scholarly journals Analysis: Intravascular Devices with a Higher Risk of Polymer Emboli: The Need for Particulate Generation Testing

2020 ◽  
Vol 54 (1) ◽  
pp. 37-43
Author(s):  
Amitabh Madhukumar Chopra ◽  
Amy Rapkiewicz ◽  
Ramesh Daggubati ◽  
Adrian Sequeira ◽  
Yin C. Hu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Polymer Coating ◽  
Performance Testing ◽  
Polymer Coatings ◽  
Draft Guidance ◽  
Interventional Devices ◽  
Polymer Separation ◽  
Associated Risk Factors ◽  
Intravascular Devices ◽  
Hydrophilic Coatings

Abstract Hydrophilic polymer coatings on intravascular devices lower friction between the device and vasculature, thereby reducing trauma during interventional procedures. Polymer coating embolism—the detachment and downstream embolism of polymer particles—has been reported as an iatrogenic complication of coated interventional devices affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges this complication and continues to work with stakeholders to close gaps in performance testing and standards related to polymer coating integrity. Recent innovations within interventional technologies have led to development of new hydrophilic-coated devices with expanded indications for use. The 2018 FDA draft guidance for intravascular guidewires expands the application of particulate generation testing to most devices and recommends labeling changes to increase industry awareness. This article highlights current procedural trends where the phenomenon of polymer coating embolism may be more prevalent. It describes the mechanisms of polymer separation, reported clinical sequelae, and risk factors for relevant indications. These procedural trends and associated risk factors articulate the need for particulate testing and support the FDA's draft guidance recommendations for performance testing of applied coatings. If standardized, particulate assessments may allow characterization and comparisons of coating integrity among devices from various manufacturers, and are an important foundation for setting particulate limits. As hydrophilic coatings enable endovascular treatment for a range of patient populations, setting particulate limits or finding alternative solutions without compromise to device function may be essential. Particulate testing is relevant to physicians, regulators, and manufacturers for the purposes of product development and quality improvement of interventional devices.

scholarly journals Analysis: Particulate Limits for Intravascular Devices: Considerations for Polymer Coating Embolism

2019 ◽  
Vol 53 (6) ◽  
pp. 426-432 ◽  
Author(s):  
Amitabh Madhukumar Chopra
Keyword(s):  
Polymer Coating ◽  
Animal Studies ◽  
Polymer Coatings ◽  
Medical Instrumentation ◽  
New Device ◽  
Iatrogenic Complication ◽  
Industry Standard ◽  
Step Procedure ◽  
Release Limits ◽  
Intravascular Devices

Abstract Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.

Bone mineral density and associated risk factors: in healthy Indian population

2016 ◽  
Author(s):  
Swati Waghdhare ◽  
Neelam Kaushal ◽  
Rajinder K Jalali ◽  
Divya Vohora ◽  
Sujeet Jha
Keyword(s):  
Risk Factors ◽  
Bone Mineral Density ◽  
Bone Mineral ◽  
Indian Population ◽  
Mineral Density ◽  
Associated Risk Factors

Causes and associated risk factors of heart failure patients in Aljouf region of Saudi Arabia

2021 ◽  
pp. 185-189
Author(s):  
Md Sheikh ◽  
Manahel Alotaibi ◽  
Nouf Almutairi ◽  
Eid Aljohani ◽  
Omar Alruwaili ◽  
...  
Keyword(s):  
Risk Factors ◽  
Heart Failure ◽  
Saudi Arabia ◽  
Heart Failure Patients ◽  
Associated Risk Factors

Stress, anxiety, depression and burnout in frontline health care workers during COVID-19 pandemic: a brief systematic review and new data from Russia

2021 ◽  
Author(s):  
Ekaterina Mosolova ◽  
Dmitry Sosin ◽  
Sergey Mosolov
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Female Gender ◽  
Assessment Tools ◽  
Care Workers ◽  
Younger Age ◽  
Wide Range ◽  
Associated Risk Factors ◽  
Anxiety Depression ◽  
The Impact

During the COVID-19 pandemic, healthcare workers (HCWs) have been subject to increased workload while also exposed to many psychosocial stressors. In a systematic review we analyze the impact that the pandemic has had on HCWs mental state and associated risk factors. Most studies reported high levels of depression and anxiety among HCWs worldwide, however, due to a wide range of assessment tools, cut-off scores, and number of frontline participants in the studies, results were difficult to compare. Our study is based on two online surveys of 2195 HCWs from different regions of Russia during spring and autumn epidemic outbreaks revealed the rates of anxiety, stress, depression, emotional exhaustion and depersonalization and perceived stress as 32.3%, 31.1%, 45.5%, 74.2%, 37.7% ,67.8%, respectively. Moreover, 2.4% of HCWs reported suicidal thoughts. The most common risk factors include: female gender, nurse as an occupation, younger age, working for over 6 months, chronic diseases, smoking, high working demands, lack of personal protective equipment, low salary, lack of social support, isolation from families, the fear of relatives getting infected. These results demonstrate the need for urgent supportive programs for HCWs fighting COVID-19 that fall into higher risk factors groups.

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