Expert review of medical devices
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Expert Rev Med Devices · Jun 2020
ReviewCOVID-19: ensuring our medical equipment can meet the challenge.
To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities with the required technology is a challenge. The availability of essential medical equipment to support patients affected by Covid-19 is globally limited. Areas covered This perspective gives a technical view of the pandemic focusing on the main actions taken by regulatory agencies to cope with the shortage of devices. ⋯ In this exceptional situation scientist and technology experts in collaboration with medical specialists should work together to re-assess the risk analysis on medical equipment management and their use and re-use in this context with the aim to improve global health care Every effort must be made to provide the necessary devices at least with the minimum acceptable performances for Covid-19 patients while maintaining a high standard of safety for users. The aim of the present manuscript is to highlight the technical challenges in order to prevent, through targeted actions, operating standards from falling below the standards of care due to a lack of medical devices. Abbreviations AKI: acute Kidney Injury; ARGMD: Australian Regulatory Guidelines for Medical Devices; Covid-19: Coronavirus disease; FDA: Food and Drug Administration; ECMO: Extracorporeal Membrane Oxygenation; EU: European Union; ICU: Intensive Care Unit; WHO: World Health Organization; MHRA: Medicines and Healthcare products Regulatory Agency; MDR: Medical Device Regulation; SARI: Severe Acute Respiratory Infection.
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Expert Rev Med Devices · Jul 2019
ReviewDural sealants for the management of cerebrospinal fluid leakage after intradural surgery: current status and future perspectives.
Introduction: Cerebrospinal fluid leakage is a complication after intradural surgery and is associated with severe secondary complications like compromised wound healing and meningitis. Dural sealants are meant to augment the primary dural closure in order to achieve a watertight closure. Areas covered: This review summarizes the efficacy of currently available dural sealants. ⋯ However, based on the efficacy of currently available dural sealants according to systematic reviews and in vitro studies, a significant effective dural sealant seems is still lacking. A new dural sealant has to be thoroughly assessed before clinical application in in vitro, in vivo and clinical trials. A new research area within sealant development might be the introduction of dural sealants with both antimicrobial and analgesic properties.
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Expert Rev Med Devices · Feb 2019
ReviewWearable sensors to improve detection of patient deterioration.
Monitoring a patient's vital signs forms a basic component of care, enabling the identification of deteriorating patients and increasing the likelihood of improving patient outcomes. Several paper-based track and trigger warning scores have been developed to allow clinical evaluation of a patient and guidance on escalation protocols and frequency of monitoring. However, evidence suggests that patient deterioration on hospital wards is still missed, and that patients are still falling through the safety net. ⋯ A review of the literature was performed. Expert commentary: Findings suggest that several sensor designs are available with the potential to improve patient safety for both hospital patients and those at home. Larger clinical trials are required to ensure both diagnostic accuracy and usability.
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Expert Rev Med Devices · Feb 2019
ReviewAdvanced methods of spinal stimulation in the treatment of chronic pain: pulse trains, waveforms, frequencies, targets, and feedback loops.
Spinal cord stimulation has emerged as a state-of-the-art evidence-based treatment for chronic neuropathic pain and mixed nociceptive-neuropathic pain. In recent years, several newer devices and treatment algorithms have provided unique and effective ways of treating chronic pain by spinal cord stimulation. In a previous review, the authors commented on the 5-year forecast for high frequency and Burst waveforms, as the only two paresthesia independent SCS strategies. Over the last 5 years, there has been considerable addition to the outcome data related to these modalities. Additionally, new treatment algorithms and modalities for spinal cord stimulation have emerged. In this review, the authors provide an up to date summary of these modalities of treatment, indications, and evidence on all different modalities and programming paradigms that are available today. ⋯ The evidence to support outcomes of spinal cord stimulation has evolved considerably since our last review in 2014. New targets, frequencies and pulse trains, and feedback appear to have advanced the efficacy of spinal cord stimulation. Future developments aim to continue to refine patient selection and maintenance of patients in therapy.
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Expert Rev Med Devices · Dec 2018
ReviewDeveloping an optimized strategy with transcranial direct current stimulation to enhance the endogenous pain control system in fibromyalgia.
Fibromyalgia affects more than 5 million people in the United States and has a detrimental impact on individuals' quality of life. Current pharmacological treatments provide limited benefits to relieve the pain of fibromyalgia, along with a risk of adverse effects; a scenario that explains the increasing interest for multimodal approaches. A tailored strategy to focus on this dysfunctional endogenous pain inhibitory system is transcranial direct current stimulation (tDCS) of the primary motor cortex. ⋯ Also, we reviewed the neural control of different pathways that integrate the endogenous pain inhibitory system, as well as the effects of tDCS and aerobic exercise both alone and combined. In addition, potential neurophysiological assessments are addressed: conditioned pain modulation, temporal slow pain summation, transcranial magnetic stimulation, and electroencephalography in the context of fibromyalgia. Expert commentary: By understanding the neural mechanisms underlying pain processing and potential optimized interventions in fibromyalgia with higher accuracy, the field has an evident potential of advancement in the direction of new neuromarkers and tailored therapies.