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Background and Aims: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope. Methods: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures. Results: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation. Conclusion: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: Disposable duodenoscopes and duodenoscopes with disposable endcaps are being used in clinical practice to reduce or eliminate the risk of transmitting infections. The study aim was to assess perceptions and experiences regarding the use of these duodenoscopes among advanced endoscopy fellows in a nationally representative sample. Methods: A 17-item electronic survey was sent to 74 advanced endoscopy training programs. The survey was completed by 50 participants and their responses were included for analysis. Results: Most participants were from academic training programs (82.7%) and identified as being in their 7th year of post graduate training (92%; PGY-7). Participants performed an average of 414 ERCPs. 29% reported difficulty with cannulation using disposable duodenoscopes versus 15.7% with duodenoscopes with disposable endcaps (vs. standard duodenoscope). 96% of trainees perceived disposable duodenoscopes as not cost effective and 92% stated they would not use this device during independent practice. 100% of trainees stated that they would use duodenoscopes with disposable endcaps during independent practice. For their most challenging cases, 90% of trainees preferred using standard reprocessable duodenoscopes while no trainee indicated they would prefer using a disposable duodenoscope in this scenario. 82% of participants stated that disposable duodenoscopes and disposable endcaps should be used exclusively or preferentially for high-risk patients citing cost, functionality, and concerns regarding environmental impact. Discussion: Advanced endoscopy fellows perceive disposable duodenoscopes as impacting technical maneuverability. Concerns about functionality, cost effectiveness and environmental impact are barriers to adoption. [ABSTRACT FROM AUTHOR]

Patients benefit from the use of check valves when drugs with a particularly short half-life (e.g., catecholamines) are continually administered through a one-way valve or when an accidental retrograde bolus application must be prevented, as in the event of a rapid sequence induction and intubation. The lack of a check valve can prevent the administered drug from working in the intended manner resulting in potentially insufficient treatment and negative consequences for the patient. In order to ensure the highest level of patient safety while using check valves appropriate training of medical personnel is essential. In contrast, preventable dangers (e.g., infections, awareness) exist when safety measures are disregarded, including the re-use of medications, syringes or disposable materials in successive patients after having only exchanged the check valves. It is not clear how often this is practiced in German-speaking areas. [ABSTRACT FROM AUTHOR]

Background: The removal of ureteral stent can be performed with disposable or reusable flexible cystoscopes, but limited comparative data are available on functionality, risk of infections, and costs. Methods: We performed a multicentric, prospective, observational study on patients undergoing in-office ureteral stent removal with Isiris-α® or a reusable Storz™ flexible cystoscope. Study endpoints were the functionality and effectiveness of the devices, the rate of postoperative bacteriuria and UTIs, and the costs of the procedure. Results: A total of 135 patients were included, 80 (59.2%) treated with reusable cystoscopes and 55 (40.8%) with Isiris-α®. No significant baseline differences between groups were detected. Isiris-α® outperformed the reusable device in terms of quality of vision (p 0.001), manoeuvrability (p 0.001), grasper functionality (p < 0.001), and quality of the procedure (p 0.01). Mean procedure time was shorter with Isiris-α® (p < 0.001) due to a shorter instrument preparation time (p < 0.001). No differences were found in terms of perceived patient pain (p 0.34), nor postoperative bacteriuria or symptomatic UTIs. According to our cost analysis, the in-office procedure performed with Isiris-α® was more expensive (+ 137.8€) but was independent from instrument turnover or disinfection. Among limitations of study we acknowledge the lack of randomization, the use of antibiotic prophylaxis in several patients, and the high rate of missing preoperative urine cultures. Conclusions: Isiris-α® outperforms reusable cystoscopes for in-office ureteral stent removal in terms of total operative time and quality of the procedure, at the cost of being more expensive. No significant differences in postoperative bacteriuria or symptomatic UTIs were found. [ABSTRACT FROM AUTHOR]

Laparoscopic common bile duct exploration (LCBDE) remains underutilized in the management of common bile duct (CBD) stones. The exact cause of this under-utilization remains unclear; however, identified barriers to LCBDE implementation include lack of training and unavailability of dedicated instruments. LCBDE is an attractive alternative for stone retrieval in patients with Roux-en-Y gastric bypass given the anatomical difficulty in endoscopic retrograde cholangiopaneatography (ERCP). Direct visualization through choledochoscopy is the method of choice for LCBDE. However, dedicated choledoscopes are expensive and not widely available, which may lead surgeons to seek for alternatives at their particular environment. With the COVID-19 pandemic, disposable bronchoscopes have become widely accessible at our institution, raising the possibility of using one for direct vision of the biliary tract. We present the case of a 61-year-old male with past medical history of Roux-en-Y gastric bypass, who presented to the emergency department with a CBD stone. Successful LCBDE was achieved with the aid of a disposable bronchoscope for direct visualization of the biliary tract. [ABSTRACT FROM AUTHOR]

Background: As the US healthcare sector contributes to 5–10% of national CO2 emissions, with a substantial contribution from surgical services, a collective effort is important to minimize the climate footprint of surgery. Solid plastic waste generated from single-use items in operating rooms is a major contributor to greenhouse gas emissions. To address this problem, we implemented a pilot study to replace single-use scrub caps with reusable caps. Methods: Ninety-two surgical trainees at the Massachusetts General Hospital, Boston, were provided reusable personalized scrub caps. Over 6 months, their use of the reusable cap was compared with corresponding use of disposable single-use caps. We then used the cost of raw materials, fabric and cap manufacturing, transportation, and end-of-life/waste treatment to perform an economic and environmental burden analysis. Results: After 6 months of reusable scrub cap use, 33 participants (51.6%) reported that due to their use of a reusable scrub cap, their utilization of disposable bouffant or caps had decreased by 76–100%. This was associated with a significant reduction in the use of single-use caps after adjusting for surgical case volume. The carbon footprint of single-use scrub caps was significantly higher than reusable caps during the study period. Reusable scrub cap usage also strongly correlated with substantial reductions in energy consumption and freshwater toxicity. Conclusions: Reusable personalized cloth scrub caps are cost-effective and can help reduce surgery's carbon footprint by reducing waste generated from disposable scrub cap use. More programs should consider replacing single-use polypropylene caps with reusable scrub caps for their operating room staff. [ABSTRACT FROM AUTHOR]

Tremendous progress has been made towards achieving tight glycaemic control in individuals with diabetes mellitus through the use of frequent or continuous glucose measurements. However, in patients who require insulin, accurate dosing must consider multiple factors that affect insulin sensitivity and modulate insulin bolus needs. Accordingly, an urgent need exists for frequent and real-time insulin measurements to closely track the dynamic blood concentration of insulin during insulin therapy and guide optimal insulin dosing. Nevertheless, traditional centralized insulin testing cannot offer timely measurements, which are essential to achieving this goal. This Perspective discusses the advances and challenges in moving insulin assays from traditional laboratory-based assays to frequent and continuous measurements in decentralized (point-of-care and home) settings. Technologies that hold promise for insulin testing using disposable test strips, mobile systems and wearable real-time insulin-sensing devices are discussed. We also consider future prospects for continuous insulin monitoring and for fully integrated multisensor-guided closed-loop artificial pancreas systems. An urgent need exists for technologies and devices capable of frequent and real-time insulin measurements in patients with diabetes mellitus to guide optimal insulin dosing. This Perspective discusses the advances and challenges in moving insulin assays from laboratory-based assays to frequent and continuous measurements in decentralized settings. [ABSTRACT FROM AUTHOR]

A recent study published in Digestive Diseases & Sciences analyzed the learning curve for a single-use duodenoscope, a device used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The study found that an experienced endoscopist achieved proficiency with the single-use duodenoscope after performing 10 cases. However, the study had limitations, including a small sample size and the fact that the procedures were performed by only one endoscopist. The study also highlighted concerns about the device's performance and its application in real-world practice. While the single-use duodenoscope showed promise for non-complex cases, it may not be suitable for complex cases. The authors suggested that future advancements in manufacturing could address the device's deficiencies and improve its performance. [Extracted from the article]

No comprehensive cost estimates exist for performing ureteropyeloscopy (URS), which is increasingly utilised as a treatment of upper tract urolithiasis in Australia. To estimate expenditure associated with URS in an Australian public hospital setting and determine factors contributing to increased cost. Patients who underwent flexible URS for urolithiasis over a 2-year period at a Victorian public health site were included. Data describing demographics, stone factors, disposable equipment and admission length were retrospectively collected. Procedures were performed using reusable flexible scopes. Previously validated costing models for cystoscopic stent extraction, theatre and recovery per hour and ward admission were used to attach cost to individual episodes. The cost of emergency stent insertion was beyond the scope of this study. 222 patients underwent URS; the combined total number of procedures was 539, comprising 202 stent extractions and 115 stent insertions in addition to 222 URS. Mean procedural cost was $2885 (range $1380–$4900). Mean episode cost excluding emergency stent insertion was $3510 (range $1555–$7140). A combination of flexible scopes, operative time and disposable equipment accounted for nearly 90% of the total procedural cost. Significant cost is associated with URS for treatment of renal and ureteric stones. A large burden of the cost is time in theatre, equipment and the need for multiple associated procedures per episode. Utilising other available treatments such as extracorporeal shockwave therapy (SWL) where appropriate may reduce the financial burden of URS and associated procedures. [ABSTRACT FROM AUTHOR]

Accidental foreign bodies (FBs) in the oral cavity, airway, esophagus and breathing circuit associated with anesthetic procedures are rare but can cause serious and life-threatening complications. We here present a case in which an unusual FB in the oral cavity was found after emergence from general anesthesia. The FB was later identified as a melted cap of a felt-tip pen. We investigated the cleaning process for reusable materials and concluded that the FB was accidentally placed in the inner lumen of the reusable bite block during the cleaning process. We then performed a review of the literature on FBs other than those of dental origin which were entrapped in the oral cavity, pharynx, larynx, trachea, esophagus, and anesthetic breathing circuit due to anesthetic procedures. From our case and 53 cases found in the search, we concluded that 1) use of disposable medical devices is recommended, 2) FBs can easily migrate into the oral cavity and airway during anesthesia, 3) delayed FB recognition may be associated with difficult intubation situations, and 4) more attention should be paid to the possibility of any medical or non-medical device becoming an FB during anesthesia. [ABSTRACT FROM AUTHOR]

Aim: Since its introduction, transanal endoscopic microsurgery (TEM) has become the treatment of choice for rectal benign lesions not amenable to flexible endoscopic excision and for early rectal cancer. Disposable soft devices as the Trans-anal Minimally Invasive Surgery (TAMIS) are a valid alternative to non-disposable rigid trans-anal endoscopic microsurgery (TEM) platforms. The aim of the present study is to compare TEM and TAMIS in terms of incidence of R1 resection and lesion fragmentation which were combined in a composite outcome called quality resection. Perioperative complication and operative time were also investigated. Methods: A total of 132 patients were eligible for this study of whom 63 (47.7%) underwent TAMIS and 69 (52.3%) underwent TEM. Patients were extracted for from a prospective maintained database and groups resulted homogenous after matching using propensity score in terms of size of the lesion, height from the anal verge, position within the rectal lumen, preoperative histology, neoadjuvant treatment. A multivariate logistic and linear regression analysis was carried out using those variables that have significant independent relationship with the quality of surgical resection and operative time. Results: The incidence of R0 resection and lesion fragmentation was similar between groups. No differences were found in terms of perioperative complication. TAMIS was associated with less setup time and less operative time compared with TEM. Variables influencing quality resection at the multivariate analysis were larger lesion (> 5 cm) and ≥ T2 stage. Variables influencing operative time were surgical procedure (TEM vs TAMIS), height from the anal verge and size of the lesion. Conclusion: The present study shows that TEM and TAMIS are equally effective in terms of quality of local excision and perioperative complication. TAMIS resulted less operative time consuming compared to TEM. [ABSTRACT FROM AUTHOR]

Aims: To compare current General Medical Practitioner treatment as usual (TAU) for the treatment of female urinary incontinence with a novel disposable home electro-stimulation device (Pelviva). Methods: Open label, Primary Care post-market evaluation. 86 women with urinary incontinence were randomly assigned to one of two 12-week treatments: TAU or Pelviva for 30 min every other day plus TAU. Outcome measures included ICIQ-UI (primary), PISQ-IR, PGI-S / PGI-I and FSFI (secondary) at recruitment and immediately after intervention, 1-h pad test at recruitment and usage diaries throughout. Results: Pelviva plus TAU produced significantly better outcome than TAU alone: 3 versus 1 point for ICIQ-UI (Difference − 1.8 95% CI: − 3.5 to − 0.1, P = 0.033). Significant differences were also observed for PGI-I at both 6 weeks (P = 0.001) and 12 weeks (P < 0.001). In the Pelviva group, 17% of women described themselves as feeling very much better and 54% a little or much better compared to 0% and 15% in the TAU. Overall PISQ-IR score reached statistical significance (P = 0.032) seemingly related to impact (P = 0.027). No other outcome measures reached statistical significance. Premature termination due to COVID-19 meant only 86 women were recruited from a sample size of 264. TAU did not reflect NICE guidelines. Conclusions: This study suggests Pelviva is more successful than TAU in treating urinary incontinence in Primary Care. The study had reduced power due to early termination due to COVID-19 and suggests TAU does not follow NICE guidelines. [ABSTRACT FROM AUTHOR]

During the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs) were recommended to protect healthcare workers when providing care to infected patients. Despite their single-use disposable nature, the need to disinfect and repurpose FFRs is paramount during this global emergency. The objectives of this study were to (1) determine if UV treatment has an observable impact on respirator integrity; (2) test the impact of UV treatment on N95 FFR user fit; and (3) test the impact of UV treatment on FFR integrity. Ultraviolet (UV) disinfection was assessed in maintaining N95 FFR integrity. Two models of FFRs were exposed to UV fluences ranging from 0 to 10,000 mJ cm−2 per side and subsequently tested for fit, respirator integrity, and airflow. Inspection of N95 FFRs before and after UV treatment via microscopy methods showed no observable or tactile abnormalities in the integrity of respirator material or straps. Tensile loading tests on UV-treated and untreated respirator straps also demonstrated no impact on breaking strength. Standardized fit test methods showed no compromise in user fit following UV treatment. Evaluation of particle penetration and airflow through N95 FFRs showed no impact on integrity, and average filtration efficiency did not fall below 95% for any of the respirator types or fluence levels. This work provides evidence that UV disinfection does not compromise N95 FFR integrity at UV fluences up to 10,000 mJ cm−2. UV disinfection is a viable treatment option to support healthcare professionals in their strategy against the spread of COVID-19. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the feasibility and safety of a 2-μm thulium laser to perform lung nodule resection under video-assisted thoracoscopic surgery (VATS) compared with disposable linear cutting staplers. In total, 72 patients underwent thoracoscopic resection of lung nodules between January 2016 and December 2017 in the Department of Thoracic Surgery, Xuanwu Hospital. Of them, 31 underwent 2-μm thulium laser dissection, while 41 underwent the standard technique with a stapler. The primary endpoints of the study included analysis of intraoperative and postoperative course and costs. There was no significant difference between the laser and stapler groups in terms of clinical characteristics including sex, age, smoking history, and lesion size. Intraoperative evaluation demonstrated grade ≤ 2 air leaks with 29 cases in the laser group and 40 cases in the stapler group (P = 0.574). No significant intergroup differences were seen in the postoperative hospital stay (P = 0.063) or total hospital stays (and P = 0.993). Chest tube placement duration was significantly shorter in the laser group than in the stapler group (P = 0.015). However, total hospitalization costs were not significantly different between the two groups. In addition, 10 patients in each group were given a Thopaz digital chest drainage system after surgery. The postoperative hospitalization time was significantly shorter in the laser group than that in the stapler group (P = 0.049). Our results suggest that the 2-μm thulium laser has high value with minimal invasiveness, higher accuracy, and safety during thoracoscopic resection of pulmonary nodules in comparison with the controls. [ABSTRACT FROM AUTHOR]

Background: As the cost of health care increases in the US, focus has been placed upon efficiency, cost reduction, and containment of spending. Operating room costs play a significant role in this spending. We investigated whether surgeon education and universal preference cards can have an impact on reducing the disposable supply costs for common laparoscopic general surgery procedures.Methods: General surgeons at two institutions participated in an educational session about the costs of the operative supplies used to perform laparoscopic appendectomies and cholecystectomies. All the surgeons at one institution agreed upon a universal preference card, with other supplies opened only by request. At the other, no universal preference cards were created, and surgeons were free to modify their own existing preference cards. Case cost data for these procedures were collected for each institution pre- (July 2014-December 2014) and post-intervention (February 2015-November 2017).Results: At the institution with an education only program, there was no statistically significant change in supply costs after the intervention. At the institution that intervened with the combined education and universal preference card program, there was a statistically significant supply cost decrease for these common laparoscopic procedures combined. This significant cost decrease persisted for each appendectomies and cholecystectomies when analyzed independently as well (p = 0.001 and p < 0.001 respectively).Conclusions: In this study, surgeon education alone was not effective in reducing operating room disposable supply costs. Surgeon education, combined with the implementation of universal preference cards, significantly maintains reductions in operating room supply costs. As health care costs continue to increase in the US and internationally, universal preference cards can be an effective tool to contain cost for common laparoscopic general surgery procedures. [ABSTRACT FROM AUTHOR]

Fecal incontinence (FI) is a highly prevalent condition known to substantially impair a patient's quality of life. Although a non-invasive treatment option, currently available anal plugs are poorly tolerated, not significantly effective and therefore not often used. We present a new disposable device based on an innovative concept that renews the interest for non-invasive "external" control of bowel content for FI patients. The Contix™ (Forconti Medical Ltd, Cesarea, Israel) permits creation of temporary "artificial" fecal impaction to avoid bowel leakage while inserted high into the "non sensitive" rectum where it is not felt by the patient and therefore tolerated for 6- to 12- hour use. This European conformity (CE)-marked device has a unique design that allows insertion, usage and removal in a similar manner to a vaginal pad. It comes in 2 parts: a flexible silicone-based oval-shaped biocompatible balloon and an applicator in which the balloon is folded for self-insertion. An external tube allows for the balloon to be inflated with 60-100ml. of air. In doing this, small smooth tines deploy on its surface to help maintain the balloon in place. A pulling string with a ring stays out of the anal canal to deflate and withdraw the balloon inverted on itself at end of use. Device handling that includes rectal insertion and withdrawal feasibility, wear time, comfort at the different steps of use, safety and of course effectiveness of Contix™ have been tested in small trials yet to be published but pilot studies support its uses at greater scale in expert centers in Europe and the United States. In summary the Contix™ is a non-invasive device for FI management based on an innovative concept. Initial results support its spread to identify its role as an ancillary service to existing approaches. [ABSTRACT FROM AUTHOR]

Background: During COVID-19 lockdown, non-urgent medical procedures were suspended. Grade of urgency of electroencephalography (EEG) may vary according to the clinical indication, setting, and status of infection of SARS-CoV-2 virus. "Italian Society of Clinical Neurophysiology" (SINC), "Italian League Against Epilepsy" (LICE), and the "Italian Association of Neurophysiology Technologists" (AITN) aimed to provide clinical and technical recommendation for EEG indications and recording standards in this pandemic era. Methods: Presidents of SINC, LICE, and AITN endorsed three members per each society to formulate recommendations: classification of the degree of urgency of EEG clinical indications, management and behavior of physicians and neurophysiology technologists, hygiene and personal protection standards, and use of technical equipment. Results: Scientific societies endorsed a paper conveying the recommendation for EEG execution in accordance with clinical urgency, setting (inpatients/outpatients), status of SARS-CoV-2 virus infection (positive, negative and uncertain), and phase of governmental restrictions (phase 1 and 2). Briefly, in phase 1, EEG was recommended only for those acute/subacute neurological symptoms where EEG is necessary for diagnosis, prognosis, or therapy. Outpatient examinations should be avoided in phase 1, while they should be recommended in urgent cases in phase 2 when they could prevent an emergency room access. Reduction of staff contacts must be encouraged through rescheduling job shifts. The use of disposable electrodes and dedicated EEG devices for COVID-19-positive patients are recommended. Conclusions: During the different phases of COVID-19 pandemic, the EEG should be reserved for patients really benefiting from its execution in terms of diagnosis, treatment, prognosis, and avoidance of emergency room access. [ABSTRACT FROM AUTHOR]

Background: Utilization of robotic-assisted inguinal hernia repair (IHR) has increased in recent years, but randomized or prospective studies comparing outcomes and cost of laparoscopic and Robotic-IHR are still lacking. With conflicting results from only five retrospective series available in the literature comparing the two approaches, the question remains whether current robotic technology provides any added benefits to treat inguinal hernias. We aimed to compare perioperative outcomes and costs of Robotic-IHR versus laparoscopic totally extraperitoneal IHR (Laparoscopic-IHR).Methods: Retrospective analysis of consecutive patients who underwent Robotic-IHR or Laparoscopic-IHR at a dedicated MIS unit in the USA from February 2015 to June 2017. Demographics, anthropometrics, the proportion of bilateral and recurrent hernias, operative details, cost, length of stay, 30-day readmissions and reoperations, and rates and severity of complications were compared.Results: 183 patients had surgery: 45 (24.6%) Robotic-IHR and 138 (75.4%) Laparoscopic-IHR. There were no differences between groups in age, gender, BMI, ASA class, the proportion of bilateral hernias and recurrent hernias, and length of stay. Operative time (Robotic-IHR: 116 ± 36 min, vs. Laparoscopic-IHR: 95±44 min, p < 0.01), reoperations (Robotic-IHR: 6.7%, vs. Laparoscopic-IHR: 0%, p = 0.01), and readmissions rates were greater for Robotic-IHR. While the overall perioperative complication rate was similar in between groups (Robotic-IHR: 28.9% vs. Laparoscopic-IHR: 18.1%, p = 0.14), Robotic-IHR was associated with a significantly greater proportion of grades III and IV complications (Robotic-IHR: 6.7% vs. Laparoscopic-IHR: 0%, p = 0.01). Total hospital cost was significantly higher for the Robotic-IHRs ($9993 vs. $5994, p < 0.01). The added cost associated with the robotic device itself was $3106 per case and the total cost of disposable supplies was comparable between the 2 groups.Conclusions: In the setting in which it was studied, the outcomes of Laparoscopic-IHR were significantly superior to the Robotic-IHR, at lower hospital costs. Laparoscopic-IHR remains the preferred minimally invasive surgical approach to treat inguinal hernias. [ABSTRACT FROM AUTHOR]

The use of single-use items (SUDs) is now ubiquitous in medical practice. Because of the high costs of these items, the practice of reusing them after sterilisation is also widespread especially in resource-poor economies. However, the ethics of reusing disposable items remain unclear. There are several analogous conditions, which could shed light on the ethics of reuse of disposables. These include the use of restored kidney transplantation and the use of generic drugs etc. The ethical issues include the question of patient safety and the possibility of infection. It is also important to understand the role (or otherwise) of informed consent before reuse of disposables. The widespread practice of reuse may bring down high healthcare costs and also reduce the huge amount of hospital waste that is generated. The reuse of disposables can be justified on various grounds including the safety and the cost effectiveness of this practice. [ABSTRACT FROM AUTHOR]

Model transformations are essential elements of model-driven engineering (MDE) solutions, as they enable the automatic manipulation of models. MDE promotes the creation of domain-specific metamodels, but without proper reuse mechanisms, model transformations need to be developed from scratch for each new metamodel. In this paper, our goal is to understand whether transformation reuse across metamodels is needed by the community, evaluate its current state, identify practical needs and propose promising lines for further research. For this purpose, we first report on a survey to understand the reuse approaches used currently in practice and the needs of the community. Then, we propose a classification of reuse techniques based on a feature model and compare a sample of specific approaches—model types, concepts, a-posteriori typing, multilevel modeling, typing requirement models, facet-oriented modeling, mapping operators, constraint-based model types, and design patterns for model transformations—based on this feature model and a common example. We discuss strengths and weaknesses of each approach, provide a reading grid used to compare their features, compare with community needs, identify gaps in current transformation reuse approaches in relation to these needs and propose future research directions. [ABSTRACT FROM AUTHOR]

The goal of this study was to compare performance parameters of a single-use syringe and a multi-use MR contrast injector. We compared preparation time, cost for disposables and volumes of contrast material used for a single-use (SI) and a multi-use (MI) MR contrast injector in a prospective cross-over trial. During the first study period all consecutive patients eligible for dynamic MR on two systems were included during a period of 20 working days. After 10 days, the injector was switched. Radiographer satisfaction was evaluated using a questionnaire. Contrast usage and waste on system MI was optimised by extra instructions for our radiographers and measured during the second study period of 10 consecutive working days. A total of 202 and 163 patients for systems SI and MI were included, respectively. Average preparation time was 4:55 min for SI and 2:24 min for MI (p < 0.05). Contrast waste for SI was 13% using 7.5 ml syringes. Contrast waste for MI was 5% for 7.5 ml containers. Costs for disposables were lower for MI if more than 5 patients per day were injected. Radiographer satisfaction was higher for MI (4.7 versus 2.8 on a 5-point scale; p < 0.05). The multi-use MR contrast injector led to higher radiographer satisfaction, shorter preparation time, and lower cost if more than 5 patients were injected per day. In addition, cheaper contrast containers of 15 or 30 ml could be used for the first patients if more than 2 or more than 4 injections are performed per day, potentially leading to lower contrast waste. [ABSTRACT FROM AUTHOR]

Objective: Laparoscopic totally extraperitoneal inguinal hernia repair (TEP) can be performed using either telescopic (TD) or balloon dissection (BD). The use of a disposable balloon dissector increases the cost of TEP. However, it remains unclear whether BD saves enough time to justify its cost. We hypothesized that BD would consistently save 15 min in operative time. To test this hypothesis, we designed a registry-based randomized controlled trial (RB-RCT) embedded into the Americas Hernia Society Quality Collaborative.Methods: A single-blinded, parallel, RB-RCT was conducted. Adults with inguinal hernias presenting for elective repair were screened. Patients with unilateral hernias deemed fit to undergo TEP were eligible; those with bilateral hernias (BIH) or undergoing open repair were excluded. Individuals were randomized to TD or BD with a disposable device. TEP was performed with synthetic mesh and tacks. Subjects were blinded and followed up for 30 day. Main outcome was operative time.Results: 207 patients were screened: 166 were excluded and 41 were randomized (21 BD, 20 TD). One patient (TD group) was excluded due to the incidental finding of BIH. 40 patients were analyzed (median age 56, median BMI 26 kg/m2, 98% males). Hernias were 72% indirect, 17% direct, 10% pantaloon, and 8% recurrent. Other than obesity (26.5% vs. 0, p = 0.018), there were no baseline differences between the groups. Median operative times were similar (TD 43 min, IQR 33-63; BD 46 min, IQR 35-90, p = 0.490). There were 2 seromas and 2 hematomas in the BD group, and none in the TD (p = 0.108).Conclusions: BD does not consistently result in 15-min time saving during TEP. Use of a disposable balloon dissector can be deferred in the experienced hands.Trial Registration: ClinicalTrials.gov (NCT03276871). [ABSTRACT FROM AUTHOR]

Background: Presently, there is equipoise regarding the surgical technique used to manage the appendiceal stump during laparoscopic appendectomy. The purpose of this research was to determine whether the routine use of loop ligature, compared to stapling, is cost effective from a hospital payer perspective.Methods: A retrospective cohort study was conducted amongst patients undergoing emergency laparoscopic surgery for acute appendicitis at two major academic hospitals. In order to eliminate possible systematic bias arising from one technique being preferentially employed with more complex presentations, patients were divided into study groups based on the technique routinely employed by their surgeon, loop ligature (LLA) versus stapler (LSA). Pediatric patients and open appendectomies were excluded. Costs were determined using a previously published model derived from publicly available data from the Ontario Case Costing Initiative, in conjunction with local cost data for disposable procurement. Secondary outcomes included operating room time, length of stay, and complication rates.Results: Between Jan 1, 2014 and Dec 31, 2015, 567 adult patients had an emergency laparoscopic appendectomy for acute appendicitis. In comparing surgeons who routinely employed LLA to LSA, there was a significant decrease in total mean hospital cost with LLA ($1988 ± $143 vs. $2253 ± $99, p = 0.002). In addition, mean disposable cost was reduced for surgeons using LLA ($310 ± $27 vs. $668 ± $26, p < 0.001). This reduction in cost was not associated with a difference in length of stay (1.5 vs. 1.4 days, p = 0.28) or complication rates (8% vs. 10%, p = 0.43).Conclusions: These findings suggest that surgeons who routinely use loop ligature to secure the appendiceal base during emergency laparoscopic appendectomy offer more cost-effective care compared to stapler users, saving their institution more than $200 per case with no clear disadvantages. A shift from routine use of staplers to loop ligature should result in significant overall cost savings to the hospital. [ABSTRACT FROM AUTHOR]

A system product line (PL) often has a large number of reusable and configurable requirements, which in practice are organized hierarchically based on the architecture of the PL. However, the current literature lacks approaches that can help practitioners to systematically and automatically develop structured and configuration-ready PL requirements repositories. In the context of product line engineering and model-based engineering, automatic requirements structuring can benefit from models. Such a structured PL requirements repository can greatly facilitate the development of product-specific requirements repository, the product configuration at the requirements level, and the smooth transition to downstream product configuration phases (e.g., at the architecture design phase). In this paper, we propose a methodology with tool support, named as Zen-ReqConfig, to tackle the above challenge. Zen-ReqConfig is built on existing model-based technologies, natural language processing, and similarity measure techniques. It automatically devises a hierarchical structure for a PL requirements repository, automatically identifies variabilities in textual requirements, and facilitates the configuration of products at the requirements level, based on two types of variability modeling techniques [i.e., cardinality-based feature modeling (CBFM) and a UML-based variability modeling methodology (named as SimPL)]. We evaluated Zen-ReqConfig with five case studies. Results show that Zen-ReqConfig can achieve a better performance based on the character-based similarity measure Jaro than the term-based similarity measure Jaccard. With Jaro, Zen-ReqConfig can allocate textual requirements with high precision and recall, both over 95% on average and identify variabilities in textual requirements with high precision (over 97% on average) and recall (over 94% on average). Zen-ReqConfig achieved very good time performance: with less than a second for generating a hierarchical structure and less than 2 s on average for allocating a requirement. When comparing SimPL and CBFM, no practically significant difference was observed, and they both performed well when integrated with Zen-ReqConfig. [ABSTRACT FROM AUTHOR]

Abstract: In this work, a screen-printed carbon paste electrode (SPCE) combined with multi-walled carbon nanotubes (MCNT) and graphene (GP) in different mixing ratios was fabricated. Electrode materials were characterized by scanning electron microscopy as well as Raman spectroscopy and their performance as electrochemical sensors was evaluated by cyclic voltammetry. Results showed that SPCEs composited with 1 w% MCNT and 1 w% graphene achieved the most promising sensing performance for K4FeCN6 with a sensitivity of 0.0054 µA µM−1 and limit of detection (LOD) (3S/N) at 3.1 µM. The so-prepared electrode was then employed to detect H2O2 and nicotinamide adenine dinucleotide (NAD+/NADH) achieving sensitivity and LOD of 0.0027 µA µM−1 and 7.1 µM for H2O2, and 0.0075 µA µM−1 and 3.6 µM for NADH, respectively. Therefore, it was found that the addition of MCNT and graphene to commercial carbon paste for screen printable electrochemical sensor is feasible for fabrication of sensing electrodes for electrochemical detection.Graphical abstract: [ABSTRACT FROM AUTHOR]

The article provides information on reprocess single-use devices (RSUD) in laparoscopy. Topics discussed include regulation and life cycle of RSUD, cost savings and environmental impact of RSUD, and safety and performance of laparoscopic RSUD. Challenges pertaining to the reuse of single-use laparoscopic insufflation trocars are also discussed.

Background: Flexible optical bronchoscopes are essential for management of airways in ICU, but the conventional reusable flexible scopes have three major drawbacks: high cost of repairs, need for decontamination, and possible transmission of infectious agents. The main objective of this study was to measure the cost of bronchoalveolar lavage (BAL) and percutaneous tracheostomy (PT) using reusable bronchoscopes and single-use bronchoscopes in an ICU of an university hospital. The secondary objective was to compare the satisfaction of healthcare professionals with reusable and single-use bronchoscopes. Methods: The study was performed between August 2009 and July 2014 in a 16-bed ICU. All BAL and PT procedures were performed by experienced healthcare professionals. Cost analysis was performed considering ICU and hospital organization. Healthcare professional satisfaction with single-use and reusable scopes was determined based on eight factors. Sensitivity analysis was performed by applying discount rates (0, 3, and 5%) and by simulation of six situations based on different assumptions. Results: At a discount rate of 3%, the costs per BAL for the two reusable scopes were 188.86€ (scope 1) and 185.94€ (scope 2), and the costs per PT for the reusable scope 1 and scope 2 and single-use scopes were 1613.84€, 410.24€, and 204.49€, respectively. The cost per procedure for the reusable scopes depended on the number of procedures performed, maintenance costs, and decontamination costs. Healthcare professionals were more satisfied with the third-generation single-use Ambu aScope™. Conclusions: The cost per procedure for the single-use scope was not superior to that for reusable scopes. The choice of single-use or reusable bronchoscopes in an ICU should consider the frequency of procedures and the number of bronchoscopes needed. [ABSTRACT FROM AUTHOR]

Purpose: To prospectively evaluate the new Flexor©Parallel™ Rapid Release™ (Cook, Bloomington, IN, USA) access sheath (UAS) which allows the use of a single wire to serve as both safety and working guide. Materials and methods: Between June and September 2014, adult patients from five European centers who underwent flexible ureteroscopy (fURS) for therapeutic and diagnostic purposes were included. The 12/14Fr Flexor©Parallel™ UAS was evaluated. Data were collected and examined by both univariate and multivariate analyses. The UAS material and usage characteristics were rated per case by the surgeons on a scale from very bad to very good. Results: In total, 134 UASs were used in 67 male and 67 female patients. Fifty percent of ureters (67 patients) were pre-stented. Ninety percent of the procedures were therapeutic. The overall successful insertion rate was 94 %. Pre-stenting status was the only independent factor for a successful access sheath insertion: 98.5 % of the pre-stented patients had a successful UAS placement vs. 82 % of non-pre-stented ( p = 0.001, C.I. 95 %: 1.2). Evaluation of the material and radiopacity was considered very good in over 90 % of cases. Release of the guidewire, hydrophilic coating, gliding of the endoscope and repeatability were considered very good in over 80 %. There were two (1.4 %) UAS malfunctions and one submucosal lesion reported. Conclusions: The use of the Flexor©Parallel™ Rapid Release™ (Cook, Bloomington, IN, USA) with usage of a single guidewire in a prospective multicentric scenario was clinically applicable in the majority of cases. Pre-stenting increased the chance of a successful insertion from 82 to 98.5 %. [ABSTRACT FROM AUTHOR]

Background: According to the recent guidelines supraglottic airways, such as laryngeal tubes are recommended to ensure oxygenation in patients with unexpected difficult airways. The novel Intubating Laryngeal Tube Suction Disposable (iLTS-D) is a modified laryngeal tube designed for secondary tracheal intubation. This pilot study evaluated the use of the iLTS-D in clinical practice with respect to practicality and efficacy.Methods: In this study the airways of 30 consecutive adult patients with no evidence of a difficult airway undergoing elective ear, nose and throat (ENT) surgery were managed with the iLTS-D. After induction of anesthesia the iLTS-D was placed in position and checked for correct ventilation. Following muscle relaxation, endotracheal intubation through the iLTS-D was performed under continuous visualization using a flexible bronchoscope. Finally, the iLTS-D was removed leaving the endotracheal tube in place. Data were collected anonymously as part of a quality assurance program. Publication of the data was approved by the institutional review board.Results: Initial iLTS-D placement took a median of 17 s (range 12-90 s) and provided sufficient ventilation in all patients; however, the position of the iLTS-D needed to be adjusted in four patients. Endotracheal intubation through the iLTS-D was achieved in 29 out of 30 patients at the first attempt (n = 23) or after 2 attempts (n = 6) and the median time required for intubation was 32 s (range 18-187 s). In five patients no laryngeal structures could initially be identified by bronchoscopy. Blind endotracheal intubation through the iLTS-D was performed in two cases and in two other patients the endotracheal tube was also blindly advanced but into the esophagus. After removal of the endotracheal tube and repositioning of the iLTS-D, successful tracheal intubation was subsequently achieved under bronchoscopic vision. The procedure was aborted and uneventful conventional intubation using direct laryngoscopy was carried out in one patient. The median time for removal of the iLTS-D after successful intubation was 20 s (range 15-80 s). Minor blood stains on the iLTS-D were observed in three patients. With one exception, all problems and adverse events occurred during the first 10 patients.Conclusion: This first clinical study demonstrated that in patients with apparently normal airways and in the hands of users without previous experience, the iLTS-D allowed sufficient ventilation in all patients and had a high success rate for subsequent endotracheal intubation. The results are, however, preliminary until confirmed by further studies, particularly in patients with difficult airways. [ABSTRACT FROM AUTHOR]

Purpose: Disposable devices for retrograde intrarenal surgery (RIRS) form a significant part of the urologist's armamentarium for the endoscopic management of urologic diseases. Herein, we provide an overview of the literature regarding the advances and controversies of these devices. Methods: A PubMed search was used to identify the literature discussing the subject of disposable devices for RIRS. Articles published between 2012 and 2013 were considered. Results: Ureteral access implements including access sheaths, wires, and dilators are an area of both improvement and controversy regarding their proper use. The safety, effectiveness, and limitations of lithotrites continue to be refined. Stone retrieval devices are undergoing persistent miniaturization, and their use may prove to be cost effective. The debate over perioperative stenting remains, while symptom management is explored. A cost-effective option for disposable flexible ureteroscopy shows promise. Conclusions: While rapid advances in technology and knowledge continue, continual improvements are necessary. Disposable equipment needs persistent refinement and possible miniaturization. More efficient fragment retrieval devices are needed. Durability of laser fibers and safety within ureteroscopes needs to be improved. Reducing stent morbidity remains an ongoing challenge. Lastly, costs need to be reduced by the further development of disposable flexible ureteroscopes and in the recyclability of disposable devices to improve availability worldwide. [ABSTRACT FROM AUTHOR]

Both disposable and non-disposable T-piece resuscitator (TPR) devices are used. Accuracy of the disposable and non-disposable infant TPR was compared. Peak inspiratory pressures (PIP) and positive end-expiratory pressures (PEEP) were measured during ventilation of a test lung. Measured PIP ±1 cmHO and PEEP ±0.5 cmHO of the desired pressures were considered acceptable. We tested the following: (A) Accuracy of setting pressures using built-in manometers of three disposable TPRs, (B) Minimal and maximal PIP and PEEP levels for the non-disposable and disposable TPR were measured using different gas flow rates, and (C) Accuracy of 25 caregivers setting pressures (PIP 25 cmHO and PEEP 5 cmHO). The results of the tests performed were as follows: (A) With pressures set: PIP 20, 25, 30, and 40 cmHO and PEEP 5-8 cmHO with 1 cmHO stepwise increment, measured PIPs and PEEPs were in acceptable range. (B) At gas flow rates 5, 8, 10, and 15 L/min (disposable vs. non-disposable), min-max PIP were 4.0-43.2 vs. 2.9-77.1 cmHO and min-max PEEP were 0.3-22.3 and 0.6-59.7 cmHO. (C) Set PIP (cmHO) by participants using disposable vs. non-disposable TPR was 25.8 (0.8) vs. 25.9 (1.3) (ns). PEEP was 5.4(0.5) vs. 4.7(0.5); p < 0.001. Conclusion: The accuracy of the disposable TPR is comparable to that of the non-disposable TPR. [ABSTRACT FROM AUTHOR]

Nanofibrous polyporous membranes imprinted with cyhexatin (CYT) were formed via the ordered distribution of the imprints in electrospun nanofibers. The MIPs have a high mass transfer rate and enhanced adsorption capacity. In addition, a printed carbon electrode with enhanced sensitivity was developed via electrochemical fabrication of reduced graphene oxide (rGO) and gold nanoparticles (AuNPs). The molecularly imprinted sensor exhibits excellent selectivity and sensitivity for CYT. The structure and morphology of the nanohybrid films were characterized by using scanning electron microscopy, atomic force microscopy and chronoamperometry. The sensing performances were evaluated by cyclic voltammetry, differential pulse voltammetry and electrochemical impedance spectroscopy by using hexacyanoferrate(IV) as an electrochemical probe. The electrode, best operated at a working potential of around 0.16 V (vs. Ag/AgCl), has a linear response in the 1–800 ng mL−1 CYT concentration range and a detection limit of 0.17 ng mL−1 (at S/N = 3). The sensor demonstrated satisfactory recoveries when applied to the determination of CYT in spiked pear samples. [ABSTRACT FROM AUTHOR]

The design of a smart robot for colonoscopy is challenging because of the limited available space, slippery internal surfaces, and tortuous 3D shape of the human colon. Locomotion forces applied by an endoscopic robot may damage the colonic wall and/or cause pain and discomfort to patients. This study reports a Soft Pneumatic Inchworm Double balloon (SPID) mini-robot for colonoscopy consisting of two balloons connected by a 3 degrees of freedom soft pneumatic actuator. SPID has an external diameter of 18 mm, a total length of 60 mm, and weighs 10 g. The balloons provide anchorage into the colonic wall for a bio-inspired inchworm locomotion. The proposed design reduces the pressure applied to the colonic wall and consequently pain and discomfort during the procedure. The mini-robot has been tested in a deformable plastic colon phantom of similar shape and dimensions to the human anatomy, exhibiting efficient locomotion by its ability to deform and negotiate flexures and bends. The mini-robot is made of elastomer and constructed from 3D printed components, hence with low production costs essential for a disposable device. [ABSTRACT FROM AUTHOR]

Auto-injection devices must be easy and intuitive to use, especially in emergency situations. However, there are many reports of safety-related issues affecting auto-injectors and pen injectors, due to usability deficits. To minimize this type of problem, the identification of potential use errors is an important and critical task in usability engineering. The aim of this systematic, qualitative literature review was to identify and catalog use errors related to disposable auto-injection devices. The key terms “auto-injector”, “usability”, and “safety/errors” were used to search in the PubMed and Scopus databases for articles from peer-reviewed journals and conference proceedings published in English or French between 2000 and 2017. Use errors, close calls, and operational difficulties were identified, extracted and hierarchically classified.The analysis showed that of the 1415 initially identified publications, 38 met all the eligibility criteria. A qualitative analysis identified 232 instances of use errors and close calls, which were classified into 10 main categories and then 39 subcategories. The present results could be used to guide the design, evaluation and risk analyses of disposable auto-injection devices. Our approach is in line with the European Union’s latest regulations on improving the safety of medical devices - especially those concerning transparency and traceability. [ABSTRACT FROM AUTHOR]

The point-of-care testing (POCT) is having increasing role on modern health care systems due to a possibility to perform tests for patients conveniently and immediately. POCT includes lot of disposable devices because of the environment they are often used. For a disposable system to be reasonably utilized, it needs to be high in quality but low in price. Optics based POCT systems are interesting approach to be developed, and here we describe a low-cost fabrication process for microlens arrays for microscopy. Lens arrays having average lens diameter of 222 μm with 300 μm lens pitch were fabricated. The lenses were characterized to have standard deviation of 0.06 μm in height and 4.61 μm in diameter. The resolution limit of 3.9μm is demonstrated with real images, and the images were compared with ones made with glass and polycarbonate lens arrays. The image quality is at the same level than with the glass lenses and the manufacturing costs are very low, thus making them suitable for POCT applications. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Gloves Reprocessing: Does It Really Save Money?" by P. Arora et al. which appeared in a 2015 issue.