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Journal of the American College of... Apr 2013The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly... (Review)
Review
Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System.
The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.
Topics: Advisory Committees; Blood Pressure Monitoring, Ambulatory; Blood Pressure Monitors; Device Approval; Electrodes, Implanted; Female; Heart Failure; Humans; Length of Stay; Male; Outcome and Process Assessment, Health Care; Patient Selection; Pulmonary Wedge Pressure; Research Design; United States
PubMed: 23352783
DOI: 10.1016/j.jacc.2012.08.1035 -
Sensors (Basel, Switzerland) Aug 2015Continuous respiratory monitoring is an important tool for clinical monitoring. Associated with the development of biomedical technology, it has become more and more...
Continuous respiratory monitoring is an important tool for clinical monitoring. Associated with the development of biomedical technology, it has become more and more important, especially in the measuring of gas flow and CO2 concentration, which can reflect the status of the patient. In this paper, a new type of biomedical device is presented, which uses low-power sensors with a piezoresistive silicon differential pressure sensor to measure gas flow and with a pyroelectric sensor to measure CO2 concentration simultaneously. For the portability of the biomedical device, the sensors and low-power measurement circuits are integrated together, and the airway tube also needs to be miniaturized. Circuits are designed to ensure the stability of the power source and to filter out the existing noise. Modulation technology is used to eliminate the fluctuations at the trough of the waveform of the CO2 concentration signal. Statistical analysis with the coefficient of variation was performed to find out the optimal driving voltage of the pressure transducer. Through targeted experiments, the biomedical device showed a high accuracy, with a measuring precision of 0.23 mmHg, and it worked continuously and stably, thus realizing the real-time monitoring of the status of patients.
Topics: Carbon Dioxide; Electric Power Supplies; Electricity; Equipment and Supplies; Humans; Monitoring, Physiologic; Pressure; Respiration; Signal Processing, Computer-Assisted
PubMed: 26270665
DOI: 10.3390/s150819618 -
Health Devices 1993Combined defibrillator/monitors enable the operator to assess and monitor the ECG and rapidly deliver a defibrillating countershock to patients suffering from...
Combined defibrillator/monitors enable the operator to assess and monitor the ECG and rapidly deliver a defibrillating countershock to patients suffering from ventricular fibrillation during a cardiac arrest. In addition, these units provide synchronized cardioversion for treating other arrhythmias, such as ventricular tachycardia, and most now offer external noninvasive pacemaker capability for treating patients with ventricular bradycardia or asystole. Defibrillator/monitors are critical resuscitation instruments and must perform effectively to avoid the otherwise preventable death of a cardiac arrest patient. However, both ECRI and the Food and Drug Administration (FDA) continue to receive a large number of problem reports on these devices each year. Device failures can occur for such reasons as operator error, depleted or defective batteries, or component failures. We evaluated eight units--three intended for crash-cart use and four intended for portable use, all with noninvasive pacemaker capability either standard or as an option, as well as one portable physiologic patient monitor to which a defibrillator (with or without a pacing option) can be attached--from six manufacturers.* We also evaluated one stand-alone noninvasive pacemaker. Although we did not include automated external defibrillators (AEDs) in our study, two of the evaluated units have options that allow them to function as AEDs. We rated the seven crash-cart and portable defibrillator/monitor/pacemakers according to three primary applications: (1) general crash-cart use, (2) prehospital (emergency medical service [EMS]) use, and (3) in-hospital transport. They are rated either Acceptable or Acceptable--Not Recommended for these applications, based primarily on technical performance (including battery operation, which is especially important in portable units), characteristics (such as line-powered operation and portability), features (such as automatic documentation), and human factors design (especially ease of use); some are inappropriate for specific uses because of their respective limitations in these applications. The portable physiologic patient monitor is not rated, but is discussed.** All of the pacemakers available as components of the evaluated units are acceptable for use; however, in most cases, purchasing decisions should be made according to defibrillator/monitor needs. The stand-alone pacemaker is rated Unacceptable because of its numerous performance, safety, and human factors disadvantages and because, other than its being a stand-alone unit, it offers no advantages over the other evaluated pacemakers; see "The Zoll NTP-1000 Stand-alone Noninvasive Pacemaker." Readers are cautioned not to base purchasing decisions on our ratings and rankings alone, but on a thorough understanding of the issues surrounding defibrillator/monitors and noninvasive pacemakers, which can be gained only by reading this study in its entirety.(ABSTRACT TRUNCATED AT 400 WORDS)
Topics: Catalogs, Commercial as Topic; Electric Countershock; Electric Power Supplies; Electrocardiography; Equipment Design; Equipment Safety; Evaluation Studies as Topic; Humans; Monitoring, Physiologic; Pacemaker, Artificial; Technology Assessment, Biomedical
PubMed: 8253590
DOI: No ID Found -
Diabetic Medicine : a Journal of the... Apr 2020Real-time continuous glucose monitors using subcutaneous needle-type sensors continue to develop. The limitations of currently available systems, however, include time... (Review)
Review
Real-time continuous glucose monitors using subcutaneous needle-type sensors continue to develop. The limitations of currently available systems, however, include time lag behind changes in blood glucose, the invasive nature of such systems, and in some cases, their accuracy. Non-invasive techniques have been developed, but, to date, no commercial device has been successful. A key research priority for people with Type 1 diabetes identified by the James Lind Alliance was to identify ways of monitoring blood glucose constantly and accurately using a discrete device, invasive or non-invasive. Integration of such a sensor is important in the development of a closed-loop system and the technology must be rapid, selective and acceptable for continuous use by individuals. The present review provides an update on existing continuous glucose-sensing technologies, and an overview of emergent techniques, including their accuracy and limitations.
Topics: Biosensing Techniques; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 1; Equipment Design; Equipment and Supplies; Glycemic Control; Humans; Monitoring, Physiologic
PubMed: 30803028
DOI: 10.1111/dme.13942 -
Health Devices Sep 2000Defibrillator/monitors allow operators to assess and monitor a patient's ECG and, when necessary, deliver a defibrillating shock to the heart. When integral noninvasive...
Defibrillator/monitors allow operators to assess and monitor a patient's ECG and, when necessary, deliver a defibrillating shock to the heart. When integral noninvasive pacing capability is added, the resulting device is referred to as a defibrillator/monitor/pacemaker. In this Update Evaluation, we present our findings for nine such units, including complete Product Profiles for two newly evaluated models and update information for seven other models evaluated in our May-June 1993 and February 1998 studies. We tested the two newly evaluated models using the same basic protocol as in our previous studies. However, we did add some new tests--and revise some old ones--to account for advances in the technology. These advancements include the increasing use of advisory modes and the increasing availability of expanded monitoring capabilities (which allow units to function, at least to some degree, like a physiologic monitor). As in our previous studies, we rated each model separately for three common defibrillation applications: (1) general crashcart use, (2) in-hospital transport use, and (3) prehospital use by emergency medical services (EMS) personnel. Because each application requires its own set of capabilities, it's not surprising that few models are appropriate for all applications. However, we did identify three models that perform well--earning a rating of either Acceptable or Preferred--in all three areas.
Topics: Electric Countershock; Equipment Design; Humans; Materials Testing; Monitoring, Physiologic; Pacemaker, Artificial; United States
PubMed: 11022316
DOI: No ID Found -
Zhongguo Yi Liao Qi Xie Za Zhi =... Nov 2016Analyzing the status of medical device adverse events, the function of the clinical medical engineers in medical device adverse event monitoring was investigated.
OBJECTIVE
Analyzing the status of medical device adverse events, the function of the clinical medical engineers in medical device adverse event monitoring was investigated.
METHODS
Through introducing the functions of the various departments in the medical device adverse event monitoring, the technical requirements and management responsibilities of clinical medical engineer and medical staff were defined.
RESULTS
Enhancing the function of clinical medical engineers in medical device adverse event monitoring,which is an effective measure to prevent medical device adverse events.
CONCLUSION
Play the functions of clinical engineers in the medical device adverse event monitoring, which is significant to improve the using quality of medical devices and to ensure patient safety.
Topics: Equipment Safety; Equipment and Supplies; Humans
PubMed: 29792609
DOI: No ID Found -
Zhongguo Yi Liao Qi Xie Za Zhi =... Jul 2017To analyze the current situation about informatization construction of medical device administration in China, including such links of market access of medical device,...
To analyze the current situation about informatization construction of medical device administration in China, including such links of market access of medical device, occupation access of enterprise, risk monitoring of postmarketing, sampling and testing of post-marketing, complaint and inspecting, advertising management and standard management. By the informatization of medical device administration, some supervision problems can be solved, supervision efficiency can be promoted. For accelerating the informatization construction of medical device administration, we should do top-level design and implement by step, pay more attention to the informatization of manufacturing enterprise, product tracing and standard management, in order to continually improve the level of medical device administration.
Topics: China; Device Approval; Equipment and Supplies; Product Surveillance, Postmarketing
PubMed: 29862788
DOI: 10.3969/j.issn.1671-7104.2017.04.011 -
Journal of Clinical Monitoring and... Oct 2016Resonance in pressure monitoring catheters is a well-known problem which was studied several years ago. Current piezoelectric devices have mechanical properties...
Resonance in pressure monitoring catheters is a well-known problem which was studied several years ago. Current piezoelectric devices have mechanical properties providing a resonance frequency and damping factor that theoretically assure resonance-free data. However, in particular cases, the coupling between the device, the catheter, and the vascular compliance of the patient could introduce artefacts in clinical settings leading to wrong pressure waveforms and values displayed in the monitor. In this research work we study a laboratory model of a clinical setting to evaluate in which cases the compound (catheter and device) could cause resonances in an unacceptable range. The classical pop-test is expanded for analysing the effect of the catheter. Results indicate that the presence of different catheters may alter significantly the acquired signal, up to an unacceptable level. Particular care should be used in the selection of the appropriate catheter. In particular, smaller diameters introduce higher damping coefficient that could help in avoiding undesired oscillations.
Topics: Algorithms; Artifacts; Blood Pressure Determination; Blood Pressure Monitors; Cardiac Surgical Procedures; Catheterization; Hemodynamics; Humans; Models, Statistical; Monitoring, Physiologic; Oscillometry; Software; Stress, Mechanical; Transducers, Pressure
PubMed: 26310613
DOI: 10.1007/s10877-015-9760-1 -
American Journal of Health-system... Sep 2003
Topics: Drug Packaging; Drug Therapy; Electronics, Medical; Equipment and Supplies; Humans; Patient Compliance; Pharmaceutical Preparations; Reminder Systems; Tablets
PubMed: 14521048
DOI: 10.1093/ajhp/60.18.1910 -
Science and Engineering Ethics Jun 2017Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used... (Review)
Review
Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.
Topics: Awareness; Certification; Costs and Cost Analysis; Equipment Safety; Equipment and Supplies; Health Personnel; Humans
PubMed: 27896610
DOI: 10.1007/s11948-016-9836-4