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.

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.

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.

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.

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.

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.

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.

[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.

Obstacles to Studying Emerging Technologies.

Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.

Hydrodynamic comparison of the Penumbra system and commonly available syringes in forced-suction thrombectomy.

BACKGROUND: The Penumbra system uses a coaxial separator and continuous extracorporeal suction to remove a clot from a cerebral artery. Forced-suction thrombectomy (FST) involves aspirating clots through the same reperfusion catheter using only a syringe, decreasing the procedure time and supplies needed. OBJECTIVE: To evaluate multiple combinations of catheters and syringes to determine the optimal pairing for use in FST. METHODS: Tests were performed using both the Penumbra system and syringes to aspirate water through Penumbra 0.041 inch (041), 4Max, 0.054 inch (054) and 5Max reperfusion catheters and a shuttle sheath. Dynamic pressure and flow at the catheter tip were calculated from the fill times for each system. Static pressure and force for each aspiration source were determined with a vacuum gauge. RESULTS: All syringes provided significantly higher dynamic pressure at the catheter tip than the Penumbra system (p<0.001). Increasing syringe volume significantly increased static pressure (p<0.001). Both flow and aspiration force significantly increased with catheter size (p<0.001). Cases are presented to demonstrate the clinical value of the laboratory principles. CONCLUSIONS: Maximizing static and dynamic pressure when performing FST is achieved by aspirating with a syringe possessing both the largest volume and the largest inlet diameter available. Maximizing aspiration force and flow rate is achieved by using the largest catheter possible.

Standardization of operative equipment reduces cost.

BACKGROUND: We hypothesize that standardizing operative equipment, and reducing variability can safely achieve cost reduction. METHODS: We retrospectively measured supply costs, operative time, intra-operative complications, and length of stay in a cohort of 145 patients at a children's hospital who underwent a laparoscopic appendectomy. A standardized preference card for laparoscopic appendectomy was developed and implemented. Data were prospectively collected on 101 consecutive patients and compared to the retrospective cohort using multiple linear regression. A survey assessing the perception of surgeons, nurses and scrub technologists of the impact of standardization on patient safety, patient care, OR efficiency, and cost was conducted. Wilcoxon rank sum test was used to evaluate associations between clinical role and years of experience with the total level of agreement on the survey. RESULTS: A 20% average reduction was achieved in supply cost per case, with no significant change in operative time (p=0.14), total time in OR (p=0.15), or length of stay (p=0.60). No intra-operative complications were identified in either group. Survey participants agreed that standardization improves cost and safety. Nurses tended to have greater agreement that standardization improved efficiency and patient care compared to other roles (p=0.06). CONCLUSIONS: Standardization of operative equipment can result in a significant cost reduction without impacting quality or delivery of care. Based on average case number per year, a total annual cost savings of >$41,000 could be realized. Survey participants agree that standardization improves cost and patient safety, yet perceptions regarding the impact on efficiency and patient care varied by occupation.

Systematic reviews of surgical procedures in children: quantity, coverage and quality.

AIM: Systematic reviews have the potential to map those areas where children are under-represented in surgical research. We aimed to describe and evaluate the quantity, coverage and the quality of conduct and reporting of systematic reviews of surgical procedures in children. METHODS: We searched four biomedical databases, a systematic review register, reference lists and conducted hand searching to identify relevant reviews. Two reviewers worked independently to critically appraise included studies and abstract data. We assessed reporting quality using the preferred reporting items for systematic reviews and meta-analysis statement and methodological quality using the Assessment of Multiple SysTemAtic Reviews tool. RESULTS: Fifteen systematic reviews were identified, representing 0.01% of all paediatric surgical citations in MEDLINE and Embase. Thirteen of the reviews were Cochrane reviews, and most reviews (12/15) addressed subspecialty interests such as otorhinolaryngology. The median number of included trials per systematic review was four (interquartile range 1 to 9.5), the median number of primary outcomes was 5.5 (interquartile range 3.5 to 7.5). In general, reporting and methodological quality was good although there were several omissions, particularly around completeness of reporting of statistical methods used, and utilisation of quality assessments in analyses. Outcomes were often not clearly defined and descriptions of procedures lacked sufficient detail to determine the similarities and differences among surgical procedures within the contributing trials. CONCLUSION: Systematic reviews of surgical procedures in children are rarely published. To improve the evidence base and guide research agendas, more systematic reviews should be conducted, using standard guidelines for conduct and reporting.