Procedimento operacional padrão para armazenamento de materiais estéreis em ambiente extra hospitalar / Standard operating procedure for storage of sterile materials in extra-hospital environment

Introdução: Procedimento Operacional Padrão é um recurso de gestão, baseado em evidências científicas que auxilia no raciocínio e tomada de decisões de profissionais da área da saúde. Objetivo: Elaborar um Procedimento Operacional Padrão para armazenamento de materiais cirúrgicos estéreis em ambiente extra hospitalar, guiado por evidências científicas. Material e Métodos: Estudo metodológico descritivo baseado em uma revisão integrativa da literatura, cuja busca foi realizada nas bases National Library of Medicine, Red de Revistas Científicas de América Latina y el Caribe: Redalyc, Portal Regional da Biblioteca Virtual em Saúde, em setembro de 2023, com recorte temporal entre 2018 a 2023, além de busca no site do Ministério da Saúde. Resultados: Incluiram-se oito artigos, embasados na Resolução da Diretoria Colegiada, nº 15, de 2012. Os estudos abordaram temas sobre processamento de produtos para a saúde em ambiente hospitalar e não hospitalar, etapas do processamento de produtos para a saúde, segurança do paciente e educação permanente em saúde. A partir das evidências científicas elaborou-se o Procedimento Operacional Padrão, bem como um fluxograma. Conclusão: Pautado em evidências científicas e normativas instrucionais brasileiras, o Procedimento Operacional Padrão pode contribuir para um processo de trabalho qualificado, maior segurança na realização do cuidado e aprimoramento gerencial de materiais estéreis em ambiente extra hospitalar

Introduction: Standard Operating Procedure is a management resource, based on scientific evidence that assists in reasoning and decision-making by healthcare professionals. Objective: Develop a Standard Operating Procedure for storing sterile surgical materials in an extra-hospital environment, guided by scientific evidence. Material and Methods: Descriptive methodological study based on an integrative literature review, whose search was carried out in the National Library of Medicine, Red de Revistas Científicas de América Latina y el Caribe: Redalyc, Regional Portal of the Virtual Health Library, in September 2023 with clipping period between 2018 and 2023, in addition to a search on the Ministry of Health website. Results: Eight articles were included, based on the Resolution of the Collegiate Board, nº 15, of 2012. The studies addressed topics on the processing of health products in an environment hospital and non-hospital, stages of processing health products, patient safety and continuing health education. Based on the scientific evidence, the Standard Operating Procedure was created, as well as a flowchart. Conclusion: Based on scientific evidence and Brazilian instructional regulations, the Standard Operating Procedure can contribute to a qualified work process, greater safety in providing care and management improvements of sterile materials in an extra-hospital environment

Introducción: El Procedimiento Operativo Estándar es un recurso de gestión, basado en evidencia científica, que ayuda al razonamiento y la toma de decisiones de los profesionales de la salud. Objetivo: Desarrollar un Procedimiento Operativo Estándar para el almacenamiento de material quirúrgico estéril en un ambiente extrahospitalario, guiado por evidencia científica. Material y Métodos: Estudio metodológico descriptivo basado en una revisión integradora de la literatura, cuya búsqueda se realizó en la Biblioteca Nacional de Medicina, Red de Revistas Científicas de América Latina y el Caribe: Redalyc, Portal Regional de la Biblioteca Virtual en Salud, en septiembre de 2023 con periodo de recorte entre 2018 y 2023, además de una búsqueda en el sitio web del Ministerio de Salud. Resultados: Se incluyeron ocho artículos, con base en la Resolución del Consejo Colegiado, nº 15, de 2012. Los estudios abordaron temas sobre el procesamiento de productos para la salud en un ambiente hospitalario y no hospitalario, etapas de procesamiento de productos para la salud, seguridad del paciente y educación sanitaria continua. Con base en la evidencia científica se creó el Procedimiento Operativo Estándar, así como un diagrama de flujo. Conclusión: Basado en evidencia científica y normas de instrucción brasileñas, el Procedimiento Operativo Estándar puede contribuir para un proceso de trabajo calificado, mayor seguridad en la prestación de atención y mejoras en la gestión de materiales estériles en un ambiente extrahospitalario

Controle de materiais e instrumental cirúrgico no intraoperatório: percepção e estratégias utilizadas por instrumentadores / Control of materials and surgical instruments in the intraoperative period: perception and strategies used by surgical technologists

Objetivo: Conhecer as estratégias utilizadas por instrumentadores para o controle de materiais e instrumental cirúrgico no intraope-ratório. Método: Estudo descritivo e qualitativo, realizado em hospital privado. Participaram 13 instrumentadores cirúrgicos. Os dados foram coletados entre agosto e setembro de 2022 por meio de entrevistas gravadas em áudio. Como instrumento para coleta dos dados, utilizou-se um roteiro estruturado, contendo sete perguntas, e questões referentes ao perfil da amostra. Foram incluídos técnicos de enfermagem forma-dos, atuantes como instrumentadores cirúrgicos. Foram excluídos instrumentadores ausentes no período da coleta de dados. Os dados foram analisados por meio da análise de conteúdo. Resultados: Com base na análise dos dados, emergiram quatro categorias: protocolo de cirurgia segura; controle de materiais e instrumentais; desafios no seguimento do protocolo de cirurgia segura; facilitadores do seguimento do proto-colo de cirurgia segura. Conclusão: Pôde-se conhecer as estratégias utilizadas por instrumentadores cirúrgicos para o controle dos materiais dispostos na mesa de instrumentação durante o intraoperatório. Pressa de profissionais, falta de adesão e o não seguimento de rotinas insti-tucionais caracterizam-se como desafios para o seguimento das etapas do protocolo de cirurgia segura

Objective: To know the strategies used by surgical technologists to control materials and surgical instruments in the intraopera-tive period. Method: This qualitative descriptive study was carried out in a private hospital. A total of 13 surgical technologists participated in the research. Data were collected during audio-recorded interviews between August and September 2022. The data collection instrument was a structured questionnaire consisting of seven questions, as well as items related to the sample profile. We included trained nursing technicians, working as surgical technologists. Those who were absent during data collection were excluded. Data were analyzed by con-tent analysis. Results: The data analysis produced four categories: surgical safety checklist; control of materials and instruments; challenges in following the surgical safety checklist; facilitators to following the surgical safety checklist. Conclusions: The study allowed us to know the strategies used by surgical technologists to control the materials arranged on the instrument table during the intraoperative period. The haste of professionals, lack of adherence, and non-compliance with institutional routines are regarded as challenges in following the steps of the surgical safety checklis

Objetivo: Conocer las estrategias utilizadas por instrumentistas para el control de materiales e instrumental quirúrgico en el intraope-ratorio. Método: Estudio descriptivo y cualitativo, realizado en hospital privado. Participaron 13 instrumentistas quirúrgicos. Los datos fueron colectados entre agosto y septiembre de 2022 por medio de entrevistas grabadas en audio. Como instrumento para colecta de los datos, se utilizó um guion estructurado, conteniendo siete preguntas, y cuestiones referentes al perfil de la muestra. Fueon incluidos técnicos de enfermería egre-sados, actuantes como instrumentistas quirúrgicos. Fueron excluidos instrumentistas ausentes en el período de la colecta de datos. Los datos fue-ron analizados por medio del análisis de contenido. Resultados: Con base en el análisis de los datos, emergieron cuatro categorías: protocolo de cirugía segura; control de materiales e instrumentales; desafíos en el seguimiento del protocolo de cirugía segura; facilitadores del seguimiento del protocolo de cirugía segura. Conclusión: Se pueden conocer las estrategias utilizadas por instrumentistas quirúrgicos para el control de los materiales dispuestos en la mesa de instrumentación durante el intraoperatorio. Prisa de profesionales, falta de adhesión y el no seguimiento de rutinas institucionales se caracterizan como desafíos para el seguimiento de las etapas del protocolo de cirugía segura

A laboratory evaluation of nozzle tip damage in four generations of intraocular lens injector systems using a self-developed damage scale.

During intraocular lens (IOL) implantation it is not uncommon for the injector's nozzle-tip to get damaged. However, the damage has not been systematically described or evaluated using an objective scale. In this study we developed our own system-the Heidelberg Score for IOL Injector Damage ("HeiScore"), which was used to grade 60 injectors from four generations of injector models (Monarch III D, AcrySert C, UltraSert, AutonoMe) made by the same manufacturer. (Alcon Laboratories Inc.) HeiScore has six grades of nozzle-tip damage: no damage (which was graded 0); slight scratches (1), deep scratches (2), extensions (3), cracks (4) and bursts (graded number 5). The score for each injector model was the sum of all grades (total number), and we could compare the four injector models. The injectors showed varying damage profiles, from "no damage" to "crack". A tendency of a lower damage score in the newer generations of IOL injectors was noted. However, a statistically significant difference was observed only between Monarch III D and AutonoMe. The "Heidelberg Score for IOL Injector Damage" could efficiently and effectively evaluate the damage to IOL injector systems, which might help manufacturers optimize the positioning of the IOL in the injector during pre-loading.

Mask then classify: multi-instance segmentation for surgical instruments.

PURPOSE: The detection and segmentation of surgical instruments has been a vital step for many applications in minimally invasive surgical robotics. Previously, the problem was tackled from a semantic segmentation perspective, yet these methods fail to provide good segmentation maps of instrument types and do not contain any information on the instance affiliation of each pixel. We propose to overcome this limitation by using a novel instance segmentation method which first masks instruments and then classifies them into their respective type. METHODS: We introduce a novel method for instance segmentation where a pixel-wise mask of each instance is found prior to classification. An encoder-decoder network is used to extract instrument instances, which are then separately classified using the features of the previous stages. Furthermore, we present a method to incorporate instrument priors from surgical robots. RESULTS: Experiments are performed on the robotic instrument segmentation dataset of the 2017 endoscopic vision challenge. We perform a fourfold cross-validation and show an improvement of over 18% to the previous state-of-the-art. Furthermore, we perform an ablation study which highlights the importance of certain design choices and observe an increase of 10% over semantic segmentation methods. CONCLUSIONS: We have presented a novel instance segmentation method for surgical instruments which outperforms previous semantic segmentation-based methods. Our method further provides a more informative output of instance level information, while retaining a precise segmentation mask. Finally, we have shown that robotic instrument priors can be used to further increase the performance.

Escovas de limpeza em centrais de materiais e esterilização: características e cuidados / Cleaning brushes in Central Materials and Sterilization

A limpeza é a primeira e mais essencial etapa antes que qualquer processo de desinfecção ou esterilização possa ocorrer. Nesta etapa ocorre a fricção manual dos materiais com escovas apropriadas a fim de eliminar sujidades. A depender das características, estas escovas podem ter um custeio elevado para os serviços de saúde, especialmente em países com recursos limitados como o Brasil. Elucidar, em tempo oportuno, o que traz a literatura sobre as características necessárias às escovas de limpeza em Centrais de Materiais e Esterilização (CME), especialmente sobre a necessidade de serem autoclavadas.

Clinical Outcome of Elderly Patients with Subarachnoid Hemorrhage: Validation of Modality Assignment Based on Aneurysmal Morphology and Location.

BACKGROUND: The number of elderly patients with subarachnoid hemorrhage is increasing. Elderly patients have been postulated to benefit more from endovascular coiling, compared with neurosurgical clipping. However, we based our therapeutic modality on the morphology and location of the aneurysms, rather than patients' age or their World Federation of Neurological Surgeons grade. The aim of this study was to investigate the validity of our therapeutic modality over earlier approaches by assessing their clinical outcomes. METHODS: The study sample included 539 patients who underwent surgical procedures between January 2010 and May 2019. Baseline characteristics, aneurysmal morphology and location, surgical and clinical complications, and clinical outcomes were compared between elderly (defined as aged 75 years or older) and young patients. RESULTS: There were 124 elderly patients (23.0%) in the sample. Eighty-five elderly patients (68.5%) received neurosurgical clipping, whereas 67.0% of the young patients (P = 0.827) received neurosurgical clipping. Of the elderly patients who had a poor World Federation of Neurological Surgeons grade, 49.4% and 48.7% underwent neurosurgical clipping and endovascular coiling, respectively (P = 1.000). Elderly patients had fewer favorable outcomes (21.8%) relative to young patients (61.8%; P < 0.001). There were no significant differences in the rate of favorable outcomes between patients undergoing neurosurgical clipping relative to endovascular coiling (21.2% vs. 23.1%; P = 0.818). CONCLUSIONS: Neurosurgical clipping and endovascular coiling yield comparable clinical outcomes in elderly and young patients with subarachnoid hemorrhage. These findings indicate that using a therapeutic modality based on aneurysmal morphology and location may be an effective treatment approach.

Does closure of fascia, type, and location of trocar influence occurrence of port site hernias? A literature review.

BACKGROUND: Since the introduction of laparoscopic surgery, it has become more popular with many advantages over open surgery including faster recovery, shorter hospital stays, and decreased tissue trauma. Despite its benefits, laparoscopic surgery can result in its own unique complications, such as the formation of a trocar site hernia (TSH), which have been reported in approximately 0-1.0% of laparoscopic cases when using non-bladed trocars. METHODS: A literature review was performed from June 1990 to June 2019. PubMed was searched using the keywords "laparoscopic surgery," "trocar site hernia," and "port site hernia." Only articles in English were identified but not limited to the USA. RESULTS: The total number of patients in all articles was 18,533 with a mean follow-up period of 22.50 ± 1.76 months. The overall trocar site hernia rate was 0.104%. When comparing open vs. closed ports, there was no significant difference in the hernia incidence rate for 5-mm and 10-mm ports. When comparing bladed versus non-bladed trocars left open, there was a statistically significant difference with lower hernia incidence rates for non-bladed trocars over bladed trocars for 5-mm, 10-mm, and 12-mm ports. And when comparing trocar location from midline versus off-midline, there was a statistically significant higher TSH incidence in midline trocar locations. CONCLUSION: Results suggest that TSH rate is lower when using non-bladed trocars for any size of trocar. When comparing whether fascial closure had an effect, the 5-mm and 10-mm ports had no difference in incidence rates and leaving the fascia open can reduce operative time, risk of needlestick injuries, and overall procedural cost. In addition, trocars at midline locations resulted in higher TSH incidence rates. Future research is still needed to assess for other factors that may influence hernia formation and how it can be minimized.

Technical feasibility of a newly designed bendable forceps for difficult endoscopic tissue samplings (with video).

BACKGROUND: Biopsies with conventional forceps beyond the operating range are difficult and cumbersome. Thus, we developed a new bendable forceps for improved access to gastrointestinal lesions and evaluated its technical feasibility. METHODS: A bendable forceps was constructed with two channels and a two-stage knob. The bending motion-related structures were designed to improve the range of motion. For the evaluation of the forceps, we used 2 gastrointestinal simulators: an ex vivo porcine model, and an in vivo porcine model with some difficult endoscopic biopsy cases. All evaluations were performed by 5 expert endoscopists and an expert pathologist. RESULTS: Compared with the conventional forceps, the bendable forceps had greater efficacy in the simulator (6.2 ± 0.4 vs. 1.96 ± 0.2, p < 0.001), ex vivo porcine model (6.33 ± 0.52 vs. 4.25 ± 0.89, p < 0.001), and in vivo porcine model (6.33 ± 0.52 vs. 4.25 ± 0.89, p < 0.001); greater safety in the simulator (1.92 ± 0.13 s vs. 4.88 ± 0.50 s, p < 0.001), ex vivo porcine model (2.02 ± 0.15 s vs 4.66 ± 0.27 s, p < 0.001), and in vivo porcine model (2.02 ± 0.15 s vs. 4.08 ± 0.70 s, p = 0.002); and larger specimens in the ex vivo porcine model (3.92 ± 0.03 mm vs. 3.85 ± 0.07 mm, p = 0.020). CONCLUSIONS: This study showed that compared with the conventional forceps, the bendable forceps was effective and safe to use for accessing difficult lesions in the three models. We believe that the bendable forceps serves as a useful supplementary diagnostic tool for accessing difficult lesions. However, further validation of its usefulness in the human body is needed.

Modern Brain Retractors and Surgical Brain Injury: A Review.

Surgical brain injury caused by brain retraction is a well-known consequence of intracranial surgery. Modern retractor designs, particularly since the 1980s, have significantly improved ease of use, improved visibility for surgeons, and minimized retraction-induced injuries, though not yet been entirely eliminated. Today, brain retractors come in a broad range of styles, each with its own pros and cons regarding operational utility and patient safety. Which type is chosen for use depends on the surgical approach, lesion size and depth, cost, and surgeon preference. Traditionally, self-retaining brain retractors with moveable arms and 1 or more attachable blades made from malleable stainless steel or silicone rubber have been the tool of choice; however, recently tubular retraction systems that only require fixation to the head frame and cause less focal pressure damage than older retractors have gained in popularity for some cases. This review aims to address the history of brain retraction and discuss each of the commonly used brain retractor types, as well as some newer and less common varieties especially in terms of the extent of tissue damage typically caused as well as the types of injuries reported by the users.

Laparoscopic or robotic intraoperative management to minimize aerosol dispersion: Adaptations to the context of the COVID-19 pandemic. / Manejo intraoperatório em cirurgia laparoscópica ou robótica para minimizar a dispersão de aerossóis: Adaptações ao contexto da pandemia por COVID-19.

The coronavirus infection, also known as SARS-COV2, has proven to be potentially fatal, representing a major global health problem. Its spread after its origin in the city of Wuhan, China has resulted in a pandemic with the collapse of the health system in several countries, some with enormous social impact and expressive number of deaths as seen in Italy and Spain. Extreme intra and extra-hospital measures have been implemented to decrease the transmission and dissemination of the COVID-19. Regarding the surgical practice, a huge number of procedures considered non-essential or elective were cancelled and postponed until the pandemic is resolved. However, urgent and oncological procedures have been carried out. In this publication, we highlight and teach adaptations to be made with commonly used materials in laparoscopy to help prevent the spread and contamination of the healthcare team assisting surgical patients.

A infecção pelo coronavírus determinante da doença COVID-19, também conhecida como SARS-COV2 foi classificada nos últimos meses como pandemia. Essa é potencialmente fatal, representando enorme problema de saúde mundial. A disseminação, após provável origem zoonótica na cidade de Wuhan, China, resultou em colapso do sistema de saúde de diversos países, alguns com enorme impacto social e número grande de mortes descritas na Itália e Espanha. Medidas extremas intra e extra-hospitalares têm sido implementadas a fim de conter a transmissão e disseminação da COVID-19. No âmbito cirúrgico, enorme quantidade de procedimentos considerados não essenciais ou eletivos foram prorrogados ou suspensos até resolução da pandemia. No entanto, cirurgias de urgência e oncológicas não permitem que o paciente espere. Nesta publicação, sugerimos e ensinamos adaptação a ser feita com materiais de uso corriqueiro em laparoscopias para evitar a contaminação ou a disseminação entre as equipes assistenciais e os pacientes.

Customized disposable kit versus a conventional stainless steel instrument for an intravitreal injection: A comparison.

Comparison of a customized disposable kit with a conventional stainless steel instrument was performed for an intravitreal injection. A total of 2700 eyes of 2250 patients were enrolled in two groups. Comfort level of the patients was assessed using a 'Pain Scale' and any post intravitreal injection complications were examined clinically by a slit lamp biomicroscopy. Surgeon's ease was assessed by a questionnaire. In group A, no pain was recorded in 1231(82.06%) eyes, mild pain was d escribed in 184(12.27%), moderate pain was documented in 78 (5.2%) while, severe pain was noticed in 7(0.47%). In group B, no pain was seen in 1014(84.5%), mild pain was present in 123(10.25%), moderate pain was perceived in 58 (4.83%) while, severe pain was recorded in 5 (0.42%). With respect to surgeon's ease, 6 out of the 7 surgeons found the kit to be more convenient and cost effective as compared to the conventional instruments. Disposable intravitreal kit is beneficial for both the patients as well as the surgeons.

Management of ophthalmic surgical instruments and processes optimization: mixed method study.

AIM: Analysis of the use of ophthalmic instruments during surgical procedures in order to propose a material management method. METHOD: Mixed method study, sequential exploratory design, performed from January to June 2015, at a university hospital in southern Brazil. First, a qualitative approach was held from brainstorming and field observation. Themes were grouped into thematic categories. By connection, the quantitative stage happened through matrix arrangement and linear programming, culminating in the instrument management proposal. RESULTS: Given categories - instruments reorganization according to the time of the surgical procedure and the need surgical instruments for in each procedure - guided the definition of existing restrictions and application of mathematical models. There was an average reduction of 13.10% in the number of surgical instruments per tray and an increase of 17.88% in surgical production. FINAL CONSIDERATIONS: This proposal allowed the rationalization and optimization of ophthalmic instruments, favoring sustainability of the organization.

Assessing and Adopting New Medical Devices for Obstetric and Gynecologic Care: ACOG Committee Opinion Summary, Number 801.

The purpose of this document is: 1) to help obstetrician-gynecologists better understand the U.S. Food and Drug Administration's regulatory process for the marketing of medical devices; 2) to educate obstetrician-gynecologists on the importance of understanding available evidence on the safety, efficacy, and indications for devices in clinical practice; 3) to encourage obstetrician-gynecologists to report safety events associated with medical devices; and 4) to provide guidance on what to consider when adopting new medical devices. The decision to incorporate new technology in a patient's care may be complex. Some medical devices are marketed for gynecologic conditions but may have unclear indications for use or unclear safety and efficacy profiles, or both. Patients often have questions about treatments and procedures involving devices, especially if a device has received media attention; therefore, a basic understanding of how devices are regulated and what type of data are or are not required before a device is brought to market is important for patient care. When adopting a new medical device, obstetrician-gynecologists should achieve proper training and should understand the evidence on safety and effectiveness and the indications for the device's use. Obstetrician-gynecologists and other health care providers should be aware of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database and, ideally, should become familiar with the adverse event report form and report serious adverse events that may be associated with a medical device, use errors, product quality issues, and therapeutic failures.

Assessing and Adopting New Medical Devices for Obstetric and Gynecologic Care: ACOG Committee Opinion, Number 801.

The purpose of this document is: 1) to help obstetrician-gynecologists better understand the U.S. Food and Drug Administration's regulatory process for the marketing of medical devices; 2) to educate obstetrician-gynecologists on the importance of understanding available evidence on the safety, efficacy, and indications for devices in clinical practice; 3) to encourage obstetrician-gynecologists to report safety events associated with medical devices; and 4) to provide guidance on what to consider when adopting new medical devices. The decision to incorporate new technology in a patient's care may be complex. Some medical devices are marketed for gynecologic conditions but may have unclear indications for use or unclear safety and efficacy profiles, or both. Patients often have questions about treatments and procedures involving devices, especially if a device has received media attention; therefore, a basic understanding of how devices are regulated and what type of data are or are not required before a device is brought to market is important for patient care. When adopting a new medical device, obstetrician-gynecologists should achieve proper training and should understand the evidence on safety and effectiveness and the indications for the device's use. Obstetrician-gynecologists and other health care providers should be aware of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database and, ideally, should become familiar with the adverse event report form and report serious adverse events that may be associated with a medical device, use errors, product quality issues, and therapeutic failures.

Evaluation of the angiographic outcomes after clipping of intracranial aneurysms: determination of predisposing factors for occurrence of aneurysm remnants.

Objectives: Aneurysm remnants after microsurgical clipping have a risk of regrowth and rupture and have not been validated in the era of three-dimensional angiography. Therefore, this study aimed to evaluate the angiographic outcome using three-dimensional rotational images and determine the predictors for remnants after microsurgical clipping.Methods: Between January 2014 and May 2017, 139 aneurysms in 106 patients who were treated with microsurgical clipping, were eligible for this study. For the determination of aneurysm remnants after microsurgical clipping, the angiographic outcomes were evaluated using follow-up digital subtraction angiography within 7 days for unruptured aneurysms or within 2 weeks for ruptured aneurysms. According to the Sindou classification, the aneurysm remnants were dichotomized, and subgroup analysis was performed to identify the predictors of aneurysm remnants after clipping with various imaging parameters and clinical information.Results: The overall rate of aneurysm remnants was 29.5% (41/139), in which retreatments were needed in 6.5% (9/139). The neck size and maximum diameter of aneurysms were independent predisposing factors for the aneurysm remnants that need retreatment (OR: 2.30; p < 0.001; OR: 1.38; p < 0.001, respectively).Conclusions: This study demonstrated a low incidence of aneurysm remnants after microsurgical clipping which need to retreatment. However, selective postoperative angiography could provide us clear information of surgical result and evidence for long-term follow-up for some aneurysms with larger neck size (>5.7 mm) and maximum diameter (>7.1 mm).

Assessment of arthroscopic shavers: a comparison test of resection performance and quality.

BACKGROUND: Arthroscopic shavers play an indispensable role in arthroscopic debridement. They have exquisite structures and similar designs. The purpose of this study was to establish a reproducible testing protocol to compare the resection performance and the quality (tensile strength, torsional strength, and corrosion resistance) of different arthroscopic shavers with comparable designs. We hypothesized that there could be little difference in resection performance and quality between these shavers. METHODS: Incisor Plus Blade (IPB; Smith & Nephew, Andover, MA) and Double Serrated Plus Blade (DSPB; BJKMC, Shanghai, China) were selected for resection performance and quality test. For resection performance testing, the resection torque, which is the minimum torque required to cut off silicone blocks with the same cross-sectional area, was measured to evaluate the resection performance of shaver blades when the other factors remain the same. For quality testing, tensile and torsion tests of the shavers' joint part were performed, and ultimate failure load and maximum torque were measured and compared. The corrosion resistance of these blades was assessed by the boiling water test based on the ISO13402. RESULTS: No significant difference existed in the resection torque between the shaver blades of IPB and DSPB (P = 0.54). To the failure load of shavers' joint parts, IPB was significantly higher than DSPB, both in the outer and inner blades (P < 0.0001). The maximum torque of the joint part had no significant difference between IPB and DSPB (for inner blades P = 0.60 and outer blades P = 0.94). The failure load (for both IPB and DSPB P < 0.0001) and maximum torque (for IPB P = 0.0475 and DSPB P = 0.015) of the inner blades were higher than those of the outer blades. No blemishes were observed on the surface of the blades after corrosion resistance tests. CONCLUSIONS: This study provided some new methods to evaluate the resection performance and quality of different shavers. The resection performance, the torsional strength of the joint part, and the corrosion resistance of IPB and DSPB may show comparable properties, whereas the tensile strength of the shavers' joint part showed some level of difference.

How clean is clean enough? An observational pilot study to assess central sterilization processing efficacy with adenosine triphosphate levels.

BACKGROUND: There is strong evidence showing the need for quantitative assessment of the efficacy of cleaning medical devices. Studies comparing visual and microscopic analysis have demonstrated that visual inspection alone is insufficient to determine cleanliness. OUR OBJECTIVE WAS TO: collect baseline adenosine triphosphate testing data for surgical instruments to inform future quality improvement programs, and to develop a process to comply with standards recommended by the Association for the Advancement of Medical Instrumentation. METHODS: The central sterilization processing department (CSPD) identified difficult to clean tools in hip, spinal fusion, and colon procedures. Instruments used during the procedures were swabbed at arrival to the CSPD, after manual washing, and after a standard 24-minute machine wash cycle. Each instrument was swabbed in a uniform manner on surface areas including hinged joints and teeth, consistent with manufacturer recommendations. Instruments were tagged to ensure accuracy of tracking. RESULTS: The mean relative light unit (RLU) readout of all instruments on entry to the CSPD, postmanual wash, and postmachine wash was 240,416, 3,352, and 47, respectively. A total of 97.7% of all instruments had a passable final RLU readout. One Rongeur had a failed final RLU readout of 171. CONCLUSIONS: This study suggests that the current cleaning process is adequate for the instruments tested. Ongoing quality assessment would be beneficial to validate other instruments.

Comparison of Carbon Dioxide Absorption Rates in Gynecologic Laparoscopy with a Valveless versus Standard Insufflation System: Randomized Controlled Trial.

STUDY OBJECTIVE: The primary objective was to compare carbon dioxide (CO2) absorption rates in patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg. Secondary objectives were assessment of surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO2 (etCO2), and patients' report of postoperative shoulder pain. DESIGN: A randomized controlled trial using an equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation/IAP 10 mm Hg, and valveless insufflation/IAP 15 mm Hg. SETTING: Single tertiary care academic institution. PATIENTS: Women ≥ 18 years old undergoing nonemergent conventional or robotic gynecologic laparoscopic surgery. INTERVENTIONS: A standard or valveless insufflation system at IAPs of 10 or 15 mm Hg. MEASUREMENTS AND MAIN RESULTS: One hundred thirty-two patients were enrolled and randomized with 33 patients per group. There were 84 robotic cases and 47 conventional laparoscopic cases. CO2 absorption rates (mL/kg*min) did not differ across groups with mean rates of 4.00 ± 1.3 in the valveless insufflation groups and 4.00 ± 1.1 in the standard insufflation groups. The surgeons' rating of overall visualization of the operative field on a 10-point Likert scale favored the valveless insufflation system (median visualization, 9.0 ± 2.0 cm and 9.5 ± 1.8 cm at 10 and 15 mm Hg, respectively) over standard insufflation (7.0 ± 3.0 cm and 7.0 ± 2.0 cm at 10 and 15 mm Hg, respectively; p <.001). The anesthesiologists' ability to maintain adequate etCO2 was similar across groups (p = .417). Postoperative shoulder pain scores were low overall with no significant difference across groups (p >.05). CONCLUSION: CO2 absorption rates, anesthesiologists' ability to maintain adequate etCO2, and postoperative shoulder pain did not differ based on insufflation system type or IAP. Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.

Feasibility of the new sutureless excimer laser-assisted non-occlusive anastomosis clip in a rabbit model.

BACKGROUND: The excimer laser-assisted non-occlusive anastomosis (ELANA) technique facilitates the construction of anastomoses without temporary occlusion of the recipient artery. Experiments aimed at simplifying the technique eventually resulted in a sutureless ELANA slide (SEsl) anastomosis. After the first clinical use, new insights lead to the application of a clip at the back of the device, the SELANA clip (SEcl). The SEcl offers a distinct advantage over the SEsl since no sealant is necessary. In this study, we determine the feasibility of the SEcl anastomosis in an in vivo rabbit model. METHODS: 15 SEcl anastomoses and 15 conventional ELANA anastomoses were created on the abdominal aorta in 5 rabbits. Mean application times, flap retrieval rates, hemostasis, and burst pressures were assessed. RESULTS: The mean application time of the SEcl anastomoses was 11.4 min versus 39.0 min for the ELANA anastomoses (mean difference, 27.6 min; 95% CI, 20.6-34.7). The flap retrieval rate of the SEcl anastomoses (14/15) was not inferior to the flap retrieval rate of the ELANA anastomoses (13/15). Direct hemostasis was achieved in 13/15 (87%) SEcl anastomoses and in 14/15 (94%) ELANA anastomoses. All SEcl anastomoses were resistant to provoked pressures until 250 mmHg. CONCLUSION: The SEcl anastomosis is technically feasible in in vivo experiments. Mean application time, flap retrieval rate, hemostasis, and burst pressure are not inferior to the conventional ELANA anastomosis. Further long term experiments should be performed to assess safety, patency, and reendothelialization.