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Research carried out at ORNL has led to the development of solid state thin- film rechargeable lithium and lithium-ion batteries. These unique devices can be fabricated in a variety of shapes and to any required size, large or small, on virtually any type...
The feasibility of transdermal controlled delivery of propranolol was investigated by conducting in vitro skin permeation studies using rabbit pinna (ear) skin. A new multilaminate adhesive device which is capable of releasing propranolol in a controlled fashion over a 24-hr period had been developed and was evaluated transdermally using rabbit pinna skin. Skin permeation of propranolol from the device was
The feasibility of transdermal controlled delivery of propranolol was investigated by conducting in vitro skin permeation studies using rabbit pinna (ear) skin. A new multilaminate adhesive device which is capable of releasing propranolol in a controlled fashion over a 24-hr period had been developed and was evaluated transdermally using rabbit pinna skin. Skin permeation of propranolol from the device was found to be controlled by the stratum corneum during the early phase of permeation and then by the adhesive device during steady-state permeation. The rabbit pinna skin was shown to be a good animal model for studying the transdermal permeation of propranolol from the device, when compared to human cadaver skin. PMID:2813272
The aim of this work is to examine the effectiveness of mucilage/hydroxypropylmethylcellulose (HPMC) based transdermal patch (matrix type) as a drug delivery device. We have successfully extracted mucilage from Colocasia esculenta (Taro) corms and prepared diltiazem hydrochloride incorporated mucilage/HPMC based transdermal patches using various wt% of mucilage by the solvent evaporation technique. Characterization of both mucilage and transdermal patches has been done by several techniques such as Molisch's test, organoleptic evaluation of mucilage, mechanical, morphological and thermal analysis of transdermal patches. Skin irritation test is studied on hairless Albino rat skin showing that transdermal patches are apparently free of potentially hazardous skin irritation. Fourier transform infrared analysis shows that there is no interaction between drug, mucilage and HPMC while scanning electron microscopy shows the surface morphology of transdermal patches. In vitro drug release time of mucilage-HPMC based transdermal patches is prolonged with increasing mucilage concentration in the formulation. PMID:24556117
A transdermal sensing platform for detection of electrolytes is developed by P. R. Miller, R. Narayan, R. Polsky and colleagues. On page 876, hollow polymer microneedles are integrated with a microfluidic chip for detecting potassium using a solid state ion selective electrode transducer. The device could one day be used as an on body point-of-care medical diagnostic device. PMID:24912886
Miller, Philip R; Xiao, Xiaoyin; Brener, Igal; Burckel, D Bruce; Narayan, Roger; Polsky, Ronen
... is a MedicalDevice Recall? Recalls Database Safety Communications MedWatch: The FDA Safety Information and Adverse Event Reporting Program FDA 101: Product Recalls - From First Alert to Effectiveness Checks [ARCHIVED] Older Recalls 2011 Medical ...
Until 1995 all disinfectants available on the Dutch market were\\u000aregistered under the Pesticides Act. With the introduction of the\\u000aMedicalDevice Directive in the Dutch law disinfectants specifically\\u000aintended for use on medicaldevices are considered as medicaldevices. \\u000aThese are CE marked by the manufacturer and freely marketed in the EU\\u000awithout the need for national approval. In
Bruijn APC de; Drongelen AW van; Peters-Volleberg GWM
Medicaldevice security represents a growing problem within the healthcare industry. An increasing number of medicaldevices and systems contain critical health related information for which integrity, availability, and confidentiality must be maintained. HIPAA's Security Rule requires that US healthcare providers have a security program addressing this problem in place by April 21, 2005. Through a collaborative effort, ACCE and
Determination of the ability of a medicaldevice to interact with the immune system currently involves assessment of the immunogenic potential and biocompatibility of the device or an extract of the device. However, implants are often in the body for extended periods of time and\\/or are placed by a surgical procedure that in and of itself will generate an acute
Globally the medicaldevice (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medicaldevices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries.
Objective A few cases of adverse reactions linked to erroneous use of transdermal opioid patches have been reported in the literature. The aim of this study was to describe and characterize medication errors (MEs) associated with use of transdermal fentanyl and buprenorphine. Methods All events concerning transdermal opioid patches reported between 2004 and 2011 to a regional incident reporting system and assessed as MEs were scrutinized and characterized. MEs were defined as “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient”. Results In the study 151 MEs were identified. The three most common error types were wrong administration time 67 (44%), wrong dose 34 (23%), and omission of dose 20 (13%). Of all MEs, 118 (78%) occurred in the administration stage of the medication process. Harm was reported in 26 (17%) of the included cases, of which 2 (1%) were regarded as serious harm (nausea/vomiting and respiratory depression). Pain was the most common adverse reaction reported. Conclusions Of the reported MEs related to transdermal fentanyl and buprenorphine, most occurred during administration. Improved routines to ascertain correct and timely administration and educational interventions to reduce MEs for these drugs are warranted.
This paper describes a system for transferring power across a transdermal needle into a smart refill port for recharging implantable\\u000a drug delivery systems. The device uses a modified 26 gauge (0.46 mm outer diameter) Huber needle with multiple conductive\\u000a elements designed to couple with mechanical springs in the septum of the refill port of a drug delivery device to form an
Allan T. Evans; Srinivas Chiravuri; Yogesh B. Gianchandani
The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medicaldevices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can
Electrical creation of aqueous pathways across the skin's outer layer [stratum corneum (SC)] provides an approach to transdermal delivery of medium-size water-soluble compounds. However, nerve stimulation should be avoided. Here, we show that a microstructured electrode array can significantly confine the electric field to the nerve-free SC. The prototype electrode-reservoir device (ERD) contains field-confining electrodes and a fluorescent drug surrogate
The US Food and Drug Administration (FDA) has defined a medicaldevice as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medicaldevices. Such devices play an essential role in the practice of medicine. The FDA classifies medicaldevices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medicaldevices were introduced without much testing, either technical or clinical, the process of introducing a Class III medicaldevice from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medicaldevices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medicaldevice industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.
Micro- and nanofabrication techniques have revolutionized the pharmaceutical and medical fields as they offer the possibility for highly reproducible mass-fabrication of systems with complex geometries and functionalities, including novel drug delivery systems and bionsensors. The principal micro- and nanofabrication techniques are described, including photolithography, soft lithography, film deposition, etching, bonding, molecular self assembly, electrically induced nanopatterning, rapid prototyping, and electron, X-ray, colloidal monolayer, and focused ion beam lithography. Application of these techniques for the fabrication of drug delivery and biosensing systems including injectable, implantable, transdermal, and mucoadhesive devices is described.
Pacemakers, ICDs, neurostimulators like deep brain stimulator electrodes, spiral cord stimulators, insulin pumps, cochlear implants, retinal implants, hearing aids, electro cardio gram (ECG) leads, or devices in interventional MRI such as vascular guide wires or catheters are affected by MRI magnetic and electromagnetic fields. Design of MRI Safe medicaldevices requires computer modeling, bench testing, phantom testing, and animal studies. Implanted medicaldevices can be MRI unsafe, MRI conditional or MRI safe (see glossary). In the following paragraphs we will investigate how to design implanted medicaldevices MRI safe. PMID:23739365
The number of indwelling medicaldevices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce biofilms on synthetic materials, which facilitates adhesion of the organisms to devices and renders them relatively refractory to medical therapy. Management of device-related Candida infections can be challenging. Removal of the infected device is generally needed to establish cure of Candida infections of medicaldevices. However, since the pathogenesis of Candida bloodstream infection is complicated, more studies are necessary to determine the role of catheter exchange in patients with both gastrointestinal tract mucositis and indwelling catheters. The medical and economic impact of these infections is enormous.
... retention of blood, tissue and other biological debris (soil) in certain types of reusable medicaldevices. This ... For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs ...
...tax imposed on the sale of certain medicaldevices, enacted by the Health...of taxable medicaldevice to the FDA's...read ``of a taxable medicaldevice to the FDA's...heading ``Installment Sales, Leases, and...
Model IV of the Army Hear Monitor is an electronic device that monitors the electrocardiogram (ECG); sounds an alarm on diagnosing a high or low heart rate, excess electrical noise, cardiac arrest, or ventricular fibrillation. Because of the successful pe...
Summary Superelastic Nitinol is now a common and well-known engineering materi al in the medical industry. While the greater flexibility of the alloy drives many of its applications, there are also a large number of lesser- known advantages of Niti nol in medicaldevices. This paper reviews 7 of these less-obvious but very important reasons for Nitinol's success, bot h
This paper describes a system for transferring power across a transdermal needle into a smart refill port for recharging implantable drug delivery systems. The device uses a modified 26 gauge (0.46 mm outer diameter) Huber needle with multiple conductive elements designed to couple with mechanical springs in the septum of the refill port of a drug delivery device to form an electrical connection that can sustain the current required to recharge a battery during a reservoir refill session. The needle is fabricated from stainless steel coated with Parylene, and the refill port septum is made from micromachined stainless steel contact springs and polydimethylsiloxane. The device properties were characterized with dry and wet ambient conditions. The needle and port pair had an average contact resistance of less than 2 Omega when mated in either environment. Electrical isolation between the system, the liquid in the needle lumen, and surrounding material has been demonstrated. The device was used to recharge a NiMH battery with currents up to 500 mA with less than 15 degrees C of resistive heating. The system was punctured 100 times to provide preliminary information with regard to device longevity, and exhibited about 1 Omega variation in contact resistance. The results suggest that this needle and refill port system can be used in an implant to enable battery recharging. This allows for smaller batteries to be used and ultimately increases the volume efficiency of an implantable drug delivery device. PMID:19936931
Evans, Allan T; Chiravuri, Srinivas; Gianchandani, Yogesh B
The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medicaldevices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.
This review examines the diffusion of modern medicaldevices in India by analyzing trends in India's cross-border trade in medicaldevices, its domestic medicaldevice production and utilization by households. We explore the implications of this process of diffusion for the efficacy, cost-effectiveness and equitable use of new medicaldevices in India, and review recent efforts to regulate the Indian medicaldevice sector. PMID:19298166
...basis of irreversible data compression. FDA has...sufficient to ensure that any data compression features will...conditions, including high-priority, real-time...whether displaying the content and timing of an alarm...display medicaldevice data without controlling...
The most frequent and probably the earliest described surgical intervention of ENT field is tonsillectomy. Various methods were described and devices were invented up to now in order to increase safety and decrease time consumption and complications. All new created devices promises lower intraoperative blood loss, intraoperative time, postoperative pain and bleeding. But with their widely use it is seen that they cannot fulfill what they promise. Debate also continues as to which technique yields the best outcome. This study reports a summary for common medicaldevices which were previously used in tonsillectomy.
The most frequent and probably the earliest described surgical intervention of ENT field is tonsillectomy. Various methods were described and devices were invented up to now in order to increase safety and decrease time consumption and complications. All new created devices promises lower intraoperative blood loss, intraoperative time, postoperative pain and bleeding. But with their widely use it is seen that they cannot fulfill what they promise. Debate also continues as to which technique yields the best outcome. This study reports a summary for common medicaldevices which were previously used in tonsillectomy. PMID:23930051
Embedding defective software in medicaldevices increases safety risks. Given that all software is inherently defective, how can medicaldevice manufacturers identify and manage risk? An effective, tailored risk management process can make the task less daunting. Developing complex, software-based medicaldevices is a challenging business. Device manufacturers must understand the inherent differences between hardware and software components and establish
The initial contamination and the radiosensitivity of microorganisms isolated from 400 samples of disposable medicaldevices such as gauzes, eye pads, catguts and chest bottles were determined among which the Bacillus spp. were predominant. For each species the hydrophobicity of spore as measured by BATH method was greater than that of the vegetative form. Hence, it is necessary to reduce Bacillus population in samples using a suitable sterilization process such as ionizing radiation.
A reference text for health professionals and the medicaldevice industry presents 11 expert overview papers on innovations in the development of medicaldevices in the rapidly changing health care environment. The papers are grouped among three principal...
Oxybutynin transdermal patches are used to treat an overactive bladder (a condition in which the bladder muscles ... need to urinate, and inability to control urination). Oxybutynin is in a class of medications called antimuscarinics. ...
The MedicalDevice Industry Education Consortium (MDIEC) was formed to build a learning and innovation network to develop and deliver industry-endorsed solutions that address critical industry-defined technical education and training needs. St. Petersburg College (SPC) led a group of Eight Community Colleges and Fifteen Industry partners to co-found the consortium. A Department of Education (DOE) Grant funded the initial formation and curriculum development. SPC along with Anoka-Ramsey Community College in Minnesota and Edmonds Community College in Washington State was awarded a National Science Foundation (NSF) Grant to further MDIEC and develop curriculum in three critical training areas: quality systems, information management and clinical data management.
Health technology is everything that can be utilized in medical processes, i.e. drugs, biologics, devices, equipment and supplies, medical and surgical procedures, support systems, and organizational and managerial systems. Health Technology Assessment (HTA) comprises a number of various methods utilized to assess health technologies. Medicaldevices constitute a large area of interest for HTA. As an example of a comprehensive
Vladimir Rogalewicz; Alena Ujhelyiova; Lubomir Pousek; Veronika Sinkorova; Peter Kneppo
The medicine day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medicaldevices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be
On this site, visitors can learn about the regulations and standards for the production of medicaldevices in the US. The site is divided into five broad areas: Products and Medical Procedures, MedicalDevice Safety, Device Advice: Comprehensive Regulatory Assistance, Science and Research, News and Events, and Resources for You. There are also, along the right side of the screen, helpful guides to current recalls and alerts, approvals and clearances, and tools and resources.
...removing the language ``and sporting goods'' and adding ``sporting goods, and taxable medicaldevices...201(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA...as a device with the Food and Drug Administration (FDA)...
Wirelessly enabling medicaldevices such as vital signs monitors, ventilators and infusion pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present
Iontophoresis is a technique used to enhance the transdermal delivery of compounds through the skin via the application of a small electric current. By the process of electromigration and electro-osmosis, iontophoresis increases the permeation of charged and neutral compounds, and offers the option for programmed drug delivery. Interest in this field of research has led to the successful delivery of both low (lidocaine) and high molecular drugs, such as peptides (e.g., luteinising hormone releasing hormone, nafarelin and insulin). Combinations of iontophoresis with chemical enhancers, electroporation and sonophoresis have been tested in order to further increase transdermal drug permeation and decrease possible side effects. In addition, rapid progress in the fields of microelectronics, nanotechnology and miniaturisation of devices is leading the way to more sophisticated iontophoretic devices, allowing improved designs with better control of drug delivery. Recent successful designing of the fentanyl E-TRANS iontophoretic system have provided encouraging results. This review will discuss basic concepts, principles and applications of this delivery technique. PMID:16370945
Medicaldevice EMC compliance became mandatory for sales in the European Union on January 1, 1996. This paper reviews current requirements, provides examples of experiences and issues associated with compliance and provides insight on the development of a revision to the EMC standard for medicaldevices
Virtually all of the medicaldevices utilizing electronics will contain a micro or minicomputer by 1990. These devices accounted for $7 billion in U.S. sales in 1984. Their capabilities can provide the means for new or greatly improved medical procedures, and ensure greater patient safety. However, these benefits can easily be compromised if ``computer safety'' is not practiced in the
H. Bassen; J. Silberberg; F. Houston; W. Knight; C. Christman; M. Greberman
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices Â§ 892.2010 Medical image storage device. (a) Identification. A medical...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices Â§ 892.2040 Medical image hardcopy device. (a) Identification. A medical...
Implantable medicaldevices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, we examine existing privacy enhancing algorithms and discuss their applicability to implantable medicaldevices.
In an AAMI survey last year of the top medicaldevice-related challenges, 42% of respondents cited medicaldevice incident reporting and investigations as an issue. All HTM professionals should make sure that they and their team understand their role in investing and reporting of APEs that involve medicaldevices. In general, all healthcare organizations have room for improvement in how they deal with APEs and NMEs. The discussion about how to do a better job of investigating and reporting these incidents should be going on in your organization. If the HTM team is not already participating in that discussion, it's time to start. PMID:23600355
Buprenorphine is a chemically synthesized opioid characterized as the partial mu agonist and kappa antagonist, and transdermal buprenorphine patch will be considered useful as a strong analgesic with fewer psychological side effects in the treatment of chronic non-cancer pain. Use of transdermal buprenorphine should be limited for pain relief of intractable muscle skeletal pain that cannot be alleviated with other analgesics. To avoid severe complication and drug abuse or addiction, assessment of pain and medical history including drug dependence by medical team are important before administration of transdermal buprenorphine. Moreover, side effects such as nausea, vomiting, constipation, erythema and itching, loss of appetite should be treated appropriately. When transdermal buprenorphine is administered to chronic pain patients, physicians must examine the condition of patients regularly at an outpatient clinic. Moreover, decreasing and discontinuation of opioid including transdermal buprenorphine should always be considered during the treatment. Most important objective of chronic pain treatment is to improve QOL and ADL of patients. PMID:23905402
The handbook is a statistical and general information profile of the medicaldevice industry--from 1958 through 1972. It covers the manufacture and distribution of all health-related products except pharmaceuticals, which are treated elsewhere (in FDA's D...
The US Army Institute of Surgical Research (USAISR) has developed a Special Medical Emergency Evacuation Device (SMEED) platform (US patent pending) , designed to secure commercial, off-the-shelf monitors, infusion pumps, ventilators, and similar equipmen...
Anesthesiologists are unique among most physicians in that they routinely use technology and medicaldevices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medicaldevices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medicaldevices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use.
Wirelessly enabling MedicalDevices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medicaldevices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medicaldevices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medicaldevices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors. PMID:18003568
\\u000a Microbial infections resulting from bacterial adhesion to biomaterial surfaces have been observed on almost all medicaldevices.\\u000a Biofilm infections pose a number of clinical challenges due to their resistance to immune defence mechanisms and antimicrobials,\\u000a and, regardless of the sophistication of the implant, all medicaldevices are susceptible to microbial colonisation and infection.\\u000a Research efforts are currently directed towards eliminating
The history of laser medicine dates back to the 1970ís. Since that time laser medicine and medical laser engineering have become individual branches of medicine and medical industry. Laser medicine has three main directions: laser therapy, laser surgery, and laser diagnosis. About 100,000 laser devices are presently used in Russia. Therapeutic, surgical, and diagnostic lasers account for 80, 15, and
To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.
Due to its high chemical specificity, Raman spectroscopy has been considered to be a promising technique for non-invasive disease diagnosis. However, during Raman excitation, less than one out of a million photons undergo spontaneous Raman scattering and such weakness in Raman scattered light often require highly efficient collection of Raman scattered light for the analysis of biological tissues. We present a novel non-imaging optics based portable Raman spectroscopy instrument designed for enhanced light collection. While the instrument was demonstrated on transdermal blood glucose measurement, it can also be used for detection of other clinically relevant blood analytes such as creatinine, urea and cholesterol, as well as other tissue diagnosis applications. For enhanced light collection, a non-imaging optical element called compound hyperbolic concentrator (CHC) converts the wide angular range of scattered photons (numerical aperture (NA) of 1.0) from the tissue into a limited range of angles accommodated by the acceptance angles of the collection system (e.g., an optical fiber with NA of 0.22). A CHC enables collimation of scattered light directions to within extremely narrow range of angles while also maintaining practical physical dimensions. Such a design allows for the development of a very efficient and compact spectroscopy system for analyzing highly scattering biological tissues. Using the CHC-based portable Raman instrument in a clinical research setting, we demonstrate successful transdermal blood glucose predictions in human subjects undergoing oral glucose tolerance tests.
Kong, Chae-Ryon; Barman, Ishan; Dingari, Narahara Chari; Kang, Jeon Woong; Galindo, Luis; Dasari, Ramachandra R.; Feld, Michael S.
The manual describes in detail the range of regulatory requirements by FDA for marketing a device in the United States. It does not cover Good Manufacturing Practices. The Manual is intended for use in workshops sponsored by the Bureau of MedicalDevices ...
The report was written by the CDRH Ad Hoc Home Health Care Committee in order to begin to address specific concerns associated with medicaldevices used in home health care. The report includes summaries of the following eight device-related issues: accre...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...
... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES RADIOLOGY DEVICES Diagnostic Devices Â§ 892.2020 Medical image communications device. (a) Identification. A...
The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia - including medicaldevices. Many medicaldevices are not programmable, electronic, or even electrical. However more devices are becoming programmable, and existing medicaldevice software is becoming more complex. Currently in Australia, certain types of medicaldevices are subjected to extensive pre-market documentary evaluation by the TGA.
Novel copolymers of vinyl acetate and dialkylfumarates, poly(VA-co-DRF) with R = isopropyl (DIPF) or octan-2-yl (DOF), were synthesized by radical copolymerization under microwave conditions. The products were characterized by (1)H NMR and FTIR spectroscopies, size exclusion chromatography and differential scanning calorimetry. Based on these copolymers three membranes supported on polyvinyl alcohol were prepared and their morphology, swelling and mechanical properties were studied. The swelling kinetic was analyzed and interpreted in light of the Fick transport model, showing that the water transport occurs through a non-Fickian diffusion mechanism. The results show that the membrane prepared of poly(VA-co-DOF) exhibited excellent properties as potential platform for transdermal delivery system: they exhibited good tensile strength, moderated swelling and form thin and transparent films. PMID:23588672
A graphical procedure was proposed for the optimum design of transdermal drug-delivery systems enhanced by iontophoresis. Contour plots displayed the relationships among steady-state plasma level, current density and initial drug concentration in a vehicle. This information was combined with a closed-form expression of the process time constant, estimated as the medicament in the blood reaches a plateau after application of the electric field. Analysis was conducted using Laplace-transformed variables and did not require time-domain solutions. Simulation results show that a current density of 0.044 mA/cm(2) and a loading of 3500 ?g/ml of dexamethasone sodium m-sulfobenzoate were necessary to achieve an equilibrium plasma concentration of 1.254 ng/cm(3) with a time constant of 8.34 h. PMID:21345513
Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability of iontophoresis to control delivery rates in real time provides added functionality. Third-generation delivery systems target their effects to skin’s barrier layer of stratum corneum using microneedles, thermal ablation, microdermabrasion, electroporation and cavitational ultrasound. Microneedles and thermal ablation are currently progressing through clinical trials for delivery of macromolecules and vaccines, such as insulin, parathyroid hormone and influenza vaccine. Using these novel second- and third-generation enhancement strategies, transdermal delivery is poised to significantly increase impact on medicine.
High quality, well-designed medicaldevices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. Capturing the user requirements of users and incorporating these into design is an essential component of this. The field of ergonomics has an opportunity to assist, not only with this area, but also to encourage a more general consideration of the user during medicaldevice development. A review of the literature on methods for assessing user requirements in engineering and ergonomics found that little published work exists on the ergonomic aspects of medicaldevice development. In particular there is little advice available to developers on which issues to consider during design and development or recommendations for good practice in terms of the methods and approaches needed to capture the full range of user requirements. The Multidisciplinary Assessment of Technology Centre for Health care (MATCH) is a research collaboration that is working in conjunction with industrial collaborators to apply ergonomics methods to real case study projects with the ultimate aim of producing an industry-focused guide to applying ergonomics principles in medicaldevice development. PMID:18061139
Martin, Jennifer L; Norris, Beverley J; Murphy, Elizabeth; Crowe, John A
...consumer groups, the device industry, health care professionals...representatives of the device industry: The Advanced Medical Technology...Medical Imaging and Technology Alliance (MITA); and, the American...stakeholders and the device industry, and many of the...
...Docket No. FDA-2010-N-0585] Neurological Devices Panel of the MedicalDevices...the public. Name of Committee: Neurological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide...
...Docket No. FDA-2010-N-0001] Neurological Devices Panel of the MedicalDevices...the public. Name of Committee: Neurological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide...
...Docket No. FDA-2011-N-0002] Neurological Devices Panel of the MedicalDevices...the public. Name of Committee: Neurological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide...
...Docket No. FDA-2012-N-0001] Neurological Devices Panel of the MedicalDevices...the public. Name of Committee: Neurological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide...
...Administration [Docket No. FDA-2011-N-0001] Circulatory System Devices Panel of the MedicalDevices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the MedicalDevices Advisory...
...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the MedicalDevices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the MedicalDevices Advisory...
...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the MedicalDevices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the MedicalDevices Advisory...
...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the MedicalDevices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the MedicalDevices Advisory...
...AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the MedicalDevices Advisory Committee...meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the MedicalDevices Advisory...
...Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the MedicalDevices Advisory Committee...meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the MedicalDevices Advisory...
...Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the MedicalDevices Advisory...meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the MedicalDevices...
...Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the MedicalDevices Advisory...meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the MedicalDevices...
...Drug Administration [Docket No. FDA-2010-N-0001] Gastroenterology and Urology Devices Panel of the MedicalDevices Advisory...meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the MedicalDevices...
...Drug Administration [Docket No. FDA-2013-N-0001] Gastroenterology and Urology Devices Panel of the MedicalDevices Advisory...meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the MedicalDevices...
...Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the MedicalDevices Advisory Committee...Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel of the MedicalDevices Advisory Committee...
...Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the MedicalDevices Advisory Committee...The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the MedicalDevices Advisory...
Complex administrative procedures have gradually been established for the evaluation of implantable medicaldevices, resulting in improved patient safety. These procedures include in vitro testing, animal experimentation, clinical premarketing studies, and post-market surveillance. Further improvements are needed, however, including more independent experts and clinical studies, while ensuring that the approval process is neither to slow nor too hasty. PMID:23259342
...section 201(h) of the Federal Food, Drug & Cosmetic Act (FFDCA), (codified as...Department also consulted with the Food and Drug Administration (FDA) and the Centers...MedicalDevice Amendments to the Food, Drug, and Cosmetic Act of 1976 remain...
To protect the public from unsafe and ineffective medicaldevices, a 1976 law expanded the Food and Drug Administration's authority. But FDA has not implemented major portions of the law, and some sections may not be workable. Amendments to the Federal Fo...
Bench-top testing of a typical catheter is described here to show how early prototype evaluation can decrease product development time. Trackability and pushability are assessed and compared using some novel laboratory tests, which can be applied to a variety of medicaldevices. PMID:16886818
Metal Injection moulding (MIM) is an advanced near net shape forming process. This paper presents the attempt to manufacture medicaldevices particularly fracture fixation plates for orthopedic applications for commercial purposes by MIM process. The stainless steel powder with the median particle size of 15 mum and a binder consisting of polyethylene, paraffin wax and stearic acid were mixed at
M. A. Omar; M. Mustapha; E. A. G. E. Ali; I. Subuki; B. Meh
Problem The NHS is perceived to have a poor record of learning from incidents. Despite efforts of the MedicalDevices Agency, which issues safety warnings, adverse incidents with medicaldevices continue to occur, some of which result in serious injury or death through device failures, user errors, and organisational problems. Design Introduction of feedback notes on a supportive investigation that seeks to determine latent factors, immediate triggers, causes, and positive actions taken by staff that minimised adverse consequences. Background and setting Medical physics department providing equipment management services in a major NHS teaching trust. Key measures for improvement Reduction in repetitions of adverse incidents and improved staff competency in using devices. Strategy for change A feedback note was developed to describe the incident and generic details of the equipment, summarise the investigation (focusing on latent causes and immediate triggers), and describe lessons to be learnt and positive actions by staff. Effects of change Feedback notes have been used in teaching sessions and given to ward link nurses. Despite being new, the positive supportive approach has encouraged an open reporting culture. Lessons learnt Adverse incidents are typically caused by alignment of different factors, but good practice can prevent errors becoming incidents. Careful analysis of incidents reveals both the multifactorial causes and the good practices that can help minimise repetitions.
...2013-07-01 false In-kind donations of medicine, medicaldevices, and medical services... Â§ 597.511 In-kind donations of medicine, medicaldevices, and medical services...S. persons of in-kind donations of medicine, medicaldevices, and...
...2013-07-01 false In-kind donations of medicine, medicaldevices, and medical services... Â§ 594.515 In-kind donations of medicine, medicaldevices, and medical services...authorized to provide in-kind donations of medicine, medicaldevices, and...
...2013-07-01 false In-kind donations of medicine, medicaldevices, and medical services... Â§ 595.513 In-kind donations of medicine, medicaldevices, and medical services...authorized to provide in-kind donations of medicine, medicaldevices, and...
Medicaldevices historically have been monolithic units - developed, validated, and approved by regulatory authorities as stand-alone entities. Modern medicaldevices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single customizable displays, and coordinate the actions of groups of cooperating devices to realize ldquoclosed looprdquo scenarios
Andrew L. King; Sam Procter; Daniel Andresen; John Hatcliff; Steve Warren; William Spees; Raoul Praful Jetley; Paul L. Jones; Sandy Weininger
...Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the MedicalDevices...will be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical...
Featuring items on loan from the U.S. Food and Drug Administration, the American Medical Association, and others, the Minneapolis-based Museum of Questionable MedicalDevices is an interesting resource about the history of medicine. From frightening turn-of-the-century phrenology machines to the vibrating "Relaxicisor," taken off the market in 1971, and even an electric shock contraption, "The Stimulator," introduced in 1996, the site features a wide array of machines. Visitors can click on a machine's name and go to a page that includes a photo or illustration, a bit of history of the machine including the date and manufacturer, and a series of related links both to other pages on the museum's site and to outside sites. The links take readers to interesting, informative quackery sites such as Quackwatch.com, Internet Hoax Watch, and the National Council for Reliable Health Information. Well-organized, lively, and information-rich, the Museum of Questionable MedicalDevices Website provides a worthwhile diversion.
Safety concerns relating to medicaldevices have been raised through recent failures of heart valves, breast implants and pacemaker leads. Under common law in Australia, people who are engaged in the provision of medical care are under a duty to disclose, fully and frankly, the risks associated with any medical treatment, including those associated with new medicaldevices. A study
Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medicaldevices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medicaldevices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference. PMID:22702259
Censi, Federica; Mattei, Eugenio; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni
The United States medicaldevice market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a MedicalDevice Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medicaldevices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. PMID:23578741
The revised MedicalDevice Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medicaldevice. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medicaldevice. This paper identifies some issues at stake and discusses them. PMID:23388310
Pelayo, Sylvia; Bras Da Costa, Sabrina; Leroy, Nicolas; Loiseau, Séverine; Beuscart-Zephir, Marie-Catherine
Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medicaldevices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.
...FDA-2010-N-0001] MedicalDevice Epidemiology Network: Developing Partnership Between...workshop entitled ``MedicalDevice Epidemiology Network (MDEpiNet): Developing Partnership...academic researchers with expertise in epidemiology and health services research on...
The introduction of medicaldevices onto healthcare facility networks presents a myriad of problems, both for the medicaldevice or system being connected to the network, as well as other information technology devices on the network. The current state of security in healthcare, specifically security planning, is not as effective as other business areas. The value of the equipment associated
The critical nature of safety in medicaldevice software requires a repeatable and compliant software engineering process. This process should take into account the whole development life cycle, risk management, and software verification and validation activities that would commensurate with the device's complexity and risk. This paper discusses some of the key challenges medicaldevice manufacturers are facing in the
This study looks at the implementation and effectiveness of risk management (RM) activities in the medicaldevice industry. An online survey was distributed to medicaldevice professionals who were asked to identify RM-related activities performed during the device life cycle. RM activities and techniques included Establishing Risk Acceptance Criteria, Hazard Identification, Human Factors\\/Usability, Fault Tree Analysis (FTA), Design Failure Mode
We proposea proximity-based access control scheme forimplantable medicaldevices (IMDs). Ourscheme is based onultrasonic distance- bounding and enables an implanted medicaldevice to grant access to its resources only to those devices that are in its close proxim- ity. We demonstrate the feasibility of our approach through tests in an emulated patient environment. We show that, although im- planted, IMDs
Kasper Bonne Rasmussen; Claude Castelluccia; Thomas S. Heydt-benjamin; Srdjan Capkun
This study provides an analytical overview of the state of the European Union medicaldevice industry. The medicaldevice industry sector encompasses an extremely large variety of products and technologies. It covers hundreds of thousands of products that range from more traditional products, such as bandages or syringes, to sophisticated devices that incorporate bioinformatics, nanotechnology and engineered cells. These are
Handling missing data is an important consideration in the analysis of data from all kinds of medicaldevice studies. Missing data in medicaldevice studies can arise for all the reasons one might expect in pharmaceutical clinical trials. In addition, they occur by design, in nonrandomized device studies, and in evaluations of diagnostic tests. For dichotomous endpoints, a tipping point
...FDA-2011-N-0499] MedicalDevices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound Stimulator...878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part 878...
...FDA-2010-N-0513] MedicalDevices; General and Plastic Surgery Devices; Classification of Non-Powered Suction Apparatus...878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part 878...
...MedicalDevices; General and Plastic Surgery Devices; Classification of Tissue Adhesive...follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for...including punctures from minimally invasive surgery, and simple, thoroughly cleansed,...
...866 [Docket No. FDA-2012-N-0165] MedicalDevices; Immunology and Microbiology Devices; Classification of Norovirus Serological...Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation...
...866 [Docket No. FDA-2011-N-0026] MedicalDevices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal...Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation...
Mobile phones' electromagnetic interference with medicaldevices is an important issue for the medical safety of patients who are using life-supporting medicaldevices. This review mainly focuses on mobile phones' interference with implanted medicaldevices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medicaldevices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medicaldevices and developing technology standards can lead to their effective use in hospital communication systems. PMID:23559585
The assessment of overall residual risk is the primary objective of performing risk-management activities and is required by ISO 14971:2000-Application of Risk Management to MedicalDevices. Despite this requirement, much confusion remains among medical-device manufacturers and the various regulatory-approval bodies as to what is required. Today, many medical-device manufacturers do not formally address the subject. This paper will address the
The nomadic nature of medical professionals can hinder their ability to access efficient medical tools at locations of their choice. The portability and connectivity characteristics of handheld medicaldevices can help resolve this issue. However, these handhelds have a physical size constraint inhibiting their system resource capacity. This limits their ability to support a wide range of medical applications effectively.
This manual covers the range of basic regulatory requirements that all manufacturers must consider when they begin to import or export a medicaldevice. The materials it contains are useful for guidance and reference on establishment registration, device ...
Medicaldevices in the abdomen and pelvis are probably less frequently seen than those in the chest or extremities, but they are important and should be recognized. These devices can be grouped into a few major categories: intestinal tubes, genitourinary devices, postoperative appa- ratus, and a wide variety of odds and ends. Many of these devices are used to monitor
The Food and Drug Administration (FDA) is clarifying that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's MedicalDevice Reporting regulation, pending future FDA notice under the Federal Food, Drug, and......
This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medicaldevices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medicaldevices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medicaldevice problems that may be unique to these environments. PMID:24978574
Simone, Lisa K; Brumbaugh, JoAnn; Ricketts, Catherine
Adverse event reporting enables FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered. Within FDA, the Center for Devices and Radiological Health (CDRH) is...
In looking at the reimbursement system for medicaldevices in Germany, one must be conscious of the market for medicaldevices in Europe in general. The German market, with 14 billion euros, is by far the largest in Europe (total: 40 billion Euros estimated sales in 1999). The German market is twice as large as that in France, three times
The article intends to analyze the software safety problems in high-risk medicaldevices based on the investigation of software R & D Quality control procedures in Shanghai medicaldevice manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in U.S. and Europe. PMID:21179714
It has been suggested that the role of the biomedical physics-engineering educator in faculties of health sciences should focus primarily on the functioning and effective and safe use of medicaldevices. This is a wide- ranging role which has a legal basis particularly now that the definition of the term ‚medicaldevice' has been clarified in international legislation. The array,
...Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
...Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
...Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee...
...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee: Notice...FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee...
...Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
...Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Notice...open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
...Drug Administration [Docket No. FDA-2011-N-0002] Obstetrics and Gynecology Devices Panel of the MedicalDevices Advisory...The meeting will be open to the public. Name of Committee: Obstetrics and Gynecology Devices Panel of the MedicalDevices...
Despite their sophistication and value, single-use medicaldevices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medicaldevices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medicaldevices. These types of sustainable approaches can move the medicaldevice industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137
The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medicaldevice industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term 'medicaldevices' have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medicaldevice manufacturer faces prior to market approval and the structure of the medicaldevice industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medicaldevices. PMID:23329383
...FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory...of meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices Advisory...that a meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices...
...FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory...of meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices Advisory...that a meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices...
... difficulties that might jeopardize the safety of a pediatric patient," says Samuels-Reid. "Parents and caregivers are critical ... challenging to accommodate some devices. Moreover, not all pediatric patients are alike. Devices might need to be changed ...
Off label use as applied to medicaldevices is the application of the device for a purpose that is not included as an indication in the FDA and EC approved device labeling. Such applications are also called unapproved or new uses. Beyond a use not being indicated, some off label uses may be expressly contraindicated as well as explicitly warned
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the MedicalDevices Advisory Committee: Notice of Change of Meeting Schedule...
...HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] MedicalDevices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY:...
...HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] MedicalDevices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug...
Medicaldevice labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medicaldevice labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medicaldevices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.
In the light of escalating use of medicaldevices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that have boosted the global confidence in pharmaceutical industry in India, guidelines for devices will encourage the much needed research in medicaldevices. Pharmacy personnel can certainly play an important role in the regulation of medicaldevices. Safety, risks, effectiveness and performance of the medial devices need to be well established and regulated properly. It is hoped that the guidelines are implemented and regulated properly with effective outcome.
It is believed that interoperability between medicaldevices and electronic medical records (EMR) is one key to developing a system of higher quality, safer, and efficient healthcare delivery. Interoperability speaks to either wireless or hard-wired streaming of two-way patient and related data between devices and EMRs. An analysis of a large integrated delivery system's medicaldevices and EMR was conducted to demonstrate this potential. This integration has significant impact on future care delivery processes and cost of health technologies involved. PMID:17959500
The paper deals with the problems associated with the absence of a well-defined standard basis of the standardization, licensing, etc. of medical engineering articles, which the public corporation "Izhevsk Motor Plant Axion-Holding", one of the largest manufacturers of medical equipment comes up against. PMID:11515263
Rules on the reprocessing of medicaldevices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medicaldevices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and MedicalDevices (BfArM) on the “Hygiene requirements for reprocessing of medicaldevices”.
Outcomes research for medicaldevices has always lagged, with good reason. Comparative effectiveness initiatives, though, will soon spur demand for more and better data, and that means more and better outcomes research training.
A medicaldevice generally includes a structural member having a surface wherein at least a portion of the surface is coated with a nanostructured material to a thickness of at least about 25 micrometers, and wherein the nanostructured material comprises ...
J. A. Krajewski J. D. Roth T. D. Xiao X. Ma Z. Zhang
...Brokering sales of agricultural commodities, medicine, and medicaldevices. 560.533...Brokering sales of agricultural commodities, medicine, and medicaldevices. (a) General...persons of agricultural commodities, medicine, and medicaldevices, provided...
...Radiological Health 510(k) Implementation: Online Repository of MedicalDevice Labeling...k) Implementation: Discussion of an Online Repository of MedicalDevice Labeling...topics: FDA's plans to establish an online public repository of medicaldevice...
\\u000a The benefits of effective verification and validation activities in the medicaldevice domain include increased usability\\u000a and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification\\u000a and validation in multiple standards in the medicaldevice domain, these are difficult for the manufacturer to implement,\\u000a as there is no consolidated information
M. S. Sivakumar; Valentine Casey; Fergal McCaffery; Gerry Coleman
From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medicaldevice development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medicaldevices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medicaldevices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medicaldevices will be presented from the viewpoint of an engineering mind.
Contraception selection poses special challenges to women with pre-existing medical problems and clinicians often lack the knowledge to counsel these women. The IUD represents an excellent option for many US women with medical problems. Because IUDs have no direct systemic effects other than increasing circulating immunoglobulins and possibly copper ions, they are unlikely to affect a woman's underlying disease process or to interact with medications used in disease treatment. Currently available IUDs may be appropriate for women with cardiovascular disease, diabetes mellitus with vascular disease, hematologic disorders, neurologic conditions, and psychiatric disorders. Other candidates for IUD use include women with a history of breast cancer or other hormone-sensitive cancers, active liver disease, hypertriglyceridemia, a sensitivity to hormonal contraception, and smokers over 40 years old. IUDs are contraindicated in women with diseases that increase their vulnerability to infection (e.g., AIDS, leukemia, and intravenous drug abuse), diseases or medications that produce profuse uterine bleeding, and conditions that distort the uterine cavity. Given the deleterious impact of unintended pregnancy on the clinical course of many diseases, information on contraception for women with pre-existing medical conditions should be more broadly disseminated among clinicians. PMID:9807694
Accessing routine medical equipment is often difficult or impossible for many patients and providers with disabilities. We present a novel approach for conducting physical accessibility evaluations of some commonly used medical equipment, including an examination table, two dental chairs, two hospital beds, and two weight scales. Participants with various disabilities used each device while being recorded by three cameras; psychometric
Activities related to medical innovation are accelerating and becoming increasingly important due to the demand for better and less invasive therapies, a rapidly aging population in the developed world and a globally larger population able to afford advanced medical care. Medical Innovation is occurring in the fields of pharmacy, diagnostics and therapeutic imaging, surgical products, interventional procedures and devices. Increasing understanding of basic disease processes further opens the opportunities for innovators. Increased knowledge often cause major paradigm shifts in therapeutic methods.
...Distinguishing MedicalDevice Recalls From...Center for Devices and Radiological...Division of Dockets Management (HFA-305...Center for Devices and Radiological...failures of marketed medicaldevices can pose serious risks to public...
...FDA-2010-N-0427] Public Workshop on MedicalDevices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility...announced the public workshop entitled ``MedicalDevices & Nanotechnology: Manufacturing, Characterization, and...
The authors report on the design of an inexpensive system to provide address and other pertinent data to a central monitoring point or public-safety answering point without caller intervention, that is, when activated by an external signal. In particular, it could provide a warning of a medical condition of the caller and automatically request, or indicate the need for, dispatch
Transdermal therapeutic systems (TTSs) are commonly used to treat many diverse medical conditions. There are several advantages to this form of drug delivery; however, adverse cutaneous reactions are common. This review article provides an update on skin reactions due to TTSs containing medications newly available in TTS form, including buprenorphine, diclofenac, lidocaine, oxybutynin, rotigotine, methylphenidate, rivastigmine, teriparatide, and nicardipine. PMID:21781635
The market of medicaldevices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.
The purpose of this review is to define the current standards addressing safety of medicaldevices in MRI and to describe ongoing standards development efforts. The American Society for Testing and Materials (ASTM International) began developing standard test methods for determining the MR safety of medicaldevices in MRI in 1997. To date, five ASTM standards addressing testing and marking medicaldevices and other items for use in the MR environment have been published. International Standards Organization (ISO) 14630, the general requirements standard for nonactive surgical implants, is currently being revised to include information about MR safety of passive implants and to reference the ASTM standards. To address the unique safety issues of active implants, and in particular, active implants with leads, like pacemakers and neurostimulators, a joint working group between ISO TC150/SC6 on active implants and International Electrotechnical Commission (IEC) SC 62B MT40 on magnetic resonance equipment for medical diagnosis is working to develop a technical specification for active implantable medicaldevices (AIMDs) in MRI. While much progress has been made, work still needs to continue to develop a complete body of test methods to allow the evaluation of the safety of medicaldevices in the MR environment. PMID:17969160
We describe preliminary work on semantic alarms, a framework for context-sensitive clinical alerts. Semantic alarms are intended for deployment in a multi-parameter vital sign monitoring system. Requirements for device and data interoperability within this system are discussed. Extended examples are provided for sepsis and congestive heart failure disease state alarms.
Albert Goldfain; Atanu Roy Chowdhury; Min Xu; Jim DelloStritto; Jonathan Bona; Blue Highway
Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medicaldevice used for blood sugar control. The new type compact medicaldevice comprises (1) a micropump system to extract blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 ?m in internal diameter, was measured. The wearable medicaldevice with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 ?l/sec. If the wearable medicaldevice extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medicaldevice with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15?l/sec.
New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medicaldevices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medicaldevice industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medicaldevice community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medicaldevice. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary report of those discussions. PMID:17390305
Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V
Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment. PMID:23692108
Medicaldevice recalls have called attention to the device approval process in the United States. The premarket approval (PMA) process requires clinical trials to evaluate safety and effectiveness, whereas the expedited 510(k) process does not. The 510(k) process has been considered a source of increased recalls. This study aimed to assess the relative safety of medicaldevice approval pathways based on the numbers of approvals and recalls. Data on recalls in the United States from January 2005 to December 2012 were collected from the Food and Drug Administration Web site. Over 8 years, 30,002 devices were approved, 5,728 by PMA (19%) and 24,274 (81%) by 510(k). There were 249 recalls due to serious risks, 0.45% of PMA approvals, and 0.92% of 510(k)-cleared devices, p <0.001. Over 1/2 of the recalls were during the first 2 years on the market. Percentage of recalled PMA devices was unchanged over the 8 years, whereas 510(k) recalls increased in 2010 to 2012 (from 0.65% to 1.39%, p <0.001). Cardiovascular devices represent the largest class of recalls (27%). The proportions of recalled PMA and 510(k) cardiovascular devices were the same as for all medicaldevices until 2011, but 510(k) recalls dramatically decreased in 2012 to the lowest recall rate seen (0.73%). In conclusion, recall rates were the same for 510(k)- and PMA-approved devices in 2005 to 2009 and increased for 510(k) devices subsequently. Modifying the 510(k) process with more rigorous performance testing, a conditional 2-year approval and a mandatory registry may be an approach to reduce recalls. PMID:24837271
The safety of any medicaldevice system is dependent on the application of a disciplined, well-defined, risk management process throughout the product life cycle. Hardware, software, human, and environmental interactions must be assessed in terms of intended use, risk, and cost/benefit criteria. This article addresses these issues in the context of medicaldevices that incorporate software. The article explains the principles of risk management, using terminology and examples from the domain of software engineering. It may serve as a guide to those new to the concepts of risk management and as an aide-memoire for medicaldevice system/software engineers who are more familiar with the topic. PMID:12162111
Jones, Paul L; Jorgens, Joseph; Taylor, Alford R; Weber, Markus
Ignoring over a century of tort law precedence, ultimately leaving thousands of people all over the country injured by medicaldevices without remedy, the prevailing jurisprudence on medicaldevice federal preemption is both current and relevant. Due to the inherent ambiguity of the preemption provision MedicalDevice Amendments of 1976, where contemporary medicaldevice litigation had its beginnings, the regulatory
Medicaldevices designed to network can share data with a Clinical Information System (CIS), making that data available within clinician workflow. Some lessons learned by transitioning anesthesia reporting and monitoring devices (ARMDs) on a local area network (LAN) to integration of anesthesia documentation within a CIS include the following categories: access, contracting, deployment, implementation, planning, security, support, training and workflow integration. Areas identified for improvement include: Vendor requirements for access reconciled with the organizations’ security policies and procedures. Include clauses supporting transition from stand-alone devices to information integrated into clinical workflow in the medicaldevice procurement contract. Resolve deployment and implementation barriers that make the process less efficient and more costly. Include effective field communication and creative alternatives in planning. Build training on the baseline knowledge of trainees. Include effective help desk processes and metrics. Have a process for determining where problems originate when systems share information.
Medicaldevices designed to network can share data with a Clinical Information System (CIS), making that data available within clinician workflow. Some lessons learned by transitioning anesthesia reporting and monitoring devices (ARMDs) on a local area network (LAN) to integration of anesthesia documentation within a CIS include the following categories: access, contracting, deployment, implementation, planning, security, support, training and workflow integration. Areas identified for improvement include: Vendor requirements for access reconciled with the organizations' security policies and procedures. Include clauses supporting transition from stand-alone devices to information integrated into clinical workflow in the medicaldevice procurement contract. Resolve deployment and implementation barriers that make the process less efficient and more costly. Include effective field communication and creative alternatives in planning. Build training on the baseline knowledge of trainees. Include effective help desk processes and metrics. Have a process for determining where problems originate when systems share information. PMID:24199054
Indication for radiotherapy is often questioned for patients equipped with implantable medicaldevices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device. PMID:24268844
Human errors in medicaldevice use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medicaldevice use ...
J. Zhang V. L. Patel T. R. Johnson P. Chung J. P. Turley
...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM)...
The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for overseeing the safety and effectiveness of medicaldevices sold in the United States. New devices are generally subject to FDA review via th...
Service oriented device architecture (SODA) is a promising approach for enabling a continuous IT support of medical processes in hospitals. However, there is a lack of specific design patterns for realizing the concept in an effective and efficient way. This paper addresses this research gap by introducing the Standardized Device Service design pattern, as a first fundamental pattern for encapsulating
Computational algorithms for the accurate and efficient modeling of acoustic beam propagations are presented. The algorithms are used to describe the propagations of biomedical ultrasonic imaging devices and lithotripters. The models as implemented are limited to axially symmetric sources. Linear algorithms or methods are presented which appear to form a uniquely efficient framework for describing beam propagations. The convolutionally-correct use of spatial domain sampling of the point source function (h) and the alternative of ray theory-directed sampling of the propagation function (H) are considered. The discrete Hankel transform is also presented as a means of greatly simplifying the propagation of axially symmetric sources. Nonlinear beam propagation models are presented which appear to offer significant advantages over the established nonlinear parabolic equation models. In particular, the models presented appear to offer near-field and off-axis accuracy, as well as the ability to represent beam propagations involving shockwaves. The nonlinear beam model framework should also be applicable to other forms of beam propagation involving progressive nonlinear effects. Transform-based dispersion relations are presented which appear to be a useful alternative to the traditional Kramers-Kronig relations. The new relations are used to derive a relation for the computation of discrete harmonic velocity values. Similarly, an analogous relation for computing discrete harmonic absorption values can be obtained. Problems associated with local dispersion relations are also considered. The new computational models are used to consider the in vivo or tissue path performance of biomedical ultrasonic devices. The significance of nonlinearity to tissue path beam propagations are predicted to lag well behind the corresponding water path significance. At high source intensities, though, the models predict that nonlinearity can become important to focal wave shape and focal tissue heating. For example, in the case of a high intensity, first trimester fetal examination, the inclusion of nonlinearity is predicted to account for an order of magnitude increase in the predicted focal heating rate. An extension of the nonlinear beam propagation model appropriate for modeling extracorporeal shockwave lithotripters is presented. The model is shown to agree well with water path measurements of the Dornier HM3 lithotripter. The performance of the HM3 is predicted to be strongly effected by nonlinearity in both water and tissue paths. The model predicts that the HM3's in vivo performance is quite similar to its water path performance. The model, together with measurements, suggest that the HM3's focal performance is strongly affected by the tensile strength of the fluid medium. The models presented appear to be well suited to the task of modelling axially symmetric acoustic beam propagations. Both continuous wave and pulsed sources can be considered. One of the nonlinear beam propagation models is currently available as a supported software package. Generalizing the models by dropping the constraint of axial symmetry is straightforward.
You may have heard the phrase as difficult as walking and chewing gum as a joking way of referring to something that is not difficult at all. Just walking, however, is not all that simple physiologically speaking. Even standing upright is an undertaking requiring the complex cooperation of multiple motor and sensory systems including vision, the inner ear, somatosensation (sensation from the skin), and proprioception (the sense of the body s parts in relation to each other). The compromised performance of any of these elements can lead to a balance disorder, which in some form affects nearly half of Americans at least once in their lifetimes, from the elderly, to those with neurological or vestibular (inner ear) dysfunction, to athletes with musculoskeletal injuries, to astronauts returning from space. Readjusting to Earth s gravity has a significant impact on an astronaut s ability to balance, a result of the brain switching to a different "model" for interpreting sensory input in normal gravity versus weightlessness. While acclimating, astronauts can experience headaches, motion sickness, and problems with perception. To help ease the transition and study the effects of weightlessness on the body, NASA has conducted many investigations into post-flight balance control, realizing this research can help treat patients with balance disorders on Earth as well. In the 1960s, the NASA-sponsored Man Vehicle Laboratory at the Massachusetts Institute of Technology (MIT) studied the effects of prolonged space flight on astronauts. The lab s work intrigued MIT doctoral candidate Lewis Nashner, who began conducting NASA-funded research on human movement and balance under the supervision of Dr. Larry Young in the MIT Department of Aeronautics and Astronautics. In 1982, Nashner s work resulted in a noninvasive clinical technique for assessing the cooperative systems that allow the body to balance, commonly referred to as computerized dynamic posturography (CDP). CDP employs a series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.
The systemic bioavailability of propranolol was evaluated following oral and transdermal administration in rabbits. Using a four-way crossover study, the bioavailability of propranolol following oral administration was determined to be 12.3 +/- 5.9%, indicating that propranolol is subject to extensive hepatic first-pass metabolism in rabbits. Transdermal delivery of propranolol, via an adhesive delivery device, resulted in a bioavailability of 74.8 +/- 10.1%, indicating that the transdermal delivery of propranolol can significantly increase systemic bioavailability over oral administration. Skin irritation studies indicated that neither propranolol nor the adhesive used in the device caused any appreciable skin irritation. PMID:2398465
The regulatory system for medicaldevices is quite different from that for pharmaceuticals and may catch many people unawares. For instance, it does not involve the grant of a marketing authorization by a medicines agency. Instead, a ‘declaration of conformity’ is made by the manufacturer, but in many instances this is subject to approval by an independent certification house (known
Implantable medicaldevices are finding increasing use in the treatment of diseases traditionally targeted with drugs. It is well established that the cholinergic anti-inflammatory pathway serves as a physiological regulator of inflammatory responses, but stimulation of this pathway therapeutically by electrical stimulation of the vagus nerve can also diminish excessive or dysregulated states of inflammation. Recent data from a wide
Software Risk Management (RM) within MedicalDevice (MD) companies is a critical area. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. Therefore regulators penalise MD manufacturers that do not devote sufficient attention to the areas of hazard analysis and RM throughout the software lifecycle. This paper describes the experience of a
Medical diagnostics refers to testing conducted either in vitro or in vivo to provide critical health care information for risk assessment, early diagnosis, treatment, or disease management. Typical in vivo diagnostic tests include the computed tomography scan, magnetic resonance imaging, and blood pressure screening. Typical in vitro diagnostic tests include cholesterol, Papanicolaou smear, and conventional glucose monitoring tests. Historically, devices
Purpose – The purpose of this paper is to familiarize the reader with the capabilities of EFAB technology, a unique additive manufacturing process which yields fully assembled, functional mechanisms from metal on the micro to millimeter scale, and applications in medicaldevices. Design\\/methodology\\/approach – The process is based on multi-layer electrodeposition and planarization of at least two metals: one structural
Adam Cohen; Richard Chen; Uri Frodis; Ming-Ting Wu; Chris Folk
The Italian Health sector has been experiencing, for several years, a re-organization process, to improve the efficiency of medicaldevice management by the introduction of new instruments, included the Internet. In this setting, many companies offer innovative products via the web to the health administration, especially for e-procurement. Ital TBS is an Italian Clinical Engineering Services company, managing different biomedical
D. Bravar; G. Carlini; A. Cortese; T. dell'Aquila; N. Pangher
Indwelling and temporary medical delivery devices (i.e. catheters) are increasingly used in hospital settings, providing clinicians with useful tools to administer nutrients, draw blood samples and deliver drugs. However, they can often put patients at risk for local or systemic infections, including bloodstream infections and endocarditis. Microorganisms readily adhere to the surfaces and colonize them by forming a slimy layer
New research is underway at the FDA to investigate the benefits of integrating architecture analysis into safety evaluations of medical-device software. Due to the complexity in setting up testing environments for such software, the FDA is unable to conduct large-scale safety testing; instead, it must rely on other techniques to build an argument for whether the software is safe or
Dharmalingam Ganesan; Mikael Lindvall; Rance Cleaveland; Raoul Jetley; Paul Jones; Yi Zhang
To detect errors when subjects operate a home medicaldevice, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human
Zan Gao; Marcin Detyniecki; Ming-yu Chen; Wen Wu; Alexander G. Hauptmann; Howard D. Wactlar
We perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medicaldevice to see if the patient has correctly performed
Zan Gao; Marcin Detyniecki; Ming-yu Chen; Wen Wu; A. G. Hauptmann; H. D. Wactlar; A. Cai
Elevated temperature is frequently used to accelerate the aging process in polymers that are associated with medicaldevices and other applications. A common approach is to assume that the rate of aging is increased by a factor of 2?T\\/10, where ?T is the temperature increase. This result is a mathematical expression of the empirical observation that increasing the temperature by
Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medicaldevices that must operate for long periods of time from
In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medicaldevices. This is in light of the topical, rather dissimilar, incidents involving poly-implant-prothèse (PIP) breast and metal-on-metal hip implants. Although medicines and devices are regulated under European Union (EU) law, the regulatory regimes are very different and some have argued that features of the pharmaceutical regime should be applied to medicaldevices in the current review of the medicaldevices directives. Both medicines and certain devices need to have an assessment of their risks and benefits before being used in patients, and undergo subsequent monitoring for adverse events. However, there are significant differences between these two groups in terms of the number of products, the pattern of innovation and development, and the types of adverse events that arise from their use. This review will summarise the key issues through a comparison of how both are regulated and monitored. PMID:24532735
\\u000a The range and complexity of medicaldevices used in homecare are increasing. Home medicaldevices must be safer, easier to\\u000a use and more accessible for all users. The safety and the efficiency of the medicaldevice used depend on the device’s design,\\u000a users’ ability to operate with devices and the used environments for devices. In order to investigate the proper
...Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee; Amendment...amendment to the notice of a meeting of the General and Plastic Surgery Devices Panel of the MedicalDevices Advisory Committee....
Medicaldevices play an increasingly significant role in the delivery of health care today. However, persistent quality problems with medicaldevices and the associated recalls present potential health risks to patients and personnel using these devices. This study addresses three key issues in this regard. First, it empirically assesses the financial implications of medicaldevice recalls to understand if these
...MedicalDevices; Neurological and Physical Medicine Device Guidance Document; Reopening...documents for 11 neurological and physical medicine devices. FDA is reopening the comment...documents for 11 neurological and physical medicine devices. Interested persons were...
Based on the analysis of the present status of medicaldevices management, this paper optimized management process, developed a medicaldevices management system with Web technologies. With information technology to dynamic master the use of state of the entire life-cycle of medicaldevices. Through the closed-loop management with pre-event budget, mid-event control and after-event analysis, improved the delicacy management level of medicaldevices, optimized asset allocation, promoted positive operation of devices. PMID:24941784
Photopolymerizations are widely used in medicine to create polymer networks for use in applications such as bone restorations and coatings for artificial implants. These photopolymerizations occur by directly exposing materials to light in "open" environments such as the oral cavity or during invasive procedures such as surgery. We hypothesized that light, which penetrates tissue including skin, could cause a photopolymerization indirectly. Liquid materials then could be injected s.c. and solidified by exposing the exterior surface of the skin to light. To test this hypothesis, the penetration of UVA and visible light through skin was studied. Modeling predicted the feasibility of transdermal polymerization with only 2 min of light exposure required to photopolymerize an implant underneath human skin. To establish the validity of these modeling studies, transdermal photopolymerization first was applied to tissue engineering by using "injectable" cartilage as a model system. Polymer/chondrocyte constructs were injected s.c. and transdermally photopolymerized. Implants harvested at 2, 4, and 7 weeks demonstrated collagen and proteoglycan production and histology with tissue structure comparable to native neocartilage. To further examine this phenomenon and test the applicability of transdermal photopolymerization for drug release devices, albumin, a model protein, was released for 1 week from photopolymerized hydrogels. With further study, transdermal photpolymerization potentially could be used to create a variety of new, minimally invasive surgical procedures in applications ranging from plastic and orthopedic surgery to tissue engineering and drug delivery.
Elisseeff, J.; Anseth, K.; Sims, D.; McIntosh, W.; Randolph, M.; Langer, R.
The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.
Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medicaldevice design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medicaldevices that are better suited to users' needs. However, little research has been carried out to explore medicaldevice manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medicaldevice manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medicaldevice manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medicaldevice manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised.
Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power. PMID:19964948
Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui
The European Union (EU) adopted the revised MedicalDevice Directive (MDD) in 2010. A major change is that software for certain purposes is now considered a medicaldevice (MD) and thus is subject to the same regulation as MDs. That means the integration of a usability engineering process with its documentation in a usability file is now mandatory. This paper presents a case study, performed in particular conditions, to (i) illustrate the adopted user-centered approach to be compliant with the ergonomic-essential requirement and (ii) discuss the methodological challenges associated even under such favorable conditions. The results raise the question about whether software regulation is feasible. We conclude that there is a need to think about recommendations for how regulation could be implemented with support for manufacturers, with minimal impact on innovation, and with rigorous but not too rigid evaluation procedures. PMID:23920592
Pelayo, Sylvia; Bras Da Costa, Sabrina; Leroy, Nicolas; Loiseau, Séverine; MacKeon, Damien; Trancard, Delphine; Beuscart-Zéphir, Marie-Catherine
The invention relates to a diagnosis device which is proposed for combined or combinable radiographic and nuclear medical examinations comprising: an x-ray source, an examination room for accommodating a patient, a gamma radiation source arranged in the body of the patient, a detector system which has a detector surface for simultaneously measuring the x-ray and gamma radiation without changing the patient's position or which is designed to record a two-dimensional locally-resolved and object-imaging individual x-ray projection image. The diagnosis device is designed to carry out the radiographic examination by evaluating the measurement of the x-rays and to carry out a single photon emission examination as a nuclear medical examination by evaluating the gamma radiation.
Software is becoming an increasingly important aspect of medicaldevices (MDs) and MD regulation. MDs can only be marketed\\u000a if compliance and approval is achieved from the appropriate regulatory bodies. MD companies must produce a design history\\u000a file detailing the processes undertaken in the design and development of their MD software. The safety of all MD software\\u000a produced is of
The history of the United States (US) MedicalDevice Reporting (MDR) Regulation is long and complicated. This has made compliance with the requirements an especially challenging exercise. The publication of a new regulation clarifies some outstanding reporting issues, but not all. Part I of this article includes a chronology of MDR regulations and discusses some requirements that should be of particular interest to non-US companies. Part II will discuss the contents of the new MDR regulation. PMID:10915493
Silk/absorbable polyester hybrid medicaldevices for tissue repair and regeneration are formed of degummed, naturally produced, multifilament silk yarn in combination with at least one absorbable polyester in the form of a surface coating, with or without an antimicrobial agent, for producing value-added braided silk sutures and multifilament yarn, as well as silk/absorbable polyester fiber composites, for producing tailored hybrid sutures, meshes, and scaffolds for tissue regeneration.
The Court of Justice of the European Union made a decision on medicaldevices as non-medicinal products for intended use in interpreting the concept of free movement of goods, such as operating principles concerning the subject matter of the interpretation of Directive 93/42/ EEC - in preliminary ruling according to article 267 of TFEU - on 22 November 2012. With its decision, given assigned explained the concept of the scope of medicaldevices. The decision of the Court is binding not only for the national court initiating a request for the preliminary ruling, but also for all courts of the Member States. Official reference: Dated judgement 22 November 2012 of the Court of Justice of the European Union to C-219/ Case no. 11 - in preliminary ruling according to article 267 of TFEU. Interpreted provisions: Directive 2007/47/EC of The European Parliament and of the Council of 5 September 2007 as amended by the Council Directive 93/42/EEC of 14 June 1993 concerning medicaldevices 1st (2) a) first, second and third indent. PMID:23461981
Remote point-of-care is expected to revolutionize the modern medical practice, and many efforts have been made for the development of wireless health monitoring systems for continuously detecting the physiological signals of patients. To make the remote point-of-care generally accepted and widely used, it is necessary to develop cost-effective and durable wireless health monitoring systems. Printing technique will be helpful for the fabrication of high-quality and low-cost medicaldevices and systems because it allows high-resolution and high-speed fabrication, low material consumption and nano-sized patterning on both flexible and rigid substrates. Furthermore, application of thermoelectric generators can replace conventional batteries as the power sources for wireless health monitoring systems because thermoelectric generators can convert the wasted heat or the heat from nature into electricity which is required for the operation of the wireless health monitoring systems. In this research, we propose the concept of printable thermoelectric devices and conductive patterns for the realization of more portable and cost-effective medicaldevices. To print thermoelectric generators and conductive patterns on substrates, printing inks with special characteristics should be developed. For the development of thermoelectric inks, nano-structured thermoelectric materials are synthesized and characterized; and for the development of conductive inks, two kinds of surface treated carbon nanotubes are used as active materials.
Lee, Jungmin; Kim, Hyunjung; Chen, Linfeng; Choi, Sang H.; Varadan, Vijay K.
Bacteria colonization on medicaldevices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medicaldevices represent a significant portion of the total medicaldevices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.
The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medicaldevice industry. One of the FDA regulatory mechanisms, the MedicalDevice Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and
...Developing MedicalDevices for Pediatric Patients Affected by Rare Diseases...Developing MedicalDevices for Pediatric Patients Affected by Rare Diseases...diagnosis and treatment of pediatric patients affected by rare...
Following enactment of the MedicalDevice Amendments of 1976, FDA initiated a series of studies to assess the 'baseline' conditions in the medicaldevice industries. These studies are designed to: (1) provide a basis for informed regulation, and (2) suppl...
...false Agricultural commodities, food, medicine, and medicaldevices. 561.327...327 Agricultural commodities, food, medicine, and medicaldevices. (a) The term...their derivatives. (c) The term medicine has the same meaning given the...
...FDA-2011-N-0002] MedicalDevice Epidemiology Network 2011: Second Annual Public...workshop entitled ``MedicalDevice Epidemiology Network (MDEpiNet) 2011: Second...all stakeholders with expertise in epidemiology and health services research on...
...Request on MedicalDevices To Treat Otitis Media With Effusion AGENCY: Agency for Healthcare...submissions from manufacturers of otitis media with effusion medicaldevices, such as...Comparative Effectiveness Review of Otitis Media with Effusion (OME) Treatments,...
Following enactment of the MedicalDevice Amendments of 1976, FDA initiated a series of studies to assess the 'baseline' conditions in the medicaldevice industry. Those studies are designed to (1) provide the basis for informed regulation and (2) supply ...
This BAA is providing core program support to develop key capabilities of the MedicalDevice Plug-and-Play (MD PnP) Interoperability Program to lead medicaldevice interoperability to support clinical solutions for improving patient safety and healthcare ...
...Public Workshop on MedicalDevices and Nanotechnology: Manufacturing, Characterization...workshop entitled ``MedicalDevices & Nanotechnology: Manufacturing, Characterization...your experience or expertise with nanotechnology. There will be a limited number...
This overview addresses the controversial practice of reuse and reprocessing of single-use medicaldevices and the issues this practice raises for physician liability. Specifically, we describe the health risks associated with medicaldevice reprocessing, analyze the market costs arising from the reuse and reprocessing of single-use medicaldevices, and discuss physician liability for failure to obtain informed consent of the patient for the use of reprocessed single-use medicaldevices. PMID:10932637
... have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Nitroglycerin transdermal ... called vasodilators. It works by relaxing the blood vessels so that the heart does not need to ...
This article aims to examine barriers to the efficient use of resources relating to medicaldevices, by focusing specifically on an economic analysis of the market structure of medicaldevices and on the assessment procedures for medicaldevices. A desktop analysis was conducted of the health economic literature relating to both of these aspects. This information was structured and analysed
In 1976 Congress passed legislation authorizing the regulation of all medicaldevices. Some observers predicted that this regulation would have adverse effects on the newly regulated industries. This paper examines the major features of the medicaldevice regulatory program and investigates how the regulation has affected the diagnostic imaging equipment industry. The results indicate that medicaldevice regulation has not
...FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the MedicalDevices Advisory...meeting of the Molecular and Clinical Genetics Panel (the panel) of the MedicalDevices...meeting of the Molecular and Clinical Genetics Panel of the MedicalDevices...
...Docket No. FDA-2013-N-0118] Extreme Weather Effects on MedicalDevice Safety and Quality...studying the potential effects of extreme weather and natural disasters on medicaldevice...request for comments on the topic of extreme weather effects on medicaldevice safety and...
During the last 20 years, safety evaluation of medicaldevices has evolved from screening assays to the “pharmaceutical model” of preclinical testing. Biocompatibility testing guidelines for medicaldevices are published in the International Organization for Standardization (ISO) document 10993–1: Biological evaluation of medicaldevices—Part 1: Evaluation and testing. These guidelines are recognized by most national regulatory bodies and supplement, but
Presently, there is interest in making medicaldevices such as expandable stents and intravascular microactuators from shape memory polymer (SMP). One of the key challenges in realizing SMP medicaldevices is the implementation of a safe and effective method of thermally actuating various device geometries in vivo. A novel scheme of actuation by Curie-thermoregulated inductive heating is presented. Prototype medical
Patrick R. Buckley; Gareth H. McKinley; Thomas S. Wilson; Ward Small; William J. Benett; Jane P. Bearinger; Michael W. McElfresh; Duncan J. Maitland
Human errors in medicaldevice use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medicaldevice use is critical for developing interventions to reduce such errors either by redesigning the devices or, if redesign is not an option,
Jiajie Zhang; Vimla L. Patel; Todd R. Johnson; Philip Chung; James P. Turley
The new European system for the regulation of medicaldevices is currently being introduced incrementally, having begun in 1993 with a view to completion around the turn of the century. Although still it its relative infancy there has already been valuable experience gained in relation to certain device types. The system is based upon three EC Directives; the first covering active implantable devices is now fully in force; with the second covering most other devices, currently within a transition phase. The Directives fully recognise the importance of stringent post market surveillance, one key element of which involves the reporting of certain device related incidents to and between the regulatory authorities of Member States (Competent Authorities). The objective behind the reporting requirements, or "Vigilance System", is to protect patients and other users by reducing the chance of the same types of incidents reoccurring in different places across the European Economic Area (EEA). As Competent Authority for the UK, the MedicalDevices Agency was one of the first to put the System into effect and continues to play a leading role. In broad terms, Vigilance requires manufacturers to notify Competent Authorities of incidents, known as Vigilance Cases, in which a device led to or might have led to the death or serious injury of patients or users. In addition they must also provide similar notification of device recalls undertaken for a technical or medical reason. For their part, Competent Authorities are required to share certain details of Vigilance Cases between each other, and with the European Commission. While mandatory incident reporting is not a new concept outside Europe, Vigilance is unique in attempting to coordinate this across nineteen different countries with different languages and cultures. Even after four years, there remains some confusion among industry and regulators alike over exactly what is required and how best to achieve it. In particular there is an element of concern among manufacturers over apparent variations in interpretation being demonstrated by different Competent Authorities. Although derived from an inherently sensible and straight forward objective, in practice Vigilance raises a myriad of questions such as when, how and to whom should reports be made, and perhaps most fundamentally, exactly which incidents should be reported. The Directives themselves offer little clarification, and in recognition of this the Commission drew up the EC Guidelines on the MedicalDevices Vigilance System. These Guidelines, while not legally binding offer practical and invaluable answers to these and many other important questions. Ongoing improvements to the Guidelines appear to be the best way to try to "level the playing field" across the EEA. Considerable effort continues to be made to fine tune this document with input representing regulatory and industry interests and it is hoped that a second revision may be available next year. Vigilance is gaining popularity as a model for adoption outside the EEA, particularly as it begins to overcome the operational hurdles characteristic of the first "live running" of any new system. PMID:9503691
... 2010-04-01 false Medicaldevices; name and place...HUMAN SERVICES (CONTINUED) MEDICALDEVICES LABELING General Labeling Provisions Â§ 801.1 Medicaldevices; name and place of...is shown in a current city directory or telephone...
... 2009-04-01 false Medicaldevices; name and place...HUMAN SERVICES (CONTINUED) MEDICALDEVICES LABELING General Labeling Provisions Â§ 801.1 Medicaldevices; name and place of...is shown in a current city directory or telephone...
...Annual Meeting: The MedicalDevice Epidemiology Network as a Partnership for Building Global MedicalDevice Epidemiology and Surveillance Capabilities AGENCY...Annual Meeting: The MedicalDevice Epidemiology Network as a Partnership for...
The publication summarizes key documents pertaining to the regulation of medicaldevices that manufacturers must consider when they market such devices. The material is useful as a reference for establishment registration, device listing, labeling require...
...from birth through the 21st year of life. Some devices are designed specifically for pediatric use, while others are adopted...concerns about device longevity and long- term exposure to implanted materials. The current medicaldevice market for...
Pediatric medicaldevices play a vital role in the treatment of children with cardiovascular disease. Most cardiac medicaldevices used in children today are used off-label where the risk-benefit of devices has not been well characterized. Pediatric medicaldevices face a variety of challenges to FDA approval related in large part to the small target population, heterogeneity of the patient population and ethical considerations of device testing in children. While relatively few cardiac devices have received FDA approval in children, the number of devices navigating the approval process successfully is growing. Most pediatric device approvals are being granted through the humanitarian device exemption (HDE) pathway, which is designed for rare diseases making it suitable for devices treating congenital heart disease. This review summarizes the FDA review process for pediatric medicaldevices as it continues to evolve in response to the unique challenges of understanding device performance in the pediatric population.
...Administration Staff; MedicalDevices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and...controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls...
...Administration Staff; MedicalDevices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction...of draft guidance documents for 11 neurological and physical medicine devices. The document was published with an inadvertent...
Polyurethanes have been widely used in medicine for coating and packaging implantable and other medicaldevices. Polyether-urethanes, in particular, have superior mechanical properties and are biocompatible, but in common with other medical materials they are susceptible to microbial film formation. In this study, polyether-urethane was end-capped with silver lactate and silver sulfadiazine functional groups to produce a bacterially resistant polymer without sacrificing the useful mechanical properties of the polyether-polyurethane. The silver ions were covalently incorporated into the polymer during chain extension of the prepolymer. The functionalized polymers were structurally characterized by light scattering, electron microscopy, NMR, FTIR and Raman spectroscopy. Mechanical properties, hydrophilicity, in vitro stability and antibacterial action of polymers were also investigated. Results indicate that both silver salts were successfully incorporated into the polymer structure without significant effect on mechanical properties, whilst conferring acceptable bacterial resistance. PMID:22287552
Several electronic devices for automatically correcting specific defects in a body's physiologic regulation and allowing approximately normal functioning are described. A self-injurious behavior inhibiting system (SIBIS) is fastened to the arm of a person with chronic self-injurious behavior patterns. An electric shock is delivered into the arm whenever the device senses above-threshold acceleration of the head such as occur with head-bangers. Sounding a buzzer tone with the shock eventually allows transference of the aversive stimulus to the buzzer so shocks are no longer necessary. A programmable implantable medication system features a solenoid pump placed beneath the skin and refueled by hypodermic needle. The pump functions are programmable and can deliver insulin, chemotherapy mixes and/or pain killers according to a preset schedule or on patient demand. Finally, an automatic implantible defibrillator has four electrodes attached directly to the heart for sensing electrical impulses or emitting them in response to cardiac fibrillation.
The Internet is dramatically changing the structure of the industry. For the first time, direct communication between all suppliers and all hospitals is available. The Internet-based electronic market place not only provides the ability to choose products from a standardized catalogue, but also to send orders direct to suppliers' enterprise resource planning systems. One-to-one marketing is also becoming a reality. Medicaldevice manufacturers are advised to test the different electronic sales and marketing initiatives that are now available. PMID:11200157
Medicaldevices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes. PMID:24811927
Atmospheric pressure plasma sources produce a multiplicity of different antimicrobial agents and are applicable to even complicated geometries as well as to heat sensitive materials. Thus, atmospheric pressure plasmas have a huge potential for the decontamination of even complex medicaldevices like central venous catheters and endoscopes. In this paper we present practicable realizations of atmospheric pressure plasma sources, namely plasma jet, dielectric barrier discharge and microwave driven discharge that are able to penetrate fine lumen or are adaptable to difficult geometries. Furthermore, the antimicrobial efficacy of these sources is given for one example setup in each case.
Weltmann, Klaus-Dieter; Winter, Jörn; Polak, Martin; Ehlbeck, Jörg; von Woedtke, Thomas
A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medicaldevices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medicaldevices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough cleaning procedure should precede sterilization or disinfection (with the exception of NaOCl bleach which also cleans). PMID:10713558
Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medicaldevices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medicaldevice surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.
Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun
This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medicaldevice clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medicaldevice regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medicaldevice regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medicaldevice. The importance of a working understanding of applicable medicaldevice regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.
Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medicaldevices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medicaldevices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medicaldevices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished several particular settings (mouth and dental care in patients under antiagregant or anticoagulation therapy, central nervous system surgery or acute aortic dissection). Comparative data are insufficient to determine if one product is superior to another for a specific use. To evaluate the clinical value of these products, methodologically sound clinical studies are necessary. PMID:22136914
In the market of medicaldevices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medicaldevices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of MedicalDevices has been contributing to rapid marketing of medicaldevices by working out the standards for approval review and accreditation of medicaldevices, guidances on evaluation of medicaldevices with emerging technology, and test methods for biological safety evaluation of medicaldevices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medicaldevices, 14 guidances on safety evaluation of medicaldevices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market MedicalDevices"). PMID:23243983
Modern medicaldevices have the facility to output data such as device settings and readings. Such devices include vital signs monitors, ventilators and infusion pumps to name a few. Wirelessly networking these types of devices has the advantages of patient mobility, device mobility and central data storage. This has led us to develop wireless sensors, gateways, servers and clients to
As people grow old, their need for medications increases dramatically because of the higher incidence of chronic pain, diabetes mellitus, cardiovascular and neurological diseases in the elderly population. Furthermore, the elderly require special consideration with respect to drug delivery, drug interactions and adherence. In particular, patients with chronic neurological diseases often require multiple administration of drugs during the day to maintain constant plasma medication levels, which in turn increases the likelihood of poor adherence. Consequently, several attempts have been made to develop pharmacological preparations that can achieve a constant rate of drug delivery. For example, transdermal lisuride and apomorphine have been shown to reduce motor fluctuations and duration of 'off' periods in advanced Parkinson's disease, while rotigotine allows significant down-titration of levodopa without severe adverse effects. Thus, parkinsonian patients with long-term levodopa syndrome or motor disorders during sleep could benefit from use of transdermal lisuride and apomorphine. Moreover, transdermal dopaminergic drugs, particularly rotigotine, seem the ideal treatment for patients experiencing restless legs syndrome or periodic limb movement disorder during sleep, disorders that are quite common in elderly people or in association with neurodegenerative diseases. Unlike dopaminergic drugs, transdermal treatments for the management of cognitive and behavioural dysfunction in patients with Parkinson's disease and Alzheimer's disease have inconsistent effects and no clearly established role. Nevertheless, because of their favourable pharmacological profile and bioavailability, the cholinesterase inhibitors tacrine and rivastigmine are expected to show at least the same benefits as oral formulations of these drugs, but with fewer severe adverse effects. Transdermal delivery systems play an important role in the management of neuropathic pain. The transdermal lidocaine (lignocaine) patch is recommended as first-line therapy for the treatment of postherpetic neuralgia. Furthermore, in patients with severe persistent pain, transdermal delivery systems using the opioids fentanyl and buprenorphine are able to achieve satisfactory analgesia with good tolerability, comparable to the benefits seen with oral formulations. Transdermal administration is the ideal therapeutic approach for chronic neurological disorders in elderly people because it provides sustained therapeutic plasma levels of drugs, is simple to use, and may reduce systemic adverse effects. Several transdermal delivery systems are currently under investigation for the treatment of Parkinson's disease, Alzheimer's disease and neuropathic pain. Although most transdermal delivery systems treatments cannot be considered as first-line therapy at present, some of them provide clear advantages compared with other routes of administration and may become the preferred treatment in selected patients. In general, however, most transdermal treatments still require long-term evaluation in large patient groups in order to optimise dosages and evaluate the actual incidence of local and systemic adverse effects. PMID:16823990
Priano, Lorenzo; Gasco, Maria Rosa; Mauro, Alessandro
Transdermal drug delivery is a validated technology contributing significantly to global pharmaceutical care. Since 1980, impressive growth in this field has been observed with many commercial successes; importantly, a new chemical entity was recently developed and approved for transdermal administration without having first been given as an injectable or oral dosage form. The progress achieved has been based on the clearer understanding of skin barrier function, and of the physicochemical, pharmacokinetic and physiological factors which underpin the feasibility of transdermal administration. Novel, non-invasive approaches to enhance and control drug transport across the skin are under intensive investigation, and some technologies, e.g. iontophoresis, have reached true maturity. The "local", subcutaneous delivery of drugs (for example, to underlying muscle and other tissues) is gaining increasing acceptance, and new opportunities in this under-subscribed area may be envisaged. PMID:20217537
A fundamental tension exists between safety in the com- mon case and security under adversarial conditions for wireless implantable medicaldevices. We propose a class of new, fail-open defensive techniques for im- plantable medicaldevices that attempt to strike a balance between these two goals. We refer to these defensive techniques as Communication Cloakers. Cloakers are externally worn devices, much
In order to minimize injury during a medical treatment using a low invasive sliding device, loss of cells and tissues due to wear against the device must be prevented by maintaining good lubrication condition. For this purpose, a new medicaldevice with a spiral ribbed impeller has been presented. This paper shows the potentials and problems of the proposed mechanism
The Food and Drug Administration (FDA) is revoking Compliance Policy Guide (CPG) 7124.28 because application of current good manufacturing practice (CGMP) requirements to "reconditioners/rebuilders" of used medicaldevices does not comport with definitions in the quality system (QS) regulation or guidance in the final rule that applies CGMP requirements to "manufacturers" and "remanufacturers." Because "reconditioners/rebuilders" are specifically excluded from the definition of "manufacturer" or "remanufacturer" in the QS regulation, guidance in the CPG on the applicability of registration, listing, and other statutory and regulatory requirements to "reconditioners/rebuilders" does not represent current agency thinking. In the advance notice of proposed rulemaking (ANPRM), published in the December 23, 1997, Federal Register, FDA announced its intention to consider identifying the used device market, for regulatory purposes, in terms of "refurbishers," "as-is remarketers," and "servicers" whose activities do not significantly change the safety, performance, or use of a device, and to examine alternative approaches for regulating these firms. Pending the issuance of a rule or guidance setting forth FDA's current position, CPG 7124.28 is being revoked to eliminate obsolete guidance and reduce industry burdens. PMID:10338883
... works out the details of the design and manufacturing of the new device. At this stage, many ... devices. These exempt devices still must comply with manufacturing and quality control standards. • Class II devices usually ...
Fault or failure of software contained in medicaldevices will seriously endanger users and should be considered to reduce\\u000a risk. In software development process, the risk analysis and risk control are very important for software contained in medical\\u000a devices. In order to promote the quality of software contained in medicaldevices, a website is designed to provide the operating\\u000a procedure
Yeou-Jiunn Chen; A. T. Liu; P. J. Chen; Y. T. Chen; U. Z. Hsieh; K. S. Cheng
The safety and effectiveness of medicaldevices are directly related to human health. Therefore, how to improve the accreditation validity of medicaldevices testing laboratory has been the focus of attention from every corner of society. With respect to the characteristics of medicaldevices testing laboratory, this paper represented the existing issues during the accreditation and evaluation of testing laboratory, put forward some improvement suggestions on how to improve the validity of testing laboratory evaluation based on the practical experience. PMID:24195401
The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medicaldevice use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe u...
The publication presents brief summaries of key documents pertaining to the regulation of medicaldevices that manufacturers must consider when they market such devices. The material is useful as a reference on such areas as establishment registration, de...
... Home Use Devices Brochure - Home Healthcare MedicalDevices: Infusion Therapy - Getting the Most Out of Your Pump ... therapy. What do you do before using your infusion pump? Read your pump's Instructions for Use and ...
Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medicaldevice training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medicaldevices and systems. What steps should you take to help ensure that new medicaldevices are implemented safely? Here are some tips. PMID:20464854
The tracking requirements of the Safe MedicalDevices Act became effective on August 29, 1993. The purpose of device tracking is to assure that manufacturers of certain devices (i.e., devices subject to tracking under section 519(e) of the Food, Drug, and...
... that is intended for multiple uses (e.g., infusion tubing, syringes), the device must be cleaned and ... wipe off your device regularly (e.g., mechanical infusion pumps). Keep your device out of direct sunlight. ...
The development of a minimally invasive multiplexed monitoring system for rapid analysis of biologically-relevant molecules could offer individuals suffering from chronic medical conditions facile assessment of their immediate physiological state. Furthermore, it could serve as a research tool for analysis of complex, multifactorial medical conditions. In order for such a multianalyte sensor to be realized, it must be minimally invasive, sampling of interstitial fluid must occur without pain or harm to the user, and analysis must be rapid as well as selective. Initially developed for pain-free drug delivery, microneedles have been used to deliver vaccines and pharmacologic agents (e.g., insulin) through the skin. Since these devices access the interstitial space, microneedles that are integrated with microelectrodes can be used as transdermal electrochemical sensors. Selective detection of glucose, glutamate, lactate, hydrogen peroxide, and ascorbic acid has been demonstrated using integrated microneedle-electrode devices with carbon fibers, modified carbon pastes, and platinum-coated polymer microneedles serving as transducing elements. This microneedle sensor technology has enabled a novel and sophisticated analytical approach for in situ and simultaneous detection of multiple analytes. Multiplexing offers the possibility of monitoring complex microenvironments, which are otherwise difficult to characterize in a rapid and minimally invasive manner. For example, this technology could be utilized for simultaneous monitoring of extracellular levels of, glucose, lactate and pH, which are important metabolic indicators of disease states (e.g., cancer proliferation) and exercise-induced acidosis. PMID:22688693
Miller, Philip R; Skoog, Shelby A; Edwards, Thayne L; Wheeler, David R; Xiao, Xiaoyin; Brozik, Susan M; Polsky, Ronen; Narayan, Roger J
Purpose This study investigates the psychosocial aspects of adolescent medicaldevice use and the impact on adolescent adherence and goals for the transitional years between child and adulthood. Patients and methods Interviews were carried out with 20 adolescents with cystic fibrosis, investigating adolescent medicaldevice use and experiences in relation to their personal and social lives and development through the adolescent years. The qualitative dataset was thematically examined using a content analysis method. Results The results show that adolescent users of medical technologies want their independence and capabilities to be respected. Adolescent adherence to medicaldevice use was associated with short- and long-term motivations, where older adolescents were able to comprehend the longer-term benefits of use against short-term inconvenience more acutely than younger adolescents. It was suggested that medicaldevices could provide a tool for communication with families and clinicians and could support adolescents as they take responsibility for managing their condition. Themes of “fitting into teenage life” and “use in the community” were associated with adolescents’ needs to form their own identity and have autonomy. Conclusion This study shows that adolescent needs regarding medicaldevice use are complex. It provides evidence to suggest that devices designed inclusively for adolescents may lead to improved adherence and also facilitate transition through the adolescent years and achievement of adolescent goals.
Lang, Alexandra R; Martin, Jennifer L; Sharples, Sarah; Crowe, John A
Medicaldevice software is a risky business. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. It is therefore no surprise that regulators throughout the world are penalising medicaldevice manufacturers that do not demonstrate that sufficient attention is devoted to the areas of hazard analysis and risk management (RM) throughout the
During the last decade, health care delivery has seen the introduction of ever more sophisticated and complex equipment. This means that the medicaldevices first used in critical and high dependency care units are now integral requirements in the delive ry of direct patient care in acute ward areas. Registered nurses are the primary users of such medicaldevices (McConnell
Mary R. Douglas; Jacqueline A. Leigh; Calbert H. Douglas
Purpose – The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 – “MedicalDevices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medicaldevice industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000
Izatul Hamimi Abdul Razak; Shahrul Kamaruddin; Ishak Abdul Azid; Indra Putra Almanar
The design process for medicaldevices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medicaldevices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.
The overall risk of infection from medicaldevices is very low, but high infection transmission rates have been related to inadequate reprocessing of arthroscopic shavers and flexible duodenoscopes. Monitoring of manual and automated cleaning is needed to ensure that inadequately cleaned medicaldevices are recleaned prior to disinfection or sterilization. PMID:23622750
The rapid aging population is increasing and public and private healthcare policy changes in economic recession have provided challenges as well as numerous sales opportunities to medicaldevice and supply industry. The purpose of this paper is to examine the impact of a combination of public and private healthcare policy changes and aging demography on medicaldevice and supply market
...2010-04-01 false Medicaldevices; Spanish-language version of certain required...Provisions Â§ 801.16 Medicaldevices; Spanish-language version of certain required...prescription use only are labeled solely in Spanish for distribution in the Commonwealth...
In this study, a project was developed for performance control of the medicaldevices in the Cerrahpasa Health Faculty in Istanbul University. The calibration measurements of these medicaldevices were performed and the measurement results were interpreted in according to the IPM “Inspection and Preventive Maintenance System” procedures which are developed by ECRI (Emergency Care Research Institute). By using these
The Safe MedicalDevices Act (SMDA) was signed by President George Bush on November 28, 1990, and the Federal Drug Administration's (FDA's) final ruling became effective on August 29, 1993. This act has brought about significant changes in the regulation and reporting process of medicaldevices within the health care industry over the past 3 years. This law has altered
Radiofrequency (RF) sources in the non clinical environment can expose medicaldevices to field strengths that exceed several volts per meter Electric (E) field strengths were measured at typical usage sites for home or ambulatory medicaldevices. Isotropic, broadband E field probes and calibrated antennas with spectrum analyzers were used. Three distinct categories of RF source\\/exposure situations were identified: “Distant
Howard Bassen; Paul Ruggera; Jon Casamento; Donald Witters
...educate regulated industry and FDA Staff on how, when, and why to use classification product codes for medicaldevices regulated...educate regulated industry and FDA Staff on how, when, and why to use classification product codes for medicaldevices in...
Medicaldevice interoperability is still an issue. Standards exist only for specific areas like HL7 and DICOM, or have not been widely adopted like ISO\\/IEEE 11073 except for the domain information model at the semantic level. An approach that covers interoperability below the semantics is proposed. It is based on Web services which are widely accepted outside the medicaldevice
Stephan Pöhlsen; Stefan Schlichting; Markus Strähle; Frank Franz; Christian Werner
Background Medicaldevices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Methods The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Authority website to determine the number of devices recalled from January 2006 to December 2010. Two reviewers independently assessed Field Safety Notices and MedicalDevice Alerts. The authors wrote to manufacturers to obtain further information and clinical data, and summarised data by year, Conformité Européenne classification, indication, and Food and Drug Administration recall system of severity. Results In total, 2124 field safety notices were issued over the 5-year period, an increase of 1220% (62 in 2006 to 757 in 2010). 447 MedicalDevice Alerts were issued in the same period, and 44% were assessed as a reasonable probability of causing serious adverse health consequences or death. The authors wrote to 192 manufacturers of withdrawn devices and received 101 (53%) replies; only four (2.1%) provided the clinical data the authors requested. A lack of available transparent data prevented full analyses of the safety impact. Of the highest-risk recalled devices, more than half were related to the cardiovascular system (25%) or musculoskeletal system (33%), and 88% (95% CI 80% to 97%) were assessed as a reasonable probability of causing serious adverse health consequences or death. For low-risk devices, the figure was 34% (95% CI 26% to 42%). Conclusion The number of medicaldevices subject to recalls or warnings in the UK has risen dramatically. A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices.
Background Medicaldevices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Methods The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Authority website to determine the number of devices recalled from January 2006 to December 2010. Two reviewers independently assessed Field Safety Notices and MedicalDevice Alerts. The authors wrote to manufacturers to obtain further information and clinical data, and summarised data by year, Conformité Européenne classification, indication, and Food and Drug Administration recall system of severity. Results In total, 2124 field safety notices were issued over the 5-year period, an increase of 1220% (62 in 2006 to 757 in 2010). 447 MedicalDevice Alerts were issued in the same period, and 44% were assessed as a reasonable probability of causing serious adverse health consequences or death. The authors wrote to 192 manufacturers of withdrawn devices and received 101 (53%) replies; only four (2.1%) provided the clinical data the authors requested. A lack of available transparent data prevented full analyses of the safety impact. Of the highest-risk recalled devices, more than half were related to the cardiovascular system (25%) or musculoskeletal system (33%), and 88% (95% CI 80% to 97%) were assessed as a reasonable probability of causing serious adverse health consequences or death. For low-risk devices, the figure was 34% (95% CI 26% to 42%). Conclusion The number of medicaldevices subject to recalls or warnings in the UK has risen dramatically. A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices. PMID:22021778
Heneghan, C; Thompson, M; Billingsley, M; Cohen, D
Since medicaldevices are often linked to the alarmingly high rate of medical accidents, it is speculated that newer advanced\\u000a user interface related technologies might mitigate some accidents. This paper describes some positive as well as negative\\u000a consequences of incorporating advanced technologies with particular emphasis on technologies that directly impact the design\\u000a and usability of medicaldevice user interfaces. Notably,
\\u000a Many implantable medicaldevices contain sophisticated electronic circuits. Hermetic packaging is required to provide the\\u000a implant’s electronic circuitry with protection from the harsh environment of the human body. This chapter provides a review\\u000a of available hermetic sealing methods and their applications. General considerations of implantable medicaldevice packaging\\u000a are discussed. Various testing methods applicable to the packaging of implantable medical
A transdermal absorption preparation having a support and a pressure-sensitive adhesive layer consisting of multiple layers, wherein the pressure-sensitive adhesive layer comprises a drug-retaining layer containing a drug and an acrylic pressure-sensitive adhesive and a skin adhesion layer containing a styrene-isoprene-styrene block copolymer. This preparation can continuously release bisoprolol at a constant concentration. Moreover, it can be easily produced.
In the past decennia medical technology has rapidly developed. Nowadays it plays an important\\u000arole in all medical fields. It introduced technologic solutions for many medical problems and it\\u000adefinitely increased the possibilities in the medical field to increase the quality of life. However\\u000awith this rapid development also new problems came up. Only since the last decennium the\\u000agovernment
Reminder devices reportedly improve medication adherence in the elderly patients with mild dementia; however, the efficacy of such devices remains unexplored. Therefore, a 3-month before and after study with convenience sampling was conducted to determine the efficacy of a medication reminder device used by 18 participants (aged 81.2 ± 6.2 years) with Clinical Dementia Rating scores of 0.5 or 1.
The past twenty five years have seen an explosion in the creation and discovery of new medicinal agents. Related innovations in drug delivery systems have not only enabled the successful implementation of many of these novel pharmaceuticals, but have also permitted the development of new medical treatments with existing drugs. The creation of transdermal delivery systems has been one of
Mark R. Prausnitz; Samir Mitragotri; Robert Langer
Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medicaldevices safe for use in children by reporting device problems to FDA. PMID:23116531
Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline
A study investigated the impact of variable wear times of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder (ADHD). It was concluded that duration of medication effect was directly related to the wear time of the methylphenidate transdermal system patch.
Wilens, Timothy E.; Boellner, Samuel W.; Lopez, Frank A.; Turnbow, John M.; Wigal, Sharon B.; Childress, Ann C.; Abikoff, Howard B.; Manos, Michael J.
We examined the pharmacokinetics of a transdermal nicotine patch and evaluated the usefulness of such a patch in a pilot smoking-cessation program. Use of the patch was associated with plasma nicotine concentrations that were comparable to smoking or to the use of other smoking-cessation devices. However, these plasma concentrations were maintained for 24 hours, and the patch appeared to be
Seamus C Mulligan; Joseph G Masterson; John G Devane; John G Kelly
Innovative medicaldevices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medicaldevices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medicaldevices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medicaldevices in France needs a better understanding of HB-HTA practices. PMID:24438663
Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J
Polymeric materials play a key role in the production of medical and clinical devices thanks to their special features such as flexibility, easy processing and good price/performance ratio. Among the different polymeric matrixes, one of the most used is Poly(vinyl chloride) (PVC). At room temperature PVC is hard and brittle, thus great amounts (40-50%) of phthalate esters that act as plasticizers are added to the polymer to make it flexible and appropriate for medical use. Di-(2-ethylhexyl)-phthalate (DEHP) is the most widely used plasticizer in PVC medicaldevices. However, DEHP is not chemically bound to PVC and migrates from medicaldevices with time and use. The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community. In particular, newborns in the new environment have to be considered at particularly increased risk, because of their small body size and the multiple medicaldevice-related to the DEHP exposure. The major factors determining the degree to which DEHP migrates from medicaldevices are temperature, amount of DEHP in the device, storage time, shaking of the device while in contact with the medical solutions and degree of PVC degradation. PMID:20858177
...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...about my medicaldevice report? (a) We will...that protection of the public health requires additional...information for medicaldevice reports submitted to us...
...MedicalDevice Labeling in a Standard Content and Format Public Workshop; Request for...encourage public comments regarding standard content and format for medicaldevice labeling...during the general session. Standard content and format of full labeling and a...
In order to effectively analyze and control use-related risk of medicaldevices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medicaldevices. As an example, the analysis process using this improved FMEA method for a certain medicaldevice (C-arm X-ray machine) is described. PMID:22317712
...FDA-2012-N-0001] Circulatory System Devices Panel of the...Name of Committee: Circulatory System Devices Panel of the...III devices. These systems typically consist of...provide noninvasive circulatory support by...
We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medicaldevices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects. PMID:22200603
Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir
Purpose Medicaldevices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medicaldevices in a hospital. Materials and methods The proposed medicaldevice surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services. Results The main components of the surveillance system would include an adverse medicaldevice events database, a medicaldevice/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medicaldevice/equipment networks to the hospital must be established and maintained. A feedback mechanism on medicaldevice-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined. Conclusion The effectiveness of the proposed medicaldevice surveillance system framework can be measured after it has been implemented in a Canadian hospital facility.
For the tactile recognition of human organ in minimally invasive surgery (MIS), this paper presents a novel tactile device that incorporates with magnetorheological (MR fluid). The MR fluid is contained by diaphragm and several pins. The operator for MIS can feel different force (or stiffness) from the proposed tactile device by applying different magnetic field or current. In order to generate required force from the device, the repulsive force from the human body is measured as reference data and an appropriate size of tactile device is designed and manufactured. It has been demonstrated via experiment that the repulsive force corresponding to the human body can be achieved by applying proper control input current. In addition, it has been shown that we can control the repulsive force by dividing the tactile device by several sections.
Oh, J. S.; Kim, J. K.; Lee, S. R.; Choi, S. B.; Song, B. K.
The Food and Drug Administration (FDA) is proposing a revision to the Good Manufacturing Practices (GMP) regulation covering medicaldevices. The proposed GMP will (1) extend the manufacturer's quality system in several areas including design, purchasing,...
This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medicaldevice manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination. This guidance p...
Explains the required medicaldevice reproting information for reportint adverse events tothe FDA. Designed for user facilities: Hospitals, nursing homes, etc. Informs user facilities of actions FDA takes after it receives their adverse event reports.
... 2013-07-01 false Calculation of patent term extension for a medicaldevice. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review Â§ 1.777...
Health care services are moving out to the community and into the home; e-health services, remote monitoring technology and self-management are replacing hospitalization and visits to medical clinics and custom-tailored medicines are making inroads into normative treatment. These developments have great implications for the scope and design of home health care equipment.The paper discusses the unique nature of home medical
The acquisition of new technologies represents a vitally important and fundamental goal of many corporate managers, particularly\\u000a those within the medicaldevice industry. We collect data on ten medicaldevice companies as our sample in this study, covering\\u000a the period from 1990 to 2006; this sample is drawn from the top 20 companies in the US, on the basis of
...regulatory science; and Prepare for and respond to transformative innovative technologies and scientific breakthroughs. Part...facilitate a more efficient regulatory review process for transformative devices. CDRH is seeking public comment on the...
26 Internal Revenue 16 2013-04-01 2013-04-01...4191-2 Section 48.4191-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE...Subpart D of 21 CFR part 890 (Physical Medicine Devices). (ii) Primarily...
In this paper, we discuss the complex relationship between health technology assessment (HTA) and the regulation of medicaldevices and procedures. The relationship is first examined through a concep- tual framework describing the itinerary from research to three levels of policy making: micro (standards of medical practice), meso (institutional rules), and macro (health policies). Four reports from the Quebec Health
Renaldo N. Battista; Jean-Marie Lance; Pascale Lehoux; Guy Regnier
Medicaldevices play a vital role in people's lives as these products are revolutionizing medicine with breathtaking advances in both the treatment and the detection of many diseases. While a similar, primarily therapeutic, revolution is ongoing in the pharmaceutical world; the focus here is the effect this device revolution is having on the statistical world. The similarities and differences between
Magnetic Resonance Imaging (MRI) has become one of medicine's most important diagnostic tools. However, due to patient safety concerns, MRI is contraindicated by both device and MRI equipment manufacturers for patients with active implanted medicaldevices (AIMDs). The primary concern is overheating of implanted leadwires due to currents induced from the powerful RF fields of the MRI scanner. In pacemaker
The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medicaldevice use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe use; guide manufacturers to improve design, labeling, and training to address known risks; and guide users to make smart decisions about the acquisition and
Marilyn Flack; Terrie Reed; Jay Crowley; Susan Gardner
The paper is an early attempt at drawing inferences of Prospective Payment System (PPS) effects on medicaldevice innovation. While the report presents some quantitative information on recent trends in R&D spending and the structure of the device industry...
The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case. PMID:15002643
Kessler, Larry; Ramsey, Scott D; Tunis, Sean; Sullivan, Sean D
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21...Devices; Clarification of Classification for Human Dura Mater; Technical Amendment AGENCY...applicability of the device classification for human dura mater. This action is being...
...and to help promote intervertebral body fusion. During the arthrodesis procedure, they...intended for use in motion-sparing, non-fusion procedures. Spinal sphere devices are...under the heading of ``Intervertebral Fusion Device with Bone Graft,...
...for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. This device...of seizures in individuals diagnosed with epilepsy. For this device, a patient's epilepsy should be characterized by...
...classifying the hemorrhoid prevention pressure wedge into class II (special...device. A hemorrhoid prevention pressure wedge provides support to the...classification will be the initial classification of the device...name hemorrhoid prevention pressure wedge, and it is...
Background The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medicaldevices. The majority of past studies have concentrated on implantable medicaldevices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medicaldevices. Methods Medicaldevices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125–134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of MedicalDevices to Specific Radio-Frequency Transmitters. Results For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medicaldevices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Conclusion Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medicaldevice EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior to RFID system deployment or prior to placing new medicaldevices in an RFID environment. The methods presented in this paper are time-consuming and burdensome and suggest the need for standard test methods for assessing the immunity of medicaldevices to RFID systems.
...Docket No. FDA-2011-N-0002] Obstetrics and Gynecology Devices Panel of the...amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the...FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of...
The recent United States Supreme Court decision in Riegel v. Medtronic, Inc. affirmed the doctrine of pre-emption protection only for those medicaldevices reaching U.S. markets via the PMA (premarketing approval) process and preserved the previous Lohr v. Medtronic decision's lack of preemption protection for those medicaldevices marketed via the generally more abbreviated 510(k) clearance mechanism. This paper reviews the logic and faults of the Riegel decision and discusses the implications of the Riegel decision for pre-emption protection for other classes of FDA-approved medical products. PMID:19493075
Development of a superelastic material with higher stiffness and plateau stresses than binary nitinol is of interest to the medicaldevice industry because it may allow for lower profile, less intrusive devices without compromising the material's characteristics. This project studied the effect of cobalt (Co) alloying additions on the stiffness and plateau stresses of a superelastic nickel-titanium alloy. In addition, the general physical, mechanical, corrosion, and biocompatibility properties of the alloy were compared to binary nitinol. The results of this study showed Co to be an interesting alloying addition that should be considered for future medicaldevices in applications, where stiffness is of concern.
Fasching, Audrey; Norwich, D.; Geiser, T.; Paul, Graeme W.
Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medicaldevices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls—most notably related to underperforming ICD leads—have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a “least burdensome” approach to approve new medicaldevices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medicaldevices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in post-market surveillance and comparative effectiveness research remains imperative.
Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medicaldevices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medicaldevices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medicaldevices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative. PMID:24760423
Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S
Usability testing is a technique that can be used to identify problems users have with a device. If usability testing is employed early in the development cycle it can identify potential use-related problems and hazards so that they can be addressed early...
Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medicaldevices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medicaldevices is discussed. Laser direct writing may be used for processing a wide variety of advanced medicaldevices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds.
Manufacturers of interactive medicaldevices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medicaldevice design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medicaldevices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability. PMID:23778022
Vincent, Christopher James; Li, Yunqiu; Blandford, Ann
The array of polymeric, biologic, metallic, and ceramic biomaterials will be reviewed with respect to their biocompatibility, which has traditionally been viewed as a requirement to develop a safe medicaldevice. With the emergence of combination products, a paradigm shift is occurring that now requires biocompatibility to be designed into the device. In fact, next-generation medicaldevices will require enhanced biocompatibility by using, for example, pharmacological agents, bioactive coatings, nano-textures, or hybrid systems containing cells that control biologic interactions to have desirable biologic outcomes. The concept of biocompatibility is moving from a "do no harm" mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing "good," that is, encouraging positive healing responses. These new devices will promote the formation of normal healthy tissue as well as the integration of the device into adjacent tissue. In some contexts, biocompatibility can become a disruptive technology that can change therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existing medicaldevices will facilitate the use of existing and new biomaterials for new medicaldevice designs. PMID:18337223
Helmus, Michael N; Gibbons, Donald F; Cebon, David
A clinical work flow is comprised of the sequential events that occur during a specific patient\\/clinician interaction. Clinical workflows track the human interactions involving equipment, staff, patients, supplies and other elements of the day-to-day environment. Understanding how these interactions work and translating this understanding into well-designed medical technology are vital to patient safety. The healthcare environment is more difficult to
A compact stacked implantable antenna for biotelemetry with PIFA structure in 402-405 MHz (medical implant communication services band) is proposed. The antenna has dimensions of pitimestimes(7.5)2times1.9 mm3, measured operating frequency of 402 MHz with a bandwidth of 50 MHz at return loss of -10 dB. The used of stacked structure can enhance bandwidth and the round structure can be easily
The MedicalDevice Reporting Regulation (MDR) requires the use of two forms for device user facilities (hospital, nursing homes, ambulatory surgical facilities, outpatient diagnostic and treatment facilities) for reporting to FDA. This videotape will expl...
In this paper, the architecture of a modular, service-oriented, Sensor Middleware for data acquisition and processing is presented. The described solution was developed with the purpose of solving two increasingly relevant problems in the context of modern pHealth systems: i) to aggregate a number of heterogeneous, off-the-shelf, devices from which clinical measurements can be acquired and ii) to provide access and integration with an 802.15.4 network of wearable sensors. The modular nature of the Middleware provides the means to easily integrate pre-processing algorithms into processing pipelines, as well as new drivers for adding support for new sensor devices or communication technologies. Tests performed with both real and artificially generated data streams show that the presented solution is suitable for use both in a Windows PC or a Windows Mobile PDA with minimal overhead. PMID:21096037
The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25016620
The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25016622
The Food and Drug Administration (FDA) is classifying the absorbable lung biopsy plug into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the absorbable lung biopsy plug's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:24693559
The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the pancreatic drainage stent and delivery system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:24873019
The Food and Drug Administration (FDA) is classifying the colon capsule imaging system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the colon capsule imaging system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:24839664
The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device. PMID:24881094
...System with Gateway PTA Balloon Catheter has been approved...System with Gateway PTA Balloon Catheter is indicated...disease, refractory to medical therapy, in intracranial...Stenting and Aggressive Medical Management for Preventing...Stent with Gateway PTA Balloon catheter. The...
The development of a minimally invasive multiplexed monitoring system for rapid analysis of biologically-relevant molecules could offer individuals suffering from chronic medical conditions facile assessment of their immediate physiological state. Furthermore, it could serve as a research tool for analysis of complex, multifactorial medical conditions. In order for such a multianalyte sensor to be realized, it must be minimally invasive, sampling of interstitial fluid must occur without pain or harm to the user, and analysis must be rapid as well as selective. Initially developed for pain-free drug delivery, microneedles have been used to deliver vaccines and pharmacologic agents (e.g., insulin) through the skin.1-2 Since these devices access the interstitial space, microneedles that are integrated with microelectrodes can be used as transdermal electrochemical sensors. Selective detection of glucose, glutamate, lactate, hydrogen peroxide, and ascorbic acid has been demonstrated using integrated microneedle-electrode devices with carbon fibers, modified carbon pastes, and platinum-coated polymer microneedles serving as transducing elements.3-7,8 This microneedle sensor technology has enabled a novel and sophisticated analytical approach for in situ and simultaneous detection of multiple analytes. Multiplexing offers the possibility of monitoring complex microenvironments, which are otherwise difficult to characterize in a rapid and minimally invasive manner. For example, this technology could be utilized for simultaneous monitoring of extracellular levels of, glucose, lactate and pH,9 which are important metabolic indicators of disease states7,10-14 (e.g., cancer proliferation) and exercise-induced acidosis.15
Miller, Philip R.; Skoog, Shelby A.; Edwards, Thayne L.; Wheeler, David R.; Xiao, Xiaoyin; Brozik, Susan M.; Polsky, Ronen; Narayan, Roger J.
Medicaldevices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medicaldevices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medicaldevices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented. PMID:23981256
Conventional gas-compensated medication reservoirs used for implantable infusion devices require perfect sealing of the gas chamber, because the gases used are generally toxic. In addition, the physical properties of selected gas critically affect the performance of infusion devices and hydraulic performance of the infusion device can be affected by the amount of medication discharged.?In this study, we suggest a new medication reservoir that adopts a cerebrospinal fluid (CSF)-compensating mechanism, such that when a medication is released from the reservoir by a mechanical actuator, native CSF enters into the reservoir to minimize the build-up of pressure drop. We evaluated in vitro performance and conducted in vivo feasibility tests by using an intrathecal infusion device developed at the Korean National Cancer Center. Experimental results showed that the proposed CSF-compensated infusion pump was essentially less affected by ambient temperature or pressure conditions compared to the gas-compensated infusion pump. Moreover, it showed moderate implant feasibility and operating stability during an animal experiment performed for 12 days. We believe that the proposed volume-compensating mechanism could be applied in various medical fields that use implantable devices. PMID:23504815
Nam, Kyoung Won; Choi, Seong Wook; Kim, In Young; Kim, Kwang Gi; Jo, Yung Ho; Kim, Dae Hyun
The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medicaldevice industry there are some inherent limitations to the traditional innovation funnel approach. In the medicaldevice industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medicaldevice, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medicaldevice which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medicaldevice for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features. PMID:23483372
de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P
The market approval of medicaldevices in Germany does not yet require a benefit assessment. Thus, there is a lack of high quality studies that clearly prove the benefit of medical innovations. In the past, the Federal Joint Committee in Germany (G-BA) did not have the opportunity to adequately address this issue of lacking evidence. A law for the improvement of the care structure in the statutory health insurance offers the possibility for the G-BA to obtain evidence for the benefit of medical practice. With an integrated regulation for testing of medicaldevices the manufacturers have the option to apply for an assessment of new and established treatment methods and to provide scientific evidence for the benefit of medicaldevices as a requirement for inclusion in the catalogue of services of the statutory health insurance. However, this expanded scope of action is also a challenge for clinicians. The already existing problem of integrating multicenter clinical trials in the surgical routine will remain. The Surgical Study Network Germany (CHIR-Net) offers an ideal way to cope with the increased requirements on studies in the field of medicaldevices through established partnerships with methodological institutions and practitioners in clinical settings. PMID:24402570
Seidel, D; Braß, P; Sehnke, N; Jakob, V; Eglmeier, W; Neugebauer, E A M
...identified as a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas...Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain...
The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25016621
Transdermal administration of drugs is generally limited by the barrier function of the skin. Vesicular systems are one of the most controversial methods for transdermal delivery of active substances. The interest in designing transdermal delivery systems was relaunched after the discovery of elastic vesicles like transferosomes, ethosomes, cubosomes, phytosomes, etc. This paper presents the composition, mechanisms of penetration, manufacturing and characterization methods of transferosomes as transdermal delivery systems of active substances. For a drug to be absorbed and distributed into organs and tissues and eliminated from the body, it must pass through one or more biological membranes/barriers at various locations. Such a movement of drug across the membrane is called as drug transport. For the drugs to be delivered to the body, they should cross the membranous barrier. The concept of these delivery systems was designed in an attempt to concentrate the drug in the tissues of interest, while reducing the amount of drug in the remaining tissues. Hence, surrounding tissues are not affected by the drug. In addition, loss of drug does not happen due to localization of drug, leading to get maximum efficacy of the medication. Therefore, the phospholipid based carrier systems are of considerable interest in this era. PMID:22171309
Rajan, Reshmy; Jose, Shoma; Mukund, V P Biju; Vasudevan, Deepa T
SUMMARY We will describe the pharmacokinetic profile, clinical efficacy and safety data of the sumatriptan iontophoretic transdermal system (Zecuity®, NuPathe Inc., PA, USA), recently approved for the acute treatment of migraine with or without aura in adults, by the US FDA. This transdermal system utilizes a low-level electrical current to deliver sumatriptan transdermally and circumvents the GI tract. Pharmacokinetic studies have shown that iontophoretic delivery of sumatriptan achieves detectable plasma concentrations 15 min after activation with a maximum mean serum concentration of 22 ng/ml. A randomized, double-blind, controlled clinical trial demonstrated minimal triptan-related side effects and superior efficacy versus placebo. The pain-free rate at 2 h postdose was 18% of patients applying the sumatriptan patch versus 9% using the placebo (p = 0.0092). This sumatriptan transdermal system may be a good choice for migraineurs with severe nausea or vomiting, those with intolerable triptan-related adverse events and/or those not responding optimally to oral medications. PMID:24641436
Vikelis, Michail; Mitsikostas, Dimos D; Rapoport, Alan M
Transdermal administration of drugs is generally limited by the barrier function of the skin. Vesicular systems are one of the most controversial methods for transdermal delivery of active substances. The interest in designing transdermal delivery systems was relaunched after the discovery of elastic vesicles like transferosomes, ethosomes, cubosomes, phytosomes, etc. This paper presents the composition, mechanisms of penetration, manufacturing and characterization methods of transferosomes as transdermal delivery systems of active substances. For a drug to be absorbed and distributed into organs and tissues and eliminated from the body, it must pass through one or more biological membranes/barriers at various locations. Such a movement of drug across the membrane is called as drug transport. For the drugs to be delivered to the body, they should cross the membranous barrier. The concept of these delivery systems was designed in an attempt to concentrate the drug in the tissues of interest, while reducing the amount of drug in the remaining tissues. Hence, surrounding tissues are not affected by the drug. In addition, loss of drug does not happen due to localization of drug, leading to get maximum efficacy of the medication. Therefore, the phospholipid based carrier systems are of considerable interest in this era.
Rajan, Reshmy; Jose, Shoma; Mukund, V. P. Biju; Vasudevan, Deepa T.
A standardised terminology for describing medicaldevices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medicaldevices regulations mandate the use of such a system. This article reviews two important classification systems for medicaldevices in the UK. The Global MedicalDevice Nomenclature (GMDN) provides a classification system specifically for medicaldevices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients’ healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medicaldevices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medicaldevices. Successful implementation of these elements depends on having a consistent nomenclature for medicaldevices.
Interest in bacteriophages as therapeutic agents has recently been reawakened. Parenteral delivery is the most routinely-employed method of administration. However, injection of phages has numerous disadvantages, such as the requirement of a health professional for administration and the possibility of cross-contamination. Transdermal delivery offers one potential means of overcoming many of these problems. The present study utilized a novel poly (carbonate) (PC) hollow microneedle (MN) device for the transdermal delivery of Escherichia coli-specific T4 bacteriophages both in vitro and in vivo. MN successfully achieved bacteriophage delivery in vitro across dermatomed and full thickness skin. A concentration of 2.67 × 10(6)PFU/ml (plaque forming units per ml) was detected in the receiver compartment when delivered across dermatomed skin and 4.0 × 10(3)PFU/ml was detected in the receiver compartment when delivered across full thickness skin. An in vivo study resulted in 4.13 × 10(3)PFU/ml being detected in blood 30 min following initial MN-mediated phage administration. Clearance occurred rapidly, with phages being completely cleared from the systemic circulation within 24h, which was expected in the absence of infection. We have shown here that MN-mediated delivery allows successful systemic phage absorption. Accordingly, bacteriophage-based therapeutics may now have an alternative route for systemic delivery. Once fully-investigated, this could lead to more widespread investigation of these interesting therapeutic viruses. PMID:22750416
Ryan, Elizabeth; Garland, Martin J; Singh, Thakur Raghu Raj; Bambury, Eoin; O'Dea, John; Migalska, Katarzyna; Gorman, Sean P; McCarthy, Helen O; Gilmore, Brendan F; Donnelly, Ryan F
...intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra- tentorial region of the brain. The device is intended to be...
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...For this device, the patients should have normal gonioscopic anatomy and a visually significant cataract eligible for...
...safety; (3) appropriate analysis and nonclinical testing must...device; and (4) appropriate analysis and nonclinical testing (such...the Federal Food, Drug, and Cosmetic Act and under authority delegated...exemption: (i) Appropriate analysis and nonclinical testing...
...Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use AGENCY...Administration (FDA) is classifying the contact cooling system for aesthetic use into...II Special Controls Guidance Document: Contact Cooling System for Aesthetic...
...Rule that misbranded breast transilluminators and effectively placed them in class III based on the recommendation of the Obstetrics and Gynecology Devices Panel, which concluded there were no published studies or clinical data demonstrating the safety...
The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. PMID:21053532
The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the MedicalDevice Amendments of 1976 (the 1976 Amendments), the Safe MedicalDevices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device. PMID:21516875
Akinetic crisis (AC) is a much-feared complication of Parkinson’s disease (PD) which may appear upon abrupt cessation or malabsorption of dopaminergic medication due to gastrointestinal tract disorders or acute surgery. Intravenous infusion of amantadine sulphate or subcutaneous administration of apomorphine are established treatment strategies for AC. We speculate whether the use of a non-invasive transdermal application form (patch) of a
Manuel Dafotakis; Roland Sparing; Agnes Juzek; Frank Block; Christoph M. Kosinski
Recent years, China medicaldevices industry has been a sunrise industry with widely-ranged products, high-tech innovation, and booming market demands. But with the globalization of market economy, China industry is still in the inferior position of competition. How to promote the industrial structure transition, increase scientific and technological level, speed up the updating of products, enhance the international competitiveness is one of the major tasks to maintain the healthy development of industry. This article makes a study on current situation of China medicaldevices industry, analyses the new opportunities, challenges and restriction factors, provides the countermeasures of strengthening industry competitiveness as well. PMID:23189649
\\u000a A recent standard for medicaldevice software lifecycle processes, ISO\\/IEC 62304 (ISO 2006), assumes and specifies a software\\u000a safety classification scheme, where documentation, verification and validation tasks to be carried out depend on the safety\\u000a classification. This means that a risk-driven approach has become an accepted standard for medicaldevices.\\u000a \\u000a \\u000a This paper describes how Systelab have progressively defined a quality
Nanomaterials play a significant role in biomedical research and applications because of their unique biological, mechanical, and electrical properties. In recent years, they have been utilized to improve the functionality and reliability of a wide range of implantable medicaldevices ranging from well-established orthopedic residual hardware devices (e.g., hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopedic implants, the largest market segment of implantable medicaldevices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopedic implants is also discussed, the focus being on a low-intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The article concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medicaldevices, and potential directions to address these. PMID:23335493
Shirwaiker, Rohan A; Samberg, Meghan E; Cohen, Paul H; Wysk, Richard A; Monteiro-Riviere, Nancy A
Nanomaterials play a significant role in biomedical research and applications due to their unique biological, mechanical, and electrical properties. In recent years, they have been utilised to improve the functionality and reliability of a wide range of implantable medicaldevices ranging from well-established orthopaedic residual hardware devices (e.g. hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopaedic implants, the largest market segment of implantable medicaldevices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopaedic implants is also discussed,, the focus being on a low intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The paper concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medicaldevices, and potential directions to address these.
Samberg, Meghan E.; Cohen, Paul H.; Wysk, Richard A.; Monteiro-Riviere, Nancy A.
Portable implantable medicaldevice systems are playing a larger role in modern health care. Increasing attention is now being given to the wireless control interface of these systems. Our position is that wireless security in portable implantable medical...
A case-control study was conducted among 205 women in Michigan and Ohio who were diagnosed with undifferentiated connective tissue disease (UCTD) to investigate the significance of self-reported past exposures to implanted silicone-containing or non-silicone-containing medicaldevices. The 205 UCTD cases were compared with 2,095 controls who were sampled by random digit dialing. When silicone-containing devices, including shunts and catheters, were
Timothy J. Laing; David Schottenfeld; James V. Lacey; Brenda W. Gillespie; David H. Garabrant; Brenda C. Cooper; Steven G. Heeringa; Kirsten H. Alcser; Maureen D. Mayes
Development of a superelastic material with higher stiffness and plateau stresses than binary nitinol is of interest to the\\u000a medicaldevice industry because it may allow for lower profile, less intrusive devices without compromising the material’s\\u000a characteristics. This project studied the effect of cobalt (Co) alloying additions on the stiffness and plateau stresses of\\u000a a superelastic nickel-titanium alloy. In addition,
Audrey Fasching; D. Norwich; T. Geiser; Graeme W. Paul
Continuous delivery of antiparkinsonian medication during a perioperative period is desirable to avoid 'off'-symptom complications in surgical patients with concomitant Parkinson's disease (PD). Fourteen PD patients undergoing surgery under general anesthesia were switched from oral dopaminergic medication to transdermally delivered 24-h rotigotine (median dose 12 mg/24 h) for the perioperative period. Rotigotine treatment was considered feasible by patients, their anesthesiologists and neurologists with good control of PD symptoms and easy switching and re-switching of PD medication. PMID:20535621
Continuous delivery of antiparkinsonian medication during a perioperative period is desirable to avoid ‘off’-symptom complications in surgical patients with concomitant Parkinson’s disease (PD). Fourteen PD patients undergoing surgery under general anesthesia were switched from oral dopaminergic medication to transdermally delivered 24-h rotigotine (median dose 12 mg/24 h) for the perioperative period. Rotigotine treatment was considered feasible by patients, their anesthesiologists and neurologists with good control of PD symptoms and easy switching and re-switching of PD medication.
With home health care patients and their care givers using an increasing number of medicaldevices of varying complexity, the Center for Devices and Radiological Health, Food and Drug Administration (FDA), has concerns about the safe and effective use of ...
The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to special controls. The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). PMID:24754095
The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. PMID:24236336
With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.
Carbon nanotube (CNT) membranes were employed as the active element of a switchable transdermal drug delivery device that can facilitate more effective treatments of drug abuse and addiction. Due to the dramatically fast flow through CNT cores, high charge density, and small pore dimensions, highly efficient electrophoretic pumping through functionalized CNT membrane was achieved. These membranes were integrated with a nicotine formulation to obtain switchable transdermal nicotine delivery rates on human skin (in vitro) and are consistent with a Fickian diffusion in series model. The transdermal nicotine delivery device was able to successfully switch between high (1.3 ± 0.65 ?mol/hr-cm2) and low (0.33 ± 0.22 ?mol/hr-cm2) fluxes that coincide with therapeutic demand levels for nicotine cessation treatment. These highly energy efficient programmable devices with minimal skin irritation and no skin barrier disruption would open an avenue for single application long-wear patches for therapies that require variable or programmable delivery rates.
Wu, Ji; Paudel, Kalpana S.; Strasinger, Caroline; Hammell, Dana; Stinchcomb, Audra L.; Hinds, Bruce J.
Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medicaldevice industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.
...this optical radiation is easily transmitted into the eye as a very bright, intense light beam that may produce lesions on the retina. This hazard is addressed by device labeling, which includes recommendations for not looking directly at the laser beam...
...From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure...comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because...published at 75 FR 16347, April 1, 2010, is withdrawn on July 19, 2010. FOR...
Transcatheter closure of the left atrial appendage with the Amplatzer™ cardiac plug device and double antiplatelet treatment for 3 mo has become an alternative treatment for patients with atrial fibrillation at high embolism risk and contraindications for chronic oral anticoagulation. The inadequate implantation of the left atrial appendage closure device and the discontinuation of double antiplatelet therapy are well-known as factors related to device thrombosis. Nevertheless, device thrombosis after adequate implantation requiring surgical treatment or restarting chronic oral anticoagulation has been reported and can reach 15% of patients. The connector pin thrombosis of the Amplatzer™ cardiac plug, despite a good adherence to antiplatelet treatment, has been recently described as a potential mechanism for device thrombosis. Our clinical case reports the management of this condition for the first time, showing that the early detection of thrombotic complications by transesophageal echocardiography permits solving this serious complication with medical treatment only.
Microbial adhesion and biofilm formation on medicaldevices represent a common occurrence that can lead to serious illness and death. The process by which bacteria and yeast colonize open and closed implants is fairly complicated and involves a series of steps commencing with deposition of host substances onto the material. Prevention and treatment of established biofilms with antimicrobial agents are
Risk management is the systematic application of management strategies, procedures, and practices to the identifying, analyzing, controlling, and monitoring of process risk. It is an important guarantee to keep good quality and reduce failures of product. For medicaldevice, it has more risk to relate with patient health and human life, so it is necessary to manage the process risk
This work reports on a new and simple method to locate and track the medical robotic device based on the static magnetic field and Hall effort sensor array. In the design, we established an experimental platform based on the static magnetic field and Hall effect sensor array. The platform includes static magnetic source, sensor array module, computer interface and algorithm.
Xudong Wu; Chenglin Peng; Xiaolin Zheng; Wensheng Hou; Jianguo Cui
Medical technologies and assistive devices such as ventilators and power wheelchairs are designed to sustain life and\\/or improve functionality but they can also contribute to stigmatization and social exclusion. In this paper, drawing from a study of ten men with Duchenne muscular dystrophy, we explore the complex social processes that mediate the lives of persons who are dependent on multiple
B. E. Gibson; R. E. G. Upshur; N. L. Young; P. McKeever
Around the world, hospitals receiving government funding and insurance payments are under increasing pressure to cut costs. Based on the literature in relationship value and transaction cost economics, long-term relationships between suppliers and customers can be beneficial to cost reduction and value creation. This study explores the value of long-term relationships between medicaldevice vendors and hospitals from the hospital
In this paper, the SWOT analysis method is used to find out the internal strength, weakness, exterior opportunities and threats of the present medicaldevices' procurements in hospitals and some strategic considerations are suggested as "one direction, two expansions, three changes and four countermeasures". PMID:16929781
Implantable MedicalDevices (IMDs) are widely used to treat chronic diseases. Nowadays, many IMDs can wirelessly communicate with an outside programmer (reader). However, the wireless access also introduces security concerns. An attacker may get an IMD reader and gain access to a patient's IMD. IMD security is an important issue since attacks on IMDs may directly harm the patient. A
Following recent sanctions on foreign trade, financial and banking services, Iran has faced major difficulties for importing medicines (both finished products and pharmaceutical raw materials) and medicaldevices. Problems with money transfer have made it extremely lengthy in time to import medicine and medicaldevices and these have negatively affected access to and affordability of medicines. Quality of pharmaceuticals and treatment of patients have also been affected due to changing the sources of imported medicines and raw materials for locally produced pharmaceuticals. Several interventions have been employed during the past few months in Iran to overcome the effects imposed by recent sanctions and drug shortages have been managed to some extent with attempts made by Iran Food and Drug Organization (IRI FDO). As recommended by the experts, a specific Society for Worldwide Interbank Financial Telecommunication line should be allocated for transferring money for medicines and medicaldevices and certain financial institutions are assigned for this purpose. It is also suggested that defining a white list of Iranian pharmaceuticals and medicaldevice companies together with their foreign counterparts would facilitate this process. It appears that, in a public health prospective, ordinary people and patients are hurt and paying the cost for current sanctions. It remains the responsibility of the public health and international communities to separate public health from politics and to ease the pain of public from sanctions. PMID:24329148
Safety assessment of medicaldevices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.
On July 31, 1996, new regulations took effect that were promulgated under the Safe MedicalDevices Act (SMDA). These regulations squarely address the home health care provider, creating new reporting and communication challenges for home health care agencies (HHAs). As the months have elapsed, questions have begun to emerge regarding the SMDA regulations that reflect the unique nature of home
We examined the differential benefits of instructional materials for younger and older adults learning to use a home medicaldevice. Participants received training on use of a blood glucose meter via either a user manual (a text guide with pictures) or an instructional video. Performance was measured immediately and then after a 2-week retention interval. Type of instruction was critical
Amy L. Mykityshyn; Arthur D. Fisk; Wendy A. Rogers
Embedding a thermoelectric generator (TEG) in a biological body is a promising way to supply electronic power in the long term for an implantable medicaldevice (IMD). The unique merit of this method lies in its direct utilization of the temperature difference intrinsically existing throughout the whole biological body. However, little is known about the practicability of such a power
This study compared the potential for interference to medicaldevices from radio frequency (RF) fields radiated by GSM 900/1800-MHz, general packet radio service (GPRS) 900/1800-MHz, and wideband code division multiple access (WCDMA) 1900-MHz handsets. The study used a balanced half-wave dipole antenna, which was energized with a signal at the standard power level for each technology, and then brought towards the medicaldevice while noting the distance at which interference became apparent. Additional testing was performed with signals that comply with the requirements of the international immunity standard to RF fields, IEC 61000-4-3. The testing provides a sense of the overall interference impact that GPRS and WCDMA (frequency division duplex) may have, relative to current mobile technologies, and to the internationally recognized standard for radiated RF immunity. Ten medicaldevices were tested: two pulse oximeters, a blood pressure monitor, a patient monitor, a humidifier, three models of cardiac defibrillator, and two models of infusion pump. Our conclusion from this and a related study on consumer devices is that WCDMA handsets are unlikely to be a significant interference threat to medical electronics at typical separation distances. PMID:17926684
Iskra, Steve; Thomas, Barry W; McKenzie, Ray; Rowley, Jack
This paper describes the design and initial implementation of a modular framework for Clinical Decision Support Systems and highlights the need for medicaldevice plug-and-play standards. The software handles the tasks of data acquisition and validation, visualization, and treatment management in order to enable the development of protocol guideline modules as \\
M. Williams; F. Wu; P. Kazanzides; K. Brady; J. Fackler
Recently investigated applications of polymeric materials for tissue engineering, regenerative medicine, implants, stents, and medicaldevices are described in the present review. Papers published during the last 2 years about polymeric materials used for preparation of various polymeric scaffolds, methods of fabrication of such scaffolds and their effectiveness in providing support for cell growth and development into various tissues and
Nonequilibrium low-pressure plasma discharges are extensively studied for their applications in the field of decontamination and sterilization of medicaldevices. The aim of this contribution is to discuss and demonstrate feasibility of oxygen low-pressure inductively coupled plasma (ICP) discharges for removal of various kinds of biological contamination. We demonstrate the ability of ICP discharges for the sterilization of bacterial spores
François Rossi; Ondrej Kylián; Hubert Rauscher; Douglas Gilliland; Lucel Sirghi
On 3 October 2013 the European Court of Justice made a decision regarding the interpretation of definitions of medicaldevices (Directive 93/42/EC) and medicinal product for human use (Directive 2001/83/EC), based on the Article 267 TFEU preliminary ruling. Orv. Hetil., 2014, 155(11), 429-433. PMID:24613779
Formal methods have long been proposed as an effective technique for developing safety-critical software. However, few medicaldevice manufacturers employ such methods. One way to encourage the use of formal methods is to leverage these techniques in such a way as to enhance the review process for regulatory bodies, such as the U.S. Food and Drug Administration. In this paper
Raoul Praful Jetley; S. Purushothaman Iyer; Paul L. Jones; William Spees
Polymeric materials have contributed significantly to the development and improvement of medicaldevices and systems. Various interactions take place between biomaterials and a body when polymeric biomaterials come into contact with a living organism. Ion implantation is a physicochemical surface modification process that results from the impingement of a high-energy ion beam. The chemical characteristics of a material surface are
Nitinol, a nickel titanium alloy, is widely used as a biocompatible metal with applications in high strain medicaldevices. The alloy exhibits both superelasticity and thermal shape memory behaviour. Basic mechanical properties can be established and are provided by suppliers; however the true stress–strain response under repeated load is not fully understood. It is essential to know this behaviour in
This report describes the development of a risk analysis approach for evaluating the use of radiation-emitting medial devices. This effort was performed by Lawrence Livermore National Laboratory for the US Nuclear Regulatory Commission (NRC). The assessment approach has bee applied to understand the risks in using the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step to evaluate the potential role of risk analysis for developing regulations and quality assurance requirements in the use of nuclear medicaldevices. The risk approach identifies and assesses the most likely risk contributors and their relative importance for the medical system. The approach uses expert screening techniques and relative risk profiling to incorporate the type, quality, and quantity of data available and to present results in an easily understood form.
Nitinol, a nickel titanium alloy, is widely used as a biocompatible metal with applications in high strain medicaldevices. The alloy exhibits both superelasticity and thermal shape memory behaviour. Basic mechanical properties can be established and are provided by suppliers; however the true stress-strain response under repeated load is not fully understood. It is essential to know this behaviour in order to design devices where failure by fatigue may be possible. The present work develops an approach for characterising the time varying mechanical properties of fine Nitinol wire and investigates processing factors, asymmetric stress-strain behaviour, temperature dependency, strain rate dependency and the material response to thermal and repeated mechanical loading. Physically realistic and accurately determined mechanical properties are provided in a format suitable for use in finite element analysis for the design of medicaldevices. Guidance is also given as to the most appropriate experimental set up procedures for gripping and testing thin Nitinol wire. PMID:21316613
This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medicaldevices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medicaldevices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying the most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC.
Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)
Discusses the use of transdermal nicotine (TN) in smoking cessation and its value as an effective procedure. The article reveals that, compared to a placebo, TN has double the quit rate percentages, and less than 5% of smokers quit TN due to side effects. (GLR)
Public safety can be enhanced through the development of a comprehensive medicaldevice risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medicaldevices. The framework consists of the following sixteen
This article is a review of the book “Joining and assembly of medical materials and devices” edited by Y. (Norman) Zhou and Mark D. Breyen. This book (hardcover) was published by Woodhead Publishing, Cambridge, UK in 2013. The contents of the book and its relevance to medicaldevice design and education are discussed in this invited review.
Portable implantable medicaldevice systems are playing a larger role in modern health care. Increasing attention is now being given to the wireless control interface of these systems. Our position is that wireless security in portable implantable medicaldevice systems is just a part of the overall system security, and increased attention is needed to address low-tech security issues.
Paul, Nathanael R [ORNL; Kohno, Tadayoshi [University of Washington, Seattle
Printed Spiral Coil (PSC) is a coil antenna for near-field wireless power transmission to the next generation implant medicaldevices. PSC for implant medicaldevice should be power efficient and low electromagnetic radiation to human tissues. We utilized a physical model of printed spiral coil and applied our algorithm to design PSC operating at 13.56 MHz. Numerical and electromagnetic simulation
In FDA regulated medicaldevice manufacturing, real time inspection of manufactured product is limited by the requirement to destructively test random samples of the product post production. Infra Red thermography offers the ability to non-destructively test, key critical to quality attributes of medicaldevices during laser welding and facilitates real time statistical process control for enhanced product quality and yield.
Sean Moore; Alan Conneely; Eric Stenzel; Eamonn Murphy
Noninvasive and minimally invasive techniques for monitoring glucose via the skin are reviewed. These approaches rely either on the interaction of electromagnetic radiation with the tissue or on the extraction of fluid across the barrier. The structure and physiology of the skin make the technical realization of transdermal glucose monitoring a difficult challenge. The techniques involving transdermal fluid extraction circumvent and/or compromise the barrier function of skin's outermost and least permeable layer, the stratum corneum, by the application of physical energy. While sonophoresis and microporation methods, for example, are in relatively early-stage development, a device using reverse iontophoresis [the GlucoWatch Biographer (Cygnus, Inc., Redwood City, CA)] is already commercially available. Optical techniques to monitor glucose are truly noninvasive. The tissue is irradiated, the absorbed or scattered radiation is analyzed, and the information is processed, to provide a measure proportional to the concentration of glucose in the dermal tissue. These techniques include near-infrared and Raman spectroscopy, polarimetry, light scattering, and photoacoustic spectroscopy. By contrast, impedance spectroscopy measures changes in the dielectric properties of the tissue induced by blood glucose variation. Large-scale studies in support of efficacy of these methodologies are as yet unavailable. At present, therefore, transdermal fluid extraction technologies are offering greater promise in terms of practical and realizable devices for patient use. The truly noninvasive allure of the optical approach assures continued and intense research activity--for the moment, however, an affordable, efficient, and portable system is not on the immediate horizon. PMID:15738715
Sieg, Anke; Guy, Richard H; Delgado-Charro, M Begoña
Transdermal delivery offers an attractive, noninvasive administration route but it is limited by the skin's barrier to penetration. Minimally invasive techniques, such as the use of microneedles (MNs), bypass the stratum corneum (SC) barrier to permit the drug's direct access to the viable epidermis. These novel micro devices have been developed to puncture the skin for the transdermal delivery of hydrophilic drugs and macromolecules, including peptides, DNA and other molecules, that would otherwise have difficulty passing the outermost layer of the skin, the SC. Using the tools of the microelectronics industry, MNs have been fabricated with a range of sizes, shapes and materials. MNs have been shown to be robust enough to penetrate the skin and dramatically increase the skin permeability of several drugs. Moreover, MNs have reduced needle insertion pain and tissue trauma and provided controlled delivery across the skin. This review focuses on the current state of the art in the transdermal delivery of drugs using various types of MNs and developments in the field of microscale devices, as well as examples of their uses and clinical safety. PMID:24144208
Pierre, Maria Bernadete Riemma; Rossetti, Fabia Cristina
Introduction The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medicaldevice approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medicaldevices are subject to comparable scrutiny. Objective To improve health outcomes, we must enhance our scrutiny of medicaldevices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medicaldevices? Conclusions Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.
Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.
Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.
Health aspects of the use of radiating devices, like mobile phones, are still a public concern. Stand-alone electrocardiographic systems and those built-in, more sophisticated, medicaldevices have become a standard tool used in everyday medical practice. GSM mobile phones might be a potential source of electromagnetic interference (EMI) which may affect reliability of medical appliances. Risk of such event is particularly high in places remote from GSM base stations in which the signal received by GSM mobile phone is weak. In such locations an increase in power of transmitted radio signal is necessary to enhance quality of the communication. In consequence, the risk of interference of electronic devices increases because of the high level of EMI. In the present paper the spatial, temporal, and spectral characteristics of the interference have been examined. The influence of GSM mobile phone on multilead ECG recordings was studied. It was observed that the electrocardiographic system was vulnerable to the interference generated by the GSM mobile phone working with maximum transmit power and in DTX mode when the device was placed in a distance shorter than 7.5 cm from the ECG electrode located on the surface of the chest. Negligible EMI was encountered at any longer distance.
Buczkowski, T.; Janusek, D.; Zavala-Fernandez, H.; Skrok, M.; Kania, M.; Liebert, A.
Regulatory bodies weighing market approval for novel medicaldevices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health. PMID:24772683
Kramer, Daniel B; Tan, Yongtian T; Sato, Chiaki; Kesselheim, Aron S
Background It is well established that considering users is an important aspect of medicaldevice development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medicaldevice development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medicaldevice development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product.
Elderly and other people who live at home but required some physical assistance to do so are often more susceptible injury causing falls in and around their place of residence. In the event that a fall does occur, as a direct result of a previous medical condition or the fall itself, these people are typically less likely to be able to seek timely medical help without assistance. The goal of this research is to develop a wearable sensor device that uses an accelerometer for monitoring the movement of the person to detect falls after they have occurred in order to enable timely medical assistance. The data coming from the accelerometer is processed in real-time in the device and sent to a remote monitoring station where operators can attempt to make contact with the person and/or notify medical personnel of the situation. The ADXL330 accelerometer is contained within a Nintendo WiiMote controller, which forms the basis of the wearable medical sensor. The accelerometer data can then be sent via Bluetooth connection and processed by a local gateway processor. If a fall is detected, the gateway will then contact a remote monitoring station, on a cellular network, for example, via satellite, and/or through a hardwired phone or Internet connection. To detect the occurrence of ta fall, the accelerometer data is passed through a matched filter and the data is compared to benchmark analysis data that will define the conditions that represents the occurrence of a fall. PMID:19163185
Transdermal delivery of ketorolac acid, a potent analgesic, through human skin in vitro and in vivo was evaluated. The following three transdermal solutions were selected to study the in vitro skin permeation rate of ketorolac acid: formulation A, isopropyl alcohol: water: isopropyl myristate (IPA/water/IPM; 11:7:1); formulation B, ethanol: propylene glycol:isopropyl myristate (ET/PG/IPM; 11:7:2); and formulation C, IPM/capmul (glyceryl mono- and dicaprylate; Monoctanoin). The permeation of ketorolac acid through cadaver skin from a saturated drug solution was evaluated at 32 degrees C with a modified Franz diffusion cell. The in vitro skin fluxes were 180, 177, and 14 micrograms/cm2/h for formulations A, B, and C, respectively. The systemic bioavailability of ketorolac acid from three transdermal formulations was evaluated in nine healthy subjects in a randomized three-way crossover fashion. Hill Top chambers were used as prototype dermal delivery devices to load the drug solution. This procedure was followed by the immediate application of devices to human subjects for 24 h. Blood samples were collected at various time intervals up to 48 h, and the samples were assayed by HPLC. The basic pharmacokinetic parameters were derived from the drug plasma concentration versus time plot. The maximum drug plasma concentrations were 1.265, 0.696, and 0.092 micrograms/mL for formulations A, B, and C, respectively. Formulation A provided the highest in vitro and in vivo transdermal delivery rate among the three formulations studied. An excellent correlation between the in vitro steady-state skin flux and the area under the curve of in vivo plasma drug concentration versus time was observed for all the three formulations. PMID:7714743
Healthcare expenditures in the US are approaching 2 trillion dollars, and hospitals and other healthcare providers are under tremendous pressure to rein in costs. One cost-saving approach which is gaining popularity is the reuse of medicaldevices which were designed only for a single use. Device makers decry this practice as unsanitary and unsafe, but a growing number of third-party firms are willing to sterilize, refurbish, and/or remanufacture devices and resell them to hospitals at a fraction of the original price. Is this practice safe? Is reliance on single-use devices sustainable? A Markov decision process (MDP) model is formulated to study the trade-offs involved in these decisions. Several key parameters are examined: device costs, device failure probabilities, and failure penalty cost. For each of these parameters, expressions are developed which identify the indifference point between using new and reprocessed devices. The results can be used to inform the debate on the economic, ethical, legal, and environmental dimensions of this complex issue. PMID:17323656
The growing availability of continuous data from medicaldevices in diabetes management makes it crucial to define novel information technology architectures for efficient data storage, data transmission, and data visualization. The new paradigm of care demands the sharing of information in interoperable systems as the only way to support patient care in a continuum of care scenario. The technological platforms should support all the services required by the actors involved in the care process, located in different scenarios and managing diverse information for different purposes. This article presents basic criteria for defining flexible and adaptive architectures that are capable of interoperating with external systems, and integrating medicaldevices and decision support tools to extract all the relevant knowledge to support diabetes care.
Hernando, M. Elena; Pascual, Mario; Salvador, Carlos H.; Garcia-Saez, Gema; Rodriguez-Herrero, Agustin; Martinez-Sarriegui, Inaki; Gomez, Enrique J.
Failure of medicaldevice (MD) software can have potentially catastrophic effects, leading to injury of patients or even death.\\u000a Therefore, regulators penalise MD manufacturers who do not demonstrate that sufficient attention is devoted to the areas of\\u000a hazard analysis and risk management (RM) throughout the software lifecycle. This paper has two main objectives. The first\\u000a objective is to compare how
A medicaldevice communication framework for a ubiquitous healthcare service based on ISO11073 with USN (ubiquitous sensor\\u000a network) was studied in view of a ubiquitous computing and networking environment. We introduce the USN for e-healthcare service\\u000a in smart environments. Beyond e-healthcare service, as an application of u (ubiquitous)-healthcare service for USN including\\u000a PLC technology, we implemented a real-time health-monitoring service
From an innovation systems perspective the performance of the German medicaldevices industry, future challenges and barriers to innovation are assessed. Current performance indicators (e.g., R&D intensity, export growth rates) paint a favourable picture. Nonetheless, a number of innovation barriers are identified: in particular, insufficient network integration of small and medium-sized enterprises (SMEs) and ineffective policy coordination. Finally, recommendations addressing identified future challenges and innovation barriers are developed. PMID:21147432
In summary, it is possible with the technology and scientific knowledge currently available to allow products intended for single use to be reprocessed using validated and certified processing procedures, while maintaining the full function and without any loss in quality. How many times a product can be re-processed must be determined separately for each individual medical technology device; it is not possible to make any kind of blanket statement as to the permissible number of cycles. This is due to the differing construction, the various combinations of materials and the diverse demands made of each device during clinical use. The exigency of the reprocessing issue is evident both to the user and the primary manufacturer. For the user, where there is a correspondingly high-quality primary product with suitably costed, technically-sound and certified reprocessing procedures, repeat usage can mean real savings while maintaining full functionality in each use. For the primary manufacturers of highly specialised instruments, only part of which can be represented by the medical facility in terms of a corresponding DRG (Diagnosis-Related Group), it is reprocessing that opens the door to widespread routine clinical use. The patient, in turn, benefits greatly from this, since his demand for medical treatment using the most up-to-date technology is taken into account. If processing complies in full with medical technology and hygiene directives, from the medical point of view (without being able to definitively evaluate each individual case using this criterion) the specific advantages of the reprocessing procedure are obvious. In order to establish broad acceptance for the purposes of good marketing, corresponding controlling and quality instruments have to be developed to allow the decision-making process regarding the permissibility of the reprocessing of a certain device and the number of times it can be reprocessed using this procedure to be made transparent.Taking this a step further, possibilities arise for the establishment of corresponding quality-assurance instruments on the part of the clinical establishments involved, within which reprocessed products, in the interest of quality assurance, can be referred back to the processor in the event of defective function and can also be removed from clinical use prior to completing the intended number of processing cycles. Furthermore, it can be assumed that the widespread use of reprocessing procedures in today's high-cost single-use medicaldevice sector will have a long-term cost/price-regulating effect for the primary products, to the benefit of the users. Thus, the heated debate regarding the safety of processing procedures that have already been certified and validated in accordance with current industry standards should be evaluated in particular from the point of view of the justified fears of the leading manufacturers with regard to their currently established market share. From a purely surgical point of view, the reprocessing of disposable products should be welcomed as a revolution. The main criteria for surgeons and medics should always be the benefit for the patient. If the quality is ensured through corresponding processing and validation procedures based on recognised certificates, then economic arguments take precedence. Cases in which a DRG (and thus a payment calculation) does not fully cover the use of medicaldevices are conceivable. Withholding medically necessary services on grounds of the costs, or making these services available to a limited extent only, is not acceptable from the medical point of view and furthermore goes beyond what is ethically acceptable. Each procedure, even the systematic use of reprocessing of suitable medical technology disposable items, should, where the quality is guaranteed, be supported unequivocally. Taken a step further, this branch of the economy will have a long-lasting price-regulating effect on the primary producers market. PMID:20204093
... disease (a brain disease that slowly destroys the memory and the ability to think, learn, communicate and ... movement, muscle weakness, shuffling walk, and loss of memory). Rivastigmine is in a class of medications called ...
... is in a class of medications called local anesthetics. It works by stopping nerves from sending pain ... if you are allergic to lidocaine; other local anesthetics such as bupivacaine (Marcaine), etidocaine (Duranest), mepivacaine (Carbocaine, ...
Scopolamine is used to prevent nausea and vomiting caused by motion sickness.This medication is sometimes prescribed ... Scopolamine comes as a patch to be placed on the skin behind your ear. Apply one patch ...
The aim of this study was to determine if the EpiDerm™ reconstructed human skin model (MatTek Corp.) could be an acceptable alternative to the ISO 10993-required rabbit skin irritation test for assessing medicaldevice biocompatibility. Eleven medicaldevice polymers were tested. Four extracts were prepared per polymer, two each with saline and sesame oil; half were spiked with two R-38 irritants, lactic acid for saline extracts and heptanoic acid for the sesame oil extracts. Tissue viability was assessed by MTT reduction and the proinflammatory response was assessed by IL-1? release. LOAELs of 2% for lactic acid in saline and 0.7% for heptanoic acid in sesame oil were determined. A cell viability reduction of >50% was indicative of skin irritation. Cells exposed to saline extracts spiked with 3.25% lactic acid had significantly reduced mean cell viabilities (12.6-17.2%). Cells exposed to sesame oil extracts spiked with 1.25% heptanoic acid also exhibited reduced mean cell viabilities (25.5%-41.7%). All spiked cells released substantial amounts of IL-1? (253.5-387.4pg/ml) signifying a proinflammatory response. These results indicate that the EpiDerm™ model may be a suitable in vitro replacement for the assessment of the irritation potential of medicaldevice extracts. PMID:23999410
Casas, J W; Lewerenz, G M; Rankin, E A; Willoughby, J A; Blakeman, L C; McKim, J M; Coleman, K P
Background Fourteen African countries are scaling up voluntary medical male circumcision (VMMC) for HIV prevention. Several devices that might offer alternatives to the three WHO-approved surgical VMMC procedures have been evaluated for use in adults. One such device is PrePex, which was prequalified by the WHO in May 2013. We utilized data from one of the PrePex field studies undertaken in Zimbabwe to identify cost considerations for introducing PrePex into the existing surgical circumcision program. Methods and Findings We evaluated the cost drivers and overall unit cost of VMMC at a site providing surgical VMMC as a routine service (“routine surgery site”) and at a site that had added PrePex VMMC procedures to routine surgical VMMC as part of a research study (“mixed study site”). We examined the main cost drivers and modeled hypothetical scenarios with varying ratios of surgical to PrePex circumcisions, different levels of site utilization, and a range of device prices. The unit costs per VMMC for the routine surgery and mixed study sites were $56 and $61, respectively. The two greatest contributors to unit price at both sites were consumables and staff. In the hypothetical scenarios, the unit cost increased as site utilization decreased, as the ratio of PrePex to surgical VMMC increased, and as device price increased. Conclusions VMMC unit costs for routine surgery and mixed study sites were similar. Low service utilization was projected to result in the greatest increases in unit price. Countries that wish to incorporate PrePex into their circumcision programs should plan to maximize staff utilization and ensure that sites function at maximum capacity to achieve the lowest unit cost. Further costing studies will be necessary once routine implementation of PrePex-based circumcision is established.
Medical imaging has become an absolutely essential diagnostic tool for clinical practices; at present, pathologies can be detected with an earliness never before known. Its use has not only been relegated to the field of radiology but also, increasingly, to computer-based imaging processes prior to surgery. Motion analysis, in particular, plays an important role in analyzing activities or behaviors of live objects in medicine. This short paper presents several low-cost hardware implementation approaches for the new generation of tablets and/or smartphones for estimating motion compensation and segmentation in medical images. These systems have been optimized for breast cancer diagnosis using magnetic resonance imaging technology with several advantages over traditional X-ray mammography, for example, obtaining patient information during a short period. This paper also addresses the challenge of offering a medical tool that runs on widespread portable devices, both on tablets and/or smartphones to aid in patient diagnostics.
Medical imaging has become an absolutely essential diagnostic tool for clinical practices; at present, pathologies can be detected with an earliness never before known. Its use has not only been relegated to the field of radiology but also, increasingly, to computer-based imaging processes prior to surgery. Motion analysis, in particular, plays an important role in analyzing activities or behaviors of live objects in medicine. This short paper presents several low-cost hardware implementation approaches for the new generation of tablets and/or smartphones for estimating motion compensation and segmentation in medical images. These systems have been optimized for breast cancer diagnosis using magnetic resonance imaging technology with several advantages over traditional X-ray mammography, for example, obtaining patient information during a short period. This paper also addresses the challenge of offering a medical tool that runs on widespread portable devices, both on tablets and/or smartphones to aid in patient diagnostics. PMID:24489600
García Sánchez, Carlos; Botella Juan, Guillermo; Ayuso Márquez, Fermín; González Rodríguez, Diego; Prieto-Matías, Manuel; Tirado Fernández, Francisco
Transdermal drug delivery offers a non-invasive route of drug administration, although its applications are limited by low skin permeability. Various enhancers including iontophoresis, chemicals, ultrasound, and electroporation have been shown to enhance transdermal drug transport. Although all these methods have been individually shown to enhance transdermal drug transport, their combinations have often been found to enhance transdermal transport more effectively
Transdermal drug delivery offers a non-invasive route of drug administration, although its applications are limited by low skin permeability. Various enhancers including iontophoresis, chemicals, ultrasound, and electroporation have been shown to enhance transdermal drug transport. Although all these meth- ods have been individually shown to enhance transdermal drug transport, their combinations have often been found to enhance transdermal transport more
Power and current management in emerging wearable medicaldevices, intended to continuously monitor physiological signals, are crucial design issues. The overall size of the electronic part of these systems is generally going to be dominated by the size of the batteries. Unfortunately, the options of smaller batteries do not only come at the expense of a lower capacity and hence shorter operation time. It also significantly constrains the amount of available current that can be used by different electronic blocks, as well as their operating power supply voltage. This paper discusses all the typical power and current management system level issues in the design of a typical miniature wearable wireless medicaldevice. The discussion is illustrated with experimental results obtained with two devices built using two of the currently most popular low power commercial transceivers in the market, the Texas Instruments (TI) CC2500 and the Nordic Semiconductor nRF24L01+. The numbers presented can be used as a more realistic guidance of the energy per bit required in a real system implementation, as opposed to the ideal figures normally quoted by the manufacturers. Furthermore the analysis in this paper can also be extrapolated to the design of future wireless monitoring wearable devices with further optimized radio transceivers. PMID:21096352
A capacitive, tube-shaped tri-axis contact force sensor is fabricated and characterized in this paper. The sensor is inserted into a tubular medicaldevice just like a small section of tube in order to sense the applied contact force on the tip of this tubular device. It comprises two SU-8 plates, wherein the outer and inner rims of the plates with diameters of 2.3 and 1.1 mm, respectively, are assembled together. Three proof masses were hinged to the outer and inner rims of the first plate by membranes. The different signals received from the three electrodes provide collective information indicating the precision and accurate direction of contact forces exerted on the tip of the tubular medicaldevice. In the test, applied force range from 10 mN to 1.0 N was detected, the performance of the sensor is stable from 25 to 65 °C, and the device was functional under a shock of 2.0 N for 10 s in a shock test. In addition, a two-wire readout approach was also developed to minimize the lead wires.
The association between specific blood flow patterns and blood behaviour through medicaldevices suggests that a Lagrangian study may be a useful instrument for the evaluation of the thrombogenic and/or hemolytic potential of certain devices' geometries and biomaterials. In this study a description of blood particle trajectories in terms of their spiral contents is proposed; such a mathematical description for blood spiral flow, computed along several pathlines, is tested for a quantitative determination of the spiralled motion of blood flow into two three-dimensional numerical models, having different design characteristics, of venous cannula inserted in a vessel. As the influence of vortical flow conditions have been observed to have both beneficial and detrimental influence on blood behaviour in terms of blood-device interaction, of the degradation of its components, and of the efficiency of mass-exchange (in red cells oxygenation and plasma filtration, for example), the herein proposed method for the description of spiral laminar motion may be a helpful instrument to build up a tool to investigate, for example, the existence of correlations between level of spiral flow and geometry (as in the present investigated test case), rather than the effects of blood-surface contact. The results obtained in this test case investigation, confirm the effectiveness of the proposed function for a quantitative analysis of spiral flow in medicaldevices. PMID:15112889
Grigioni, M; Daniele, C; Morbiducci, U; Del Gaudio, C; D'Avenio, G; Balducci, A; Barbaro, V
Nicotine has been shown to improve attentiveness in smokers and attenuate attentional deficits in Alzheimer’s disease patients,\\u000a schizophrenics and adults with attention-deficit\\/hyperactivity disorder (ADHD). The current study was conducted to determine\\u000a whether nicotine administered via transdermal patches would improve attentiveness in non-smoking adults without attentional\\u000a deficits. The subjects underwent the nicotine and placebo exposure in a counterbalanced double-blind manner. Measures
E. D. Levin; C. Keith Conners; Donna Silva; Sean C. Hinton; Warren H. Meck; John March; Jed E. Rose
Objective: To test the efficacy and tolerability of the methylphenidate transdermal formulation (MTS) against immediate-release methylphenidate (IR MPH) and placebo in a 12-hr analog classroom setting. Method: A total of nine boys ages 6 to 9 years, medicated with MPH for ADHD, complete a within-subject, double-blind study. For the purpose of the…
Pelham, William E.; Waxmonsky, James G.; Schentag, Jerome; Ballow, Charles H.; Panahon, Carlos J.; Gnagy, Elizabeth M.; Hoffman, Martin T.; Burrows-MacLean, Lisa; Meichenbaum, David L.; Forehand, Gregory L.; Fabiano, Gregory A.; Tresco, Katy E.; Lopez-Williams, Andy; Coles, Erika K.; Gonzalez, Mario A.
Skin has at least two barriers with protective functions: the stratum corneum physical barrier and a biochemical barrier in the epidermis and dermis. Numerous chemical and physical enhancers exist for transdermal therapeutic systems; some cause irritation, and possibly influence enzyme deactivation. Knowledge of enzymatic skin reactions is important for developing safe and efficacious transdermal systems for treatment not only of
Biomaterials-associated infection incidence represents an increasing clinical challenge as more people gain access to medicaldevice technologies worldwide and microbial resistance to current approaches mounts. Few reported antimicrobial approaches to implanted biomaterials ever get commercialized for physician use and patient benefit. This is not for lack of ideas since many thousands of claims to new approaches to antimicrobial efficacy are reported. Lack of translation of reported ideas into medical products approved for use, results from conflicting goals and purposes between the various participants involved in conception, validation, development, commercialization, safety and regulatory oversight, insurance reimbursement, and legal aspects of medicaldevice innovation. The scientific causes, problems and impressive costs of the limiting clinical options for combating biomaterials-associated infection are well recognized. Demands for improved antimicrobial technologies constantly appear. Yet, the actual human, ethical and social costs and consequences of their occurrence are less articulated. Here, we describe several clinical cases of biomaterials-associated infections to illustrate the often-missing human elements of these infections. We identify the current societal forces at play in translating antimicrobial research concepts into clinical implant use and their often-orthogonal constituencies, missions and policies. We assert that in the current complex environment between researchers, funding agencies, physicians, patients, providers, producers, payers, regulatory agencies and litigators, opportunities for translatable successes are minimized under the various risks assumed in the translation process. This argues for an alternative approach to more effectively introduce new biomaterials and device technologies that can address the clinical issues by providing patients and medical practitioners new options for desperate clinical conditions ineffectively addressed by biomedical innovation. PMID:24034505
Grainger, David W; van der Mei, Henny C; Jutte, Paul C; van den Dungen, Jan J A M; Schultz, Marcus J; van der Laan, Bernard F A M; Zaat, Sebastian A J; Busscher, Henk J
While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medicaldevices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medicaldevices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medicaldevices to consumers without thorough or sufficient examination of evidence. PMID:22032398
Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E
Public safety can be enhanced through the development of a comprehensive medicaldevice risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medicaldevices. The framework consists of the following sixteen attributes of a comprehensive medicaldevice risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medicaldevices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medicaldevice risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.
Medicaldevices are essential to the practice of mod- ern healthcare services. Their benefits will increase if clinical soft- ware applications can seamlessly acquire the medicaldevice data. The need to represent medicaldevice observations in a format that can be consumable by clinical applications has already been recog- nized by the industry. Yet, the solutions proposed involve bilateral mappings
Open-Source MedicalDevices (OSMD) was initiated with the goal of facilitating medical research by developing medical technologies including both hardware and software on an open-source platform. Our first project was to develop an integrated imaging and radiotherapy device for small animals that includes computed tomography (CT), positron emission tomography (PET) and radiation therapy (RT) modalities for which technical specifications were defined in the first OSMD conference held in Madison, Wisconsin, USA in December 2011. This paper specifically focuses on the development of a small animal RT (micro-RT) system by designing a binary micro multileaf collimator (bmMLC) and a small animal treatment planning system (SATPS) to enable intensity modulated RT (IMRT). Both hardware and software projects are currently under development and their current progresses are described. After the development, both bmMLC and TPS will be validated and commissioned for a micro-RT system. Both hardware design and software development will be open-sourced after completion.
...give public notice of the ISO standard(s) under which FDA accepts...thinking on ``MedicalDevice ISO 13485:2003 Voluntary...appropriate quality system standards set by the International...Organization for Standardization (ISO) and identified by...
...SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible MedicalDevice Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...
...SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible MedicalDevice Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction AGENCY: Food and Drug Administration, HHS. ACTION:...
...2013-07-01 false Routine checking of hearing aids and external components of surgically implanted...300.113 Routine checking of hearing aids and external components of surgically implanted medicaldevices. (a) Hearing aids. Each public agency must ensure...
In medicaldevice manufacturing there is an increasing interest to enhance machining of biocompatible materials on a micrometer scale. Obviously there is a trend to generate smaller device structures like cavities, slits or total size of the device to address new applications. Another trend points to surface modification, which allows controlling selective growth of defined biological cell types on medical implants. In both cases it is interesting to establish machining methods with minimized thermal impact, because biocompatible materials often show degradation of mechanical properties under thermal treatment. Typical examples for this effect is embrittlement of stainless steel at the edge of a cutting slit, which is caused by oxidation and phase change. Also for Nitinol (NiTi alloy) which is used as another stent material reduction of shape-memory behavior is known if cutting temperature is too high. For newest biodegradable materials like Polylactic acid (PLA) based polymers, lowest thermal impact is required due to PLA softening point (65°C) and melting temperature (~170 °C ). Laser machining with ultra-short pulse lasers is a solution for this problem. In our work we demonstrate a clean laser cut of NiTi and PLA based polymers with a high repetition-rate 1030 nm, 400-800 fs laser source at a pulse energy of up to 50 ?J and laser repetition rate of up to 500 kHz.
Stolberg, Klaus; Friedel, Susanna; Kremser, Bert; Roehner, Markus
Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medicaldevice approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medicaldevice regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medicaldevice regulation in the US or EU. We searched Medline using two nested categories that included medicaldevices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n?=?9), studies of device recalls (n?=?8), and surveys of device manufacturers (n?=?3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions Few studies have quantitatively assessed medicaldevice regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting. Please see later in the article for the Editors' Summary.
Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.
One of the main objectives of pharmaceutical policies in developing countries is to ensure accessibility and affordability of good quality medicines for the population. The Essential Medicines and Generic Drugs Purchasing Central (French acronym, CAMEG-Togo) is a not-for-profit association established in 1998 to ensure procurement for public and not-for-profit private public health facilities within the framework of recovery of costs. Although attention has been focused mainly on medicines, medicaldevices account for a growing part of the pharmaceutical products purchased by central stores, hospitals and health programs. Recognizing this need in 2002, CAMEG-Togo in collaboration with the French cooperation agency decided to upgrade its competency in evaluating the quality of medicaldevices. For that purpose the information sheet used to preselect suppliers for international tenders and the technical specifications sheet for medicaldevices was revised and pharmacists responsible for processing these files were given specific training. European directive N 93/42/CEE of 14 June 1993 is currently used by CAMEG-Togo as the regulatory basis for preselection of medicaldevice suppliers. Referencing based on American regulatory requirements is now under way to widen the scope of suppliers eligible for preselection. The purpose of this article is first to describe the main guidelines of the European directive used by medicaldevice manufacturers to obtain EC certification and second to present the procedures used by the CAMEG-Togo to preselect medicaldevice suppliers, with special focus on the technical specifications sheet. PMID:17286037
Technology is major stimulus for change and is imbibed in various forms; especially in the field of medicaldevices and bio-medical instruments used in life and death situations. Cardiotocograph (CTG), a foetal heart rate and uterine contraction monitoring and measurement machine, is a valuable tool in the process of childbirth. The Quality Function Deployment (QFD) is an engineering technique with the number one priority being to satisfy the customer. The aim of using QFD in this paper is to highlight the limitations and complexities of the present instrument. The paper attempts to first discuss out the operational details of the instrument along with a brief review of the relevant literature. Following this, its functional analysis is carried out through QFD - a TQM tool. The resultant outcome enlists CTG functions with their Raw Weight and Priority Score. A detailed theoretical analysis of results pinpoints basic functional limitation of exiting machine. PMID:23008844
Objectives: The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. Methods: An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. Results: The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Conclusions: Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Implications: Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes.
The development of health funding policy in Korea has followed the country's rapid economic development, with a comprehensive National Health Insurance (NHI) system in place by 1989. The funding of medicaldevices has followed this progression, with incorporation into the NHI reimbursement system in 2000 (several years later than pharmaceuticals), but important issues affecting patient access remain. Although the effect of devices on the NHI budget is relatively modest (only about 4%), because of concerns about NHI sustainability, attention has increasingly been paid to their management and funding. Unlike pharmaceuticals, however, it has been quite challenging to develop clear and fair criteria for reimbursement coverage and pricing of medicaldevices. The two key and longstanding issues around the reimbursement of medicaldevices in Korea are how to expedite market entry of improved or innovative medicaldevices at appropriate prices, and how to satisfactorily lower the reimbursement levels of older devices, thereby making headroom for new technologies to be reimbursed. Despite protracted discussions over the last decade, industry and government have been unable to reach full agreement. There has been some progress (e.g., introduction of the Value Appraisal and the Revaluation Systems), but there remains urgent need for productive discussion and consensus between government and industry regarding reasonable funding rules, transparency, and clarity in the reimbursement pricing process for medicaldevices. PMID:24969010
Product vendors and manufacturers are increasingly aware that purchasers of health care will fund new clinical treatments only if they are perceived to deliver value-for-money. This influences companies' internal commercial decisions, including the price they set for their products. Other things being equal, there is a price threshold, which is the maximum price at which the device will be funded and which, if its value were known, would play a central role in price determination. This paper examines the problem of pricing a medicaldevice from the vendor's point of view in the presence of uncertainty about what the price threshold will be. A formal solution is obtained by maximising the expected value of the net revenue function, assuming a Bayesian prior distribution for the price threshold. A least admissible price is identified. The model can also be used as a tool for analysing proposed pricing policies when no formal prior specification of uncertainty is available. PMID:22021085
Girling, Alan J; Lilford, Richard J; Young, Terry P
Early adoption of a new medicaldevice by a physician carries with it some degree of malpractice liability risk. The legal standard for malpractice varies from place to place, but generally requires an evaluation of the physician's conduct either against that of a hypothetical "reasonable physician," or else against professional custom. Where the use of a new device involves a significant departure from traditional modalities of care, and a bad clinical result follows, questions may arise about whether the legal standard for malpractice has been violated. We suggest that a liberal interpretation of the malpractice standard of care is appropriate, and even necessary to avoid the potential for perverse disincentives to technical innovation in medicine. PMID:19715141
In this paper, directing at the peculiarity of south China, the technique and quality control of Co-80 r radiation sterilization of medicaldevices have been studied. Radiation dose setting is determined by the AAMI method. Experiment shows that radiation treatment has no effect upon the attributes of the products. Under the same condition of packing and environment, storing time of radiation sterilization is 4 times than that of sterilization by heat. Clinical appliances of 1000 carton products show that radiation sterilization products are safe and reliable.
ABSTRACT A 79-year-old female with type 2 diabetes and mild cognitive impairment (Clinical Dementia Rating score of 0.5) was supported with medication with regard to the daily requirements using a medication reminder device. Use of this device not only improved her medication adherence, hemoglobin A1c level, and self-confidence but also reduced caregiver's burden. For elderly patients with such diseases, loading the device with medication, providing advance notice before mechanical reminders for a short period after the device's activation, monitoring unused medication, and adjusting the timing of reminders according to users' daily routine, seemed to facilitate daily use of the device. PMID:24382135
There is a perception that the express preemption holding of the Supreme Court in Riegel v. Medtronic, 552 U.S. 312(2008), immunizes medicaldevice manufacturers from common law personal injury actions involving Class III devices that received FDA clearance under a premarket approval application (PMA). In the aftermath of Riegel, many lawsuits involving Class III PMA devices have been dismissed by district courts applying the new heightened pleading standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Other lawsuits involving Class III PMA devices premised on fraud-on-FDA have been dismissed based on the implied preemption holding of the Supreme Court in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). When these decisions are carefully analyzed together with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found no preemption regarding a Class III device receiving FDA clearance through the 510(k) mechanism, it is apparent that the preemption defense does not apply universally to Class III PMA devices. The overall methodology for framing a non-preempted claim is to first identify conduct which violated the PMA or other specific requirements related to safety or efficacy. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements. PMID:24475536
Membrane permeation-controlled transdermal drug delivery systems were prepared using the natural polymer, chitosan. An adhesive sealing technique was used to construct the devices. Propranolol hydrochloride was selected as the model drug for the present study. Chitosan membranes with different permeability to propranolol hydrochloride obtained by controlled cross-linking with glutaraldehyde were used to regulate the drug release in the devices. Chitosan
Health Canada recommends that hospitals should have procedures in place to ensure Reusable MedicalDevices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medicaldevices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable MedicalDevice (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medicaldevices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it begins with proper cleaning and processing of the surgical instruments. Surgical site infections can increase the length of stay and the cost of the patients' hospitalization, as well as increased risk, morbidity and even mortality. 1 Today's patients are far more informed than they were in the past. They can gather information from the internet as well as from television, radio, and print media. This knowledge empowers the patient to expect that their healthcare providers are practicing due diligence. It is the ethical duty and responsibility of nurses to provide safe, competent care while protecting the rights of the patient and being accountable to the professional governing bodies. In other words, we are advocates for both our patients and the healthcare system.2 Using both new and innovative instruments in the OR was, in the past, as simple as a surgeon requesting an instrument, the perioperative nurse ordering the instrument and CPD processing it for use in the OR. That is no longer the case. With a wide range of more complex instrumentation and an increasing focus on sterilization strategies, healthcare facilities have had to adopt a more rigorous approach. There are many challenges in the world of sterile processing. A common one, faced on a regular basis, is the provision of vague, inaccurate reprocessing recommendations from the medicaldevice manufacturer. Canadian centres are not able to meet European standards for reprocessing. European cycles, often referred to as "Fractionated Steam Cycles", are different than the pre-vacuum steam cycles run in Canada. PMID:21366000
Purpose Transdermal insulin delivery is an attractive needle-free alternative to subcutaneous injection conventionally used to treat\\u000a diabetes. However, skin’s barrier properties prevent insulin permeation at useful levels.\\u000a \\u000a \\u000a \\u000a \\u000a Methods We investigated whether microdermabrasion can selectively remove skin’s surface layers to increase skin permeability as a\\u000a method to administer insulin to diabetic rats. We further assessed the relative roles of stratum corneum and viable
Samantha Andrews; Jeong Woo Lee; Seong-O Choi; Mark R. Prausnitz
There are several intra-operative use cases which require the surgeon to interact with medicaldevices. We used the Leap Motion Controller as input device and implemented two use-cases: 2D-Interaction (e.g. advancing EPR data) and selection of a value (e.g. room illumination brightness). The gesture detection was successful and we mapped its output to several devices and systems. PMID:24732520
Continuous delivery of antiparkinsonian medication during a perioperative period is desirable to avoid ‘off’-symptom complications\\u000a in surgical patients with concomitant Parkinson’s disease (PD). Fourteen PD patients undergoing surgery under general anesthesia\\u000a were switched from oral dopaminergic medication to transdermally delivered 24-h rotigotine (median dose 12 mg\\/24 h) for the\\u000a perioperative period. Rotigotine treatment was considered feasible by patients, their anesthesiologists and neurologists
Ullrich Wüllner; Jan Kassubek; Per Odin; Michael Schwarz; Markus Naumann; Hermann-Josef Häck; Babak Boroojerdi; Heinz Reichmann
Medicaldevices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature. In this study, we show that the in vitro pyrogen test (IPT), which measures the release of the inflammatory cytokine IL-1beta in fresh or cryopreserved human whole blood, can be used to assess the pyrogenic contamination of implantable medicaldevices. This test was used to check neurosurgical implants, namely aneurysm clips, as a proof of principle. Owing to the direct contact of the test material with the blood cells, this test does not require rinsing procedures, which have variable efficacy. The use of human blood ensures the detection of all substances that are pyrogenic for humans and reflects their relative potency. The safety of the products as delivered could be confirmed. The effects of sterilization and depyrogenization procedures on intentional pyrogenic contaminations of samples could be followed. This new application of the already internationally validated method promises to replace further rabbit pyrogen tests. It generates extremely sensitive results with an extended range of detectable pyrogenic contaminants. PMID:16958052
The unique ability of cyclodextrins (CDs) to form inclusion complexes can be transmitted to polymeric networks in which CDs are chemically grafted or cross-linked. Combination of CDs and hydrogels in a single material leads to synergic properties: the hydrophilic network enhances biocompatibility and prevents dilution in the physiological medium increasing the stability of the inclusion complexes, while CDs finely tune the mechanical features and the stimuli-responsiveness and provide affinity-based regulation of drug loading and release. Therefore, CD-functionalized materials are opening new perspectives in pharmacotherapy, emerging as advanced delivery systems (DDS) for hydrophobic and hydrophilic drugs to be administered via almost any route. Medicaldevices (catheters, prosthesis, vascular grafts, bone implants) can also benefit from surface grafting or thermofixation of CDs. The present review focuses on the approaches tested to synthesize nano- to macro-size covalently cross-linked CD networks: i) direct cross-linking through condensation with di- or multifunctional reagents, ii) copolymerization of CD derivatives with acrylic/vinyl monomers, and iii) grafting of CDs to preformed medicaldevices. Examples of the advantages of having the CDs chemically bound among themselves and to substrates are provided and their applicability in therapeutics discussed. PMID:23631979
The growing number of revisions in orthopaedic surgery as well as the multifactorial reasons for implant failure give cause for taking a closer look at the clinical documentation of adverse events. Based on our long-term experience it is our goal to present recommendations for an adequate documentation and filing. In the framework of the introduction of a quality management system (ISO 9001:2008) in our hospital, a process was developed for reportable incidents with medicaldevices regulating adequate documentation. Therefore, specific forms were developed. The retrievals are stored for subsequent damage analyses and are available for possible legal claims and tracking. A file should be opened for each reportable incident containing information about the event, a copy of the obligatory BfArM report, surgery report, medicaldevice labels, radiographs and photographs. Declarations of agreement as well as handover certificates should be maintained in order to keep record of the retrievals. In order to assure consistent documentation, we recommend use of specific forms as presented in this paper. Identification of risk factors for implant failure and a long-term reduction of damage cases will only be possible under consequent incident reporting and responsible documentation of adverse events. Processing of cases of damage is accelerated and simplified by the presented recommendations and forms. Together with the newly established joint replacement registry, a higher quality of patient treatment and implant safety should be obtained. PMID:23296561
Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medicaldevice. Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference. Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs. Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies.
Youn, Ji-Hee; Lord, Joanne; Hemming, Karla; Girling, Alan; Buxton, Martin
Transdermal drug delivery using patches offers many advantages, but is limited primarily by the stratum corneum barrier. Amongst the various methods to overcome this barrier, physical methods are gaining in popularity and commercial devices development. Macroflux, MTS and Silex are based on microporation, involving use of microneedles that pierce thereby bypassing the stratum corneum. Intraject , Powderject and Helios are based on needleless jet injectors wherein very fine, solid particulate drug, is fired directly into the skin, using high-pressure gas. Med- Tats incorporate use of modified drug-containing tattoos, which bind to the skin, wherein the drug is absorbed. CHADD is based on use of heat, which increases skin - permeation of drugs. High-power, pulsed lasers transmit positive mechanical forces to the skin and create intercellular channels into the skin transiently. Sonophoresis involves use of ultrasound, which transiently disrupts the stratum corneum barrier. This technique offers a non-invasive transdermal extraction of interstitial fluids of sampling body fluids. Modified Liposomes include Ethosomes (containing alcohol) and Transferosomes (containing surfactants), which have enhanced skin permeability. Pulsed magnetic fields may create transient pores in cell membranes, including skin, resulting in increased permeation. Iontophoresis is based on application of electric potential for enhancing the movement of substances to and from the body. Dupel, Ionzyme, Liposite, ETrans, Phoresor and Drionic are based on iontophoresis. GlucoWatch offers non-invasive blood glucose monitoring, based on reverse iontophoresis. This review outlines recent commercial developments in physical transdermal drug delivery technology and the specific devices and applications being targeted by the pharmaceutical industry. PMID:16848725
Film-forming lotions, precast films and adhesive patches containing testosterone (T) were prepared by compounding vinylic, acrylic and cellulosic polymers with a variety of excipients in order to achieve distribution of T in domains of heterogeneity within multicomponent matrices. The feasibility of this approach in achieving episodic transdermal delivery of testosterone (T) was investigated. Composition-dependent differences in extent of in vitro drug release and periodicity were observed. Representative formulations showing the most pronounced episodic T release in vitro were tested in female rats. Whereas intravenously administered T decayed exponentially, three maxima of T in serum were observed upon application of selected formulations. Thus, peak serum concentrations of 240, 36, and 29 ng/dL were observed at 0.2, 5, and 16.8 h after application of the preferred lotion formulation, and 89, 65, and 64 ng/dL at 1, 16.4, and 48.8 h after patches. Deconvolution, noncompartment pharmacokinetic analysis and multiple peak fitting also indicated episodicity. These results suggest the feasibility of using transdermal systems for pulsatile T delivery in a variety of clinical applications, including hormone supplementation and male contraception. PMID:22533605
Malik, Ritu; Venkatesh, K S; Dwivedi, Anil Kumar; Misra, Amit
Determining the MR compatibility of medical implants and devices is becoming increasingly relevant. In most cases, the heating of conductive implants due to radiefrequency (RF) excitation pulses is measured by fluoroptic temperature sensors in relevant tests for approval. Another common method to determine these heating effects is MR thermometry using the proton resonance frequency. This method gives good results in homogeneous phantoms. However in many cases, technical shortcomings such as susceptibility artifacts prohibit exact proton resonance frequency thermometry near medical implants. Therefore, this work aimed at developing a fast T?-based method which allows controlled MR-related heating of a medical implant while simultaneously quantifying the spatial and temporal temperature distribution. To this end, an inversion recovery snapshot Fast Low-Angle Shot (FLASH) sequence was modified with additional off-resonant heating pulses. With an accelerated imaging method and a sliding-window technique, every 7.6 s a new temperature map could be generated with a spatial in-plane resolution of 2 mm. The temperature deviation from calculated temperature values to reference fluoroptic probe was found to be smaller than 1 K. PMID:22287286
Gensler, D; Fidler, F; Ehses, P; Warmuth, M; Reiter, T; Düring, M; Ritter, O; Ladd, M E; Quick, H H; Jakob, P M; Bauer, W R; Nordbeck, P
The main aim of the present study was to electrospin ibuprofen (IBU)-loaded composite nanofibers to improve the performances of transdermal patches. Cellulose acetate/poly(vinyl pyrrolidone) (CA/PVP) blends were used to fabricate uniform nanofibers. Investigations on the physicochemical properties of CA/PVP solutions indicated that the addition of appropriate PVP improved the electrospinnability of original CA solutions. Detections on the physical states of IBU in medicated CA/PVP nanofibers suggested that IBU was uniformly distributed in nanofibers in an amorphous state. Comparing to IBU-loaded casting membrane, the medicated CA/PVP nanofibers provided a faster IBU diffusion manner and a better ex vitro skin permeation profile due to their high superficial areas and the amorphous IBU. Furthermore, CA/PVP nanofibers exhibited a high water vapor permeability, which could render an improved breathability to transdermal patches. In sum, the electrospun drug-loaded CA/PVP nanofibers exhibited great potentials to improve the thermodynamic stability and breathability of transdermal patches, which could be used to develop new types of transdermal drug delivery system (TDDS). PMID:23862418
The objective of this study was to explore the electrically assisted transdermal delivery of buprenorphine. Oral delivery of buprenorphine, a synthetic opiate analgesic, is less efficient due to low absorption and large first-pass metabolism. While transdermal delivery of buprenorphine is expected to avoid the first-pass effect and thereby be more bioavailable, use of electrical enhancement techniques (iontophoresis and\\/or electroporation) could
Sagarika Bose; William R. Ravis; Yuh-Jing Lin; Lei Zhang; Günter A. Hofmann; Ajay K. Banga
Adherence to prescribed psychiatric and nonpsychiatric medication is a serious issue in people with mental illness that can contribute to poor health outcomes. Some of the factors influencing adherence include side effects of medication and the ease of use. With mental healthcare provision increasingly focusing on a community model of health delivery, there seems to be a renewed interest in addressing complex dilemmas of safety and adherence to treatment. The use of alternative methods of safely delivering medication in innovative ways may resolve some of these difficulties. There has been little discussion about the wider use of transdermal patches in the field of psychiatry in published literature. This article describes the findings from the literature on key principles underlying transdermal delivery strategies, the scope of clinical use in psychiatric illness and explores its challenges and advantages.
The economic evaluation of medical products and services is increasingly prioritised by healthcare decision makers and plays a key role in informing funding allocation decisions. It is well known that there are a number of methodological difficulties in the health technology assessment of medicaldevices, particularly in the provision of efficacy evidence. By contrasting devices with pharmaceuticals, the way in which the differing systems of innovation mould the UK's industry landscape is described and substantiated with market statistics. In recognition of the challenges faced by industry, as well as the growing need for cost-effective allocation of National Health Service (NHS) resources, the National Institute for Health and Care Excellence (NICE) led the development of the Medical Technologies Evaluation Programme (MTEP), which launched in 2009/2010. The review of the UK's medicaldevices market supports the programme's three principal aims: to simplify access to evaluation, speed up the process, and increase evaluative capacity for devices within NICE. However, an analysis of the output of MTEP's first 3 years suggests that it has some way to go to meet each of these aims. PMID:24934924
With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. However, for direct interactive 3D visualization, which plays an important role in radiological diagnosis, the mobile device cannot provide a satisfactory quality of experience for radiologists. This paper developed a medical system that can get medical images from the picture archiving and communication system on the mobile device over the wireless network. In the proposed application, the mobile device got patient information and medical images through a proxy server connecting to the PACS server. Meanwhile, the proxy server integrated a range of 3D visualization techniques, including maximum intensity projection, multi-planar reconstruction and direct volume rendering, to providing shape, brightness, depth and location information generated from the original sectional images for radiologists. Furthermore, an algorithm that changes remote render parameters automatically to adapt to the network status was employed to improve the quality of experience. Finally, performance issues regarding the remote 3D visualization of the medical images over the wireless network of the proposed application were also discussed. The results demonstrated that this proposed medical application could provide a smooth interactive experience in the WLAN and 3G networks. PMID:24705800