part of any change was effective in engaging all professional categories in co-creation of clinical relevant solutions to improve hand hygiene. CONCLUSION: Enabling nurses and physicians to think and talk differently about hospital acquired infections and hand hygiene requires a shift from the concept of one-way directed compliance towards change and learning as the result of a participatory and meaning-making process. The present study is a part of the Safe Hands project, and is registered with ClinicalTrials.gov (ID: NCT02983136 ). Date of registration 2016/11/28, retrospectively registered.

Risk of Obtaining Routine Cultures During Presumed Aseptic Orthopaedic Procedures.

Treating patients with antibiotics that are selected based on routine cultures obtained from presumed aseptic orthopaedic procedures may lead to an increased risk of antibiotic-related complications without reducing the rate of late deep infection. Routine cultures obtained from 60 of 169 procedures resulted in 23 (38.3%) positive and 37 (61.7%) negative results. Twenty-two patients (13.5%) developed late infections. Seven of 14 patients with positive cultures, who were treated with antibiotics, developed a late infection, while two of nine patients with routine cultures, who received no antibiotic treatment, developed a late infection. Six of 37 patients with negative cultures and seven of 109 patients with no cultures developed a late infection. In patients who developed late deep infection, the microorganism isolated on routine culture only corresponded to the microorganism causing late infection 55.5% of the time. Of all patients treated with antibiotics, seven (29%) experienced an antibiotic-related complication (p = .01). (Journal of Surgical Orthopaedic Advances 26(4):239-245, 2017).

The malpractices of student nurses in clinical practice in Turkey and their causes.

OBJECTIVE: The study was conducted to identify whether or not student nurses made the medical errors as well as the reasons for the errors. METHODS: A study was conducted with 1067 student nurses studying at 12 universities in Turkey. The data were collected by using medical error scale and a questionnaire on demographic characteristics and malpractices. RESULTS: Overall 28% of the student nurses performed malpractice during clinical practice. Medical errors included failure of complying with sterility and asepsis rules (32%), wrong identification of patient identity (19%), and administrating wrong dosage of medications (12%). They obtained a mean score of 4.19±0.62 from the overall scale and the lowest score was 3.9±0.78 for drug administrations. CONCLUSIONS: Nursing students perform considerable amount of malpractice and they should especially improve concerning administration of drugs.

Microbiological Contamination of Drugs during Their Administration for Anesthesia in the Operating Room.

BACKGROUND: The aseptic techniques of anesthesiologists in the preparation and administration of injected medications have not been extensively investigated, but emerging data demonstrate that inadvertent lapses in aseptic technique may be an important contributor to surgical site and other postoperative infections. METHODS: A prospective, open, microbiological audit of 303 cases in which anesthesiologists were asked to inject all bolus drugs, except propofol and antibiotics, through a 0.2-µm filter was performed. The authors cultured microorganisms, if present, from the 0.2-µm filter unit and from the residual contents of the syringes used for drawing up or administering drugs. Participating anesthesiologists rated ease of use of the filters after each case. RESULTS: Twenty-three anesthesiologists each anesthetized up to 25 adult patients. The authors isolated microorganisms from filter units in 19 (6.3%) of 300 cases (3 cases were excluded), including Staphylococcus capitis, Staphylococcus warneri, Staphylococcus epidermidis, Staphylococcus haemolyticus, Micrococcus luteus/lylae, Corynebacterium, and Bacillus species. The authors collected used syringes at the end of each case and grew microorganisms from residual drug in 55 of these 2,318 (2.4%) syringes including all the aforementioned microorganisms and also Kocuria kristinae, Staphylococcus aureus, and Staphylococcus hominus. Participants' average rating of ease of use of the filter units was 3.5 out of 10 (0 being very easy and 10 being very difficult). CONCLUSIONS: Microorganisms with the potential to cause infection are being injected (presumably inadvertently) into some patients during the administration of intravenous drugs by bolus during anesthesia. The relevance of this finding to postoperative infections warrants further investigation.

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.

Establishment and maintenance of asepsis in endodontics - a review of the literature.

OBJECTIVES: Successful endodontic treatment depends on effective measures to eliminate and prevent infection of root canals. Initially treatment should start with isolation and disinfection of the operating field. This review makes an inventory of the available knowledge regarding its establishment and maintenance. MATERIALS AND METHODS: A literature search was conducted in the PubMed database in order to identify clinical trials examining disinfection or unintentional contamination of the endodontic operative field. A list of 115 articles was obtained and screened. Five relevant articles were identified. These articles were read in full text. The reference lists from these articles were checked manually for additional studies and three studies were obtained. A total of eight articles met the inclusion criteria. RESULTS: There was a great variety in terms of aim, method, and material of the included studies. None could prove a totally reliable aseptic operative field and not one chemical, or combination of chemicals, were found in more than one study. CONCLUSIONS: No study documented complete asepsis following initial disinfection, and no study could document predictable maintenance of an established bacteria-free surface. Critical appraisal and standardization of the disinfection and aseptic procedures in endodontics are needed.

[Aseptic techniques for minor surgical procedures]. / Actualización en técnica aséptica y uso de antibióticos profilácticos en procedimientos quirúrgicos ambulatorios que comprometan piel y mucosas: An update.

Aseptic techniques are those practices designed to reduce the risk of surgical site infection (SSI), defined as such, all those that occur within the first 30 days of the procedure. While the patient’s risk of developing an SSI in dermatologic surgery is low since many of the procedures are considered sterile, there are different factors associated with an increased or decreased risk of developing SSI. The characteristics of the surgical wound (such as involving infected or inflamed tissue or when breaks in the aseptic technique occur), patient characteristics (such as age, comorbidities, medication use and smoking) and procedure factors (such as setting, surgical technique, type of procedure, duration and body region involved). In this article we discuss the management of potential sources of infections such as personnel (hand washing, dressing), preparation of the patient, maintenance of a clean surgical environment, sterilization and the use of antiseptic solutions. Similarly, the current indications for prophylactic antibiotics for these procedures are considered.

Adjunctive Systemic Antimicrobial Therapy vs Asepsis in Conjunction with Guided Tissue Regeneration: A Randomized, Controlled Clinical Trial.

AIM: This randomized clinical trial compares the usefulness of adjunctive antibiotics, while strict asepsis was followed during periodontal surgery involving guided tissue regeneration. MATERIALS AND METHODS: Two groups of 20 consecutive patients each with advanced periodontal disease were randomly assigned to treatment. They displayed one angular defect each with an intrabony component ≥3 mm, probing pocket depth and probing attachment level (PAL) ≥7 mm. Test group included 13 males, mean age 60 years, treated with enamel matrix derivative (EMD) and demineralized freeze-dried bone allograft with modified papilla preservation technique, received oral amoxicillin 1 gm, 1 hour preoperatively and 2 gm for 2 days postoperatively. Control group included 10 males, mean age 57 years, treated with EMD and demineralized freeze-dried bone allograft with modified papilla preservation technique, received no antibiotics. Outcome measures were clinical attachment level (CAL) gain, residual periodontal pocket depth (res. PD), gingival recession (GR), bleeding on probing (BOP), adverse events and postoperative complications. Patients were followed up to 12 months after periodontal surgery involving guided tissue regeneration. RESULTS: There were no significant differences between both groups for CAL gain, res. PD, GR, BOP nor other clinical parameters, though patients' subjective perception of postoperative discomfort was significantly smaller in the group receiving antibiotics. CONCLUSION: Antibiotics do not provide significant advantages concerning clinical periodontal parameters nor concerning postoperative infections in case of proper asepsis. It does, on the contrary, reduce postoperative discomfort. CLINICAL SIGNIFICANCE: Regarding the results of this study, adjunc-tive systemic antibiotics in combination with guided tissue regeneration may be useful in reducing postoperative discomfort but may not be helpful for improving periodontal regeneration outcomes.

Economic assessment of aseptic compounding rooms in hospital pharmacies in five European countries.

PURPOSE: The aims of the study are to make an inventory of fixtures of aseptic compounding structures, to compare, using real examples, the design and operating costs of controlled atmosphere area (CAA) with isolators and CAA with laminar flow biological safety cabinets (BSCs) in order to determine the most economical scheme in hospitals and to give a final facilities cost calculated for one workstation. METHODS: Forty-three hospitals were interviewed (21 French and 22 from four European countries) over seven months. Hospital pharmacists completed a form with 390 items. Hospitals are compared according to their workstation type: BSCII or BSCIII (group B) and isolator (group I), using Mann and Whitney's statistical test and Monte-Carlo modeling. RESULTS: Twenty-one hospitals responded (11 French and 10 from other European countries). All European compounding unit organizations are not significantly different. The study compared items such as infrastructure cost, equipment cost, staff cost, consumable cost, cleaning cost and control cost. A synthesis of all costs has been drafted to calculate an estimated preparation cost which seemed to be higher for group B than for group I when staff costs were included ($46 and $31, respectively, in study conditions). CONCLUSIONS: The different costs studied have revealed little significant difference between group B and I. The preparation cost in group B appears higher than in group I. This pilot study has resulted in the calculation of an estimated manufactured preparation cost but this work should be completed to help optimize resources and save money.

Pre-filled syringes: a review of the history, manufacturing and challenges.

Pre-filled syringes are convenient devices for the delivery of parenteral medications. They are small which makes them easy to carry and are dependable for delivering a precise dose of medication. These and many other reasons are leading to their growth in the pharmaceutical market. There are a number of review articles that describe the advantages and disadvantages of pre-filled syringes. However, there are few journal articles that present information on their manufacturing and challenges. The intent of this review article is to provide information on the history of the pre-filled syringe, methods of their manufacture, methods of filling syringes as a drug product and to examine the types of syringes available. This type of knowledge can familiarize the formulation scientist with the choices available and their possible challenges.

Aseptic practice recommendations for circulating operating theatre nurses.

Aseptic practices prevent exposure of a surgical wound to microbes, operating theatre environment and personnel. The circulating nurse assists the operating theatre personnel and supervises aseptic practices preventing surgical site infections. In the absence of analytical tools, few studies exist on intraoperative nursing-related aseptic practices. This study introduces recommendations to assess the role of the circulating nurse in aseptic practices. The authors used international recommendations and research findings to construct a 20-item self-report instrument with a demonstrated reliability across the scale. The authors structured the scale based on three phases: establishment; maintenance; and disestablishment of a sterile operating field. The tool was tested among operating theatre and day surgery nurses, and compared the differences in the mean acceptance rates of aseptic practice recommendations based on background characteristics. College-level nurses and nurses with 15 or more years' work experience accepted the recommendations at higher levels than bachelor-level nurses and nurses with less work experience. Continual assessment of the evidence base and comprehensive evaluation represent important components in further developing the tool. A reasonable number of items covering clinical practice are necessary for assessing the effectiveness and cost-effectiveness of aseptic practices, and a larger response rate is needed to validate the tool in future.

[Intra-articular injections]. / Les injections intra-articulaires.

It is not unusual for a specialist or general practitioner to be presented with a pathology which necessitates the use of an intra-articular injection of corticosteroids, hyaluronic acid or a local anaesthetic. It would seem to be interesting to update and to precise the techniques and methods of intraarticular injections which have appeared in recent international publications, when we know that 30 % of the injections given into the knee and so called "dry" are incorrect and, therefore, inefficient. The indication of an articular injection depends, firstly, on the diagnosis which should be done with great care; after which should be an objective analysis complete with secondary effects linked to both the injection and the product used. The conditions of asepsis, the choice of needles and quantities of the injection and even the ways of the injections should be reviewed in detail. The last studies clearly question the secondary effects of the cartilage degradations of the cortisone given as an intra-articular injection and shows its efficiency on the pain and inflammatory phenomonen in osteoarthritis. Studies on hyaluronic acid are often contradictory going from a modest result to an important pain relief but it is necessary to be aware that the objective criteria are difficult to interpret. The use of local anaesthetics in intra-articular is limited by the few indications in view of the major risk of aggravating the pre-existing lesions by the disappearing signs of pain.