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Farmacia Hospitalaria : Organo Oficial... 2024The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous... (Review)
Review
OBJECTIVE
The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
METHOD
A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: "silicone" AND "syringes" AND ("intraocular" OR "intravitreal") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS
Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS
From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
Topics: Syringes; Humans; Silicone Oils; Intravitreal Injections; Off-Label Use; Spain
PubMed: 38556370
DOI: 10.1016/j.farma.2024.01.008 -
Wound Management & Prevention Nov 2023The attitudes of nurses should be measured using valid and reliable tools to develop effective nursing care strategies for the prevention of medical device-related...
BACKGROUND
The attitudes of nurses should be measured using valid and reliable tools to develop effective nursing care strategies for the prevention of medical device-related pressure injuries and to organize necessary training programs.
PURPOSE
This study was planned to conduct the Turkish validity and reliability study of the Attitude towards Medical Device-Related Pressure Ulcers/Injuries Questionnaire (MDRPU/I Questionnaire (the English-language version)) in nurses.
METHODS
This methodological study included 134 nurses working in hospitals of different sizes and characteristics (public hospitals, training and research hospitals, and university hospitals) in Turkey. The validity and reliability of the Attitude Towards Medical Device-Related Pressure Injuries (MDRPI Questionnaire (the Turkish-language version)) Questionnaire were tested using language validity, content validity, face validity, construct validity, and reliability analyses.
RESULTS
The final version of the questionnaire had a content validity index of 98.03%, sufficient construct validity, and a Cronbach α value of 0.92 for the total questionnaire.
CONCLUSIONS
The Turkish version of the MDRPI Questionnaire is valid, reliable, and suitable for measuring the attitudes of nurses in Turkey toward the prevention and care of medical device-related pressure injuries.
Topics: Humans; Hospitals, University; Language; Pressure Ulcer; Reproducibility of Results; Surveys and Questionnaires; Turkey; Equipment and Supplies; Attitude of Health Personnel
PubMed: 38090951
DOI: 10.25270/wmp.22099 -
BMC Research Notes Oct 2023There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting...
There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery. Whereas medical technologies developed in HICs face substantial challenges in getting to the bedside, there are at least clear pathways in most of the major markets, such as the UK, the EU, and the USA. Much less is known about the challenges that innovators of medical technologies face in LMICs. The aim of this study was to map out current bottlenecks in medical device innovation in Uganda, a LMIC in Sub-Saharan East Africa.A cross-sectional survey was carried out using a digital questionnaire. Twenty-one individuals completed the questionnaire, with the majority being medical device innovators (n = 12). Only one of these had undertaken all the innovation stages, up to clinical validation. Very few innovators had established companies, and/or acquired intellectual property. It is evident from similar studies that challenges in medical device translations are multidimensional, and hence interdisciplinary collaborations are key to accelerating translation processes, especially for LMICs.
Topics: Humans; Developing Countries; Uganda; Cross-Sectional Studies; Delivery of Health Care; Income
PubMed: 37814313
DOI: 10.1186/s13104-023-06541-6 -
Scientific Reports Dec 2023Retinal prostheses stimulate inner retinal neurons to create visual perception for blind patients. Implanted arrays have many small electrodes. Not all electrodes induce...
Retinal prostheses stimulate inner retinal neurons to create visual perception for blind patients. Implanted arrays have many small electrodes. Not all electrodes induce perception at the same stimulus amplitude, requiring clinicians to manually establish a visual perception threshold for each one. Phosphenes created by single-electrode stimuli can also vary in shape, size, and brightness. Computational models provide a tool to predict inter-electrode variability and automate device programming. In this study, we created statistical and patient-specific field-cable models to investigate inter-electrode variability across seven epiretinal prosthesis users. Our statistical analysis revealed that retinal thickness beneath the electrode correlated with perceptual threshold, with a significant fixed effect across participants. Electrode-retina distance and electrode impedance also correlated with perceptual threshold for some participants, but these effects varied by individual. We developed a novel method to construct patient-specific field-cable models from optical coherence tomography images. Predictions with these models significantly correlated with perceptual threshold for 80% of participants. Additionally, we demonstrated that patient-specific field-cable models could predict retinal activity and phosphene size. These computational models could be beneficial for determining optimal stimulation settings in silico, circumventing the trial-and-error testing of a large parameter space in clinic.
Topics: Humans; Visual Prosthesis; Electrodes, Implanted; Retina; Vision, Ocular; Computer Simulation; Electric Stimulation
PubMed: 38097732
DOI: 10.1038/s41598-023-49580-6 -
Advanced Science (Weinheim,... Nov 2023The conformal integration of the electronic skin on the non-developable surface is in great demand for the comprehensive tactile sensing of robotics and prosthetics....
The conformal integration of the electronic skin on the non-developable surface is in great demand for the comprehensive tactile sensing of robotics and prosthetics. However, the current techniques still encounter obstacles in achieving conformal integration of film-like electronic skin on non-developable surfaces with substantial curvatures for contact pressure detection and tactile mapping. In this paper, by utilizing the 3D printing technology to prepare the 3D electrode array in the structural component following its surface curvature, and covering it with a molded functional shell to form the pressure sensitive iontronic interface, a device is proposed to achieve high-sensitive pressure detection and high-fidelity tactile mapping on a complicated non-developable surface, called structural electronic skin (SES). The SES is prepared in a 3D printed fingertip with 46 tactile sensing units distributed on its curved surface, achieving the integration of both structural and tactile functions in a single component. By integrating the smart fingertip into a dexterous hand, a series of demonstrations are presented to show the dead-zone free pressure detection and tactile mapping with high sensitivity, for instance, 2D pulse wave monitoring and robotic injection in a medical robot, object recognition and compliant control in a smart prosthesis.
Topics: Touch; Wearable Electronic Devices; Artificial Limbs; Printing, Three-Dimensional; Robotics
PubMed: 37737619
DOI: 10.1002/advs.202304106 -
Toxins Jul 2023Bisphenol A (BPA)-based materials are used in the manufacturing of hemodialyzers, including their polycarbonate (PC) housings and polysulfone (PS) membranes. As concerns...
Bisphenol A (BPA)-based materials are used in the manufacturing of hemodialyzers, including their polycarbonate (PC) housings and polysulfone (PS) membranes. As concerns for BPA's adverse health effects rise, the regulation on BPA exposure is becoming more rigorous. Therefore, BPA alternatives, such as Bisphenol S (BPS), are increasingly used. It is important to understand the patient risk of BPA and BPS exposure through dialyzer use during hemodialysis. Here, we report the bisphenol levels in extractables and leachables obtained from eight dialyzers currently on the market, including high-flux and medium cut-off membranes. A targeted liquid chromatography-mass spectrometry strategy utilizing stable isotope-labeled internal standards provided reliable data for quantitation with the standard addition method. BPA ranging from 0.43 to 32.82 µg/device and BPS ranging from 0.02 to 2.51 µg/device were detected in dialyzers made with BPA- and BPS-containing materials, except for the novel FX CorAL 120 dialyzer. BPA and BPS were also not detected in bloodline controls and cellulose-based membranes. Based on the currently established tolerable intake (6 µg/kg/day), the resulting margin of safety indicates that adverse effects are unlikely to occur in hemodialysis patients exposed to BPA and BPS quantified herein. With increasing availability of new data and information about the toxicity of BPA and BPS, the patient safety limits of BPA and BPS in those dialyzers may need a re-evaluation in the future.
Topics: Kidneys, Artificial; Renal Dialysis; Phenols
PubMed: 37505734
DOI: 10.3390/toxins15070465 -
Injury Oct 2023The new EU Medical Device Regulation (MDR) was introduced in 2017 to increase the safety and quality of medical devices in the European Union. Theoretically, several...
The new EU Medical Device Regulation (MDR) was introduced in 2017 to increase the safety and quality of medical devices in the European Union. Theoretically, several hundred thousand medical devices must be approved under the new MDR guidelines, although the majority of these products have been and will be in daily use in countless operations on the European market for decades. The expected expenditure of time and money until the MDR is fully implemented is associated with high costs, patient disadvantages but also manufacturer problems. The following briefly summarizes the current situation in many European countries and presents the consequences for patients and hospitals and in this context also emphasizes the interdependence between hospitals, patients and manufacturers.
Topics: Humans; Medical Device Legislation; European Union; Europe; Hospitals
PubMed: 37414699
DOI: 10.1016/j.injury.2023.110907 -
Langenbeck's Archives of Surgery Oct 2023Hospitalisation and surgery are major risk factors for venous thromboembolism (VTE). Intermittent pneumatic compression (IPC) and graduated compression stockings (GCS)... (Review)
Review
PURPOSE
Hospitalisation and surgery are major risk factors for venous thromboembolism (VTE). Intermittent pneumatic compression (IPC) and graduated compression stockings (GCS) are common mechanical prophylaxis devices used to prevent VTE. This review compares the safety and efficacy of IPC and GCS used singularly and in combination for surgical patients.
METHODS
Ovid Medline and Pubmed were searched in a systematic review of the literature, and relevant articles were assessed against eligibility criteria for inclusion along PRISMA guidelines.
RESULTS
This review is a narrative description and critical analysis of available evidence. Fourteen articles were included in this review after meeting the criteria. Results of seven studies comparing the efficacy of IPC versus GCS had high heterogeneity but overall suggested IPC was superior to GCS. A further seven studies compared the combination of IPC and GCS versus GCS alone, the results of which suggest that combination mechanical prophylaxis may be superior to GCS alone in high-risk patients. No studies compared combination therapy to IPC alone. IPC appeared to have a superior safety profile, although it had a worse compliance rate and the quality of evidence was poor. The addition of pharmacological prophylaxis may make mechanical prophylaxis superfluous in the post-operative setting.
CONCLUSION
IPC may be superior to GCS when used as a single prophylactic device. A combination of IPC and GCS may be more efficacious than GCS alone for high-risk patients. Further high-quality research is needed focusing on clinical relevance, safety and comparing combination mechanical prophylaxis to IPC alone, particularly in high-risk surgical settings when pharmacological prophylaxis is contraindicated.
Topics: Humans; Venous Thromboembolism; Intermittent Pneumatic Compression Devices; Stockings, Compression; Combined Modality Therapy; Risk Factors
PubMed: 37851108
DOI: 10.1007/s00423-023-03142-6 -
Infection, Disease & Health Nov 2023Patients require vascular access for medical treatments, diagnostic procedures and symptom management. Current failure rates of peripheral intravascular catheters... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patients require vascular access for medical treatments, diagnostic procedures and symptom management. Current failure rates of peripheral intravascular catheters (PIVCs) are unacceptably high (40-50%). This systematic review aimed to determine the effect of different PIVC materials and designs on the incidence of PIVC failure.
METHODS
A systematic search was conducted in November 2022 using CINAHL, PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases. Randomised controlled trials that compared PIVC novel PIVC material/design and standard material/design were included. The primary outcome was all causes of PIVC failure, any reason for device removal due to cessation of device function; and secondary outcomes included individual PIVC complications and infection (local or systemic), and dwell times. Quality appraisal was conducted using the Cochrane risk of bias tool. A meta-analysis was performed using random effects model.
RESULTS
Seven randomised controlled trials were eligible for inclusion. In meta-analysis, the impact of material and design on PIVC failure in the studies favoured the intervention arms (RR 0.71, 95% CI 0.57-0.89), however there was substantial heterogeneity (I = 81%, 95% CI 61-91%). Through subgroup analyses, a significant difference on PIVC failure favoured the closed system over the open system (RR 0.85, 95% CI 0.73 to 0.99; I = 23%, 95% CI 0-90%).
CONCLUSION
Catheter material and design can impact PIVC outcome. Conclusive recommendations are limited due to the small number of studies and inconsistent reporting of clinical outcomes. Further rigorous research of PIVC types is necessary to improve clinical practice and device selection pathways should reflect the resulting evidence.
Topics: Humans; Catheters; Catheterization, Peripheral; Incidence; Equipment Failure
PubMed: 37419781
DOI: 10.1016/j.idh.2023.05.005 -
Nursing Reports (Pavia, Italy) Dec 2023Pressure ulcers associated with the non-invasive ventilation mask can significantly reduce the quality of life of the patient who needs this therapy. This study aims to... (Review)
Review
BACKGROUND
Pressure ulcers associated with the non-invasive ventilation mask can significantly reduce the quality of life of the patient who needs this therapy. This study aims to identify clinical interventions to prevent skin lesions associated with the use of non-invasive ventilation medical devices.
METHODS
The Scoping Review followed the methodology of the Joanna Briggs Institute. For this study the research was carried out, during the month of January 2022, in several databases, such as PubMed, Web of Science, Scopus, EBSCOhost, RCAAP and OpenGrey, and studies published between 2010 and 2022 were included.
RESULTS
Of the 33 articles identified, 11 articles were included in this review, in which we identified several interventions for the prevention of skin lesions associated with the use of medical devices for non-invasive ventilation. The interventions identified include skin assessment, optimal fixation of the device, and the use of interfaces, namely, hydrocolloid or foam dressing under the NIV mask, among others Conclusion: This scoping review demonstrates that there is some scientific evidence for prevention, however the methodological approaches are very different, which makes it difficult to clearly describe the referenced interventions. This study was not registered.
PubMed: 38251183
DOI: 10.3390/nursrep14010005