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Journal of Clinical Nursing Oct 2023Current evidence shows that medical device-related pressure injury (MDRPI) has a high prevalence (10%) and incidence (12%), and much research has been done to prevent... (Review)
Review
BACKGROUND
Current evidence shows that medical device-related pressure injury (MDRPI) has a high prevalence (10%) and incidence (12%), and much research has been done to prevent MDRPI in recent years. However, to our knowledge, there is limited systematic review available on interventions and strategies to prevent MDRPI.
AIM
To synthesise research evidence on interventions and strategies used to prevent MDRPI.
METHODS
This systematic review adhered to the PRISMA Guidelines. We searched six databases including Medline, CINAHL, EMBASE, Cochrane library, Web of Science and ProQuest with no restriction to year of publication. Data were extracted and checked by two authors independently. A narrative summary technique was used to describe the findings. Implementation strategies were grouped into six classifications: dissemination/implementation process/integration/capacity building/sustainability/scale-up strategies.
RESULTS
Twenty-four peer-reviewed papers met the inclusion criteria, which comprised of 11 quality improvement projects and 13 original research. Types of devices included respiratory devices (non-invasive ventilation mask, CPAP/BiPAP mask, endotracheal tube), gastrointestinal/urinary devices and other devices. Interventions used included the use of dressing, hyperoxygenated fatty acids, full-face mask, training, and/or multidisciplinary education, use of special securement devices or tube holder, repositioning, application of stockinette, early removal and foam ring use. Common implementation strategies included ongoing staff education, audit and standardising documentation or guideline development.
CONCLUSION
Much work on MDRPI prevention strategies has been undertaken. There were a variety of devices reported, however, it is evident that higher quality research is needed.
RELEVANCE TO CLINICAL PRACTICE
Current evidence shows that interventions including use of dressing or special securement device, repositioning, and training/multidisciplinary education can be beneficial for MDRPI prevention. High-quality research, such as randomised controlled trials are needed to test the effectiveness of the interventions and their implementation strategies. No patient or public contribution.
Topics: Humans; Adult; Pressure Ulcer; Bandages
PubMed: 37300246
DOI: 10.1111/jocn.16790 -
The Analyst Sep 2023Implantable microfluidics involves integrating microfluidic functionalities into implantable devices, such as medical implants or bioelectronic devices, revolutionizing... (Review)
Review
Implantable microfluidics involves integrating microfluidic functionalities into implantable devices, such as medical implants or bioelectronic devices, revolutionizing healthcare by enabling personalized and precise diagnostics, targeted drug delivery, and regeneration of targeted tissues or organs. The impact of implantable microfluidics depends heavily on advancements in both methods and applications. Despite significant progress in the past two decades, continuous advancements are still required in fluidic control and manipulation, device miniaturization and integration, biosafety considerations, as well as the development of various application scenarios to address a wide range of healthcare issues. In this review, we discuss advancements in implantable microfluidics, focusing on methods and applications. Regarding methods, we discuss progress made in fluid manipulation, device fabrication, and biosafety considerations in implantable microfluidics. In terms of applications, we review advancements in using implantable microfluidics for drug delivery, diagnostics, tissue engineering, and energy harvesting. The purpose of this review is to expand research ideas for the development of novel implantable microfluidic devices for various healthcare applications.
Topics: Microfluidics; Drug Delivery Systems; Lab-On-A-Chip Devices; Miniaturization; Prostheses and Implants
PubMed: 37698090
DOI: 10.1039/d3an00981e -
Regenerative Medicine Aug 2023New developments in additive manufacturing and regenerative medicine have the potential to radically disrupt the traditional pipelines of therapy development and medical... (Review)
Review
New developments in additive manufacturing and regenerative medicine have the potential to radically disrupt the traditional pipelines of therapy development and medical device manufacture. These technologies present a challenge for regulators because traditional regulatory frameworks are designed for mass manufactured therapies, rather than bespoke solutions. 3D bioprinting technologies present another dimension of complexity through the inclusion of living cells in the fabrication process. Herein we overview the challenge of regulating 3D bioprinting in comparison to existing cell therapy products as well as custom-made 3D printed medical devices. We consider a range of specific challenges pertaining to 3D bioprinting in regenerative medicine, including classification, risk, standardization and quality control, as well as technical issues related to the manufacturing process and the incorporated materials and cells.
Topics: Tissue Engineering; Bioprinting; Printing, Three-Dimensional; Regenerative Medicine; Cell- and Tissue-Based Therapy; Tissue Scaffolds
PubMed: 37403962
DOI: 10.2217/rme-2022-0194 -
Journal of Medical Engineering &... Nov 2023The human factors engineering (HFE) process supports the design and development of medical devices, especially novel devices requiring clinical investigation. The... (Review)
Review
The human factors engineering (HFE) process supports the design and development of medical devices, especially novel devices requiring clinical investigation. The typical culmination of the HFE process prior to market approval is a human factors (HF) validation study, with specific requirements of participant, environment and task representation that carry a financial and temporal burden for medical device manufacturers. Whilst strongly recommended ahead of clinical investigations by regulators (and the authors), the prescribed methodology for HF validation studies required for pre-market approval may be excessive ahead of a clinical investigation during the development process. However, the stringent nature of HF validation studies will support effective clinical investigation design and minimise risks of poor clinical outcome or compliance. This paper provides recommendations in what to consider when determining what type of HF study to conduct ahead of each clinical investigation phase as well as insights into the symbiotic benefits of HFE and clinical investigations.
Topics: Humans; Ergonomics; Equipment and Supplies
PubMed: 38856984
DOI: 10.1080/03091902.2024.2355322 -
European Journal of Heart Failure Feb 2024Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug... (Review)
Review
Integration of implantable device therapy in patients with heart failure. A clinical consensus statement from the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC).
Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug treatment. Although the number of these devices is growing, only few are supported by robust evidence. Current devices aim to improve haemodynamics, improve reverse remodelling, or provide electrical therapy. A number of these devices have guideline recommendations and some have been shown to improve outcomes such as cardiac resynchronization therapy, implantable cardioverter-defibrillators and long-term mechanical support. For others, more evidence is still needed before large-scale implementation can be strongly advised. Of note, devices and drugs can work synergistically in HF as improved disease control with devices can allow for further optimization of drug therapy. Therefore, some devices might already be considered early in the disease trajectory of HF patients, while others might only be reserved for advanced HF. As such, device therapy should be integrated into HF care programmes. Unfortunately, implementation of devices, including those with the greatest evidence, in clinical care pathways is still suboptimal. This clinical consensus document of the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) describes the physiological rationale behind device-provided therapy and also device-guided management, offers an overview of current implantable device options recommended by the guidelines and proposes a new integrated model of device therapy as a part of HF care.
Topics: Humans; Cardiac Resynchronization Therapy; Cardiology; Defibrillators, Implantable; Heart Failure
PubMed: 38269474
DOI: 10.1002/ejhf.3150 -
Journal of Hypertension Dec 2023There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate...
European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.
BACKGROUND
There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use.
OBJECTIVE
This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common.
VALIDATION PROCEDURES
Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position.
CONCLUSION
The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.
Topics: Humans; Blood Pressure; Blood Pressure Determination; Hypertension; Sphygmomanometers; Blood Pressure Monitors
PubMed: 37303198
DOI: 10.1097/HJH.0000000000003483 -
Disability and Rehabilitation.... Oct 2023To determine the medical complexities and comorbidities of individuals who utilise wheeled mobility devices. As well as, to examine costly events including the number of...
OBJECTIVE
To determine the medical complexities and comorbidities of individuals who utilise wheeled mobility devices. As well as, to examine costly events including the number of urinary tract infections (UTIs), hospitalizations, urgent care(UC)/emergency department (ED) visits that are commonly seen in this population over a period of time one year prior to and one year post receiving their wheeled mobility equipment.
DESIGN/SETTING
A retrospective data review of 857 individual medical charts at a Level 1 Trauma Hospital and Clinic System.
PARTICIPANTS
330 male and female (24-92 years old) mobility device users with a wide range of diagnoses, of which: 56 used manual wheelchairs (MWC),138 scooters (POV), 123 power wheelchairs without integrated standing (PWC), and 13 power wheelchairs with integrated standing (iS-PWC).
RESULTS
Overall, 92% ( = 304) had at least three medical comorbidities and medical complexities. The most common comorbidity was pain (91%). A change was noted in a lower incidence of UTIs in those using an iS-PWC, respectively 23% with at least 1 UTI in the year prior to and 8% in the year after the mobility device evaluation.
CONCLUSIONS
The large number of comorbidities and medical complexities amongst all mobility device users is concerning. The burden and the accompanying healthcare costs of this population is high. The potential that iS-PWC and other interventions could have on reducing these issues should be explored further.Implications of rehabilitationRegardless of a person's primary diagnosis or the wheeled mobility device they use, 100% have at least one and 92% have at least three comorbidities and medical complexities if they spend the majority of their day sittingThe high healthcare cost situations such as Emergency Department visits, Urgent Care visits, hospitalizations, and Urinary Tract Infections are present across those that use all mobility device types and the means to potentially reduce these incidences should be further exploredThe introduction of integrated standing within a power wheelchair, as a means to minimize the frequency of comorbidities and medical complications, should also be investigated further.
Topics: Humans; Male; Female; Young Adult; Adult; Middle Aged; Aged; Aged, 80 and over; Retrospective Studies; Self-Help Devices; Wheelchairs; Comorbidity; Urinary Tract Infections; Disabled Persons
PubMed: 34472994
DOI: 10.1080/17483107.2021.1969453 -
Cardiac Electrophysiology Clinics Dec 2023Pediatric and congenital heart disease patients may require cardiac implantable electronic device implantation, inclusive of pacemaker, ICD, and implantable cardiac... (Review)
Review
Pediatric and congenital heart disease patients may require cardiac implantable electronic device implantation, inclusive of pacemaker, ICD, and implantable cardiac monitor, for a variety of etiologies. While leads, generators, and monitors have decreased in size over the years, they remain less ideal for the smallest patients. The potential for a miniature pacemaker, fetal micropacemaker, improving leadless technology, and rechargeable devices creates hope that the development of pediatric-focused devices will increase. Further, alternative approaches that avoid the need for a transvenous or surgical approach may add more options to the toolbox for the pediatric and congenital electrophysiologist.
Topics: Humans; Child; Defibrillators, Implantable; Pacemaker, Artificial; Arrhythmias, Cardiac; Heart; Electrocardiography
PubMed: 37865523
DOI: 10.1016/j.ccep.2023.06.007 -
Neuropsychopharmacology : Official... Jan 2024Recent research and technological developments have led to an expanding number of novel and rapidly acting therapeutics being developed across a variety of... (Review)
Review
Recent research and technological developments have led to an expanding number of novel and rapidly acting therapeutics being developed across a variety of neuropsychiatric disorders. Novel medical devices range from implantable and non-invasive brain stimulating and recording technologies to digital therapeutics. This perspective provides an overview of FDA regulatory oversight for medical devices, including a discussion of regulatory pathways and the review of neuromodulation devices for psychiatric disorders. We highlight the importance of early engagement with FDA and special programs that may be useful to device developers participating in interactions with the FDA that are solution focused. We explore current novel and rapid treatments for psychiatric disorders and those on the horizon. Lastly, we provide considerations for developers in navigating the regulatory landscape for neuromodulation devices intended for psychiatric disorders, including approaches to incorporating patient perspectives.
Topics: Humans; Mental Disorders; United States Food and Drug Administration; Government Regulation; Equipment and Supplies
PubMed: 37853093
DOI: 10.1038/s41386-023-01723-z -
Neurosurgery Clinics of North America Jul 2024Transvenous treatment of paralysis is a concept less than a decade old. The Stentrode (Synchron, Inc, New York, USA) is a novel electrode on stent device intended to be... (Review)
Review
Transvenous treatment of paralysis is a concept less than a decade old. The Stentrode (Synchron, Inc, New York, USA) is a novel electrode on stent device intended to be implanted in the superior sagittal sinus adjacent to the motor cortex. Initial animal studies in sheep demonstrated the safety of the implant as well as its accuracy in detecting neural signals at both short and long term. Early human trials have shown the safety of the device and demonstrated the use of the Stentrode system in facilitating patients with paralysis to carry out daily activities such as texting, email, and personal finance. This is an emerging technology with promise, although certainly more research is required to better understand the capabilities and limitations of the device.
Topics: Humans; Stents; Animals; Paralysis; Cranial Sinuses; Electrodes, Implanted
PubMed: 38782530
DOI: 10.1016/j.nec.2024.03.003