Expert review of medical devices
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Expert Rev Med Devices · Mar 2021
Multicenter Study Observational StudyA novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain.
Background: Treating chronic pain using sub-perception Spinal Cord Stimulation (SCS) does not elicit paresthesia but is associated with long analgesic 'wash-in' (i.e. duration until maximum pain relief) and prolonged assessment of therapy. We describe the attainment of clinically meaningful and rapid-onset analgesic outcomes using a novel sub-perception SCS approach. Methods: This observational case-series evaluated patients implanted with an SCS device for chronic pain, who underwent re-programming utilizing a new methodology in which paresthesia was used to guide sub-perception stimulation field targeting at specific parameters including charge-balanced symmetrical pulses at 90 Hz (termed Fast-Acting Sub-Perception Therapy, FAST). ⋯ At last follow up (mean = 223 ± 132 days), a pain score of 1.6 ± 0.3, n = 30 was determined. Conclusions: After FAST implementation, a profound analgesic response, requiring substantially less energy than conventional sub-perception methodologies, was observed. This rapid analgesic onset achieved with the novel FAST technique suggests the potential for an alternative mechanism of action(s) of sub-perception SCS.
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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 · Feb 2021
Reflection efficiencies of AnaConDa-S and AnaConDa-100 for isoflurane under dry laboratory and simulated clinical conditions: a bench study using a test lung.
Background: Adequate sedation is important for the treatment of ICU patients. AnaConDa (Anesthetic-Conserving-Device; ACD; Sedana Medical, Sweden), connected between ventilator and the patient, retains isoflurane during expiration, and releases it back during inspiration. The reflection efficiency (RefEff) corresponds to the percentage of expired anesthetic molecules that are re-inspired. ⋯ For 1 Vol.% isoflurane at TV500, the infusion rate with ACD-50 was twofold higher compared to ACD-100 (4 versus 2 mL·h-1). Conclusion: Under DRY and concentrations <1.5 Vol.%, RefEff of both devices is around 90%. Under CLIN, ACD-100 performs better with RefEff between 80% and 90% (ACD-50:70-80%), decreasing with increased vapor volume exhaled in one breath.
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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.