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Design inputs: Part II
Published in Marie B. Teixeira, Design Controls for the Medical Device Industry, 2019
Examples of events reported to the FDA regarding the consequence of misconnection include: A child’s oxygen tubing became disconnected from his nebulizer and was accidentally reattached to his IV tubing. Although the connection was broken in seconds, it wasn’t in time to prevent an air embolism that caused the child’s death.A patient’s blood pressure tubing was inadvertently connected to the patient’s IV catheter and delivered 15 mL of air. This patient also died as a result of an air embolism.An infant’s feeding tube was inadvertently placed in the tracheal tube and bile was delivered into the infant’s lungs causing death.An epidural set was mistakenly connected to the patient’s IV tubing thereby delivering epidural medicine to the IV and resulting in patient death.IV tubing was mistakenly connected to a child’s tracheal cuff port causing the IV fluid to fill the tracheal cuff to the point of breaking and allowing IV fluids to enter the child’s lung. The child died.A patient having a central line with three ports and a tracheal tube had medicine intended for the central line inadvertently injected into the tracheal cuff. The tracheal cuff was damaged, and the medicine entered the patient’s lungs; however, a new tracheal tube was quickly inserted and the patient survived.
Nuclear Terrorism
Published in Robert A. Burke, Counter-Terrorism for Emergency Responders, 2017
Blast waves created by nuclear explosions can produce serious injury and death to those close to the point of detonation (Table 10.3). Even those who might be protected from the initial blast wave by fortified buildings or heavy vehicles can be affected by the atmospheric overpressure created by the blast. The blast wave can enter buildings and vehicles and be reflected and reinforced within. Injuries to humans from blast waves vary based upon changeable susceptibility from person to person, accounting for age, physical condition, and the existence of disease or other injury in the victim. When the blast wave comes into contact with the human body, there is first a rapid compression followed by decompression, resulting in the transmission of pressure waves through body tissues. Sites where damage occurs include junctions of different tissues such as bone and muscle, or where tissue and airspaces intersect. Lungs and gastrointestinal components are very susceptible because of the amount of air present within. Hemorrhage or air embolism can occur, which can be fatal. While not serious, eardrum perforation can occur from blast over pressurization of the surrounding atmosphere. Pressures of 193 kPa (1.9 atm) can be fatal. There have been people, however, who have survived overpressures of 262 kPa (2.5 atm). As it turns out, the body is quite resilient to blast pressures as compared to something like a concrete block wall. Blast overpressures of 10.1–20.2 kPa (0.1–0.2 atm) can shatter a concrete block wall. Overpressures much less than those that are lethal can cause serious injury to those exposed. Lung damage can occur at 68.9 kPa, while eardrum rupture occurs at 22 kPa (0.2 atm), with a 50% chance of eardrum rupture from 90 to 130 kPa (0.9 to 1.2 atm). It is therefore likely that overpressures above 70 kPa will produce injuries. Radiation and thermal injuries will make up the largest portion of injuries produced by a nuclear explosion. Additional injuries can also be expected from flying debris and crushing caused by collapsing structures and vehicles.
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy
Published in Expert Review of Medical Devices, 2023
Daniel Curley, Jan Sindhar, Adam Howard, Hany Zayed, Prakash Saha
Although these data seem promising, there have also been significant safety concerns reported. Ho et al. reported a 17% device-related death rate in a six-patient series [23]. Qamhawi et al. showed 3% aneurysm-related deaths, 2% device-related deaths, and 11.9% all cause 30-day mortality [29]. One study reported EndoAnchor dislocation, resulting in a Type IIIb endoleak and aortic diameter expansion [37]. Five EndoAnchor-related issues in a 54-patient multicenter series were reported, including four EndoAnchor losses, although none had any clinical significance [31]. Kasprzak et al. reported multiple visceral and cerebral infarctions and death 4 weeks post-procedure in a single patient, and the authors warn that there may be an increased risk of severe thrombotic events with interventions in the proximal aortic arch [15]. More recently, air embolism has been described that has led to ischemic changes in cardiac monitoring and stroke [39].
Injectable enzyme-catalyzed crosslinking hydrogels as BMSCs-laden tunable scaffold for osteogenic differentiation
Published in Journal of Biomaterials Science, Polymer Edition, 2023
Hongwei Pan, Wanxin Li, Yue Qu, Simei Li, Ayixiemu Yusufu, Jia Wang, Lihua Yin
BMSCs were isolated from the bone marrow of a New Zealand (4 weeks old) rabbit [42]. The auricular vein was killed by air embolism, and 30 min was sterilized by 75% ethanol immersion. Move to the sterile super clean table, dissociate the bilateral femur and tibia under aseptic condition, remove the muscles and other soft tissues on the surface of the femur and tibia as far as possible, rinse with PBS, cut off the metaphysis on both sides, and rinse the bone marrow cavity repeatedly with PBS until the bone marrow cavity is whitened. The bone marrow cavity flushing solution was collected in the 15 ml centrifuge tube, the rotational speed of 1000r/min was centrifuged 5 min, the supernatant was discarded, the α-MEM culture medium containing 10% fetal bovine serum and 1% double antibody was blown and precipitated into a suspension, and the suspension was inoculated into 25 cm2 flask and incubated at 37 °C in cell culture incubator with 5% CO2 and 95% saturated humidity. The culture medium liquid was changed for the first time after 48 h, and then every 3 days. The passages of BMSCs used in all the experiment were controlled in passage 3–5.The BMSCs were identified the expression of cell surface antigens by flow cytometric.
Laser balloon in pulmonary vein isolation for atrial fibrillation: current status and future prospects
Published in Expert Review of Medical Devices, 2021
Shota Tohoku, Stefano Bordignon, Fabrizio Bologna, Shaojie Chen, Lukas Urbanek, Felix Operhalski, KR Julian Chun, Boris Schmidt
The LB catheter is not equipped with electrodes, which precludes recording of the electrophysiological signals. The ablation method is hence purely visually guided. This decision of not having electrodes on the balloon led to a clearer workflow and a higher rate of a first-pass isolation of 85–91.6% [4,10,20–23] per PV irrespective of the learning curve and catheter generation. However, in all cases, the operators must insert another mapping catheter into each PV after the lesion set of all PVs to confirm the electrical isolation. For this maneuver, the operators are forced to choose one of the two options: (1) perform a second transseptal puncture to avoid the risk of an air embolization due to the catheter exchange, or (2) perform a catheter exchange with the same sheath as the LB to reduces the risk of tamponade due to an additional transseptal puncture. Furthermore, about 10–15% of PVs still require two or more attempts to be isolated. In the case of an incomplete PVI, the physical effect on the balloon durability should also be considered. The incidence of an iatrogenic atrial septal defect and air embolism during the LB ablation has been unclear. Some technical implications during the CB ablation to prevent iatrogenic complications have been reported [44,45] and should be applicable to the LB ablation. Overall, no clear comparative data on the risk-benefit exists at present. If the LB catheter remains as purely visually guided, the feasibility and consistency of the anatomical approach without an electrical mapping systems should be investigated in a further trial.