The SXFEL Upgrade: From Test Facility to User Facility

The Shanghai soft X-ray Free-Electron Laser facility (SXFEL), which is the first X-ray FEL facility in China, is being constructed in two phases: the test facility (SXFEL-TF) and the user facility (SXFEL-UF). The test facility was initiated in 2006 and funded in 2014. The commissioning of the test facility was finished in 2020. The user facility was funded in 2016 to upgrade the accelerator energy and build two undulator lines with five experimental end-stations. The output photon energy of the user facility will cover the whole water window range. This paper presents an overview of the SXFEL facility, including considerations of the upgrade, layout and design, construction status, commissioning progress and future plans.

Schließungsstudien von Aerosol/Wolkenwechselwirkungen anhand von Lidar- und Radarbeobachtungen während MOASiC

<p>Während MOSAiC (Multidisciplinary drifting Observatory for the Study of Arctic Climate) wurden verschiedene Aerosol- und Wolkentypen mit einem Mehrwellenlängen-Polarisations-Raman-Lidar (Polly-XT) der OCEANET-Atmosphere-Plattform und mit dem KAZR-Wolkenradar der ARM (Atmospheric Radiation Measurement user facility) an Bord des Eisbrechers POLARSTERN beobachtet. Im Winterhalbjahr (2019/20) wurden dafür in der zentralen Arktis regelmäßig Aerosole in Oberflächennähe bis in 4-6 km Höhe (arktischer Dunst) und in der oberen Troposphäre und unteren Stratosphäre (Waldbrandrauch, bis in 18 km Höhe) beobachtet. Neu entwickelte Methoden der Fernerkundung ermöglichen die Bestimmung der Konzentrationen von Wolkenkondensationskernen (CCNC), der Wolkentröpfchenanzahl (CDNC), der eiskeimbildenden Partikel (INPC) und sogar, mit Hilfe von Dopplerradarbeobachtungen, der Eiskristallzahl (ICNC). Gleichzeitig sind Profile der relativen Luftfeuchtigkeit und der Temperatur aus Raman-Lidar, Mikrowellen-Radiometer und Radiosondierungen verfügbar. Mit Hilfe dieses einzigartigen Datensatzes präsentieren wir eine Aerosol-Wolkenschlussstudie, in der wir zeigen, dass CCNC und CDNC sowie INPC und ICNC miteinander verknüpft werden können. Die Ergebnisse können verwendet werden, um zu testen, welche CCN- und INP-Parametrisierungen (aus idealisierten Labormessungen) im arktischen Regime am besten zutreffen. <br>In Anlehnung an diese Methoden werden im zukünftigen Projekt SCiAMO (Smoke Cirrus interaction in the Arctic during MOSAiC) etwa 65 beobachtete Zirren im Hinblick auf Eisnukleationsprozesse in Abhängigkeit vom Auftreten von Rauchpartikeln in der Winter- und Sommersaison analysiert und verglichen.</p>

A review of hospital based ventilator malfunctions reported to the FDA in 2021

Ventilator care is synonymous with Intensive care. These devices are electromechanical and as such can fail. Most failures are without patient incident, injury, and harm. The FDA requires manufacturers who learn of malfunction, injury or death while operating their product to report to the agency via the Manufacturer and User Facility Device Experience database. I reviewed 500 recent events reported to the FDA and found an increasing trend from 2020 to 2021 in hospital ventilator malfunction reports. Examination of these reports is critical to assuring quality ventilator care. The author concluded that intensive training on the device characteristics and feature and a more rigorous examination of ventilator performance between patients may assist in reducing device malfunctions. Keywords: Mechanical ventilation, Ventilator malfunction, FDA

Complications Associated With Nasopharyngeal COVID-19 Testing: An Analysis of the MAUDE Database and Literature Review

Background Nasopharyngeal swab testing, which has greatly increased in utilization due to the COVID-19 pandemic, is generally safe and well-tolerated, although it may be rarely associated with adverse events. Methods Publicly reported adverse events associated with nasopharyngeal COVID-19 testing within the Manufacturer and User Facility Device Experience (MAUDE) database and the published literature were queried. Results A total of 129 adverse events were reported, including 66 from the MAUDE database and 63 from literature review. The most common complications were swab fracture resulting in retained foreign body (47%), followed by epistaxis (17%), and headache (11%). Seven (12%) of the reported retained foreign body cases required removal under general anesthesia, while 1 (5%) of the epistaxis cases required surgical intervention. The most serious adverse event was meningitis following cerebrospinal fluid leak. Conclusions Patients and healthcare providers should be aware of the potential risks associated with testing, with attention to ensuring proper technique, and be prepared to recognize and manage adverse events.

The Impact of COVID-19 on Medical Device Reporting and Investigation

Introduction The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports submitted to the U.S. Food and Drug Administration (FDA). In May 2020, the FDA released guidance about medical device reporting during a pandemic, anticipating delays in reporting and investigating events involving medical devices. Methods We aimed to understand how the COVID-19 pandemic impacted medical device reporting by analyzing reports in the MAUDE database that mention COVID-19. Results From the 816,470 reports submitted between January 1 and July 31, 2020, 3,500 (0.43%) included phrases related to COVID-19. Of these reports, 4.8% (167/3,500) described adverse events during COVID-19 patients’ treatment, and 90.3% (3,161 /3,500) described barriers manufacturers faced investigating malfunctioning devices during the pandemic. 4.9% (172/3,500) of reports were not related to COVID-19. Malfunctions were clinically significant in 85.8% (3,004/3,500) of reports. Discussion Reports indicate challenges some manufacturers had when investigating medical devices during the pandemic. The pandemic made investigating implants uniquely difficult, as restrictions to person-to-person contact limited the type of care patients could receive. Because full-scale investigations into malfunctioning devices may be difficult to perform during the pandemic, safety issues may go unaddressed and result in future harm to patients. Conclusion The COVID-19 pandemic and the myriad of healthcare, travel, and shipping challenges it created impacted how manufacturers reported and investigated medical devices. At the current time, it is unclear how manufacturers will address delayed clinical management of implant devices and other uninvestigated malfunctions after the pandemic and how this will impact patient safety.

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

Background Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Objective To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Methods The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. Results After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). Conclusions PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.

Bent or broken: analysis of set screw fracture in the TFNa implant

Objectives To evaluate set screw fracture in the Trochanteric Femoral Nail Advanced implant (TFNa, Synthes, West Chester, PA) and to identify additional mechanisms of set screw failure in the TFNa. Materials and methods Patients who had experienced failure after open reduction and internal fixation (ORIF) with the TFNa were identified. TFNa implants were explanted and inspected following revision surgery. Medical device reports (MDRs) and manufacturer’s inspection reports describing similar failures for the TFNa in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database were also reviewed. Results Four set screw fractures that occurred at a level II trauma center were observed. Sixty-seven reported failures were identified in the MAUDE database for review. Twenty-eight failed implants were returned to the manufacturer for inspection with a published inspection report available for analysis. Set screw fractures can occur in the TFNa when the set screw is deployed prematurely into the proximal screw aperture prior to blade/screw insertion. The set screw can also bend and deform if it is advanced against a helical blade/lag screw that is not fully seated into position, thereby potentially compromising its function. Conclusion The TFNa set screw allows for potential fracture during implant insertion leading to uncontrolled collapse, early excessive proximal femoral shortening, and rotational instability of the helical blade/lag screw. Similar failures in the TFNa can be prevented by having the surgeon inspect the proximal screw aperture after attachment of the proximal aiming aim to ensure the set screw has not been deployed prematurely. Level of evidence Therapeutic Level III.