Expert Review of Medical Devices最新文献

Background: Needlestick injuries (NSIs) may potentially expose healthcare professionals (HCPs) to bloodborne pathogens. Safety needles are designed to protect against NSIs. We evaluated whether a new fully passive safety needle could be used safely by HCPs.

Research design and methods: The passive safety needle was tested by physicians, nurses, and pharmacists in subcutaneous or intramuscular injection scenarios in simulation studies (1-3). Data collected included successes, close calls, difficulties, use errors, and failures. In study 4, HCPs rated the device safety (21-item questionnaire).

Results: Overall, 104 participants completed 4772 simulated tasks, including 932 injections. 915 injections (98.18%) were performed successfully and no NSIs (0%) were observed in any of the studies. Studies 1 & 2: 84.15% tasks and 96.06% injections were completed successfully, but use errors occurred, mostly arising from the participants' mental model. There were no failures in Study 3. In Study 4, >98% of participants responded positively to every question, while all felt that the passive safety feature could eliminate NSIs and would better protect against bloodborne pathogens than other existing devices with active or semi-passive safety mechanisms.

Conclusions: The passive safety needle was used successfully by HCPs, did not lead to any NSIs, and was rated as the safest compared to similar devices.

Background: Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques.

Research design and methods: Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months.

Results: Among 149 randomized patients, 122 received CTR-US (n = 94) or mOCTR (n = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) (p < 0.001). Median time to return to daily activities (2 vs. 2 days; p = 0.81) and work (3 vs. 4 days; p = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%; p < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; p = 0.55).

Conclusions: The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05405218.

Objectives: This study aimed to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonular length measurements using very high-frequency digital ultrasound (Insight 100).

Methods: Two examiners performed ultrasound imaging independently in each subject. The length of temporal and nasal zonules were then measured with a built-in software. Coefficient of variations (CVs) of the three repeated measurements were used to determine intra-examiner variances. Inter-examiner reproducibility was evaluated using intraclass correlation coefficients (ICCs) and the Bland-Altman method.

Results: 40 eyes of 40 subjects (14male and 26female; mean age 23.9 ± 2.4 years) were included in the study. The CVs for intra-examiner measurement were 2.74% temporally and 4.32% nasally for Examiner 1, and were 1.96% temporally and 1.75% nasally for Examiner 2. For inter-examiner reproducibility, all ICCs were above 0.9. However, there were significant differences between the two examiners in temporal zonular length measurements (p = 0.001), and the differences mainly came from measuring the zonular length manually (p = 0.001) rather than recording images (p = 0.480). No significant differences were found between two measurements by the same examiner after one month (all p > 0.05, all ICCs > 0.8).

Conclusion: The Insight 100 device can be used to measure the length of anterior lens zonule with relatively good repeatability and reproducibility.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05657951.

Introduction: Peri-implantitis is the leading cause of dental implant loss and is initiated by a polymicrobial dysbiotic biofilm formation on the implant surface. The destruction of peri-implant tissue by the host immune response and the low effectiveness of surgical or non-surgical treatments highlight the need for new strategies to prevent, modulate and/or eliminate biofilm formation on the implant surface. Currently, several surface modifications have been proposed using biomolecules, ions, antimicrobial agents, and topography alterations.

Areas covered: Initially, this review provides an overview of the etiopathogenesis and host- and material-dependent modulating factors of peri-implant disease. In addition, a critical discussion about the antimicrobial surface modification mechanisms and techniques employed to modify the titanium implant material is provided. Finally, we also considered the future perspectives on the development of antimicrobial surfaces to narrow the bridge between idea and product and favor the clinical application possibility.

Expert opinion: Antimicrobial surface modifications have demonstrated effective results; however, there is no consensus about the best modification strategy and in-depth information on the safety and longevity of the antimicrobial effect. Modified surfaces display recurring challenges such as short-term effectiveness, the burst release of drugs, cytotoxicity, and lack of reusability. Stimulus-responsive surfaces seem to be a promising strategy for a controlled and precise antimicrobial effect, and future research should focus on this technology and study it from models that better mimic clinical conditions.

Introduction: This review summarizes the available recent literature on different mechanisms and parameters of pulsed ultrasound (US) that have been used during orthodontic treatments to prevent and repair root resorption.

Areas covered: A literature search was conducted between January (2002) and September (2022) in the following databases: PubMed, Google-Scholar, Embase, and The-Cochrane-Library. After exclusions, a total of 19 papers were included in the present review. The most used US parameters with positive outcomes were frequency of 1.5 MHz, pulse repetition frequency of 1000 Hz, output intensity of 30 mW/cm2, duration of application of 20 min and total number sessions were 14 with a repetition interval of 1 day. The suggested mechanisms induced by US were alteration of cementoblasts, osteoblasts, osteoclasts, alkaline-phosphatase (ALP), runt-related-gene-2 (Runx2), osteoprotegerin (OPG), type-I-collagen (Col-I), C-telopeptide-type-I-collagen (CTX-I), hepatocyte-growth-factor (HGF), bone morphogenetic protein-2 (BMP-2), cyclooxygenase-2 (Cox-2), calcium (Ca2+), receptor activator of nuclear factor-kappa-B ligand (RANKL), and receptor activator of nuclear factor-kappa-B (RANK).

Expert opinion: Understanding mechanisms and deciding which parameters of US that can be used during orthodontic treatment to prevent and repair root resorption is a great challenge. This work summarizes all the available data that can aid this process and suggest that US is an effective noninvasive method not only in prevention and repairing of orthodontic induced root resorption but also in accelerating teeth movement.

Introduction: Intimal hyperplasia (IH) is a significant factor limiting the success of revascularization surgery for blood flow restoration. IH results from a foreign body response and mechanical disparity that involves complex biochemical reactions resulting in graft failure. The available treatment option utilizes either different pharmacological interventions or mechanical support to the vascular grafts with limited success.

Areas covered: This review explains the pathophysiology of IH, responsible mechanical and biological factors, and treatment options, emphasizing perivascular devices. They are designed to provide mechanical support and pharmacology actions. The perivascular drug delivery concept has successfully demonstrated efficacy in various animal studies. Accurate projections of drug release mechanisms using mathematical modeling could be used to formulate prolonged drug elution devices. Numerical modeling aspects for the prediction of design outcomes have been given due importance that fulfills the unmet clinical need for better patient care.

Expert opinion: IH could be effectively prevented by simultaneous mechanical scaffolding and sustained local drug delivery. Future perivascular medical devices could be designed to integrate these essential features. Numerical modeling for device performance prediction should be utilized in the development of next-generation perivascular devices.

Introduction: Monitoring systems at home are critical in the event of a fall, and can range from standalone fall detection devices to activity recognition devices that aim to identify behaviors in which the user may be at risk of falling, or to detect falls in real-time and alert emergency personnel.

Areas covered: This review analyzes the current literature concerning the different devices available for home fall detection.

Expert opinion: Included studies highlight how fall detection at home is an important challenge both from a clinical-assistance point of view and from a technical-bioengineering point of view. There are wearable, non-wearable and hybrid systems that aim to detect falls that occur in the patient's home. In the near future, a greater probability of predicting falls is expected thanks to an improvement in technologies together with the prediction ability of machine learning algorithms. Fall prevention must involve the clinician with a person-centered approach, low cost and minimally invasive technologies able to evaluate the movement of patients and machine learning algorithms able to make an accurate prediction of the fall event.

Introduction: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease.

Areas covered: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status.

Expert opinion: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Objectives: Central venous catheters (CVC) are frequently utilized with limited data on user preferences. A simulation/survey-based study was conducted among anesthesia providers to evaluate attitudes toward general CVC system attributes, and satisfaction with elements of the most-commonly used and a novel CVC system.

Methods: Forty providers completed a simulation using both CVC systems and a 29-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: Participants chose (mean±SD) patient safety (83.9 ± 25.3), ease-of-use (64.6 ± 26.1), and reduced risk for error (61.1 ± 26.7) as the most important attributes when considering a CVC system. Satisfaction levels were significantly higher for the novel system: overall (p < 0.001), its ease-of-use (p < 0.001), tray layout/design (p < 0.001), and safety (p = 0.012). Mean satisfaction scores were significantly higher for the novel system's potential to reduce 5 of 7 common issues, including clinician error (p < 0.001), and contamination/infection (p < 0.001).

Conclusion: Anesthesia providers preferred CVC systems promoting patient safety, ease-of-use and reduce clinician error. Significantly higher (p < 0.05) satisfaction scores were awarded to a novel system featuring a sequentially organized tray, enhanced labeling, and a guidewire funnel.

Introduction: Favorable midterm outcomes have been reported with the use of low-profile endografts (LPE), but long-term data is still needed. Furthermore, it is unclear if each of these LPE may have advantages over the other, which may, in turn, affect the outcomes. We systematically reviewed the literature about complications and reintervention rates of patients submitted to endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) using LPE.

Matherials and methods: A literature search was conducted including articles that reported 30-days and follow-up mortality, complications, and reintervention rates of patients treated with EVAR using Incraft (Cordis), Zenith LP/Alpha (Cook Medical Inc) and Ovation (Endologix) endografts.

Results: 36 papers were evaluated, reporting results of 582 patients treated with Zenith device, 1211 with Incraft and 3449 with Ovation. During follow up, similar survival and freedom from reintervention rates were reported among the various types of endograft both at 1 and 3 years. The incidence of limb stenosis/kinking was significantly higher in patients treated with Zenith LP/Alpha (2.1%, P = 0.008), while the Incraft device had a significantly lower proportion of type III endoleaks (P < 0.001).

Conclusions: Long-term survival and freedom from reintervention rates were comparable among the three LPEs. The Cook Zenith device had the highest rates of limb stenosis/kinking, while the Incraft device had the lowest occurrence of type III endoleak.

Prospero: Registration number: CRD42022315875.