Adequate Operator Training Research Articles

Virtual reality simulator for pipe umbrella installation works

AbstractThe installation of pipe umbrella systems is a complex process that requires well‐trained machine operators and installation crews. Due to project and time constraints, adequate operator training in a safe environment without risk of personnel accidents or machine damage often falls victim to cost cuts. Previously, this shortcoming has been compensated by the deployment of selected expert personnel to respective tunnel projects for a certain period. This practice is, however, limited to availability of expert personnel and associated with high travel costs and significant waiting time on‐site. Virtual reality (VR) simulator‐based trainings have become state‐of‐the‐art in underground construction. They provide enhanced occupational safety by conducting virtual training before commencing works in the tunnel, increased operator performance, and improved installation cycle times. In addition to basic training, the VR simulator can be used for assembly and commissioning, maintenance, as well as refresher trainings and ongoing just‐in‐time support. Around mid‐2019, DSI Underground initiated the development of a realistic and authentic scenario‐based VR simulator for the AT – Pipe Umbrella System. This training tool also includes extensive theory background supported by a series of video modules illustrating best underground work practices. This article illustrates the background and development plan of the VR simulator and the implementation based on use cases.

Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system

BackgroundBiventricular endocardial pacing (BiV ENDO) is a therapy for heart failure patients who cannot receive transvenous epicardial cardiac resynchronization therapy (CRT) or have not responded adequately to CRT. BiV ENDO CRT can be delivered by a new wireless LV ENDO pacing system (WiSE-CRT system; EBR Systems, Sunnyvale, CA), without the requirement for lifelong anticoagulation.ObjectiveThe purpose of this study was to assess the safety and efficacy of the WiSE-CRT system during real-world clinical use in an international registry.MethodsData were prospectively collected from 14 centers implanting the WiSE-CRT system as part of the WiCS-LV Post Market Surveillance Registry. (ClinicalTrials.gov Identifier: NCT02610673).ResultsNinety patients from 14 European centers underwent implantation with the WiSE-CRT system. Patients were predominantly male, age 68.2 ± 10.5 years, left ventricular ejection fraction 30.6% ± 8.9%, mean QRS duration 180.7 ± 27.0 ms, and 40% with ischemic etiology. Successful implantation and delivery of BiV ENDO pacing was achieved in 94.4% of patients. Acute (<24 hours), 1- to 30-day, and 1- to 6-month complications rates were 4.4%, 18.8%, and 6.7%, respectively. Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms.ConclusionBiV ENDO pacing with the WiSE-CRT system seems to be technically feasible, with a high success rate. Three procedural deaths occurred during the study. Procedural complications mandate adequate operator training and implantation at centers with immediately available cardiothoracic and vascular surgical support.

Avoiding problems in tunneled dialysis catheter placement.

Tunneled dialysis catheters (TDCs) remain the predominant vascular access for initiation of hemodialysis (HD) worldwide. TDCs are also utilized in a significant number of prevalent patients for continuation of dialysis and during the periods of complications related to arteriovenous (AV) accesses. TDC placement is a routine procedure, but can be associated with mechanical and infectious complications related to placement. Imaging guidance with ultrasound and fluoroscopy has made the placement of TDC safer and more successful. Adequate operator training, careful technique, utilization of a checklist, and barrier precautions are essential to avoid problems related to TDC placement.

Left atrial appendage closure: patient, device and post-procedure drug selection.

Left atrial appendage closure (LAAC), a device-based therapy for stroke prevention in patients with atrial fibrillation, is considered an alternative to oral anticoagulation therapy, particularly for patients at high risk of bleeding. Proof of concept has been demonstrated by the PROTECT AF and PREVAIL trials which evaluated the WATCHMAN device (Boston Scientific, Marlborough, MA, USA) versus warfarin, showing favourable outcome for the device group. The most commonly used devices for LAAC are the WATCHMAN and its successor, the WATCHMAN FLX (Boston Scientific) and the AMPLATZER Cardiac Plug and more recently the AMPLATZER Amulet device (both St. Jude Medical, St. Paul, MN, USA). The procedure is typically performed via a transseptal puncture under fluoroscopic and echocardiographic guidance. Technically, it is considered quite demanding due to the anatomic variability and fragility of the appendage. Careful material manipulation, adequate operator training, and good cardiac imaging and device sizing allow a safe, uneventful procedure. Post-procedure antithrombotic drug selection is based on the patient's history, indication and quality of LAAC.

The frequency and determinants of liver stiffness measurement failure: a retrospective study of "real-life" 38,464 examinations.

ObjectiveTo investigate the frequency and determinants of liver stiffness measurement (LSM) failure by means of FibroScan in “real-life” Chinese patients.MethodsA total of 38,464 “real-life” Chinese patients in 302 military hospital of China through the whole year of 2013, including asymptomatic carrier, chronic hepatitis B, chronic hepatitis C, liver cirrhosis (LC), alcoholic liver disease, autoimmune liver disease, hepatocellular carcinoma (HCC) and other, were enrolled, their clinical and biological parameters were retrospectively investigated. Liver fibrosis was evaluated by FibroScan detection. S probe (for children with height less than 1.20 m) and M probe (for adults) were used. LSM failure defined as zero valid shots (unsuccessful LSM), or the ratio of the interquartile range to the median of 10 measurements (IQR/M) greater than 0.30 plus median LSM greater or equal to 7.1 kPa (unreliable LSM).ResultsLSM failure occurred in 3.34% of all examinations (1286 patients out of 38,464), among them, there were 958 cases (2.49%) with unsuccessful LSM, and 328 patients (0.85%) with unreliable LSM. Statistical analyses showed that LSM failure was independently associated with body mass index (BMI) greater than 30 kg/m2, female sex, age greater than 50 years, intercostal spaces (IS) less than 9 mm, decompensated liver cirrhosis and HCC patients. There were no significant differences among other diseases. By changing another skilled operator, success was achieved on 301 cases out of 1286, which reduced the failure rate to 2.56%, the decrease was significant (P<0.0001).ConclusionsThe principal reasons of LSM failure are ascites, obesity and narrow of IS. The failure rates of HCC, decompensated LC, elder or female patients are higher. These results emphasize the need for adequate operator training, technological improvements and optimal criteria for specific patient subpopulations.

Operator Training and TEMS Support: A Survey of Unit Leaders in Northern and Central California

Members of Special Weapons and Tactics (SWAT) teams routinely work in high-risk tactical situations. Awareness of the benefit of Tactical Emergency Medical Support (TEMS) is increasing but not uniformly emphasized.To characterize the current regional state of tactical medicine and identify potential barriers to more widespread implementation.A multiple-choice survey was administered to SWAT team leaders of 22 regional agencies in northern and central California. Questions focused on individual officer self-aid and buddy care training, the use and content of individual first aid kits (IFAKs), and the operational inclusion of a dedicated TEMS provider.Respondents included city police (54%), local county sheriff (36%), state law enforcement (5%), and federal law enforcement (5%). RESULTS showed that 100% of respondents thought it was ?Very Important? for SWAT officers to understand the basics of self-aid and buddy care and to carry an IFAK, while only 71% of respondents indicated that team members actually carried an IFAK. In addition, 67% indicated that tourniquets were part of the IFAK, and 91% of surveyed team leaders thought it was ?Very Important? for teams to have a trained medic available onsite at callouts or high-risk warrant searches. Also, 59% of teams used an organic TEMS element.The majority of SWAT team leaders recognize the benefit of basic Operator medical training and the importance of a TEMS program. Despite near 100% endorsement by unit-level leadership, a significant proportion of teams are lacking one of the key components including Operator IFAKs and/or tourniquets. Tactical team leaders, administrators, and providers should continue to promote adequate Operator training and equipment as well as formal TEMS support.

Probabilistic safety assessment for food irradiation facility

Probabilistic safety assessment (PSA) is widely used for safety evaluation of Nuclear Power Plants (NPPs) worldwide. The approaches and methodologies are matured and general consensus exists on using these approaches in PSA applications. However, PSA applications for safety evaluation for non-reactor facilities are limited. Due to differences in the processes in nuclear reactor facilities and non-reactor facilities, the considerations are different in application of PSA to these facilities. The food irradiation facilities utilize gamma irradiation sources, X-ray machines and electron accelerators for the purpose of radiation processing of variety of food items. This is categorized as Non-Reactor Nuclear Facility. In this paper, the application of PSA to safety evaluation of food irradiation facility is presented considering the ‘fatality due to radiation overexposure’ as a risk measure. The results indicate that the frequency of the fatal exposure is below the numerical acceptance guidance for the risk to the individual. Further, it is found that the overall risk to the over exposure can be reduced by providing the adequate operator training and observing good safety culture.

Total Endovascular Repair for Thoraco-abdominal Aneurysms: Not for All, Not for Now

Thoraco-abdominal aneurysms (TAAs) represent a surgical challenge due to the complex surgical strategy to extensively replace the visceral aorta preventing multiple-organ ischaemia. The very unlikely opportunity of a mini-invasive approach for TAA, due to the several arterial branch involvement, seems to have become a real therapeutical choice in the last few years. Increasing evidence supports the feasibility of TAA repair with a total endovascular procedure, as shown by the study of Clough et al. in this issue of EJVES reporting the largest experience in the UK with this technique.1Clough RE, Modarai B, Bell R, Salter R, Sabharwal T, Taylor P, et al. Total endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Endovasc Surg, in press.Google Scholar The authors collected 31 totally endovascular TAA repairs using custom-made endografts in a cohort considered at high-risk for open surgery and achieved early results comparable to those obtained with hybrid or surgical repair in average-risk patients. Thirty-day mortality was 9.7% (3/31) and only one patient (3.1%) presented late-onset paraparesis and a second (3.1%) developed acute renal failure after 8 months. In 32.7% of patients, deterioration of renal function was detected after treatment. There were no conversions to open repair and, of the overall three endoleaks, only one was type III originating from a coeliac bridging stent and requiring reintervention. A number of key messages can be learnt from an experience like this on present-day total endovascular management of TAA. Total endovascular repair of TAAs, although feasible, is not for all. A successful procedure requires adequate operator training, centre competence, custom-made devices and, of more importance, careful assessment of TAA suitability. Even though Clough et al. reported the largest experience in the UK, the study was a relatively small single-centre experience with only 31 patients recruited.1Clough RE, Modarai B, Bell R, Salter R, Sabharwal T, Taylor P, et al. Total endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Endovasc Surg, in press.Google Scholar Concerns remain as to whether and to which extent the total endovascular treatment can be generalised to common TAA patients. TAA is a very challenging disease and operative risks are not trivial even with the lesser invasiveness of an endovascular approach. Perioperative mortality, paraplegia and renal failure are still important concrete risks. However, the report by Clough et al.1Clough RE, Modarai B, Bell R, Salter R, Sabharwal T, Taylor P, et al. Total endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Endovasc Surg, in press.Google Scholar analysed data related to higher-risk patients for whom the new technology was the only treatment option and included all the cases treated by the authors since the application of a total endovascular approach reflecting their learning curve experience. With technology development and accumulated experience, improved results should be likely obtained in the near future and the technique may be extended to patients at a standard surgical risk. There are few data to provide the efficacy and the long-term durability of total endovascular repair. The paper of Clough et al. showed mainly 30-day results.1Clough RE, Modarai B, Bell R, Salter R, Sabharwal T, Taylor P, et al. Total endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Endovasc Surg, in press.Google Scholar Lack of conversions to open surgery and a single case of endoleak requiring reintervention seem to be reassuring but the median 12-month follow-up reached in the study needs to be supported by longer evaluations. Endovascular repair of TAA is not for routine now. The technique is not straightforward and it is applicable in centres with high level of expertise and custom-made devices availability. However, technology is continually evolving. Appropriate training, suited device planning and careful patient selection make this very appealing new approach to TAA an extremely delicate choice that would hopefully expand in the near future. Nevertheless, despite the mini-invasiveness of the new total endovascular repair, TAA repair will remain a very demanding procedure. None.

Fire in the Hole

Carotid artery stenting has weathered a withering attack during the past year.1,–,3 Comparisons of the 3 recent randomized trials from Europe comparing carotid stenting with endarterectomy in symptomatic patients4,5 lead many to favor endarterectomy.1,–,3 The other 2 trials from North America included a mix of symptomatic and asymptomatic patients with carotid stenosis,6,7 and suggest more muted differences, pointing to equivalence or at least equipoise between the 2 modes of revascularization (Figure). This transatlantic tug-of-war is particularly focused on the importance of adequate training and experience in stenting among operators, the different end points between these trials, and patient selection. Figure. Individual and pooled absolute risk reduction (carotid artery stenting – endarterectomy) for any stroke or death. Intention-to-treat analysis of events from randomization to 30 days postprocedure, stratified by symptoms and operator credentialing (from review of 20 or more carotid procedures) in the recent randomized trials.4–,7,14–,17 Analysis was performed using the STATA statistical package with random-effects model and heterogeneity assessed by the I-squared statistic. CAS indicates carotid artery stenting; CEA, carotid endarterectomy; ARR, absolute risk reduction; EVA-3S, Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis; SPACE, Stent-Protected Angioplasty versus Carotid Endarterectomy; SAPPHIRE, Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy; CREST, Carotid Revascularization Endarterectomy Versus Stenting Trial; and ICSS, International Carotid Stenting Study. As with carotid endarterectomy, adequate operator training, credentialing, and auditing are important aspects of carotid stenting.2 Credentialing to select surgeons with low complication rates was a major feature of the randomized trials of endarterectomy in comparison with medical therapy 2 decades ago.8–,13 The minimization of periprocedural stroke and death permitted an assessment of …

Embolic Protection in Carotid Artery Stenting: New Options

Carotid artery stenting (CAS) has emerged as an attractive alternative to carotid endarterectomy (CEA) in patients with carotid disease who are at high risk for CEA. With increasing experience and improved technique, results in CAS patients have improved consistently over time in several clinical trials. Carotid stenting is clearly not inferior to CEA in appropriately selected high-CEA-risk patients treated by experienced operators. With improving results, CAS now has the potential to be considered "front-line therapy" even in standard-risk CEA patients, as demonstrated in CREST and as being studied in ongoing trials, such as the ACT I trial. Successful, low-risk CAS can only be performed if distal embolization is minimized during this procedure. This can be accomplished only with appropriate patient and case selection, adequate operator training and experience, and meticulous attention to procedural detail. Embolic protection devices (EPDs) are an important cornerstone of low-risk CAS. There are well-established, study-validated embolic protection systems available for CAS. Four new EPD options have been introduced in the United States over the past 3 years. Results with these newer devices appear to be extremely promising, with low event rates seen in high-risk clinical patients. This article will offer a practical review of techniques to decrease distal embolization during CAS. We will review patient selection and provide a "cookbook" approach to procedural technique, emphasizing techniques unique to each of the various EPD systems currently available. We will also introduce the newer options in EPDs, provide practical tips on their use, and contrast their use and results with that of the existing EPD systems. We will provide practical procedural techniques that incorporate the use of various EPDs into strategies that will reduce distal embolization during CAS and also provide pertinent data referencing results of these devices seen in clinical trials.

Pitfalls of Liver Stiffness Measurement: A 5-Year Prospective Study of 13,369 Examinations

Liver stiffness measurement (LSM) based on transient elastography (TE, FibroScan) is gaining in popularity for noninvasive assessment of liver fibrosis. However, LSM has limitations, which have not yet been thoroughly evaluated. We prospectively investigated the frequency and determinants of LSM failure and unreliable results over a 5-year period, based on 13,369 examinations (134,239 shots). LSM failure was defined as zero valid shots, and unreliable examinations were defined as fewer than 10 valid shots, an interquartile range (IQR)/LSM greater than 30%, or a success rate less than 60%. LSM failure occurred in 3.1% of all examinations (4% at first examination [n = 7261]) and was independently associated at first examination with body mass index (BMI) greater than 30 kg/m(2) (odds ratio [OR], 7.5; 95% confidence interval [CI], 5.6-10.2; P = 0.0001), operator experience fewer than 500 examinations (OR 2.5 [1.6-4.0]; P = 0.0001); age greater than 52 years (OR 2.3 [1.6-3.2]; P = 0.0001), and type 2 diabetes (OR 1.6 [1.1-2.2]; P = 0.009). Unreliable results were obtained in a further 15.8% of cases (17% at first examination) and were independently associated at first examination with BMI greater than 30 kg/m(2) (OR 3.3 [2.8-4.0]; P = 0.0001), operator experience fewer than 500 examinations (OR 3.1 [2.4-3.9]; P = 0.0001), age greater than 52 years (OR 1.8 [1.6-2.1]; P = 0.0001), female sex (OR 1.4 [1.2-1.6], P = 0.0001), hypertension (OR 1.3 [1.1-1.5]; P = 0.003), and type 2 diabetes (OR 1.2 [1.0-1.5]; P = 0.05). When metabolic syndrome and waist circumference were taken into account in a subgroup of 2835 patients, waist circumference was the most important determinant of LSM failure and unreliable results. In our experience, liver stiffness measurements are uninterpretable in nearly one in five cases. The principal reasons are obesity, particularly increased waist circumference, and limited operator experience. These results emphasize the need for adequate operator training and for technological improvements in specific patient subpopulations.

OVERVIEW OF CONTEMPORARY INTERVENTIONAL FLUOROSCOPY PROCEDURES

Interventional fluoroscopy procedures are increasingly important in medical practice. As new procedures are introduced and validated, they tend to replace the equivalent surgical procedure. There is wide variation in patient dose, both among procedures and for a specific procedure. Stochastic risk is present, but interventional fluoroscopy procedures may also present deterministic risk. Radiation risk/benefit analyses are different for interventional fluoroscopy procedures than they are for diagnostic imaging procedures. The radiation risk component of an interventional fluoroscopy procedure is substantially less than the other procedural risks, and there is always clear and measurable benefit to the patient from a successful procedure. Optimizing patient dose will require both improvements in equipment technology and greater attention from regulators, accrediting bodies and medical organizations. Ensuring adequate operator training is essential.

Radiofrequency thermal ablation of abdominal tumors: lessons learned from complications.

Radiofrequency (RF) thermal ablation has shown promise as a technique for treating inoperable solid tumors involving the liver, kidney, adrenal gland, and lung. However, like all other imaging-guided interventional procedures, RF ablation involves some element of risk. Varying degrees of complications can be expected, depending on factors such as the organ site and the aggressiveness of the procedure. General complications of RF ablation may be related to either imaging-guided electrode placement (eg, bleeding, infection, tumor seeding, pneumothorax) or thermal therapy (eg, nontarget thermal damage, grounding pad burns). Liver and renal-adrenal ablation may be associated with organ-specific complications. A fundamental understanding of RF ablation principles, along with adequate operator training and experience and familiarity with both thermal ablation and the broad spectrum of postablation complications, are necessary to maximize the safety and efficacy of this procedure. The standard of care for decreasing the morbidity of complications consists of prevention (including careful patient selection), early detection, and prompt, appropriate treatment.

Lack of Settling Contributed to Canadian Crypto Outbreak

Many circumstances led to the April 2001 cryptosporidiosis outbreak that affected 5,800 to 7,100 people in the region of North Battleford, Saskatchewan, Canada. Among the factors implicated were a highly susceptible watershed, insufficient water treatment facilities, lack of adequate operator training and certification requirements, problems at an upstream wastewater plant, and inadequate and inconsistent governmental regulation, oversight, and enforcement. This excerpt from the “Report of the Commission of Inquiry into Matters Relating to the Safety of Public Drinking Water in the City of North Battleford, Saskatchewan” addresses the issues that were attributed to water treatment plant failure.

Observations on the introduction of the DEFT for the routine assessment of bacteriological quality

In the light of experiences gained and observations made in the dairy industry, the critical control points and factors that affect the operation of the DEFT (Direct Epifluorescent Filter Technique) in a routine laboratory were determined. Recommendations are made for the optimization of both the test protocol and the instrumentation, and the need for adequate operator training is strongly emphasized.