Expert review of medical devices
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Expert Rev Med Devices · Feb 2021
ReviewAcute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system.
Ultrasound-guided percutaneous peripheral nerve stimulation (PNS) may be used to treat acute postoperative pain for various types of surgeries. This modality avoids several limitations of traditional local anesthetic-based peripheral nerve blocks including avoidance of motor blockade and sensory deficits. ⋯ PNS is a novel modality in regional anesthesia that has much promise in reducing overall opioid use after surgery. Placement of PNS is very similar to that of catheter-based regional anesthesia techniques. Ultrasound is used to guide the percutaneously placed introducer needle in proximity to the target nerve. There are several benefits of PNS over catheter-based approaches, including: 1) avoidance of motor or sensory blockade; 2) no medication bag required to be carried; and 3) electric leads may be kept in situ safely for up to 60 days. While several proof-of-concept studies have been published highlighting its use in various types of surgeries, large high-quality randomized controlled trials are still needed.
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Expert Rev Med Devices · Dec 2020
ReviewPersonal protective equipment during COVID-19 pandemic: a narrative review on technical aspects.
Introduction: The current pandemic of novel Corona Virus Disease 2019 (COVID-19) has created a significant shortage of personal protective equipment (PPE) in many countries of the world, stressing medical services during this crisis. Along with addressing problems of demand and supply mismatch, there also a need to ensure the procurement of high-quality PPEs that provides both safety and comfort to users. The purpose of this article is to review existing standards and recommendations on the technical aspects of PPE. ⋯ Expert opinion: The design and materials of PPE needs further research, which might have minimal carriage of infective biological load like the use of antimicrobial repellent finishes along with adequate tensile strength and breathability through the fabric. Respirators should have the least resistance while providing maximum protection; goggles should not have fogging. Also, there is a need of formulating universal technical specifications for medically used PPE and ensuring easy availability of the testing facilities.
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Expert Rev Med Devices · Oct 2020
ReviewLifecycle evidence requirements for high-risk implantable medical devices: a European perspective.
The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. ⋯ Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.
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Expert Rev Med Devices · Oct 2020
ReviewEmerging technologies for diagnostics and drug delivery in the fight against COVID-19 and other pandemics.
A pandemic is the worst-case scenario in the field of infectious diseases. Innovative technologies have the potential to address the challenges associated with the manufacture of personalized drug delivery systems, biosensors, and medical devices during a pandemic. 3D-Printing, microfluidics, and Microelectromechanical systems (MEMS) can provide an important part on this fight, as are cheap, easy to be operated, capable to provide rapid detection and monitoring of a disease, and deliver medicines. ⋯ New manufacturing techniques are emerging with the ability to address the challenges associated with the development of medical devices or diagnostics, during a pandemic. Are many challenges in order to achieve this and especially in short times that are required under a pandemic attack, which will also be covered in this manuscript.
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Expert Rev Med Devices · Jun 2020
ReviewArtificial intelligence: improving the efficiency of cardiovascular imaging.
Artificial intelligence (AI) describes the use of computational techniques to mimic human intelligence. In healthcare, this typically involves large medical datasets being used to predict a diagnosis, identify new disease genotypes or phenotypes, or guide treatment strategies. Noninvasive imaging remains a cornerstone for the diagnosis, risk stratification, and management of patients with cardiovascular disease. AI can facilitate every stage of the imaging process, from acquisition and reconstruction, to segmentation, measurement, interpretation, and subsequent clinical pathways. ⋯ Cardiovascular medicine is primed for scalable AI applications which can interpret vast amounts of clinical and imaging data in greater depth than ever before. AI-augmented medical systems have the potential to improve workflow and provide reproducible and objective quantitative results which can inform clinical decisions. In the foreseeable future, AI may work in the background of cardiac image analysis software and routine clinical reporting, automatically collecting data and enabling real-time diagnosis and risk stratification.