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Orthopaedics & Traumatology, Surgery &... Feb 2016Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the... (Review)
Review
Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a "notified body". Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
Topics: Equipment Failure; Equipment and Supplies; European Union; Humans; Patient Safety; Product Labeling; Prostheses and Implants; Reference Standards
PubMed: 26822532
DOI: 10.1016/j.otsr.2015.05.013 -
Sensors (Basel, Switzerland) 2010In critical care units most of the patients' physiological parameters are sensed by commercial monitoring devices. These devices can also supervise whether the values of...
In critical care units most of the patients' physiological parameters are sensed by commercial monitoring devices. These devices can also supervise whether the values of the parameters lie within a pre-established range set by the clinician. The automation of the sensing and supervision tasks has discharged the healthcare staff of a considerable workload and avoids human errors, which are common in repetitive and monotonous tasks. Urine output is very likely the most relevant physiological parameter that has yet to be sensed or supervised automatically. This paper presents a low cost patent-pending device capable of sensing and supervising urine output. The device uses reed switches activated by a magnetic float in order to measure the amount of urine collected in two containers which are arranged in cascade. When either of the containers fills, it is emptied automatically using a siphon mechanism and urine begins to collect again. An electronic unit sends the state of the reed switches via Bluetooth to a PC that calculates the urine output from this information and supervises the achievement of therapeutic goals.
Topics: Biosensing Techniques; Cost-Benefit Analysis; Critical Care; Critical Illness; Equipment and Supplies; Female; Humans; Magnetics; Male; Models, Biological; Monitoring, Physiologic; Urinalysis; Urination; Urine Specimen Collection
PubMed: 22163495
DOI: 10.3390/s101210714 -
Journal of Wound, Ostomy, and... 2020The purpose of this study was to describe medical device-related pressure injuries (MDRPIs) in hospitalized pediatric patients.
PURPOSE
The purpose of this study was to describe medical device-related pressure injuries (MDRPIs) in hospitalized pediatric patients.
DESIGN
A prospective, descriptive study.
SAMPLE/SUBJECTS AND SETTING
The sample comprised 625 patients cared for in 8 US pediatric hospitals. Participants were aged preterm to 21 years, on bed rest for at least 24 hours, and had a medical device in place.
METHODS
Two nursing teams, blinded to the other's assessments, worked in tandem to assess pressure injury risk, type of medical devices in use, and preventive interventions for each medical device. They also identified the presence, location, and stage of MDRPI. Subjects were observed up to 8 times over 4 weeks, or until discharge, whichever occurred first.
RESULTS
Of 625 enrolled patients, 42 (7%) developed 1 or more MDRPIs. Two-thirds of patients with MDRPIs were younger than 8 years. Patients experiencing MDRPIs had higher acuity scores on hospital admission, were more frequently cognitively and/or functionally impaired, or were extreme in body mass index. Respiratory devices caused the most injuries (6.19/1000 device-days), followed by immobilizers (2.40/1000 device-days), gastric tubes (2.24/1000 device-days), and external monitoring devices (1.77/1000 device-days). Of the 6336 devices in place, 36% did not have an MDRPI preventive intervention in place. Clinical variables contributing to MDRPI development included intensive care unit care (odds ratio [OR] 8.9, 95% confidence interval [CI] 1.9-43.6), use of neuromuscular blockade (OR 3.7, 95% CI 1.7-7.8), and inotropic/vasopressor medications (OR 2.7, 95% CI 1.7-4.3). Multivariable analysis indicated that Braden QD scores alone predicted MDRPI development.
CONCLUSION
Medical devices are common in hospitalized infants and children and these medical devices place patients at risk for MDRPI.
Topics: Academic Medical Centers; Adolescent; Adult; Aged; Aged, 80 and over; COVID-19; Equipment and Supplies; Female; Humans; Male; Middle Aged; Pediatrics; Pressure Ulcer; Prospective Studies; Risk Assessment; Risk Factors
PubMed: 32970031
DOI: 10.1097/WON.0000000000000683 -
Dermatitis : Contact, Atopic,...Novel diabetic devices are being developed to help manage diabetes and improve the quality of life of patients with diabetes. Both insulin pumps and glucose monitors are... (Review)
Review
Novel diabetic devices are being developed to help manage diabetes and improve the quality of life of patients with diabetes. Both insulin pumps and glucose monitors are becoming increasingly convenient, long-lasting, and discrete for patients, but this often requires the use of strong external cutaneous adhesives and increased contact time with the skin. As a consequence, these devices have been associated with a variety of dermatologic reactions, namely, irritant and allergic contact dermatitis. Some of these reactions can be severe, precluding the use of these devices, which puts patients' long-term health at risk. Herein, we review the history of diabetic devices and reported cutaneous reactions to diabetic devices and commonly cited allergens.
Topics: Acrylates; Adhesives; Allergens; Blood Glucose Self-Monitoring; Dermatitis, Allergic Contact; Diabetes Mellitus; Equipment and Supplies; Humans; Insulin Infusion Systems
PubMed: 33273229
DOI: 10.1097/DER.0000000000000673 -
Current Opinion in Critical Care Jun 2008The measurement of cardiac output in the critically ill constitutes a vital part in the management of these patients. Minimally invasive techniques are gaining... (Review)
Review
PURPOSE OF REVIEW
The measurement of cardiac output in the critically ill constitutes a vital part in the management of these patients. Minimally invasive techniques are gaining popularity as they allow continuous cardiac output monitoring while avoiding the risks associated with pulmonary artery catheterization. This article focuses on some of the commonly used minimally invasive devices that rely on pulse contour waveform analysis.
RECENT FINDINGS
The current studies in the literature that assess the validity and the clinical applications of calibrated and noncalibrated arterial waveform derived cardiac output devices are discussed.
SUMMARY
The minimally invasive cardiac output monitoring devices available differ in their methodology and application. Currently there is conflicting evidence as to the accuracy of some of these systems and further investigation into their clinical application is required.
Topics: Calibration; Cardiac Output; Equipment and Supplies; Humans; Monitoring, Physiologic
PubMed: 18467894
DOI: 10.1097/MCC.0b013e3282fd6e4a -
Proceedings of the Institution of... Jan 2019There has been recent interest in placing pressure-sensing elements beneath the bladder mucosa to facilitate chronic bladder pressure monitoring. Wired submucosal...
There has been recent interest in placing pressure-sensing elements beneath the bladder mucosa to facilitate chronic bladder pressure monitoring. Wired submucosal sensors with the wires passed through detrusor have been demonstrated in vivo, with limited chronic retention, potentially due to the cable tethering the detrusor. Published studies of submucosal implants have shown that high correlation coefficients between submucosal and lumen pressures can be obtained in caprine, feline, and canine models. We have developed a wireless pressure monitor and surgical technique for wireless submucosal implantation and present our initial chronic implantation study here. Pressure monitors were implanted (n = 6) in female calf models (n = 5). Five devices were implanted cystoscopically with a 25-French rigid cystoscope. One device was implanted suprapubically to test device retention with an intact mucosa. Wireless recordings during anesthetized cystometry simultaneous with catheter-based reference vesical pressure measurements during filling and manual bladder compressions were recorded. Individual analysis of normalised data during bladder compressions (n = 12) indicated high correlation (r = 0.85-0.94) between submucosal and reference vesical pressure. The healing response was robust over 4 weeks; however, mucosal erosion occurred 2-4 weeks after implantation, leading to device migration into the bladder lumen and expulsion during urination. Wireless pressure monitors may be successfully placed in a suburothelial position. Submucosal pressures are correlated with vesical pressure, but may differ due to biomechanical forces pressing on an implanted sensor. Fully wireless devices implanted beneath the mucosa have risk of erosion through the mucosa, potentially caused by disruption of blood flow to the urothelium, or an as-yet unstudied mechanism of submucosal regrowth. Further investigation into device miniaturisation, anchoring methods, and understanding of submucosal pressure biomechanics may enable chronic submucosal pressure monitoring. However, the risk of erosion with submucosal implantation highlights the need for investigation of devices designed for chronic intravesical pressure monitoring.
Topics: Animals; Cattle; Electric Power Supplies; Feasibility Studies; Female; Monitoring, Physiologic; Mucous Membrane; Pressure; Prostheses and Implants; Urinary Bladder; Wireless Technology
PubMed: 30799738
DOI: 10.1177/0954411918754925 -
Lancet (London, England) Oct 1962
Topics: Equipment and Supplies, Hospital; Humans; Kidney Transplantation; Monitoring, Physiologic; Telemetry
PubMed: 13977557
DOI: 10.1016/s0140-6736(62)90579-2 -
European Journal of Clinical... Dec 2007The goal of this study was to evaluate clinically the acceptability of the IDAS II (Intelligent Drug Administration System), a new electronic device that enables drug... (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
The goal of this study was to evaluate clinically the acceptability of the IDAS II (Intelligent Drug Administration System), a new electronic device that enables drug adherence monitoring.
METHODS
IDAS II was compared to another electronic monitor, the Medication Event Monitoring System (MEMS) in a randomised two-way cross-over study involving 24 hypertensive patients treated with irbesartan. Patients used each device for 2 months. The main parameter of evaluation was the patients' opinion on both devices. Rates of adherence and blood pressure were also assessed.
RESULTS
Most patients considered both devices to be reliable reminders (IDAS II: 75%;MEMS: 84%, p = ns). Ten patients (42%) preferred the MEMS, while 11 (46%) preferred the IDAS II; three (12%) expressed no preference. Patients found the MEMS device easier to use than the IDAS device (p < 0.001) but appreciated the IDAS blister packs better than the MEMS bulk packaging (p < 0.01). Over the 4-month period, the median "taking adherence" was excellent (99.2%) and comparable with both devices. However, the regularity of drug intake timing was higher with the IDAS II (p < 0.01).
CONCLUSION
IDAS II, a new electronic device enabling drug adherence monitoring without reconditioning of the drugs appears to be a well-accepted device. Overall, practicability and acceptability of the IDAS II and the MEMS device were similar. Thus, IDAS II could be a useful tool for the management of long-term therapies.
Topics: Adult; Aged; Antihypertensive Agents; Biphenyl Compounds; Cross-Sectional Studies; Drug Monitoring; Equipment Design; Equipment and Supplies; Female; Humans; Hypertension; Irbesartan; Male; Middle Aged; Patient Compliance; Surveys and Questionnaires; Tetrazoles
PubMed: 17899047
DOI: 10.1007/s00228-007-0364-7 -
Printed multifunctional flexible device with an integrated motion sensor for health care monitoring.Science Advances Nov 2016Real-time health care monitoring may enable prediction and prevention of disease or improve treatment by diagnosing illnesses in the early stages. Wearable, comfortable,...
Real-time health care monitoring may enable prediction and prevention of disease or improve treatment by diagnosing illnesses in the early stages. Wearable, comfortable, sensing devices are required to allow continuous monitoring of a person's health; other important considerations for this technology are device flexibility, low-cost components and processing, and multifunctionality. To address these criteria, we present a flexible, multifunctional printed health care sensor equipped with a three-axis acceleration sensor to monitor physical movement and motion. Because the device is designed to be attached directly onto the skin, it has a modular design with two detachable components: One device component is nondisposable, whereas the other one is disposable and designed to be worn in contact with the skin. The design of this disposable sensing sheet takes into account hygiene concerns and low-cost materials and fabrication methods as well as features integrated, printed sensors to monitor for temperature, acceleration, electrocardiograms, and a kirigami structure, which allows for stretching on skin. The reusable component of the device contains more expensive device components, features an ultraviolet light sensor that is controlled by carbon nanotube thin-film transistors, and has a mechanically flexible and stable liquid metal contact for connection to the disposable sensing sheet. After characterizing the electrical properties of the transistors and flexible sensors, we demonstrate a proof-of-concept device that is capable of health care monitoring combined with detection of physical activity, showing that this device provides an excellent platform for the development of commercially viable, wearable health care monitors.
Topics: Humans; Monitoring, Physiologic; Motion; Wearable Electronic Devices
PubMed: 28138532
DOI: 10.1126/sciadv.1601473 -
Proceedings of the Institution of... 1996The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical... (Review)
Review
The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical Device Directive. The definitions of medical device and manufacturer are discussed. The application of the Directives to device/drug combinations is considered. All implants must meet certain essential requirements to ensure that they do not harm the patient, clinician or any third party. For most implants this will be indicated on the product or its packaging by CE; marking involving an independent organization called a Notified Body; the latter are appointed by the Competent Authority of the Member State. Devices are classified in proportion to the risk associated with them. The steps needed to be taken by manufacturers are outlined and the verification options discussed. The role of standards and the new approach to writing them in Europe is presented. After placing a product on the market, the manufacturer must set up a system of post-market surveillance, including a vigilance procedure, in order to monitor product performance. Individual Member States can exercise the safeguard clause when a product appears to have had the CE marking incorrectly applied.
Topics: Equipment Design; Equipment Safety; Equipment and Supplies; Europe; Evaluation Studies as Topic; Legislation as Topic; Product Surveillance, Postmarketing; Prostheses and Implants; Risk Assessment; United Kingdom
PubMed: 9046183
DOI: 10.1243/PIME_PROC_1996_210_419_02