Expert Review of Medical Devices最新文献

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US).

Areas covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored.

Expert opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Introduction: Worldwide medical device regulatory authorities increasingly rely on the benefit-risk ratio for decision-making. However, current benefit-risk assessment (BRA) methods are mostly descriptive, not quantitative.

Areas covered: We aimed to summarize the regulatory requirements of BRA, discuss the feasibility of adopting multiple criteria decision analysis (MCDA), and explore factors for optimizing the MCDA for quantitative BRA of devices.

Expert opinion: Regulatory organizations emphasize BRA in their guidance, and some recommend user-friendly worksheets to conduct qualitative/descriptive BRA. The MCDA is considered one of the most useful and relevant quantitative BRA methods by pharmaceutical regulatory agencies and the industry; the International Society for Pharmacoeconomics and Outcomes Research summarized the principles and good practice guidance of MCDA. We recommend optimizing the MCDA by considering the following unique characteristics of the device BRA: using data from state of the art as a control and clinical data from post-market surveillance and literature; considering the device's diverse characteristics when selecting controls; assigning weight according to type, magnitude/severity, and duration of benefits and risks; and including physician and patient opinions in the MCDA. This article is the first to explore using MCDA for device BRA and might lead to a novel quantitative BRA method for devices.

Background: Powered intraosseous (IO) systems are valuable devices for emergent situations, with limited data on user preferences. A simulation/survey-based study was conducted among emergency medical service (EMS) providers to evaluate attitudes toward general powered IO system features to measure preferences/satisfaction for the most-commonly used and a novel powered IO system (with a passive safety needle, battery life indicator, and snap-securement/dressing).

Research design and methods: Forty-two EMS providers completed a simulated activity using both powered IO systems and a 30-item questionnaire, including multiple choice, free-text, ranking, and Likert-like questions. Ranking scores were reported using a scale of 0 (least important/satisfactory) to 100 (most important/satisfactory). Statistical significances were evaluated via Wilcoxon signed-rank sum test.

Results: Providers indicated driver performance (mean score ± SD; 77.8 ± 27.5) and IO needle safety mechanism (63.1 ± 27.9) as the most important features. Participants reported significantly higher (p < 0.001) satisfaction with the novel IO system overall, and its needle safety, battery life indicator, securement/dressing, and ease-of-use. Powered driver performance satisfaction was similar and favorable for the novel (88.1 ± 18.2) and traditional (87.1 ± 15.3) systems.

Conclusions: These findings highlight the value of clinician/user input and demonstrate EMS providers are more satisfied with a powered IO system featuring design elements intended to enhance safety and ease-of-use.

Introduction: Compartment syndrome (CS) continues to be a legitimate orthopedic emergency as it leads to thousands of amputations and permanent nerve and tissue damage to undiagnosed patients for more than eight hours. In CS, intracompartmental pressure is elevated, causing reduced blood flow inside the limb compartments. An erroneous diagnosis may result in unnecessary fasciotomies, the only treatment for this condition.

Areas covered: This review examines the previous and current diagnostic and therapeutic practices for compartment syndrome. It also performs a comparative analysis of each diagnostic technique and its foresights.

Expert opinion: Currently, most clinicians rely on a physical examination of the patient to diagnose CS. The primary reason for the physical examination is the lack of a gold-standard device. The invasive intracompartmental pressure (ICP) measurement technique is still the most commonly used. On the other hand, many noninvasive approaches have the potential to be used as diagnostic tools; however, more research is needed before they can be accepted as standard clinical approaches.

Introduction: The rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDCE) of the China National Medical Products Administration (NMPA), which consequently influences pre-market and post-approval clinical evaluation (CE) strategies.

Areas covered: We aimed to investigate the 3-stage evolution of NMPA regulatory guidance on MDCE (1. The era before specific CE guidance, 2. 2015 CE Guidance, and 3. 2021 CE Guidance Series), analyze the gaps between each stage, and assess the evolution's impact on pre-market and post-approval CE strategies.

Expert opinion: The fundamental principles of the NMPA 2021 CE Guidance Series were transformed from the 2019 International Medical Device Regulatory Forum documents. Compared with the 2015 guidance, the 2021 CE Guidance Series further clarifies the CE definition by emphasizing the ongoing activity of CE through an entire product lifecycle and the use of scientifically sound methods for CE and narrows the pre-market CE pathways into the equivalent device and clinical trial pathways. The 2021 CE Guidance Series simplifies the process for selecting the pre-market CE strategy but does not specify post-approval CE update cadency and general requirements for post-market clinical follow-up.

Introduction: Extracorporeal membrane oxygenation (ECMO) is primarily used for the supportive treatment of patients suffering from severe cardiopulmonary failure. With the continued development of ECMO technology, the relevant scenarios also extend pre-hospital and inter-hospital. In order to meet the needs of emergency treatment in communities, disaster sites and battlefields, inter-hospital transfer and evacuation; miniaturized and portable ECMO has become a current research hotspot.

Area covered: The paper first introduces the principle, composition and common modes of ECMO and summarizes the research status of portable ECMO, Novalung and wearable ECMO, analyzes the characteristics and shortcomings of existing equipment. finally, we discussed the focus and development trend of portable ECMO technology.

Expert opinion: Currently, portable ECMO has many applications in interhospital transport and there are various studies on portable and wearable ECMO devices, but the development of portable ECMO still faces many challenges. In the future, research related to integrated components, rich sensor arrays, Intelligent ECMO system and lightweight technology can make future portable ECMO more suitable for pre-hospital emergency and interhospital transport.

Introduction: Mechanical methods aimed at the filtration of the cerebrospinal fluid (CSF) are a group of therapies that have been proposed to treat neurological conditions where pathogens are present in the CSF. Even though the industry of medical devices has not been very active in this field, there is a lack of systematization of the different systems and procedures that can be applied.

Areas covered: First, we systematize the classification and definitions of procedures and systems for mechanical filtration of the CSF. Then, we made a literature review in search of clinical or preclinical studies where any system of mechanical CSF clearance was proposed or applied.

Expert opinion: We found mechanical filtration of the CSF has been explored in subarachnoid hemorrhage, CNS infections (bacterial, viral, and fungal), meningeal carcinomatosis, multiple sclerosis, autoimmune encephalitis, and polyradiculomyelitis. Brain aging and neurodegenerative diseases are additional potential conditions of interest. While there is some preliminary positive evidence for many of these conditions, more advanced systems, detailed descriptions of procedures, and rigorous validations are needed to make these therapies a reality in the next decades.

Introduction: While 3D printing of bone models for preoperative planning or customized surgical templating has been successfully implemented, the use of patient-specific additively manufactured (AM) implants is a newer application not yet well established. To fully evaluate the advantages and shortcomings of such implants, their follow-up results need to be evaluated.

Area covered: This systematic review provides a survey of the reported follow-ups on AM implants used for oncologic reconstruction, total hip arthroplasty both primary and revision, acetabular fracture, and sacrum defects.

Expert opinion: The review shows that Titanium alloy (Ti4AL6V) is the most common type of material system used due to its excellent biomechanical properties. Electron beam melting (EBM) is the predominant AM process for manufacturing implants. In almost all cases, porosity at the contact surface is implemented through the design of lattice or porous structures to enhance osseointegration. The follow-up evaluations show promising results, with only a small number of patients suffering from aseptic loosening, wear, or malalignment. The longest reported follow-up length was 120 months for acetabular cages and 96 months for acetabular cups. The AM implants have proven to serve as an excellent option to restore premorbid skeletal anatomy of the pelvis.

Introduction: Patient-specific instrumentation (PSI) for primary total knee arthroplasty (TKA) surgery has been shown to increase accuracy of component positioning. However, it is unclear whether this also translates to actual benefits for patients in terms of better outcomes (efficacy) or less complications such as revisions (safety). We therefore systematically reviewed the literature to determine the efficacy and safety of PSI in primary TKA.

Methods: Randomized controlled trials comparing PSI to non-PSI in primary TKA were included. A random effects model was used with meta-regression in case of heterogeneity.

Results: Forty-three studies were included with a total of 1816 TKA in the PSI group and 1887 TKA in the control group. There were no clinically relevant differences between the PSI-group and non-PSI group regarding all outcomes. There was considerable heterogeneity: meta-regression analyses showed that the year the study was published was an important effect modifier. Early publications tended to show a positive effect for PSI compared to non-PSI TKA, whereas later studies found the opposite.

Conclusion: Based on evidence of moderate certainty, our study suggested that there were no clinically relevant differences in efficacy and safety between patients treated with PSI TKA and patients treated with non-PSI TKA.