Manufacturing Experience Research Articles

Автоматизація процесу теплового неруйнівного контролю шляхом застосування методу комплексування термограм

Technical Diagnostics and Non-Destructive Testing, 2022, №02. TEKHNICHESKAYA DIAGNOSTIKA I NERAZRUSHAYUSHCHIY KONTROL Quarterly scientific-technical and production journal. ISSN: 0235-3474. Established in 1989. Subscription index: 74475. State Registration Certificate KV 4787 of 09.01.2001. All rights reserved Publisher: B.E.Paton Electric Welding Institute, National Academy of Sciences of Ukraine. Main topics of the magazine: theoretical and practical articles on technical diagnosing and non-destructive testing; flaw detection, residual life of structures. Each issue features: scientific articles; manufacturing experiences; reviews; exhibitions, conferences; advertisements.

Проблеми технічної діагностики та підходи до їх вирішення

Technical Diagnostics and Non-Destructive Testing, 2022, №02. TEKHNICHESKAYA DIAGNOSTIKA I NERAZRUSHAYUSHCHIY KONTROL Quarterly scientific-technical and production journal. ISSN: 0235-3474. Established in 1989. Subscription index: 74475. State Registration Certificate KV 4787 of 09.01.2001. All rights reserved Publisher: B.E.Paton Electric Welding Institute, National Academy of Sciences of Ukraine. Main topics of the magazine: theoretical and practical articles on technical diagnosing and non-destructive testing; flaw detection, residual life of structures. Each issue features: scientific articles; manufacturing experiences; reviews; exhibitions, conferences; advertisements.

Використання статистичних методів для підтримки необхідної якості зварювальної продукції (Огляд)

Technical Diagnostics and Non-Destructive Testing, 2022, №02. TEKHNICHESKAYA DIAGNOSTIKA I NERAZRUSHAYUSHCHIY KONTROL Quarterly scientific-technical and production journal. ISSN: 0235-3474. Established in 1989. Subscription index: 74475. State Registration Certificate KV 4787 of 09.01.2001. All rights reserved Publisher: B.E.Paton Electric Welding Institute, National Academy of Sciences of Ukraine. Main topics of the magazine: theoretical and practical articles on technical diagnosing and non-destructive testing; flaw detection, residual life of structures. Each issue features: scientific articles; manufacturing experiences; reviews; exhibitions, conferences; advertisements.

Досягнення ІЕЗ ім. Є.О. Патона НАН України в галузі рентгенотелевізійного, ультразвукового та інших методів неруйнівного контролю (Огляд)

Technical Diagnostics and Non-Destructive Testing, 2022, №02. TEKHNICHESKAYA DIAGNOSTIKA I NERAZRUSHAYUSHCHIY KONTROL Quarterly scientific-technical and production journal. ISSN: 0235-3474. Established in 1989. Subscription index: 74475. State Registration Certificate KV 4787 of 09.01.2001. All rights reserved Publisher: B.E.Paton Electric Welding Institute, National Academy of Sciences of Ukraine. Main topics of the magazine: theoretical and practical articles on technical diagnosing and non-destructive testing; flaw detection, residual life of structures. Each issue features: scientific articles; manufacturing experiences; reviews; exhibitions, conferences; advertisements.

Painless Rectal Bleeding in a Patient With Prostate Cancer

Painless Rectal Bleeding in a Patient With Prostate Cancer

A structured method to achieve cognitive depth for medical device use error topic modeling

Human error associated with medical device use may lead to devastating consequences for end-users. Identifying post-market associations between instances of use error can inform human factors design decisions and guide regulatory action. The US Food and Drug Administration (FDA) requires medical device manufacturers, importers, and user facilities to track and report instances of adverse events. These reports are available in the Manufacturer and User Facility Experience (MAUDE) database. MAUDE exists to support post-market surveillance and to aid the discovery of adverse event-medical device associations. Each event contained in MAUDE contains an event narrative: a free-text description of the event. These event narratives are coded with a “device problem code” that describes the nature of each event that can aid in identifying trends, how,ever codes related to human factors are limited in detail. In the authors’ prior work, new use error categories for MAUDE entries were proposed tprovideides decomposition based on primary and secondary use error. In this work, these use error categories were used to structure entries based on narrative content. Topic modeling was performed for automatic extraction of narrative themes for use error MAUDE data from 2010 – 2019. Latent Dirichlet Allocation, an unsupervised generative model, was used to provide a descriptive analysis of this textual data and identify thematic topics. Notable outcomes included the categorization of narratives into six distinct topics; the first five primarily involved rule-based errors during the operation of glucose self-management devices, and the sixth involved knowledge-based errors during inpatient surgical procedures. Distinct divides between error narratives for healthcare providers and patients, as well as for different device types were observed, demonstrating an alignment with proposed use error categories. These categories can be used to monitor trends for specific medical device user segments and can inform device manufacturers of usability design requirements that must be addressed.

Adverse Events Associated With Image-Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis.

The utilization of image-guided navigation during endoscopic sinus surgery (ESS) has increased significantly since its introduction. However, the most common associated complications are still unknown. This study describes and analyzes adverse events related to image-guided ESS. Cross-sectional analysis. The Food and Drug Administration's 2018-2022 MAUDE database (Manufacturer and User Facility Device Experience). The MAUDE database was searched for all reports on adverse events involving sinus navigation systems used in ESS from 2018 to 2022. Reported events were reviewed and categorized. During the study period, there were 1857 adverse events from 1565 reports, which were divided into device-related (n = 1834, 98.8%) and patient-related (n = 23, 1.2%) complications. The most common device-related complications were nonfunctionality of the system (n = 512, 27.9%), device imprecision (n = 427, 23.3%), and device sensing problems (n = 277, 15.1%). The most common patient-related complications were cerebrospinal fluid (CSF) leak (n = 14, 60.9%), intracranial injury (n = 4, 17.4%), and bleeding/hemorrhage (n = 3, 13.1%). Imprecision was associated with increased risk of navigation abortion by the surgeon (odds ratio, 1.50 [95% CI, 1.38-1.65]; P < .001) and increased risk of CSF leak (odds ratio, 16.5 [95% CI, 3.66-74.0]; P < .001) as compared with other device-related complications. The most commonly reported device- and patient-related adverse events associated with image-guided sinus navigation systems were device nonfunction, imprecision, device sensing difficulties, and CSF leak. When imprecise navigation occurred, there was an increased likelihood of CSF leak and navigation abortion by the surgeon. Health care providers should be mindful of these possible complications when electing to use image-guided sinus navigation during ESS.

Comparison of technical failures and patient-related adverse events associated with 3 widely used mechanical lithotripters for ERCP: insights from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database

Mechanical lithotripsy is a commonly used, effective method for fragmenting large biliary or pancreatic duct stones. Real-world data on the most commonly reported adverse events and modes of failure associated with mechanical lithotripters are limited. We analyzed the postmarketing surveillance data from the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for 3 commercially available mechanical lithotripters for use during ERCP. A search of the MAUDE database from January 2010 to October 2021 was conducted for the following mechanical lithotripters: Trapezoid RX (Boston Scientific, Natick, Mass, USA), LithoCrush (Olympus Endoscopy, Center Valley, Pa, USA), and the Fusion Lithotripsy Extraction Basket (Cook Endoscopy, Winston Salem, NC, USA). Results were compiled and reviewed. In total, 1128 medical device reports with 2129 device malfunctions and 205 patient adverse events were identified. Most device malfunctions were because of guidewire port or sheath failure (n= 379, 17.8%), basket entrapment (n= 357, 16.8%), and basket tip separation failure (n= 315, 14.8%). The most commonly reported adverse events to patients were an additional procedure to remove an entrapped basket (170/205, 82.9%), bleeding (15/205, 7.3%), and bowel perforation (5/205, 2.4%). Findings from the MAUDE database highlight device- and patient-related adverse outcomes that should be recognized to improve clinical success and reduce patient risk.

Listeria prevention

<i>Listeria</i> prevention

Adverse events of subcutaneous loop recorders: Insights from the MAUDE database.

Complications using internal cardiac monitors (ICM) have been reported at a low rate. Targeted analyses of complications have not been well described in the literature. To investigate and describe complications associated with ICM events reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Our team reviewed all reported events for the Reveal LINQ loop recorder submitted to the MAUDE database over 7 years (1/1/2013-12/31/2019). A 5% random selection of reports was audited by two researchers to ensure report validity. Two cardiologists manually reviewed death and incongruent events for final interpretation. 12,652 records were obtained during the observed time period. A total of 15,587 device complications were reported. Of this, undersensing (n=4509, 28.93%), premature discharge of battery (n=3262, 20.93%), oversensing (n=2788, 17.89%), and other sensing issues (n=1532, 9.83%) were most commonly reported. Patient adverse events were reported 1,030 times. Pain or discomfort (n=275, 26.70%), site infection (n=213, 20.68%), erosion (n=138, 13.40%), and impaired healing (n=49, 4.76%) were most commonly reported to affect patients. Death was reported four times; after expert review, no reports justified the device or procedure as a reasonable cause. Several non-life-threatening ICM complications were commonly noted from the analysis. This study supports the safe use of ICMs. A better understanding of the complication profile will help providers select patients, provide informed consent, and expected management.

Abstract No. 12 A decade of angiographic device malfunction from the FDA MAUDE database

Vascular and interventional radiology (VIR) relies on imaging equipment to perform procedures. This presents a critical need for understanding adverse events related to equipment such as angiographic devices, with implications for patient safety. We present a decade of adverse events involving angiographic devices from the U.S. Food and Drug Administration’s postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database.

Device Complications and Outcomes Before and After FDA Recall of the VICI and Venovo Venous Stent Systems

The first two Food and Drug Administration (FDA) approved stents specific for iliofemoral vein obstruction, the VICI (Boston Scientific, Marlborough, MA) and Venovo (Becton, Dickinson and Co, Franklin Lakes, NJ) venous stent systems, were recalled on April 12, 2021 and May 12, 2021, respectively, within years of entering the market. We analyzed the publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize the predominant device and patient issues reported for each system over their recall timelines.

Oesophageal protection during AF ablation: real world registry data and mechanisms behind the therapeutic effect of tissue cooling

Abstract Funding Acknowledgements Type of funding sources: None. Background Oesophageal protection using a dedicated device to provide controlled active thermal protection of the oesophagus during atrial fibrillation ablation has been shown to be effective at reducing endoscopically detected oesophageal lesions. Real world registry data of this device and established evidence on the effect of cooling on localized tissue after thermal injury have been under review. Purpose To determine the safety of an oesophageal temperature control device by a review of real-world registry data on its clinical use during catheter ablation procedures and to clarify basic mechanisms of its therapeutic action by a literature review of scientific studies on cooling in the context of thermal injury. Methods The United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), FDA Medical and Radiation Emitting Device Recalls, the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and SwissMedic records of Field Safety Corrective Actions (FSCA) databases were reviewed for any device-related adverse events. A systematic literature review was conducted to clarify the findings from studies investigating the physiological processes behind the therapeutic effect of cooling after tissue thermal injury. Results Of over 20,000 oesophageal temperature control devices clinically used, 7976 were recorded as having been used for the purpose of oesophageal protection during left atrial catheter ablations. No adverse events occurred related to its use during left atrial catheter ablations. No case of clinically significant oesophageal injury was reported in a patient who had been protected by the oesophageal temperature control device. 208 research articles retrieved from PubMed and MEDLINE that met the search criteria were reviewed. The common finding in all the studies was that cooling had an anti-inflammatory and restorative effect via modulation of several immune-mediated pathways, local cellular function and genetic expression. Conclusions There have been no adverse events reported to date in real world clinical use of an oesophageal temperature control device during left atrial catheter ablations, for the purpose of active thermal protection. Literature review data suggests that there are complex biophysical and cellular effects from cooling that leads to its therapeutic effect but further work is required to define the mechanisms of action of thermal protection in this specific context.

Comparison of Adverse Events and Associated Mechanisms Across Three Commonly Used Balloon-Expandable Covered stents: A Review of FDA Manufacturer and User Facility Device Experience Database

This study's goal was to investigate and compare the device-specific relationships of adverse events (AEs) and associated device problems (DPs) or patient problems (PPs) from three balloon-expandable covered stents commonly used in endovascular procedures: BD Interventional LifeStream (Becton, Dickinson and Co, Franklin Lakes, NJ), Getinge Atrium iCast (Getinge, Gothenburg, Sweden), and Gore Viabahn VBX (W.L. Gore & Associates, Flagstaff, AZ).

Multi-Criteria Model for the Selection of New Process Equipment in Casting Manufacturing

The decision to introduce new process equipment is always a complex and risky process. An important competitive advantage in the automotive industry is the integration of new process equipment into the production system using different decision-making models composed of measurable key indicators, scientific methods and empirical values, study defines a multi-criteria model based on various scientific sources combined with extensive manufacturing experience, which is an important tool for making quality decisions when introducing new equipment or technology. The study considers five main areas of indicators and characteristics: internal, external, financial, knowledge level, and other important indicators. By applying the Delphi method, the importance of the indicators is defined by multidisciplinary experts and the order of each characteristic is determined, which is then prioritized using MCDM methods to select the final solution. The paper presents the model definition and a practical application of the model to the castings manufacturing in the automotive industry.

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE

The pulse-electron avalanche knife (PEAK) PlasmaBlade 3.0 and 4.0 (Medtronic, Minneapolis, MN) is an electrosurgical technology that is widely used in surgery. Our study aimed to summarize device malfunctions, patient injuries, and interventions related to PEAK PlasmaBlade 3.0 and 4.0. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of PlasmaBlade adverse events from June 6, 2010, to August 30, 2020. Data were extracted from reports pertaining to PlasmaBlade 3.0 and 4.0. A total of 384 medical device reports were identified, from which 424 adverse events were extracted. Of those, 348 (82.1%) were device malfunctions, 53 (12.5%) were patient injuries, and 23 (5.4%) were operator injuries. Device malfunctions were most frequently caused by delaminated coating (110, 25.9%), followed by ignition or fire (56, 13.2%). Operator injury was most frequently caused by thermal injury (19, 4.5%), followed by laceration (4, 0.9%). Pacemakers (22, 57.9%) were the most common devices causing interference. PEAK PlasmaBlade 3.0 and 4.0 have demonstrated utility during surgeries but are associated with adverse events. Interventions that aim to educate physicians on potential risks may help reduce the incidence of complications. Future studies with standardized reporting protocols are warranted.

A collaborative approach to cell &amp; gene therapy supply chain management

David McCall, Commissioning Editor, Cell &amp; Gene Therapy Insights, talks to Anthony Johnson, Head of Supply Chain &amp; Warehouse, Cell and Gene Therapy CatapultANTHONY JOHNSON is an Operations leader with experience in manufacturing, facilities, and supply chain management, with over 15 years experience in the pharmaceutical sector. Since 2021 Tony has worked for Catapult Cell &amp; Gene Therapy as Head of Supply Chain &amp; Warehouse. Prior to this he worked in Operations and Manufacturing leadership roles, for GSK, Bio Product laboratories and Catalent. He was responsible for leading teams in manufacturing of micronised respiratory and ODS API’s, IGG and CF blood products and modified release technologies.

Laying the foundations for success with scale-down models

Watch the video or read the poster for insights into: The driving challenges in cell-based therapy development and manufacturingNavigating complexity while saving on costsManaging complexity of scale-down modelsExploration of process knowledgeRohit Saklecha is a Process Manager with experience in research &amp; development for stem cell therapies. Rohit has over 7 years of experience working with stem cells from many different sources prior to joining Sartorius. He was most recently a Research Scientist at Intrexon working on pushing the boundaries for stem cell therapy.&#160;Andres Castillo is a Process Manager with experience in autologous manufacturing of CAR-T therapies. With over 8 years of gene editing experience prior to joining Sartorius, Andres was most recently a Research Scientist at Seattle Children&#39;s Hospital working in CAR-T manufacturing.&#160;

Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database.

Cryoablation offers a treatment option for small renal masses ideally suited ≤3 cm. In well-selected candidates, it is associated with less perioperative morbidity compared to more invasive options, such as partial or radical nephrectomy. However, little is known regarding device-related complications associated with the procedure. We provide an analysis of reports on renal cryoablation from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Reports on renal cryoablation submitted to the MAUDE database from 2015 through 6/2021 were analyzed. Cases not pertaining to renal cryoablation were excluded (n = 33). Reports were examined to identify patient morbidity related to a potential device malfunction, as well as manufacturer assessment. Complications were graded based on an established MAUDE complication-reporting stratification. Fisher's Exact test was utilized to analyze for associations between device-related adverse events and severity of post-treatment sequelae. Two hundred and thirty-nine unique cases were identified. Adverse events were related to issues with the needles or system (212 cases), technical error (12 cases), or complication related to patient or tumor complexity (14 cases). There were 187 (78.6%) minor complications (MAUDE 1-2) and 52 (21.4%) major complications (MAUDE 3-4). The manufacturer performed formal device review in 164 (68.6%) cases, accepting responsibility for malfunction in 41. Notable MAUDE 3 complications included 29 (12.1%) cases aborted due to instrument/system malfunction and 14 (5.9%) cases of hemorrhage requiring a subsequent procedure. All 3 reported patient deaths (MAUDE 4) appeared to be a consequence of poor baseline health. On statistical analysis, major complications were seen in a significantly higher proportion of non-device related adverse events compared to device related events (85.2% vs. 13.7%, P < .001). While renal cryoablation is associated with low overall perioperative morbidity, there is a diverse set of device-related and procedural complications reported in recent years. Device-related adverse events were often associated with minor complications, and major complications were often seen in higher risk patients with comorbidities, more complex tumors, and after technical error. These findings highlight the need for standardized reporting of complications, optimized patient selection and counseling to ensure the best outcomes.

B-13 | Impella Cardiac Perforation Events - A Report from FDA MAUDE Database

Impella® device (Abiomed Inc., Danvers, MA, USA) is a non-pulsatile microaxial flow pump that continuously propels blood from the left ventricle (LV) to the ascending aorta to provide short-term mechanical circulatory support, for example in patients with cardiogenic shock. Although bleeding and vascular complications have been reported data on cardiac perforation are limited. We analyzed data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to investigate this complication.