Efficacy of Ring Drape and Unused Sterile Instruments for Incisional SSI After Hepatectomy.

BACKGROUND/AIM: The aim of this study was to verify the efficacy of wound protection with a plastic ring wound protector (ring drape) and using new sterile instruments when closing the abdominal wall (wound closure set), both of which were used to prevent incisional surgical site infection (SSI) after hepatectomy. PATIENTS AND METHODS: The incidence of incisional SSIs and the clinical courses of 572 patients who underwent hepatectomy between January 2010 and December 2015 were studied retrospectively. The patients were divided into three period groups according to the period when each infection countermeasure was started. RESULTS: Incisional SSI incidence decreased significantly with additional countermeasures: 1st period 10.1%; 2nd period 2.08% (p=0.0114); 3rd period, 1.63% (1st vs. 3rd period, p=0.0016). A multivariate analysis showed that postoperative bile leakage [odds ratio (OR)=4.12, p=0.012] and not using a ring drape (OR=0.176, p=0.003) were independent factors for incisional SSI. CONCLUSION: Incisional SSI incidence was significantly reduced by using ring drape after hepatectomy.

The use of germicidal ultraviolet light, vaporized hydrogen peroxide and dry heat to decontaminate face masks and filtering respirators contaminated with a SARS-CoV-2 surrogate virus.

BACKGROUND: In the context of the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the supply of personal protective equipment remains under severe strain. To address this issue, re-use of surgical face masks and filtering facepiece respirators has been recommended; prior decontamination is paramount to their re-use. AIM: We aim to provide information on the effects of three decontamination procedures on porcine respiratory coronavirus (PRCV)-contaminated masks and respirators, presenting a stable model for infectious coronavirus decontamination of these typically single-use-only products. METHODS: Surgical masks and filtering facepiece respirator coupons and straps were inoculated with infectious PRCV and submitted to three decontamination treatments, ultraviolet (UV) irradiation, vaporized H2O2, and dry heat treatment. Viruses were recovered from sample materials and viral titres were measured in swine testicle cells. FINDINGS: UV irradiation, vaporized H2O2 and dry heat reduced infectious PRCV by more than three orders of magnitude on mask and respirator coupons and rendered it undetectable in all decontamination assays. CONCLUSION: This is the first description of stable disinfection of face masks and filtering facepiece respirators contaminated with an infectious SARS-CoV-2 surrogate using UV irradiation, vaporized H2O2 and dry heat treatment. The three methods permit demonstration of a loss of infectivity by more than three orders of magnitude of an infectious coronavirus in line with the United States Food and Drug Administration policy regarding face masks and respirators. It presents advantages of uncomplicated manipulation and utilization in a BSL2 facility, therefore being easily adaptable to other respirator and mask types.

In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces.

STUDY OBJECTIVE: To determine the ability of tissue containment systems to prevent leakage of cancer cell surrogates when subjected to forces encountered during power morcellation procedures. DESIGN: In vitro study. SETTING: Medical device research laboratory. INTERVENTIONS: Samples from 7 different legally marketed tissue containment bags (1 of which is indicated for power morcellation) were subjected to dye and bacteriophage penetration tests at pressures ranging from 0.5 to 50 times the insufflation pressure. The minimum pressure required to cause bag leakage was measured. Subsequently, the morcellation leakage safety factor for each bag was determined as the ratio of the minimum leakage pressure of the bag to the total pressure contributed from insufflation pressure and mechanical forces acting during the power morcellation procedure. MEASUREMENT AND MAIN RESULTS: The leakage performance of the bags varied markedly from brand to brand. No correlation was found between leakage pressure and the bag material or the total bag thickness. The leakage pressures ranged from 26 mmHg to >1293 mmHg for the 7 bags, and safety factors ranged from 1 to 50 when only the insufflation pressure was considered. However, if the morcellation forces were included in the calculation, the safety factor dropped by 6-fold for all brands and dropped below 1, indicating likelihood of leakage, for 2 of the 7 brands. CONCLUSION: This study provides a mechanism for more realistically simulating the conditions experienced by containment bags during morcellation and quantifying the level of safety provided by the bags.

Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study).

INTRODUCTION: Rigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation. METHODS AND ANALYSIS: A COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s). ETHICS AND DISSEMINATION: Ethical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.

The safety wire with a ureteral access sheath - does it hurt more than it helps?

INTRODUCTION: Studies indicate that with a safety wire in the ureter, an increased amount of force is necessary to advance ureteral access sheaths up to the proximal ureter. Theoretically, the compression of the ureter with the wire could lead to an increase in number and severity of ureteral injuries secondary to placement of a sheath. This prospective study aims to evaluate if there is a correlation between the use of a safety wire and ureteral injury from sheath placement by evaluating the location of the wire in relation to the injury after ureteroscopy. MATERIALS AND METHODS: Fifty-nine consecutive patients underwent ureteroscopy for upper tract urinary stone disease. A 12/14 French ureteral access sheath was used with a safety wire in place. Ureteroscopy during withdrawal of the sheath was video recorded and reviewed by a blinded observer. Visible ureteral injuries were graded per the Traxer ureteral injury scale and the proximity of the wire to the injury was noted. RESULTS: Thirty-one of 59 patients (52.4%) had a ureteral injury secondary to access sheath placement. Eighteen (30.5%) injuries were low-grade, 13 (22.0%) were high-grade (grade 2 and 3) and there were no grade 4 injuries. A total of 10 (32.3%) injuries occurred on the same side as the wire while 67.7% were on the contralateral side of the ureter. Of the injuries that occurred on the same side as the wire, 80% were grade 1 injuries and 2 (20%) were grade 3. Statistical analysis did not show a significant relationship between high/low injury grade and side of injury (p value = 0.088). This suggests that there is no association of between the safety wire and development of high injury. CONCLUSION: There is no association between the location of the safety wire and ureteral injury if injury occurs during the placement of a ureteral access sheath. This suggests that the use of a safety wire does not add significant morbidity to the procedure.

The Effectiveness of Sterile Wound Drapes in the Prevention of Surgical Site Infection in Thoracic Surgery.

BACKGROUND: The rate of surgical site infections (SSIs) has decreased in parallel to advances in sterilization techniques. Such infections increase morbidity and hospitalization costs. The use of iodine-impregnated sterile wound drapes (SWDs) is recommended to prevent or reduce the incidence of these infections. However, there is a paucity of data regarding their use in thoracic surgical procedures. The aim of the present study was to evaluate the effectiveness of sterile wound drapes in the prevention of these infections and the effects on hospitalization costs. METHODS: Perioperative iodine-impregnated SWDs have been used since January 2015 in the Thoracic Surgery Clinic of our hospital. A retrospective evaluation was made of patients who underwent anatomic pulmonary resection via thoracotomy with SWD in the period January 2015-2017, compared with a control group who underwent the same surgery without SWD in the 2-year period before January 2015. Factors that may have increased the risk of surgical site infection were documented and the occurrence of SSI was recorded from postoperative follow-up data. The cost analysis was performed as an important criterion to investigate the benefits of SWD. RESULTS: Evaluation was made of 654 patients in the study group (n:380) using SWD, the operation time was significantly longer, and perioperative blood transfusion was significantly higher, whereas treatment costs (p=0.0001) and wound culture positivity (p=0.004) were significantly lower and less surgical wound debridement was performed (p=0.002). CONCLUSION: The findings suggest that the use of sterile wound draping in thoracic surgery procedures reduces surgical site infections and hospitalization costs.

Reprocessing Single-Use Devices in the Ambulatory Surgery Environment.

Reprocessing single-use surgical supplies and devices is an option for hospitals and ambulatory surgery centers (ASCs). The US Federal Government has recognized the practice since 2000, and regulatory oversight has increased dramatically since that time. Reprocessing single-use devices is safe when personnel use approved methods, and health care facilities can experience significant cost savings by participating in this type of initiative. This article explores reprocessing and its benefits in ASCs, including a review of the oversight that the US Food and Drug Administration currently has for reprocessing and a discussion of the results of studies pertaining to this practice. The article also describes some issues that ASC leaders need to be aware of when considering the implementation of a reprocessing program. Single-use device reprocessing can be an effective tool for ASC leaders to conserve and manage resources.

Evaluation of the Sterility of Press'n Seal Cling Film for Use in Rodent Surgery.

level and improve surgical outcomes. Recently, some institutions have approved the use of Press'n Seal cling film (CF; Glad Products, Oakland, CA) as a practical, cost-effective alternative to sterile drapes for rodent surgeries. The purpose of this study was to evaluate the sterility of CF by using ATP and replicate organism detection and counting (RODAC) plates. We tested 10 boxes of CF at days 0, 14, and 28 after opening the box and compared the results with traditional packaged sterile drapes. Our data indicated that CF ATP bioluminescence remained at or below 10 relative light units for 28 d after opening the box. In addition, RODAC plates had no growth for 70% of CF boxes at day 0, 100% at day 14, and 90% at day 28. The mean growth for the positive plates was 0.024 cfu/cm² sampled after contacting locations on the front and back of the CF. The results of this study support the use of CF as an acceptable alternative to traditional sterile drapes during rodent aseptic surgery.

A Randomized Controlled Trial using iTClamp, Direct Pressure, and Balloon Catheter Tamponade to Control Neck Hemorrhage in a Perfused Human Cadaver Model.

BACKGROUND: Penetrating neck wounds are common in the civilian and military realms. Whether high or low velocity, they carry a substantial morbidity and mortality rate. OBJECTIVES: We endeavored to ascertain whether the iTClamp is equivalent to direct manual pressure (DMP) and Foley catheter balloon tamponade (BCT). METHODS: Using a perfused cadaver, a 4.5-cm wound was made in Zone 2 of the neck with a 1-cm carotid arteriotomy. Each of the hemorrhage control modalities was randomized and then applied to the wound separately. Time to apply the device and fluid loss with and without neck motion was recorded. RESULTS: There was no significant difference between the fluid loss/no movement (p > 0.450) and fluid loss/movement (p > 0.215) between BCT and iTClamp. There was significantly more fluid lost with DMP than iTClamp with no movement (p > 0.000) and movement (p > 0.000). The iTClamp was also significantly faster to apply than the Foley (p > 0.000). CONCLUSIONS: The iTClamp and BCT were associated with significantly less fluid loss than DMP in a perfused cadaver model. The iTClamp required significantly less time to apply than the BCT. Both the iTClamp and the BCT were more effective than simple DMP. The iTClamp offers an additional option for managing hard-to-control bleeding in the neck.

Ergonomics in the Operating Room: The Cervicospinal Health of Today's Surgeons.

In its many forms, operating can lead surgeons to adopt postures that have damaging long-term effects on physical health through imparting musculoskeletal fatigue. One area that is particularly susceptible is the cervical spine, as surgeons are forced into positions that require sustained cervical hyperflexion. The repercussions of resultant injuries can be steep, as they have the potential to adversely affect one's operative capacity. The purpose of this article is to assess the spinal health of today's surgeons by evaluating available research in various surgical subspecialties. By focusing on the ergonomic principles that govern the surgical arena and identifying unifying themes between plastic surgery and other surgical subspecialties, it is the goal of this article to enhance the understanding of cervical spine health as it pertains to the plastic and reconstructive surgeon.

Recommendations for the standards of equipping of the Bariatric and Metabolic Surgery Center.

INTRODUCTION: The prevalence of obesity in Poland and worldwide is constantly rising. High effectiveness of bariatric surgery has been proven in literature. It is recommended that bariatric procedures should be done by highly qualified surgeons with the appropriate, up-to-date medical equipment. AIM: The purpose of the study is to establish Polish recommendations and standards for the use of medical equipment for bariatric surgery centers. MATERIALS AND METHODS: The review of the present recommendations of the worldwide organizations and societies (including EAES, IFSO, SAGES) and guidelines was made. On the basis of current literature and authors's clinical experience we proposed standardized protocol for bariatric surgical equipment. CONCLUSIONS: Relevant equipping of bariatric surgery centers and implementation of standardized perioperative and surgery protocols will result in significant improvements in bariatric treatment. This will ensure patients safety, a shorter length of hospital stay and considerably reduce the risk of morbidity. Moreover, it will contribute to the efficacy of the bariatric and metabolic surgery procedures, in accordance with the highest globally accepted standards.

Evaluating the Effectiveness and the Impact of Donated Neurosurgical Equipment on Neurosurgical Units in Low- and Middle-Income Countries: The World Federation of Neurosurgical Societies Experience.

BACKGROUND: Surgical practice highly depends on the availability of surgical equipment; this is particularly relevant to low- and middle-income countries (LMICs), where resources are limited. A key part of the efforts to improve surgical provision globally include providing affordable equipment to LMICs; however, the effectiveness and the impact of these initiatives have not yet been assessed. We aimed to evaluate the World Federation of Neurosurgical Societies neurosurgical equipment program in this context. METHODS: Recipients were identified from the World Federation of Neurosurgical Societies records; contact details were gathered. An online survey was used to collect data on equipment, including its current use, any malfunctioning issues, suitability, reliability, serviceability, and the impact it has had on the unit. RESULTS: Responses were received from 16 units, totaling 28 pieces of equipment. A total of 75% of the equipment is still in use; of this, 57% is fully functioning, and 43% is used despite some malfunction. We found that 25% of the equipment is broken and unusable; high-maintenance items, such as high-speed drills, feature in this category (100% broken, n = 3). Units reported an increase in number of operation performed in 74% cases, improved surgery quality in 78%, and breadth of operations in 44%. Satisfaction, equipment suitability, reliability, and serviceability scored highly, with median values of 9 for all fields on a 10-point scale. CONCLUSIONS: Equipment donation positively impacts neurosurgical units in LMICs by allowing expansion of neurosurgical practice, improved safety and quality, and affordability. Adequate follow-up, considerations regarding equipment durability and maintenance needs, and improved support for repairs should be prioritized to ensure maximal benefit.

Barriers to implementation of the FUSE program.

INTRODUCTION: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) developed The Fundamental Use of Surgical Energy (FUSE) Program to promote safe use of energy devices in the operating room and endoscopy suite. Utilization of the program has been slower than anticipated. This study aims to determine the barriers to implementing FUSE. METHODS: An anonymous survey was distributed to a surgery department at an academic teaching hospital (n = 256). Participants indicated their level of training. Answers were measured using a 5-point Likert scale. RESULTS: There were 94 (36.7%) respondents to the survey from September 7 to 20, 2016. Fifteen surveys were incomplete, leaving 79 responses for analysis. Most respondents were at the faculty level (45/79, 57.0%). The majority had heard of FUSE (62/79, 78.5%), but only 19 had completed the certification (19/62, 32.3%). There was no difference in the completion rate between faculty and trainees (26.7 vs. 20.6%, OR 1.4, 95% CI 0.49-4.06, p = 0.53). The most common reasons for not taking the exam were lack of time to study (26/43, 60.5%) and lack of time to take the exam (28/43, 62.1%); however, cost was not a barrier (12/43, 27.9%). The majority identified a personal learning gap regarding the safe use of surgical energy (30/43, 69.7%). Of the 19 FUSE-certified respondents, reasons cited for completing the exam included wanting to prevent adverse events to patients and in the operating room (17/19, 89.5% and 17/19, 89.5%), and the belief that the course would make them a safer surgeon (16/19, 84.2%). CONCLUSIONS: FUSE teaches the proper use of radiofrequency energy, how to prevent unnecessary injury, and promotes safe practice. Close to three out of every four surgeons self-identified a personal knowledge gap regarding the safe use of surgical energy. Time restraints were cited most commonly as the barrier to starting and completing FUSE. Integrating the FUSE program into resident educational conferences, faculty grand rounds, or national conferences may help improve participation and drive adoption of FUSE certification.

Pilot Use of a Novel Tool to Assess Neurosurgical Capacity in Uganda.

INTRODUCTION: There is a significant burden of unmet surgical need in many low- and middle-income countries (>80% in parts of Africa). This need is even larger for specialties such as neurosurgery. Surgical capacity tools have been developed and used to assess needs and plan for resource allocation. This study piloted a new tool to assess neurosurgical capacity and describes its use. METHODS: A surgical capacity tool was adapted to assess neurosurgical capacity. An expert panel of neurosurgeons and researchers reviewed the Surgeons OverSeas PIPES (personnel, infrastructure, procedures, equipment, and supplies) assessment and added additional items essential to perform common neurosurgery procedures. This tool was then piloted at 3 public hospitals in Uganda and each hospital was given a score of neurosurgical capacity. At 1 hospital, 3 respondents were asked to answer the survey to assess reliability. RESULTS: The hospital with the largest neurosurgery caseload and 5 neurosurgeons scored the highest on our survey, followed by a regional hospital with 1 practicing neurosurgeon. The third hospital, without a neurosurgeon, scored the lowest on the scale. At the hospital that completed the reliability assessment, scores were varied between respondents. CONCLUSIONS: NeuroPIPES survey scores were in keeping with the number of neurosurgeons and respective caseloads of each hospital. However, the variation in scores between respondents at the same hospital suggests that adaptations could be made to the tool that may improve reliability and validity. The methodology used to create NeuroPIPES may be successfully applied to a variety of other surgical subspecialties for similar assessments.

[Intelligent operating room suite : From passive medical devices to the self-thinking cognitive surgical assistant]. / Der intelligente Operationssaal : Vom passiven Gerätepark zum mitdenkenden, kognitiven Assistenten.

Modern operating room (OR) suites are mostly digitally connected but until now the primary focus was on the presentation, transfer and distribution of images. Device information and processes within the operating theaters are barely considered. Cognitive assistance systems have triggered a fundamental rethinking in the automotive industry as well as in logistics. In principle, tasks in the OR, some of which are highly repetitive, also have great potential to be supported by automated cognitive assistance via a self-thinking system. This includes the coordination of the entire workflow in the perioperative process in both the operating theater and the whole hospital. With corresponding data from hospital information systems, medical devices and appropriate models of the surgical process, intelligent systems could optimize the workflow in the operating theater in the near future and support the surgeon. Preliminary results on the use of device information and automatically controlled OR suites are already available. Such systems include, for example the guidance of laparoscopic camera systems. Nevertheless, cognitive assistance systems that make use of knowledge about patients, processes and other pieces of information to improve surgical treatment are not yet available in the clinical routine but are urgently needed in order to automatically assist the surgeon in situation-related activities and thus substantially improve patient care.

Sustaining the success of medical device innovation.

Paul Fearis is CEO of Clinvue, Brandon Craft is COO of Clinvue. Clinvue is medical device innovation consultancy specializing in Insight Informed Innovation in the medical industry. Paul and Brandon are also lecturers in innovation for the 'Center for Bioengineering, Innovation & Design' Masters course in Bioengineering Innovation & Design at the Johns Hopkins University, and guest lecturers at Rice University and Virginia Tech.

[Evaluation of Medical Instruments Cleaning Effect of Fluorescence Detection Technique].

OBJECTIVE: To compare the cleaning effect of automatic cleaning machine and manual cleaning on coupling type surgical instruments. METHODS: A total of 32 cleaned medical instruments were randomly sampled from medical institutions in Putuo District medical institutions disinfection supply center. Hygiena System SUREII ATP was used to monitor the ATP value, and the cleaning effect was evaluated. RESULTS: The surface ATP values of the medical instrument of manual cleaning were higher than that of the automatic cleaning machine. CONCLUSION: Coupling type surgical instruments has better cleaning effect of automatic cleaning machine before disinfection, the application is recommended.