Expert review of medical devices最新文献

Introduction: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety.

Areas covered: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks.

Expert opinion: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.

Background: Minimally invasive surgical techniques for sacroiliac joint (SIJ) fixation have the potential to reduce risk and improve patient outcomes, but evidence remains limited. This interim analysis presents initial findings from an ongoing prospective study evaluating the safety and efficacy of the Catamaran System.

Methods: The primary endpoint of success at 6 months was defined as a ≥20 mm improvement in SIJ pain (Visual Analog Scale, VAS), no neurologic worsening, absence of device-related serious adverse events (SAEs), and no surgical reintervention. Secondary endpoints included 6 month evaluation of the Oswestry Disability Index (ODI), patient satisfaction, and 12 month radiographic CT fusion, performed by an indpendent radiologist.

Results: Thirty-three consecutive patients (mean age: 58.9 years; %-females: 76%; Body Mass Index: 30.5) were treated across six U.S. clinical sites. At the primary endpoint of 6 months, 80% of patients met the criteria for success, with no device-related SAEs and no surgical reintervention reported. VAS_SIJ-Pain significantly decreased from preoperative levels (mean: 80.9 mm) to 6 months postoperatively (31.1 mm; p < 0.001). Mean ODI scores also showed a significant improvement from preoperative values (51.9%) to 6 months postoperatively (29.6%, p < 0.01). Patients reported high satisfaction rates throughout all follow-ups, with 93.3% of patients being satisfied at 6 months.

Conclusion: In patients diagnosed with chronic SIJ pain, minimally invasive inferior-posterior delivery of the Catamaran implant was safe and effective in relieving pain and reducing disability.

Introduction: Urinary incontinence (UI), especially stress UI, is common after prostatectomy. Penile compression devices (PCDs) may be a safe, tolerable option for conservative management in men who are not candidates for or not interested in surgical intervention for their UI.

Areas covered: This article examines the epidemiology of post-prostatectomy urinary incontinence (PPI), and options for management. All available studies on PCDs are explored, including those on biomechanics, safety, tolerability, and user experience. History, availability of PCDs, and areas for future development are discussed.

Expert opinion: PCDs are an option for conservative management of PPI. They are recommended for those men without impairment in cognition, dexterity, or sensation. They should be worn for short periods of time and are best used during situations when incontinence might be precipitated. Overall, data suggest they are well tolerated and effective when tested, but large randomized comparative trials and studies of long-term use with relevant patient reported outcome measures are lacking. More studies are needed on commercially available PCDs. Biomechanical studies suggest that there are superior designs and materials both for efficacy and tolerability. With an aging population, and more older men going for prostate surgery, a larger market for these devices is likely.

Introduction: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society.

Areas covered: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data.

Expert opinion: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.

Introduction: Cardiogenic shock (CS) is a complex life-threatening condition that results from primary cardiac dysfunction, leading to persistent hypotension and systemic hypoperfusion. Among the therapeutic options for CS are various percutaneous mechanical circulatory support (MCS) devices that have emerged as an increasingly effective hemodynamic support option. Percutaneous therapies can act as short-term mechanical circulatory assistance and can be split into intra-aortic balloon pump (IABP) and non-IABP percutaneous mechanical devices.

Areas covered: This review will evaluate the MCS value while considering the mortality rate improvements. We also aim to outline the function of pharmacotherapies and percutaneous hemodynamic MCS devices in managing CS patients to avoid the onset of end-organ dysfunction and improve both early and late outcomes.

Expert opinion: Given the complexity, acuity and high mortality associated with CS, and despite the availability and efficacy of pharmacological management, MCS is required to achieve hemodynamic stability and improve survival. Various percutaneous MCS devices are available with varying indications and clinical outcomes. The rates of early mortality and complications were found to be comparable between the four devices, yet, IABP seemed to show the most optimal clinical profile whilst ECMO demonstrated its more long-term efficacy.

Introduction: Augmented reality (AR) and virtual reality (VR) are emerging tools in interventional radiology (IR), enhancing IR education, preprocedural planning, and intraprocedural guidance.

Areas covered: This review identifies current applications of AR/VR in IR, with a focus on studies that assess the clinical impact of AR/VR. We outline the relevant technology and assess current limitations and future directions in this space. We found that the use of AR in IR lags other surgical fields, and the majority of the data exists in case series or small-scale studies. Educational use of AR/VR improves learning anatomy, procedure steps, and procedural learning curves. Preprocedural use of AR/VR decreases procedure times, especially in complex procedures. Intraprocedural AR for live tracking is accurate within 5 mm live patients and has up to 0.75 mm in phantoms, offering decreased procedure time and radiation exposure. Challenges include cost, ergonomics, rapid segmentation, and organ motion.

Expert opinion: The use of AR/VR in interventional radiology may lead to safer and more efficient procedures. However, more data from larger studies is needed to better understand where AR/VR is confers the most benefit in interventional radiology clinical practice.

Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice?

Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them.

Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients.

Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).

Introduction: Since its introduction in the mid-1990s the frozen elephant trunk (FET) technique has quickly evolved into an effective hybrid treatment option for patients with various thoracic aortic pathologies, acute and chronic. However, a notable incidence of and risk for distal aortic reinterventions persists after the implementation of the FET device. In this review, the authors analyze the indications and outcomes of thoracic endovascular aortic repair completion following FET.

Areas covered: For this review, we looked not only at our own data but also searched PubMed for relevant studies, comments, and current recommendations of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Additionally, we outline our approach in this 2-stage-treatment plan.

Expert opinion: The treatment of acute or chronic aortic pathologies involving the aortic arch frequently requires a 2-stage treatment approach. Sometimes, a tertiary procedure is needed to fix the entire aortic pathology. Thoracic endovascular aortic repair completion following FET requires careful planning to achieve the excellent clinical outcomes that we and numerous other aortic centers have shown. Only a dedicated aortic clinic provides the long-term continuous follow-up required to identify the few patients in need of a tertiary procedure.

Introduction: Expanding the use of surface electromyography-biofeedback (EMG-BF) devices in different therapeutic settings highlights the gradually evolving role of visualizing muscle activity in the rehabilitation process. This review evaluates their concepts, uses, and trends, combining evidence-based research.

Areas covered: This review dissects the anatomy of EMG-BF systems, emphasizing their transformative integration with machine-learning (ML) and deep-learning (DL) paradigms. Advances such as the application of sophisticated DL architectures for high-density EMG data interpretation, optimization techniques for heightened DL model performance, and the fusion of EMG with electroencephalogram (EEG) signals have been spotlighted for enhancing biomechanical analyses in rehabilitation. The literature survey also categorizes EMG-BF devices based on functionality and clinical usage, supported by insights from commercial sectors.

Expert opinion: The current landscape of EMG-BF is rapidly evolving, chiefly propelled by innovations in artificial intelligence (AI). The incorporation of ML and DL into EMG-BF systems augments their accuracy, reliability, and scope, marking a leap in patient care. Despite challenges in model interpretability and signal noise, ongoing research promises to address these complexities, refining biofeedback modalities. The integration of AI not only predicts patient-specific recovery timelines but also tailors therapeutic interventions, heralding a new era of personalized medicine in rehabilitation and emotional detection.