The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope:A multicenter retrospective international study

Background: Duodenoscope-related multidrug-resistant organism(MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography(ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. Methods: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score(1 to 10) on performance rating of the single-use duodenoscope, and adverse event(AE) rate. Results: A total of 66 patients(26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47(71.2%) grade 3 and 19(28.8%) grade 4. The technical success rate was 98.5%(65/66). Procedural duration was 64(interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66(1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients(6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis(PEP), 1 cholangitis and 1 bleeding.Conclusions: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Single-use flexible ureteroscopes: Comparative in vitro analysis of four scopes

Objective:Single-use flexible ureteroscopes(fURSs)have recently been introduced by different companies.Goal of this in-vitro study was to compare four fURSs.Methods:We performed in vitro analysis of Uscope 7.5 Fr and Uscope 9.5 Fr(Pusen Ltd.,Zhuhai,China),LithoVue 9.5 Fr(LithoVue
,Boston Scientific,MA,USA),and Indoscope 9.5 Fr(Bioradmedisys
,Pune,India).Optical characteristics(image resolution,color representation,and luminosity)were compared at various distances of 10 mm,20 mm,and 50 mm.Deflection and irrigation were evaluated with and without accessories.Results:Color perception was comparable for all scopes at 10 mm(p<0.05),while Lithovue 9.5 Fr was comparable with Indoscope 9.5 Fr at the distances of 20 mm and 50 mm.Both scopes were statistically better than both Uscopes at the distances of 20 mm and 50 mm.Image resolution powers were comparable amongst all fURSs at the distances of 10 mm and 20 mm(3.56 line pairs per millimeter[lp/mm]).However,Indoscope(3.56 lp/mm)was superior to LithoVue and Uscope scopes(3.17 lp/mm)at the distance of 50 mm.Luminosity at the distance of 10 mm was comparable for LithoVue and Uscope 9.5 Fr.However,at the distances of 20 mm and 50 mm,LithoVue had the highest luminosity while Uscope 7.5 Fr had the lowest one.Indoscope had lower luminosity than other 9.5 Fr scopes at all distances.With empty working channel and 200 mm laser fiber,Indoscope had the maximum deflection(285
).With basket,Uscope 7.5 Fr had the maximum loss of deflection(30
)while Indoscope had no deflection loss.With empty working channel,all scopes had comparable irrigation flow rates in both deflected and undeflected state.Similarly,with 200 mm laser or basket,irrigation flow rates were comparable in all scopes.Conclusion:Color representation was equivalent for Indoscope and LithoVue,while being better than Uscope 7.5 Fr and Uscope 9.5 Fr.Image resolution was comparable in all scopes at the distances of 10 mm and 20 mm.Beyond the distance of 10 mm,luminosity of LithoVue was the highest and that of Uscope 7.5 Fr was the lowest.Deflection loss was the minimum with Indoscope and the maximum with 7.5 Fr Uscope.Under all scenarios,irrigation flow rates were comparable in all scopes.

Single-Use Bag Valve Masks: Evaluation of Device Design and Residual Bioburden Analytical Methods

Background: A recent survey of in-hospital reprocessing in Tanzanian hospitals identified bag-valve masks (BVM) as a commonly reused single-use device. In low- and middle-income countries (LMIC), in-hospital reprocessing supports neonatal resuscitation strategies by helping to maintain adequate supplies of BVM. However, there is a need for device-specific protocols defining reprocessing procedures and inspection criteria to overcome variations in reprocessing practices between hospitals. The purposes of this study were: 1) to complete a comprehensive design review and identify challenges to reprocessing BVMs;and 2) to investigate three different residual bioburden analysis methods for assessing the efficacy of decontaminating a disposable BVM. Methods: New, unused bag-valve-masks were contaminated with Staphylococcus epidermidis and Artificial Mucus Soil to simulate the worst case soiling conditions. Devices underwent one of five disinfection protocols, including one currently used in a LMIC hospital. Three analytical (two quantitative and one qualitative) methods were selected to evaluate residual bioburden on the device following decontamination. Results: Of all protocols tested, only the positive control and the Soap and Bleach protocols met disinfection targets. Most cleaning outcomes were consistent from trial to trial for each protocol. However, cleaning outcomes varied greatly for the Alcohol Wipe protocol. For the residual bioburden analyses, the two quantitative methods produced similar results, but the qualitative measurement exhibited increased variability. Conclusion: While this study revealed positive disinfection outcomes for the Tanzanian hospital decontamination protocol, more studies are required to support these findings. Design features of the BVM mask presented challenges to cleaning and drying during different decontamination protocols, as seen in the variability in the Alcohol Wipe protocol performance. These findings support the case for a device-specific protocol for the BVM. Given proper hospital personnel training and available resources, in-hospital reprocessing could support neonatal resuscitation strategies and other demands for manual resuscitation by helping to maintain adequate supplies of BVM.

ArtiSentialTM Revolutionizes Traditional Laparoscopy in Urology by Introducing the Dexterity of a Robotic System to a Laparoscopic Instrument —First Experiences in Urology in Europe by the Ukrb in Neuruppin

We describe the first two conventional, laparoscopic renal operations with a new multi-degree of freedom articulated single-use laparoscopic instrument (ArtiSentialTM). The two patients underwent different laparoscopic interventions at Ukrb University (Neuruppin, Germany): nephrectomy and Anderson-Hynes-pyeloplasty. All procedures were completed, with no need for conversion or placement of additional ports. No intraoperative complications or technical failure of the instrument was recorded. The mean operative time was 180 min median length of stay was 11.5 d. The instrument could be opened out of the sterile packaging and used at once when it was needed, because it is a single-use instrument. There was real haptical feedback and the costs are minimal compared to robot surgery. The use was straightforward and rapid processes after an intensive training of 4 h in a dry lap. Awaiting future investigations in larger series, this study proves the safety and feasibility of renal surgery with ArtiSentialTM and provides relevant data that may help early adopters of this surgical instrument.

Moving policy and regulation forward for single-use plastic alternatives

Single-use plastics are often used once or cannot be reused for extended periods.They are widely consumed with the rapid development of social economy.The waste generated by single-use plastics threatens ecosystem health by entering the environment and ultimately restricts sustainable human development.The innovation of sustainable and environmentally friendly single-use plastic alternative materials and the joint participation of governments,enterprises and the public are promising technologies and management approaches that can solve the problem of single-use plastics wastes.The development of single-use plastic alternative products can be promoted fundamentally only by improving relevant legislation and standards,providing differentiated industrial policies,encouraging scientific and technological innovation and expanding public participation.

The road to sustainable use and waste management of plastics in Portugal

As a European Union(EU)member,Portugal must comply with reductions in plastic waste.In Portugal,the 330 items/100 m of beach litter,comprising up to 3.9 million pieces and of which 88%is plastic,is higher than the EU median(149 items/100 m)and must be reduced to 20 items/100 m(94%).Integrative measures are needed to reduce littering and improve plastics’use and disposal under the circular economy.Of this 414 kt of plastic packaging waste,163 kt were declared plastic packaging,140 kt subjected to recycling,and 94 kt to energy recovery.The current recycling rate of plastic packaging(34%)should be improved to reach EU recycling averages(42%)and goals and to provide widespread benefits,considering revenues of 167€/t.As a net importer of waste,Portugal could benefit from the valorization of imported waste.Besides increased recycling,pyrolysis and gasification could provide short-term alternatives for producing value-added substances from plastic waste,such as hydrogen,consistent with the National Plan of Hydrogen and improving ongoing regulations on single-use plastics.This manuscript provides an integrative view of plastics in Portugal,from use to disposal,providing specific recommendations under the circular economy.

Bioreactor control systems in the biopharmaceutical industry:a critical perspective

Industrial-scale bioprocessing underpins much of the production of pharmaceuticals,nutraceuticals,food,and beverage processing industries of the modern world.The proftability of these processes increasingly leverages the economies of scale and scope that are critically dependent on the product yields,titers,and productivity.Most of the processes are controlled using classical control approaches and represent over 90%of the industrial controls used in bioprocessing industries.However,with the advances in the production processes,especially in the biopharmaceutical and nutraceutical industries,monitoring and control of bioprocesses such as fermentations with GMO organisms,and downstream processing has become increasingly complex and the inadequacies of the classical and some of the modern control systems techniques is becoming apparent.Therefore,with increasing research complexity,nonlinearity,and digitization in process,there has been a critical need for advanced process control that is more efective,and easier process intensifcation and product yield(both by quality and quantity)can be achieved.In this review,industrial aspects of a process and automation along with various commercial control strategies have been extensively discussed to give an insight into the future prospects of industrial development and possible new strategies for process control and automation with a special focus on the biopharmaceutical industry.