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1

Taro corms mucilage/HPMC based transdermal patch: an efficient device for delivery of diltiazem hydrochloride.  

PubMed

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

Sarkar, Gunjan; Saha, Nayan Ranjan; Roy, Indranil; Bhattacharyya, Amartya; Bose, Madhura; Mishra, Roshnara; Rana, Dipak; Bhattacharjee, Debashis; Chattopadhyay, Dipankar

2014-05-01

2

Micro-scale Devices for Transdermal Drug Delivery  

PubMed Central

Skin makes an excellent site for drug and vaccine delivery due to easy accessibility, immuno-surveillance functions, avoidance of macromolecular degradation in the gastrointestinal tract and possibility of self-administration. However, macromolecular drug delivery across the skin is primarily accomplished using hypodermic needles, which have several disadvantages including accidental needle-sticks, pain and needle phobia. These limitations have led to extensive research and development of alternative methods for drug and vaccine delivery across the skin. This review focuses on the recent trends and developments in this field of micro-scale devices for transdermal macromolecular delivery. These include liquid jet injectors, powder injectors, microneedles and thermal microablation. The historical perspective, mechanisms of action, important design parameters, applications and challenges are discussed for each method. PMID:18805472

Arora, Anubhav; Prausnitz, Mark; Mitragotri, Samir

2009-01-01

3

Recent Medical Device Recalls  

MedlinePLUS

... is a Medical Device 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 Device Recalls [ ...

4

Medical Device Reliability BIOMATERIALS  

E-print Network

of the U.S. healthcare industry, with annual sales exceeding $13 billion. In the past decade, nearly 3 Laboratory The iNEMI Medical Technology Integration Group, which includes NIST, has produced a number of documents that advance our long-term goal of better standards for medical device technology. These include

5

Medical Device Interoperability The lack of interoperability between medical devices  

E-print Network

to preventable medical errors and potentially serious inefficiencies that could otherwise be avoided. OverviewMedical Device Interoperability The lack of interoperability between medical devices can lead an accurate diagnostic and treatment discipline, medical devices are playing an ever-increasing role

6

Barriers to medical device innovation  

PubMed Central

The US Food and Drug Administration (FDA) has defined a medical device 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 medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices 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 medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices 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 medical device 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. PMID:24966699

Bergsland, Jacob; Elle, Ole Jakob; Fosse, Erik

2014-01-01

7

Reprocessing of Reusable Medical Devices  

MedlinePLUS

... acquiring such an infection from an inadequately reprocessed medical device is relatively low given the large number of such devices in use, although the potential for outbreaks of infection associated with their use remains an ...

8

Micro- and nanofabrication methods in nanotechnological medical and pharmaceutical devices  

PubMed Central

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. PMID:17722281

Betancourt, Tania; Brannon-Peppas, Lisa

2006-01-01

9

MEDIC: Medical embedded device for individualized care  

Microsoft Academic Search

Summary Objective: Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabil- ities, and commercially available microelectronic components, sensors and conven- tional personal digital assistant (PDA) (or a cell phone). Methods and materials: In this paper, we present

Winston H. Wu; Alex A. T. Bui; Maxim A. Batalin; Lawrence K. Au; Jonathan D. Binney; William J. Kaiser

2008-01-01

10

Implantable medical devices MRI safe.  

PubMed

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 medical devices requires computer modeling, bench testing, phantom testing, and animal studies. Implanted medical devices can be MRI unsafe, MRI conditional or MRI safe (see glossary). In the following paragraphs we will investigate how to design implanted medical devices MRI safe. PMID:23739365

Dal Molin, Renzo; Hecker, Bertrand

2013-01-01

11

Implantable Medical Devices  

MedlinePLUS

... A left ventricular assist device (LVAD) is a battery-operated, mechanical pump-type device that's surgically implanted. ... of the body and attached to the pump's battery and control system. LVADs are now portable and ...

12

78 FR 18233 - Medical Devices; Technical Amendment  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2013-N-0011] Medical Devices; Technical Amendment AGENCY...Administration (FDA) is amending certain medical device regulations to correct minor errors...affecting certain regulations regarding medical devices. Publication of this...

2013-03-26

13

Buying Medical Devices and Diagnostic Tests Online  

MedlinePLUS

... A to Z Index Follow FDA En Español Enter Search terms Home Food Drugs Medical Devices Radiation-Emitting Products ... been altered or updated since it was archived. Enter Search terms Medical Devices Home Medical Devices Resources for You ( ...

14

Recent medical devices for tonsillectomy  

PubMed Central

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 medical devices which were previously used in tonsillectomy. PMID:23930051

Sayin, I; Cingi, C

2012-01-01

15

Innovation and the medical devices Farady partnership.  

PubMed

Demand for development of new generation medical devices has led many governments to support medical-sector research. In the United Kingdom, the Medical Devices Faraday Partnership was created to establish a collaborative network that would enhance the transfer of good ideas into new products and processes. The services it offers medical device manufacturers are outlined here. PMID:15984545

Tavakoli, M; Dunkerton, S B

2005-06-01

16

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2013-N-1306] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition...Administration (FDA) is announcing participation in the Medical Device Single Audit Program International...

2013-11-15

17

Microneedles permit transdermal delivery of a skin-impermeant medication to humans  

PubMed Central

Drugs with poor oral bioavailability usually are administered by hypodermic injection, which causes pain, poor patient compliance, the need for trained personnel, and risk of infectious disease transmission. Transdermal (TD) delivery provides an excellent alternative, but the barrier of skin's outer stratum corneum (SC) prevents delivery of most drugs. Micrometer-scale microneedles (MNs) have been used to pierce animal and human cadaver skin and thereby enable TD delivery of small molecules, proteins, DNA, and vaccines for systemic action. Here, we present a clinical study of MN-enhanced delivery of a medication to humans. Naltrexone (NTX) is a potent mu-opioid receptor antagonist used to treat opiate and alcohol dependence. This hydrophilic and skin-impermeant molecule was delivered from a TD patch to healthy human subjects with and without pretreatment of the skin with MNs. Whereas delivery from a standard NTX TD patch over a 72-h period yielded undetectable drug plasma levels, pretreatment of skin with MNs achieved steady-state plasma concentrations within 2 h of patch application and were maintained for at least 48 h. The MNs and NTX patch were well tolerated with mild systemic and application site side effects. The MN arrays were painless upon administration and not damaged during skin insertion, and no MNs were broken off into the skin. This human proof-of-concept study demonstrates systemic administration of a hydrophilic medication by MN-enhanced TD delivery. These findings set the stage for future human studies of skin-impermeant medications and biopharmaceuticals for clinical applications. PMID:18250310

Wermeling, Daniel P.; Banks, Stan L.; Hudson, David A.; Gill, Harvinder S.; Gupta, Jyoti; Prausnitz, Mark R.; Stinchcomb, Audra L.

2008-01-01

18

Medical Devices and Systems PRECISE Center  

E-print Network

that are not likely to be met by research in your field alone? ­ Advances in medical devices domain requires12/16/2008 1 Medical Devices and Systems Insup Lee PRECISE Center Department Computer and Information Science University of Pennsylvania 12/15/08 CPS Information Day Medical Devices Containing

Rajkumar, Ragunathan "Raj"

19

Medical Device Industry Educatinon Cosortium  

NSDL National Science Digital Library

The Medical Device 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.

Sullivan, Michael

2009-07-14

20

Transdermal drug delivery  

Microsoft Academic Search

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, noncavitational ultrasound and iontophoresis have also resulted

Mark R Prausnitz; Robert Langer

2008-01-01

21

TECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects of medical devices on their  

E-print Network

TECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects. Craven and Sarah Sharples Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH of medical devices on their users, whether it be healthcare professionals or patients, is an important

Oakley, Jeremy

22

76 FR 8637 - Medical Devices; Medical Device Data Systems  

Federal Register 2010, 2011, 2012, 2013

...for purposes of the MDR system, establishment registration and device listing, reports...suggested that devices that comprise a virtual system--for example, a blood pressure...of enforcement discretion will not be permanent. The regulatory alternatives are...

2011-02-15

23

Feasibility of retroreflective transdermal optical wireless communication.  

PubMed

There is an increasing demand for transdermal high-data-rate communication for use with in-body devices, such as pacemakers, smart prostheses, neural signals processors at the brain interface, and cameras acting as artificial eyes as well as for collecting signals generated within the human body. Prominent requirements of these communication systems include (1) wireless modality, (2) noise immunity and (3) ultra-low-power consumption for the in-body device. Today, the common wireless methods for transdermal communication are based on communication at radio frequencies, electrical induction, or acoustic waves. In this paper, we will explore another alternative to these methods--optical wireless communication (OWC)--for which modulated light carries the information. The main advantages of OWC in transdermal communication, by comparison to the other methods, are the high data rates and immunity to external interference availed, which combine to make it a promising technology for next-generation systems. In this paper, we present a mathematical model and experimental results of measurements from direct link and retroreflection link configurations with Gallus gallus domesticus derma as the transdermal channel. The main conclusion from this work is that an OWC link is an attractive communication solution in medical applications. For a modulating retroreflective link to become a competitive solution in comparison with a direct link, low-energy-consumption modulating retroreflectors should be developed. PMID:22722303

Gil, Yotam; Rotter, Nadav; Arnon, Shlomi

2012-06-20

24

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2013 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

2013-04-01

25

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2013 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical...

2013-04-01

26

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section...HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL...Miscellaneous Devices § 880.6310 Medical device data system. (a)...

2011-04-01

27

[Information safety test of digital medical device].  

PubMed

According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices. PMID:25330611

Liu, Jiong

2014-07-01

28

A novel non-imaging optics based Raman spectroscopy device for transdermal blood analyte measurement  

PubMed Central

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. PMID:22125761

Kong, Chae-Ryon; Barman, Ishan; Dingari, Narahara Chari; Kang, Jeon Woong; Galindo, Luis; Dasari, Ramachandra R.; Feld, Michael S.

2011-01-01

29

A novel non-imaging optics based Raman spectroscopy device for transdermal blood analyte measurement  

NASA Astrophysics Data System (ADS)

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.

2011-09-01

30

Medical devices for the anesthetist: current perspectives  

PubMed Central

Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices 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 medical devices 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. PMID:24707188

Ingrande, Jerry; Lemmens, Hendrikus JM

2014-01-01

31

Acquisition of medical device start-ups  

E-print Network

Introduction: In the medical device space, a large proportion of the breakthrough inventions are developed by small firms that use private equity to bring their technologies from concept to varying stages of development. ...

Nair, Ganesh R

2006-01-01

32

Medical devices for the anesthetist: current perspectives.  

PubMed

Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices 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 medical devices 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. PMID:24707188

Ingrande, Jerry; Lemmens, Hendrikus Jm

2014-01-01

33

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...System Devices Panel of the Medical Devices Advisory Committee...System Devices Panel of the Medical Devices Advisory Committee...introducer, loader, dilator, balloon (used to pre-dilate the...Associate Commissioner for Special Medical Programs. [FR Doc....

2011-06-22

34

77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...System Devices Panel of the Medical Devices Advisory Committee...System Devices Panel of the Medical Devices Advisory Committee...introducer, loader, dilator, balloon (used to pre-dilate the...Associate Commissioner for Special Medical Programs. [FR Doc....

2012-04-27

35

78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...  

Federal Register 2010, 2011, 2012, 2013

...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...the regulations on premarket approval of medical devices to include requirements relating...Act requires persons who submit certain medical device applications to include, if...

2013-02-19

36

76 FR 7220 - Medical Device Innovation Initiative; Request for Comments  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0063] Medical Device Innovation Initiative; Request for Comments AGENCY...comment entitled ``Medical Device Innovation Initiative'' (the report). The...the global leader in medical device innovation and CDRH is committed to assuring...

2011-02-09

37

76 FR 45268 - Reprocessing of Reusable Medical Devices  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0294] Reprocessing of Reusable Medical Devices AGENCY: Food and Drug Administration...affecting the reprocessing of reusable medical devices, including reprocessing quality...relates to the reprocessing of reusable medical devices, reprocessing...

2011-07-28

38

Handheld Diagnostic Device Delivers Quick Medical Readings  

NASA Technical Reports Server (NTRS)

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.

2014-01-01

39

21 CFR 880.6310 - Medical device data system.  

...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a)...

2014-04-01

40

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2010 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

2010-04-01

41

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2012 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

2012-04-01

42

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2011 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

2011-04-01

43

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2013 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

2013-04-01

44

21 CFR 892.2020 - Medical image communications device.  

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

2014-04-01

45

Designing Medical Devices for the Ear  

NSDL National Science Digital Library

Students are introduced to engineering, specifically to biomedical engineering and the engineering design process, through a short lecture and an associated hands-on activity in which they design their own medical devices for retrieving foreign bodies from the ear canal. Through the lesson, they learn the basics of ear anatomy and how ear infections occur and are treated. Besides antibiotic treatment, the most common treatment for chronic ear infections is the insertion of ear tubes to drain fluid from the middle ear space to relieve pressure on the ear drum. Medical devices for this procedure, a very common children's surgery, are limited, sometimes resulting in unnecessary complications from a simple procedure. Thus, biomedical engineers must think creatively to develop new solutions (that is, new and improved medical devices/instruments) for inserting ear tubes into the ear drum. The class learns the engineering design process from this ear tube example of a medical device design problem. In the associated activity, students explore biomedical engineering on their own by designing prototype medical devices to solve another ear problem commonly experienced by children: the lodging of a foreign body (such as a pebble, bead or popcorn kernel) in the ear canal. The activity concludes by teams sharing and verbally analyzing their devices.

Biomedical Engineering

46

The physician, the manufacturer, and medical devices.  

PubMed

Better communication between physicians and manufacturers of medical devices is becoming increasingly important due to wider usage of these devices, as well as more intense scrutiny by consumer interest groups. Physicians should therefore have more complete knowledge of techniques of new product development. A new product typically passes through at least six stages, as follows: (1) idea conception; (2) merit and feasibility study; (3) design and testing; (4) production preparation; (5) market preparation; and (6) marketing. These steps are completed over a period of several years at an ever increasing cost. We propose that interaction procedures be undertaken so as to enhance direct physician-manufacturer communications in the medical device arena. Some possible techniques of improving these communications include the direct training of physicians and manufacturers in each other's problems, the establishment of hospital engineering groups, the placement of medical consultants in industry, and the active participation in device standards-generating groups and other groups of mutual interest. PMID:1200835

Bruner, J D; Drinker, P A

1975-12-01

47

Medical ice slurry production device  

DOEpatents

The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

Kasza, Kenneth E. (Palos Park, IL); Oras, John (Des Plaines, IL); Son, HyunJin (Naperville, IL)

2008-06-24

48

Diclofenac Transdermal Patch  

MedlinePLUS

Transdermal diclofenac is used to treat short-term pain due to minor strains, sprains, and bruises. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain.

49

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...  

Federal Register 2010, 2011, 2012, 2013

...Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First...facilitate early feasibility studies of medical devices, using appropriate...practices for investigational medical device studies. Concurrent with the...

2013-10-01

50

75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...  

Federal Register 2010, 2011, 2012, 2013

...the methodology of studies for medical device performance...the performance of medical devices (including...comparative effectiveness studies). The centers participating...with an interest in medical device outcome and epidemiologic study methodology....

2010-03-24

51

Advertising and promotion of medical devices.  

PubMed

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties. PMID:17002234

Portnoy, Stuart

2006-01-01

52

76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2011-11-21

53

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2012-03-28

54

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2010-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2010-09-23

55

78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2013-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2013-05-02

56

76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...  

Federal Register 2010, 2011, 2012, 2013

...Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee...Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee...

2011-09-07

57

75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2010-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2010-12-27

58

76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2011-09-19

59

[Design and application of implantable medical device information management system].  

PubMed

Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk. PMID:23777076

Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

2013-03-01

60

Overview of Agreement Statistics for Medical Devices  

Microsoft Academic Search

This paper is an overview that summarizes recently developed tools in assessing agreement for methods comparison and instrument\\/assay validation in medical devices. This paper emphasizes concept, sample sizes, and examples more than analytical formulas. We have considered a unified approach of evaluating agreement among multiple instruments (k), each with multiple replicates (m) for both continuous and categorical data. We start

Lawrence Lin

2007-01-01

61

Experience with Reviewing Bayesian Medical Device Trials  

Microsoft Academic Search

The purpose of this paper is to present a statistical reviewer's perspective on some technical aspects of reviewing Bayesian medical device trials submitted to the Food and Drug Administration. The discussion reflects the experiences of the authors and should not be misconstrued as official guidance by the FDA. A variety of applications are described, reflecting our experience with therapeutic and

Gene Pennello; Laura Thompson

2007-01-01

62

Literature Review of Testing Techniques for Medical Device Software  

E-print Network

of America, the Food and Drug Administration (FDA) regulates medical devices. However, FDA is often forcedLiterature Review of Testing Techniques for Medical Device Software John J. Majikes Department As software-controlled medical devices evolve from monolithic de- vices to modular Medical Cyber

Xie, Tao

63

Preparation of medical devices for evaluation.  

PubMed

Preparing and processing medical device implants for evaluation is a relatively high-risk and high-dollar process in which studies get made and endpoints can be lost with no second chance. It is important to customize every aspect of the preparation process to the type of device and the study endpoints. Some standard and proven approaches for a few types of implants are discussed, addressing fixation, special dissection and extraction techniques, preprocessing imaging, trimming techniques, sample processing, embedding media, and cutting and staining options. PMID:18337224

Rousselle, Serge; Wicks, Joan

2008-01-01

64

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2012 CFR

...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2012-07-01

65

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2011-07-01

66

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2014-07-01

67

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2013 CFR

...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2013-07-01

68

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2012 CFR

...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2012-07-01

69

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2013 CFR

...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2013-07-01

70

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2012 CFR

...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2012-07-01

71

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2014-07-01

72

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2011-07-01

73

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2011-07-01

74

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2014-07-01

75

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2013 CFR

...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2013-07-01

76

Medical device software: a new challenge.  

PubMed

The application of software in the medical device domain has become central to improve diagnoses and treatments. The introduction of new regulations poses issues for the qualification and classification of MD software and requires complex procedures to make them complaint with safety requirements. The paper focuses on EU, Canada and US regulations, standards and guidelines and in particular highlights the integration of the risk management process with the software lifecycle. PMID:22874320

Luzi, Daniela; Pecoraro, Fabrizio

2012-01-01

77

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2011 CFR

21 Food and Drugs 8 2011-04-01...2011-04-01 false Medical devices; misleading statements...6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2011-04-01

78

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2012 CFR

21 Food and Drugs 8 2012-04-01...2012-04-01 false Medical devices; misleading statements...6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2012-04-01

79

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2013 CFR

21 Food and Drugs 8 2013-04-01...2013-04-01 false Medical devices; misleading statements...6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2013-04-01

80

21 CFR 801.6 - Medical devices; misleading statements.  

21 Food and Drugs 8 2014-04-01...2014-04-01 false Medical devices; misleading statements...6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2014-04-01

81

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2010 CFR

21 Food and Drugs 8 2010-04-01...2010-04-01 false Medical devices; misleading statements...6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2010-04-01

82

Medical Guidelines Reconciling Medical Software and Electronic Devices: Imatinib Case-study  

E-print Network

of medical informatics and medical cyber-physical systems is an important step inMedical Guidelines Reconciling Medical Software and Electronic Devices: Imatinib Case-study Alena.demicheli@epfl.ch Abstract--Nowadays medical software is tightly coupled with medical devices that perform patient state

De Micheli, Giovanni

83

The Museum of Questionable Medical Devices  

NSDL National Science Digital Library

Featuring items on loan from the U.S. Food and Drug Administration, the American Medical Association, and others, the Minneapolis-based Museum of Questionable Medical Devices 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 Medical Devices Website provides a worthwhile diversion.

84

Hacking medical devices a review - biomed 2013.  

PubMed

Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as ?hacking?. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (?buggy?) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States. PMID:23686179

Frenger, Paul

2013-01-01

85

Electrospun PVP-indomethacin constituents for transdermal dressings and drug delivery devices.  

PubMed

A method in layering dressings with a superficial active layer of sub-micrometer scaled fibrous structures is demonstrated. For this, polyvinylpyrolidone (PVP)-indomethacin (INDO) fibres (5% w/v PVP, 5% w/w indomethacin, using a 50:50 ethanol-methanol solvent system) were produced at different flow rates (50 ?L/min and 100 ?L/min) via a modified electrospinning device head (applied voltage varied between 15 ± 2 kV). We further assessed these structures for their morphological, physical and chemical properties using SEM, AFM, DSC, XRD, FTIR and HPLC-UV. The average diameter of the resulting 3D (ca. 500 nm in height) PVP-INDO fibres produced at 50 ?L/min flow rate was 2.58 ± 0.30 ?m, while an almost two-fold increase in the diameter was observed (5.22 ± 0.83 ?m) when the flow rate was doubled. However, both of these diameters were appreciably smaller than the existing dressing fibres (ca. 30 ?m), which were visible even when layered with the active spun fibres. Indomethacin was incorporated in the amorphous state. The encapsulation efficiency was 75% w/w, with complete drug release in 45 min. The advantages are the ease of fabrication and deposition onto any existing normal or functionalised dressing (retaining the original fabric functionality), elimination of topical product issues (application, storage and transport), rapid release of active and controlled loading of drug content (fibre layer). PMID:24997411

Rasekh, Manoochehr; Karavasili, Christina; Soong, Yi Ling; Bouropoulos, Nikolaos; Morris, Mhairi; Armitage, David; Li, Xiang; Fatouros, Dimitrios G; Ahmad, Zeeshan

2014-10-01

86

Transdermal opioids for cancer pain.  

PubMed

Patients with moderate to severe malignancy-related pain frequently require the use of opioid pharmacotherapy. Unfortunately, many cancer patients continue to be prescribed subtherapeutic doses of pain medications resulting in undo suffering and diminished quality of life. The choice of analgesic pharmacotherapy should be individualized and based on the intensity and etiology of pain reported by the patient. Health care providers must be able to readily quantify the relative analgesic potency when converting from one opioid to another or from one route of administration to another. Transdermal fentanyl is effective and well tolerated pharmacotherapy for the cancer pain patients. However, clinicians need to be cognizant that the U.S./U.K. manufacturer's recommendations for equilalagesic dosing of transdermal fentanyl may result in initial doses that produce subtherapeutic levels and unrelieved pain in some patients. A more aggressive dosing algorithm for transdermal fentanyl using a 2:1 (mg/day of oral morphine: mcg/hr of transdermal fentanyl) conversion ratio that considers both a review of the literature and clinical experience should help clinicians individualize cancer pain pharmacotherapy. Transdermal buprenorphine is now being prescribed in Europe and Australia for chronic and cancer pain management. Buprenorphine's mixed agonist/antagonist activity, dosage ceiling, and high affinity to the opiate receptor limits its use to those patients who do not already require large daily doses of opioids. Thus, buprenorphine may not be an appropriate medication for some patients with advanced unremitting cancer pain. PMID:16573839

Skaer, Tracy L

2006-01-01

87

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...  

Code of Federal Regulations, 2013 CFR

21 Food and Drugs 8 2013-04-01...2013-04-01 false Medical devices; warning statements...63 Section 801.63 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2013-04-01

88

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...  

Code of Federal Regulations, 2012 CFR

21 Food and Drugs 8 2012-04-01...2012-04-01 false Medical devices; warning statements...63 Section 801.63 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2012-04-01

89

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...  

21 Food and Drugs 8 2014-04-01...2014-04-01 false Medical devices; warning statements...63 Section 801.63 Food and Drugs FOOD AND DRUG ADMINISTRATION...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

2014-04-01

90

77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Neurological Devices Panel of the Medical Devices Advisory Committee...multilumen device with two balloons mounted near the distal tip...inflation of the individual balloons. The device is placed in the...patients who have failed maximal medical management. Of note,...

2012-11-16

91

77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Neurological Devices Panel of the Medical Devices Advisory Committee...multi-lumen device with two balloons mounted near the distal tip...inflation of the individual balloons. The device is placed in the...patients who have failed maximal medical management. Of note,...

2012-10-11

92

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...  

Federal Register 2010, 2011, 2012, 2013

...Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered...rulemaking? The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C...PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority...

2010-11-17

93

76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...  

Federal Register 2010, 2011, 2012, 2013

...Medical Devices; General and Plastic Surgery Devices; Classification of Contact...rulemaking? The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S...PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority...

2011-02-07

94

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...  

Federal Register 2010, 2011, 2012, 2013

...Medical Devices; General and Plastic Surgery Devices; Classification of the Focused...of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S...PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority...

2011-07-20

95

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...  

Federal Register 2010, 2011, 2012, 2013

...Medical Devices; General and Plastic Surgery Devices; Classification of the Low...of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S...PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority...

2011-04-14

96

An update on mobile phones interference with medical devices.  

PubMed

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices 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 medical devices, 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 medical devices and developing technology standards can lead to their effective use in hospital communication systems. PMID:23559585

Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

2013-10-01

97

Functional Alarms for Systems of Interoperable Medical Devices  

PubMed Central

Alarms are essential for medical systems in order to ensure patient safety during deteriorating clinical situations and inevitable device malfunction. As medical devices are connected together to become interoperable, alarms become crucial part in making them high-assurance, in nature. Traditional alarm systems for interoperable medical devices have been patientcentric. In this paper, we introduce the need for an alarm system that focuses on the correct functionality of the interoperability architecture itself, along with several considerations and design challenges in enabling them.

Venkatasubramanian, Krishna K.; Vasserman, Eugene Y.; Sokolsky, Oleg; Lee, Insup

2014-01-01

98

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2012 CFR

...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

2012-04-01

99

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2011 CFR

...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

2011-04-01

100

21 CFR 892.2010 - Medical image storage device.  

...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

2014-04-01

101

77 FR 72924 - Taxable Medical Devices  

Federal Register 2010, 2011, 2012, 2013

...that 21 CFR part 876 (Gastroenterology- Urology Devices) be removed from the list of...21 CFR part 876 (Gastroenterology--Urology Devices), 21 CFR part 878 (General...21 CFR part 876 (Gastroenterology--Urology Devices) and product code EXH. The...

2012-12-07

102

The regulation of cognitive enhancement devices: extending the medical model  

PubMed Central

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.

Maslen, Hannah; Douglas, Thomas; Cohen Kadosh, Roi; Levy, Neil; Savulescu, Julian

2014-01-01

103

Medical Devices: Principles of Clinical Evaluation of Effectiveness and Safety  

E-print Network

Medical Devices: Principles of Clinical Evaluation of Effectiveness and Safety P1 D11 v2 050521 in trials including ethical issues. However, it goes on to indicate where trials of medical devices need basic groups of users in mind: The manager or non-specialist, including the new recruit, requiring

Oakley, Jeremy

104

Postdoctoral Scholar position Area: Vascular Fluid Mechanics in Medical Devices  

E-print Network

Postdoctoral Scholar position Area: Vascular Fluid Mechanics in Medical Devices Duration: TBD Start for a postdoctoral researcher to join an interdisciplinary team developing and testing medical devices more of the best minds in our classrooms and labs. We're increasing our scholarly capacity by investing

de Leon, Alex R.

105

Medical device regulation: what a practicing dermatologist should know.  

PubMed

The practicing dermatologist uses many medical devices during his or her day-to-day practice. The authors present a broad overview of how such medical devices are reviewed for safety and reasonable assurance of effectiveness, and evaluated for classification prior to marketing in the United States by the Food and Drug Administration. The specific example of dermal fillers as a class III medical device is discussed together with its regulatory ramifications. This article is written by staff currently employed at the Center for Devices and Radiological Health and should provide information useful to the practicing dermatologist. PMID:19453348

Dang, Jiyoung M; Krause, David; Felten, Richard P; Luke, Markham C; Luke, Markham K

2009-01-01

106

Towards sustainable design for single-use medical devices.  

PubMed

Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices 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 medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137

Hanson, Jacob J; Hitchcock, Robert W

2009-01-01

107

78 FR 15878 - Taxable Medical Devices; Correction  

Federal Register 2010, 2011, 2012, 2013

...the blood glucose monitors under 21 CFR part 862 (Clinical Chemistry and Clinical Toxicology Devices) and product code...classifies the test strips under 21 CFR part 862 (Clinical Chemistry and Clinical Toxicology Devices) and product...

2013-03-13

108

Materials for Medical Devices New materials have played a crucial role in the advancement of medical devices. For  

E-print Network

Materials for Medical Devices New materials have played a crucial role in the advancement of medical devices. For example, the introduction of titanium alloys provided a high strength basis to enhance the biology of healing either by promoting minimally invasive procedures, circumventing tissue

Li, Mo

109

A biomedical device business plan for Medicraften Devices Inc. to develop a fluid medication dispenser  

E-print Network

This thesis surrounds an analysis to understand what it would take for a company to successfully launch a prescription fluid dispensing device. This device would in theory be able to dispense medication at any time daily ...

Louison, Charles Davidson

2006-01-01

110

NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW  

PubMed Central

Medical device 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. Medical device 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 medical devices. 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. PMID:22247840

Songara, Raiendra K.; Sharma, Ganesh N.; Gupta, Vipul K.; Gupta, Promila

2010-01-01

111

Current Status of the Regulation for Medical Devices  

PubMed Central

In the light of escalating use of medical devices, 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 medical devices. Pharmacy personnel can certainly play an important role in the regulation of medical devices. 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. PMID:21369427

Shah, Anuja R.; Goyal, R. K.

2008-01-01

112

[Data transparency regarding medical devices - the position of the medical device industry].  

PubMed

The medical device industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany. PMID:21530908

Soskuty, Gabriela

2011-01-01

113

The medical physics of ventricular assist devices  

Microsoft Academic Search

Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful

Houston G Wood; Amy L Throckmorton; Alexandrina Untaroiu; Xinwei Song

2005-01-01

114

Legal framework conditions for the reprocessing of medical devices.  

PubMed

The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM).For medical devices in the category "critical C", the RKI/BfArM-recommendation provides that the processor's quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007.On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate. PMID:20204096

Großkopf, Volker; Jäkel, Christian

2008-01-01

115

Legal framework conditions for the reprocessing of medical devices  

PubMed Central

The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM). For medical devices in the category “critical C”, the RKI/BfArM-recommendation provides that the processor’s quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007. On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate. PMID:20204096

Grosskopf, Volker; Jakel, Christian

2008-01-01

116

Characteristics of disruptive innovation within the medical device industry  

E-print Network

Innovation within the medical device industry had led to tremendous advances in the provision of care for patients worldwide. Continued progress in the treatment of disease will require effective processes for managing and ...

Berlin, David B. (David Benjamin)

2011-01-01

117

A system theoretic approach to design safety into medical device  

E-print Network

The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic ...

Song, Qingyang S.M. Massachusetts Institute of Technology

2012-01-01

118

Factors influencing FDA clearance time for medical device 510(k)  

E-print Network

Since the FDA Modernization Act of 1997, recent legislation has sought to establish performance goals and consistency in the regulatory review and clearance of new medical devices. Despite these goals, regulatory review ...

Koert, Andrew J. (Andrew James)

2010-01-01

119

Green manufacturing in the medical device industry : a case study  

E-print Network

Introduction: Med Dev (name changed to protect confidentiality), is a medical device start-up using tissue engineering and drug delivery techniques to help combat the negative effects associated with secondary injury. Med ...

Gautreau, Leigh (Leigh Ann)

2009-01-01

120

Factors influencing the time for FDA review of medical devices  

E-print Network

Companies must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application ...

Singh, Inder Raj, S.M. Massachusetts Institute of Technology

2007-01-01

121

Mergers and acquisitions in the medical device industry  

E-print Network

Mergers and acquisitions in the Medical Device Industry are the primary mode of exit for early stage companies. The focus of this thesis is to examine factors which influence the value of these M&A transactions from the ...

Ohashi, Kevin Lee

2007-01-01

122

Modeling medical devices for plug-and-play interoperability  

E-print Network

One of the challenges faced by clinical engineers is to support the connectivity and interoperability of medical-electrical point-of-care devices. A system that could enable plug-and-play connectivity and interoperability ...

Hofmann, Robert Matthew

2007-01-01

123

76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop  

Federal Register 2010, 2011, 2012, 2013

...the methodology of studies for medical device performance...the performance of medical devices (including...comparative effectiveness studies). We also aim to...and epidemiologic studies, Opportunities for medical device...

2011-03-30

124

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...  

Federal Register 2010, 2011, 2012, 2013

...principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical...statistical practices for investigational medical device studies. A medical device pivotal study is a definitive...

2013-11-07

125

77 FR 52745 - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal...  

Federal Register 2010, 2011, 2012, 2013

...registries with medical device data for...surveillance, clinical studies, and evidence...registries with medical device data for...surveillance, clinical studies, and evidence...registries with medical device data for regulated studies; (5)...

2012-08-30

126

78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2013-N-0580] Battery-Powered Medical Devices Workshop: Challenges...following public workshop entitled ``Battery-Powered Medical Devices Workshop: Challenges...awareness of the challenges related to battery-powered medical devices and...

2013-06-05

127

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2013 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2013-07-01

128

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2014-07-01

129

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2011 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2011-07-01

130

31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2011 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 538.526...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices to the...

2011-07-01

131

76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0062] Medical Device Innovation Initiative; Public Meeting; Request...entitled ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The...CDRH) document, ``Medical Device Innovation Initiative'' (report). FDA is...

2011-02-09

132

78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2011-D-0916] Medical Device Classification Product Codes...availability of the guidance entitled ``Medical Device Classification Product Codes...FDA program areas to regulate and track medical devices regulated by the Center for...

2013-04-11

133

77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...  

Federal Register 2010, 2011, 2012, 2013

...and Food and Drug Administration Staff; Medical Device Classification Product Codes...availability of the draft guidance entitled ``Medical Device Classification Product Codes...to use classification product codes for medical devices regulated by the Center for...

2012-01-03

134

Development of Implantable Medical Devices: From an Engineering Perspective  

PubMed Central

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device 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 medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices 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 medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

2013-01-01

135

Cutaneous reactions to transdermal therapeutic systems.  

PubMed

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

Bershow, Andrea; Warshaw, Erin

2011-01-01

136

Power and Information Transmission to Implanted Medical Device Using Ultrasonic  

Microsoft Academic Search

Using ultrasonic, we propose here a novel method of transmitting power and information to implanted medical equipment. The proposed system is composed of two piezo oscillators and has the following functions: transmission of power and control information to an implanted device, and transmission of the information acquired by an implanted device to the outside of a living body. With amplitude

Hideyuki Kawanabe; Tamotsu Katane; Hideo Saotome; Osami Saito; Kazuhito Kobayashi

2001-01-01

137

Impact of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct on medical device physician-industry collaboration  

E-print Network

The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) or 105 CMR 970.000 was enacted by the Massachusetts state legislature and adopted by the Department of Public Health (DPH) in July ...

Wolf, Daniel W. (Daniel William)

2010-01-01

138

77 FR 6028 - Taxable Medical Devices  

Federal Register 2010, 2011, 2012, 2013

...the Federal Food, Drug, and Cosmetic Act that is intended for humans...the Federal Food, Drug, and Cosmetic Act and 21 CFR part 807, pursuant...Part 878 (General and Plastic Surgery Devices), 21 CFR part 882...drug stores, supermarkets, cosmetic supply stores and other...

2012-02-07

139

75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...  

Federal Register 2010, 2011, 2012, 2013

...FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility...announced the public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and...

2010-09-01

140

Medical devices in dermatology using DLP technology from Texas Instruments  

NASA Astrophysics Data System (ADS)

The market of medical devices 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.

Kock, M.; Lüllau, F.

2012-03-01

141

Development of wearable medical device for Bio-MEMS  

NASA Astrophysics Data System (ADS)

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 medical device used for blood sugar control. The new type compact medical device 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 medical device with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 ?l/sec. If the wearable medical device 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 medical device with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15?l/sec.

Nakanishi, Naoyuki; Yamamoto, Hidetake; Tsuchiya, Kazuyoshi; Uetsuji, Yasutomo; Nakamachi, Eiji

2006-01-01

142

Battery power comparison to charge medical devices in developing countries  

Microsoft Academic Search

Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution.

Alesia M. Casanova; Andrew S. Bray; Taylor A. Powers; Amit J. Nimunkar; John G. Webster

2009-01-01

143

Battery power comparison to charge medical devices in developing countries.  

PubMed

Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution. PMID:19964250

Casanova, Alesia M; Bray, Andrew S; Powers, Taylor A; Nimunkar, Amit J; Webster, John G

2009-01-01

144

Power and Information Transmission to Implanted Medical Device Using Ultrasonic  

NASA Astrophysics Data System (ADS)

Using ultrasonic, we propose here a novel method of transmitting power and information to implanted medical equipment. The proposed system is composed of two piezo oscillators and has the following functions: transmission of power and control information to an implanted device, and transmission of the information acquired by an implanted device to the outside of a living body. With amplitude shift keying (ASK), 9.5 Kbps is obtained for the proposed information transmission system.

Kawanabe, Hideyuki; Katane, Tamotsu; Saotome, Hideo; Saito, Osami; Kobayashi, Kazuhito

2001-05-01

145

Medical Devices Assess, Treat Balance Disorders  

NASA Technical Reports Server (NTRS)

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.

2009-01-01

146

77 FR 41417 - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices  

Federal Register 2010, 2011, 2012, 2013

...for Medical Countermeasure Radiation Biodosimetry Devices AGENCY: Food and Drug Administration...Medical Countermeasure (MCM) Radiation Biodosimetry Devices.'' The purpose of the public...performance validation of radiation biodosimetry devices. Date and Time: The...

2012-07-13

147

Lessons learned: mobile device encryption in the academic medical center.  

PubMed

The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs. PMID:19382736

Kusche, Kristopher P

2009-01-01

148

Sonicated transdermal drug transport  

Microsoft Academic Search

The following review explores the promise shown by sonicated transdermal drug transport as a novel drug delivery system in great detail. It elucidates the advantages of transdermal drug transport (TDT) over the currently prevalent modes of drug administration and then goes on to explain why despite these obvious advantages TDT is so sparingly used. This discussion includes the problems posed

Amit Joshi; Jaideep Raje

2002-01-01

149

Wireless energy transfer platform for medical sensors and implantable devices  

Microsoft Academic Search

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

Fei Zhang; Steven A. Hackworth; Xiaoyu Liu; Haiyan Chen; Robert J. Sclabassi; Mingui Sun

2009-01-01

150

MATCH Guide towards User Involvement in Medical Device Technology  

E-print Network

MATCH Guide towards User Involvement in Medical Device Technology Assessment P3 D10 V1 050429 Ian Multidisciplinary Assessment of Technology Centre for Health #12;EXECUTIVE SUMMARY Introduction This guide provides of published literature drawing on engineering, ergonomics, healthcare and social sciences. Aims · Map

Oakley, Jeremy

151

Microscale metal additive manufacturing of multi-component medical devices  

Microsoft Academic Search

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 medical devices. 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

2010-01-01

152

Medical Devices: The Therac25 \\Lambda Nancy Leveson  

E-print Network

is treated with the accelerated elec­ trons; to reach deeper tissue, the electron beam is converted into X the long physical mechanism required to accelerate the electrons, and it is more economical to produce and installation of nuclear reactors. #12; App. A -- Medical Devices: The Therac­25

Leveson, Nancy

153

A quantitative approach for medical device Health Hazard Analysis  

Microsoft Academic Search

Health Hazard Analysis (HHA) is one major type of patient health risk assessment for medical device field performance issue. U.S. Food and Drug Administration (FDA) has an online form, listing the needed information for HHA. In this paper, we will illustrate a quantitative HHA approach, which is structured in a rigorous risk assessment framework, with several critical steps, concepts and

Mingxiao Jiang; Kathy Herzog; Thomas Pepin; Michael D. Baca

2011-01-01

154

European medical device regulatory law and product liability  

Microsoft Academic Search

The regulatory system for medical devices 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

J. Bright

1999-01-01

155

Career development of biomedical engineers in medical device industry  

Microsoft Academic Search

With concerns of the current health care system, biomedical engineers have expertise, opportunity and responsibility in developing innovations that may improve cost, coverage and quality of health care delivery. This paper reviews the product development process in the medical device industry, and the associated training and experience required for biomedical engineers involved at each stage of the process. This paper

Quan Ni; Yachuan Pu

2009-01-01

156

77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...  

Federal Register 2010, 2011, 2012, 2013

...Examples of Unproven Drugs, Devices, Medical Treatments, or Procedures AGENCY: Office...for which there are demonstrations from medical literature, national organizations...accepted standards of practice in the medical community. Additionally, this rule...

2012-06-27

157

Transdermal Photopolymerization for Minimally Invasive Implantation  

NASA Astrophysics Data System (ADS)

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.

1999-03-01

158

French Sizing of Medical Devices is not Fit for Purpose  

SciTech Connect

PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

Kibriya, Nabil, E-mail: nabskib@yahoo.co.uk; Hall, Rebecca; Powell, Steven [The Royal Liverpool University Hospital, Radiology Department (United Kingdom); How, Thien [University of Liverpool, Faculty of Health and Life Sciences (United Kingdom); McWilliams, Richard G. [The Royal Liverpool University Hospital, Radiology Department (United Kingdom)

2013-08-01

159

Image Quality Characteristics of Handheld Display Devices for Medical Imaging  

PubMed Central

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10?5 mm2 at 1 mm?1, while handheld displays have values lower than 3.7×10?6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo

2013-01-01

160

An Approach to Reviewing Software in Medical Devices Raoul Jetley S. Purushothaman Iyer  

E-print Network

for software used in medical device systems. To ensure safe operation of medical device software, the US FoodAn Approach to Reviewing Software in Medical Devices Raoul Jetley S. Purushothaman Iyer Dept}@csc.ncsu.edu Paul L. Jones Center for Devices and Radiological Health Food and Drug Administration Rockville, MD

Young, R. Michael

161

Management information system of medical equipment using mobile devices  

NASA Astrophysics Data System (ADS)

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.

Núñez, C.; Castro, D.

2011-09-01

162

Quantitative risk analysis of medical devices: an endoscopic imaging example  

NASA Astrophysics Data System (ADS)

The performance of trained human observers in diagnosing a medical situation through an endoscope can be represented by a receiver operating characteristic (ROC) curve. When the ROC plot is related to a plot of signal to noise ratio (SNR) of the endoscope system display versus system resolution, the operator performance for a given size target object can be determined from the ROC. The ROC curve gives probability statistics associated with detection. When the costs of errors are assigned, this method would quantify the risks associated with the use of the device. It is proposed as a method which would allow a regulatory agency to judge imaging devices based on quantified cost/benefits.

Waynant, Ronald W.

1995-10-01

163

Wireless energy transfer platform for medical sensors and implantable devices.  

PubMed

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

2009-01-01

164

Antimicrobial selenium nanoparticle coatings on polymeric medical devices  

NASA Astrophysics Data System (ADS)

Bacteria colonization on medical devices 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 medical devices represent a significant portion of the total medical devices 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.

Tran, Phong A.; Webster, Thomas J.

2013-04-01

165

Printable thermoelectric devices and conductive patterns for medical applications  

NASA Astrophysics Data System (ADS)

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 medical devices 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 medical devices. 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.

2012-10-01

166

Simulation of cyclic reprocessing buildup on reused medical devices.  

PubMed

A series of discrete models were developed to study the development of cyclic reprocessing buildup (CRB) on medical devices, and to explore the effect of cleaning efficacy and type of disinfection on the removal of this CRB. A cellular automata (CA) model was used to simulate the development of CRB, including microbial replication and production of extracellular matrix (EM). The process of disinfection (microbes being killed, EM being cross-linked or oxidized, etc.) was also described in the CA model. Next, a stochastic model, Ising's model combined with Monte Carlo methods was used to simulate the removal of CRB from a surface by cleaning. These models were developed to simulate the persistent residual CRB that occurs on reused medical devices such as flexible endoscopes, to determine how well the various microbes survive in the CRB during disinfection and cleaning, and to predict the efficiency of disinfectants to kill microbes within the CRB. The CRB model will help evaluate cleaning methods to identify those that will reduce/eliminate the CRB from occurring; thereby reducing the infection transmission potential in clinical procedures involving reprocessed medical devices. PMID:19442966

Zhong, Wen; Alfa, Michelle; Zelenitsky, Sheryl; Howie, Rosemarie

2009-06-01

167

The liabilities and consequences of medical device development.  

PubMed

A large increase in medical products liability litigation during the past 40 years has resulted in a flood of litigation against drug and device manufacturers. The medical technology and chemical industries are prime targets for products liability litigation. Physicians and other health care providers are willing to accept a reasonable degree of risk associated with the use of a medical product when compared to the benefit to be achieved by that product but lay juries are less likely to tolerate the concept of an acceptable failure rate. Plaintiffs' lawyers believe that the medical products industry should be held to a standard of absolute liability and that anyone injured by a medical product is entitled to recover without regard for the circumstances. Large compensatory and punitive damage awards, the high cost of insurance, large defense costs, and low profit margins have forced some companies to remove their products from the market. The medical or biomaterials manufacturer can significantly reduce its exposure for products liability by adopting a successful product safety program. Manufacturers have significant control over the quality, safety, and reliability of their products through appropriate design, testing, manufacture, labeling, and sale of quality products. PMID:3571302

Price, J M

1987-04-01

168

Rivastigmine Transdermal Patch  

MedlinePLUS

... also used to treat dementia in people with Parkinson's disease (a brain system disease with symptoms of ... cure Alzheimer's disease or dementia in people with Parkinson's disease. Continue to use transdermal rivastigmine even if ...

169

Transdermal administration of emedastine.  

PubMed

Transdermal administration of emedastine was tested in vitro and in vivo. In the diffusion cell method in vitro, emedastine free base was more permeable by transdermal administration than emedastine difumarate. Emedastine had higher permeability in hydrophobic vehicles than in hydrophilic vehicles, and was most permeable in fatty acid monoesters. It was suggested that the change in permeability of emedastine from these vehicles was dependent on the change in its partition from the vehicle to the skin. In studies using rabbits in vivo, emedastine had high permeability from fatty acid monoesters and fatty acid diesters as found in in vitro studies, and bioavailability of the drug after transdermal administration was greater than that after peroral administration. The flux of emedastine in vitro was correlative with the pharmacokinetic parameters in vivo. Consequently, it is clear that transdermal permeability of emedastine is very high and that the drug may be efficacious in the system after administration by these means. PMID:7903575

Harada, S; Takahashi, Y; Nakagawa, H

1993-09-01

170

Transdermal delivery of levosimendan.  

PubMed

The aim of this study was to determine if transdermal penetration of levosimendan, a novel positive inotropic drug, could be enhanced and controlled by formulation modifications. Penetration of levosimendan across human epidermis in vitro was determined using abdominal excised skin and diffusion cells. Predicted steady-state plasma concentrations of levosimendan were estimated using permeabilities and pharmacokinetic parameters of levosimendan. For penetration enhancement we used different pH values, co-solvents, cyclodextrins, surfactants, penetration enhancers, liposomes, and iontophoresis. Sodium lauryl sulfate, ethanol, oleic acid, and soya phosphatidylcholine or their combinations clearly increased levosimendan permeation across the skin in vitro. Iontophoresis was also an efficient method to increase transdermal permeation of levosimendan. A hydrophilic co-solvent/penetration enhancer is needed to achieve better permeability of levosimendan across the skin. In conclusion, transdermal delivery of levosimendan can be significantly increased by formulation modification. Based on kinetic calculations, therapeutic plasma concentrations may be achievable transdermally. PMID:11033078

Valjakka-Koskela, R; Hirvonen, J; Mönkkönen, J; Kiesvaara, J; Antila, S; Lehtonen, L; Urtti, A

2000-10-01

171

78 FR 41065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration...collection associated with medical devices third-party review under the Food and Drug...

2013-07-09

172

Inductively Heated Shape Memory Polymer for the Magnetic Actuation of Medical Devices  

E-print Network

Presently there is interest in making medical devices such as expandable stents and intravascular microactuators from shape memory polymer (SMP). One of the key challenges in realizing SMP medical devices is the implementation ...

Buckley, Patrick R.

2007-01-23

173

75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...  

Federal Register 2010, 2011, 2012, 2013

...Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization...workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization...your experience or expertise with nanotechnology. There will be a limited number...

2010-08-23

174

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.  

Code of Federal Regulations, 2011 CFR

... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

2011-04-01

175

31 CFR 560.533 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2012 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 560.533 Section 560.533 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2012-07-01

176

31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2014-07-01

177

31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2012 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2012-07-01

178

31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2013 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2013-07-01

179

76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The Federal...

2011-08-01

180

77 FR 45359 - Medical Device User Fee Rates for Fiscal Year 2013  

Federal Register 2010, 2011, 2012, 2013

...FDA-2012-N-0785] Medical Device User Fee Rates for Fiscal Year 2013 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2013. The Federal...

2012-07-31

181

78 FR 46970 - Medical Device User Fee Rates for Fiscal Year 2014  

Federal Register 2010, 2011, 2012, 2013

...FDA-2013-N-0007] Medical Device User Fee Rates for Fiscal Year 2014 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal...

2013-08-02

182

Securing Wireless Communication with Implanted Medical Devices using Reciprocal Carrier-Phase Quantization  

E-print Network

Securing Wireless Communication with Implanted Medical Devices using Reciprocal Carrier@rit.edu Abstract Securing wireless communication with resource- constrained implanted medical devices is considered virtually no computation power or memory. These properties make the proposed method an attractive

Tsouri, Gill

183

78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...advisory committee of the Food and Drug Administration (FDA). The...Radiological Health, Food and Drug Administration, 10903 New Hampshire...is a method of non- invasive transdermal delivery in which a substance...deliver currents to transport drugs, soluble salts, or ionic...

2013-12-24

184

Improvised explosive devices: pathophysiology, injury profiles and current medical management.  

PubMed

The improvised explosive device (IED), in all its forms, has become the most significant threat to troops operating in Afghanistan and Iraq. These devices range from rudimentary home made explosives to sophisticated weapon systems containing high-grade explosives. Within this broad definition they may be classified as roadside explosives and blast mines, explosive formed pojectile (EFP) devices and suicide bombings. Each of these groups causeinjury through a number of different mechanisms and can result in vastly different injury profiles. The "Global War on Terror" has meant that incidents which were previously exclusively seen in conflict areas, can occur anywhere, and clinicians who are involved in emergency trauma care may be required to manage casualties from similar terrorist attacks. An understanding of the types of devices and their pathophysiological effects is necessary to allow proper planning of mass casualty events and to allow appropriate management of the complex poly-trauma casualties they invariably cause. The aim of this review article is to firstly describe the physics and injury profile from these different devices and secondly to present the current clinical evidence that underpins their medical management. PMID:20397601

Ramasamy, A; Hill, A M; Clasper, J C

2009-12-01

185

Safety Evaluation of Medical Devices: US Food and Drug Administration and International Standards Organization Guidelines  

Microsoft Academic Search

During the last 20 years, safety evaluation of medical devices has evolved from screening assays to the “pharmaceutical model” of preclinical testing. Biocompatibility testing guidelines for medical devices are published in the International Organization for Standardization (ISO) document 10993–1: Biological evaluation of medical devices—Part 1: Evaluation and testing. These guidelines are recognized by most national regulatory bodies and supplement, but

Sharon J. Northup

1999-01-01

186

75 FR 57801 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013

...Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration...collection in ``Medical Devices Third- Party Review under the Food and Drug Administration...information technology. Medical Devices Third-Party Review Under the Food and Drug...

2010-09-22

187

MMEC Forward Focus Innovation Meets Standardization: Neuralynx Pursuing the Medical Device Market  

E-print Network

for medical devices needed as the foundation to comply with U.S. Food and Drug Administration (FDA), CEMMEC Forward Focus Innovation Meets Standardization: Neuralynx Pursuing the Medical Device Market, is on a journey to becoming a medical device manufacturer where its signature products may provide information

Dyer, Bill

188

78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...  

Federal Register 2010, 2011, 2012, 2013

...for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate...for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate...medical devices for the treatment of morbid obesity and other metabolic diseases and...

2013-11-20

189

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...  

Federal Register 2010, 2011, 2012, 2013

...Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational...

2010-04-09

190

76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...  

Federal Register 2010, 2011, 2012, 2013

...Reprocessing Medical Devices in Health Care Settings: Validation Methods and...Reprocessing Medical Devices in Health Care Settings: Validation Methods and...Reprocessing Medical Devices in Health Care Settings: Validation Methods...

2011-05-02

191

Development of medical electronic devices in the APL space department  

NASA Technical Reports Server (NTRS)

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.

Newman, A. L.

1985-01-01

192

Navigating conflicts of interest for the medical device entrepreneur.  

PubMed

The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. PMID:23217436

Donovan, Aine; Kaplan, Aaron V

2012-01-01

193

Perspectives on transdermal ultrasound mediated drug delivery  

PubMed Central

The use of needles for multiple injection of drugs, such as insulin for diabetes, can be painful. As a result, prescribed drug noncompliance can result in severe medical complications. Several noninvasive methods exist for transdermal drug delivery. These include chemical mediation using liposomes and chemical enhancers or physical mechanisms such as microneedles, iontophoresis, electroporation, and ultrasound. Ultrasound enhanced transdermal drug delivery offers advantages over traditional drug delivery methods which are often invasive and painful. A broad review of the transdermal ultrasound drug delivery literature has shown that this technology offers promising potential for noninvasive drug administration. From a clinical perspective, few drugs, proteins or peptides have been successfully administered transdermally because of the low skin permeability to these relatively large molecules, although much work is underway to resolve this problem. The proposed mechanism of ultrasound has been suggested to be the result of cavitation, which is discussed along with the bioeffects from therapeutic ultrasound. For low frequencies, potential transducers which can be used for drug delivery are discussed, along with cautions regarding ultrasound safety versus efficacy. PMID:18203426

Smith, Nadine Barrie

2007-01-01

194

Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging  

NASA Astrophysics Data System (ADS)

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 medical devices 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 medical device 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

2014-02-01

195

[Industry regulation and its relationship to the rapid marketing of medical devices].  

PubMed

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices 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 Medical Devices"). PMID:23243983

Matsuoka, Atsuko

2012-01-01

196

August 17, 1997 Using a Bayesian Approach in Medical Device Development *  

E-print Network

1 August 17, 1997 Using a Bayesian Approach in Medical Device Development * Donald A. Berry for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD 20850 #12; 2 Using a Bayesian Approach in Medical Device Development Donald A. Berry Institute of Statistics & Decision Sciences

West, Mike

197

Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare  

E-print Network

No standard device interfaces PICU NICU How do we prevent errors and Injuries? OR #12;4 Mass General Hospital Hospitals" ­ 2000-2002 ­ 195,000 preventable deaths annually #12;6 Why Focus on Medical Device1 Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare

Rajkumar, Ragunathan "Raj"

198

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125...Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A device...

2011-04-01

199

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125...Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A device...

2010-04-01

200

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125...Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A device...

2012-04-01

201

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125...Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A device...

2013-04-01

202

Transdermal delivery of therapeutic agent  

NASA Technical Reports Server (NTRS)

A device for the transdermal delivery of a therapeutic agent to a biological subject that includes a first electrode comprising a first array of electrically conductive microprojections for providing electrical communication through a skin portion of the subject to a second electrode comprising a second array of electrically conductive microprojections. Additionally, a reservoir for holding the therapeutic agent surrounding the first electrode and a pulse generator for providing an exponential decay pulse between the first and second electrodes may be provided. A method includes the steps of piercing a stratum corneum layer of skin with two arrays of conductive microprojections, encapsulating the therapeutic agent into biocompatible charged carriers, surrounding the conductive microprojections with the therapeutic agent, generating an exponential decay pulse between the two arrays of conductive microprojections to create a non-uniform electrical field and electrokinetically driving the therapeutic agent through the stratum corneum layer of skin.

Kwiatkowski, Krzysztof C. (Inventor); Hayes, Ryan T. (Inventor); Magnuson, James W. (Inventor); Giletto, Anthony (Inventor)

2008-01-01

203

Nanobionics: the impact of nanotechnology on implantable medical bionic devices  

NASA Astrophysics Data System (ADS)

The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.

Wallace, G. G.; Higgins, M. J.; Moulton, S. E.; Wang, C.

2012-07-01

204

Evaluation of the medical device approval lag between the United States and the European Union  

E-print Network

The United States is the world leader in development and manufacture of medical devices. Even with this leadership position, there is evidence that the US is often not the first country to have new medical technology ...

Dhavale, Todd V

2011-01-01

205

Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump  

MedlinePLUS

... Home Use Devices Brochure - Home Healthcare Medical Devices: 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 ...

206

Make Sure the Medical Device You Choose Is Designed for You  

MedlinePLUS

... from Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management FDA/CDRH/OHIP/DDUPSA (PGS) ... g., Ham radio, AM FM TV broadcast antenna, electrical machinery, hand-held transmitters) affect the device? q ...

207

Safety-Ensured Coordination of Networked Medical Devices in MDPnP  

E-print Network

to generate medical errors [2]. As revealed in [2], medical errors are the leading cause of death and injury the human error-induced ac- cidents. This increasing demand has led to the establishment of the MedicalSafety-Ensured Coordination of Networked Medical Devices in MDPnP Tao Li, and Jiannong Cao

Hu, Fei

208

Encryption on the air : non-Invasive security for implantable medical devices  

E-print Network

Modern implantable medical devices (IMDs) including pacemakers, cardiac defibrillators and nerve stimulators feature wireless connectivity that enables remote monitoring and post-implantation adjustment. However, recent ...

Al-Hassanieh, Haitham (Haitham Zuhair)

2011-01-01

209

47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...  

Code of Federal Regulations, 2011 CFR

...Specific requirements for wireless medical telemetry devices operating in the 1395-1400...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the...

2011-10-01

210

47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...  

Code of Federal Regulations, 2013 CFR

...Specific requirements for wireless medical telemetry devices operating in the 1395-1400...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the...

2013-10-01

211

47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...  

Code of Federal Regulations, 2012 CFR

...Specific requirements for wireless medical telemetry devices operating in the 1395-1400...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the...

2012-10-01

212

Older Adults' Satisfaction with a Medication Dispensing Device in Home Care  

PubMed Central

Introduction Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults’ perceptions of a telehealth medication dispensing device as part of a clinical trial involving home health care clients, nurse coordination and use of the medication dispensing device. Methods Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Results Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. Conclusion The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research. Trial Registration clinicaltrials.gov identifier: NCT01321853 PMID:23323721

Demiris, George; Marek, Karen D.

2014-01-01

213

26 CFR 48.4191-2 - Taxable medical device.  

Code of Federal Regulations, 2013 CFR

...and Throat Devices), 21 CFR part 876 (Gastroenterology—Urology Devices), 21 CFR part 878 (General and Plastic Surgery...ileostomy bags under 21 CFR part 876 (Gastroenterology—Urology Devices) and product code EXH. The urinary ileostomy...

2013-04-01

214

Methodological choices for the clinical development of medical devices  

PubMed Central

Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen’s design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing a trial to be stopped early depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Other types of experimental designs exist when conventional trials cannot always be applied to the clinical development of MDs.

Bernard, Alain; Vaneau, Michel; Fournel, Isabelle; Galmiche, Hubert; Nony, Patrice; Dubernard, Jean Michel

2014-01-01

215

Devices for medical diagnosis with GaN lasers  

NASA Astrophysics Data System (ADS)

This paper presents laser-induced fluroescence method (LIF) employing endogenous ("autofluroescence") and exogenous fluorophores. LIF is applied for clinical diagnosis in dermatology, gynaecology, urology, lung tumors as well as for early dentin caries. We describe the analysers with He-Ne, He-Cd, and SHG Nd:YAG lasers and new generation systems based on blue semiconductor GaN lasers that have been implemented into clinical practice till now. The LIF method, fundamental one for many medical applications, with excitation radiation of wavelength 400 nm could be appl,ied only using tunable dye lasers or titanium lasers adequte for laboratory investigations. Development of GaN laser shows possibility to design portable, compact diagnostic devices as multi-channel analysers of fluorescence spectra and surface imaging devoted to clinical application. The designed systems used for spectra measurement and registration of fluorescence images include lasers of power 5-30 mW and generate wavelengths of 405-407 nm. They are widely used in PDT method for investigation of superficial distribution of accumulation kinetics of all known photosensitizers, their elimination, and degradation as well as for treatment of superficial lesions of mucosa and skin. Excitation of exogenous porphrins in Soret band makes possible to estimate their concentration and a period of healthy skin photosensitivity that occurs after photosensitiser injections. Due to high sensitivity of spectrum analysers, properties of photosensitisers can be investigated in vitro (e.g. their aggregation, purity, chromatographic distributions) when their concentrations are 2-3 times lower in comparison to concentrations investigated with typical spectrofluorescence methods. Dentistry diagnosis is a new field in which GaN laser devices can be applied. After induction with blue light, decreased autofluorescence intensity can be observed when dentin caries occur and strong characteristic bands of endogenous porphyrines when parodentosis or dental plaque are present.

Kwasny, Miroslaw; Mierczyk, Zygmunt

2003-10-01

216

Medical device design for adolescent adherence and developmental goals: a case study of a cystic fibrosis physiotherapy device  

PubMed Central

Purpose This study investigates the psychosocial aspects of adolescent medical device 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 medical device 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 medical device 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 medical devices 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 medical device 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. PMID:24669187

Lang, Alexandra R; Martin, Jennifer L; Sharples, Sarah; Crowe, John A

2014-01-01

217

78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...  

Federal Register 2010, 2011, 2012, 2013

...HEALTH AND HUMAN SERVICES Food and Drug Administration...FDA-2013-D-0114] Distinguishing Medical Device Recalls From Product...Guidance for Industry and Food and Drug Administration...SUMMARY: The Food and Drug Administration...entitled ``Distinguishing Medical Device Recalls From...

2013-02-22

218

Demonstration of a Medical Device Integration and Coordination Framework Andrew King, Sam Procter  

E-print Network

Demonstration of a Medical Device Integration and Coordination Framework Andrew King, Sam Procter,hatcliff,swarren}@ksu.edu William Spees, Raoul Jetley Paul Jones, Sandy Weininger US Food & Drug Administration {William and coordinating the activities of medical devices. The framework uses a publish-subscribe framework for com

Huth, Michael

219

An Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter  

E-print Network

An Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter Dan,hatcliff,swarren}@ksu.edu William Spees, Raoul Jetley Paul Jones, Sandy Weininger US Food & Drug Administration {William.Spees,Raoul.Jetley,PaulL.Jones, Sandy.Weininger}@fda.hhs.gov Abstract Medical devices historically have been monolithic units ­ de

Huth, Michael

220

78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...  

Federal Register 2010, 2011, 2012, 2013

...HEALTH AND HUMAN SERVICES Food and Drug Administration...FDA-2013-D-0743] Medical Device Reporting for Manufacturers...Guidance for Industry and Food and Drug Administration...SUMMARY: The Food and Drug Administration...guidance entitled ``Medical Device Reporting for...

2013-07-09

221

An Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter  

E-print Network

An Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter Dan,hatcliff,swarren}@ksu.edu William Spees, Raoul Jetley Paul Jones, Sandy Weininger US Food & Drug Administration {William.Spees,Raoul.Jetley,PaulL.Jones, Sandy.Weininger}@fda.hhs.gov March 7, 2009 Abstract Medical devices historically have been monolithic

Huth, Michael

222

Production planning for medical devices with an uncertain regulatory approval date  

Microsoft Academic Search

The demand for medical devices such as pacemakers, defibrillators, catheters and heart valves is growing rapidly throughout the world. This demand is driven by both the “technology push” of new medical device technologies and the “demand pull” of an aging population in North America, Western Europe, and Japan. Production planning for these products is increasing in importance as demand increases,

ARTHUR V. HILL; WILLIAM J. SAWAYA III

2004-01-01

223

10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.  

Code of Federal Regulations, 2010 CFR

...10 Energy 1 2010-01-01 2010-01-01 false Suppliers for sealed sources or devices for medical use. 35.49...MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For...

2010-01-01

224

They Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices  

E-print Network

They Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices Shyamnath}@cs.umass.edu ABSTRACT Wireless communication has become an intrinsic part of modern implantable medical devices (IMDs from the difficulty of modifying or replacing already-implanted IMDs. Thus, in this paper, we ex- plore

225

A Review of the Design Process for Implantable Orthopedic Medical Devices  

PubMed Central

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes. PMID:19662153

Aitchison, G.A; Hukins, D.W.L; Parry, J.J; Shepherd, D.E.T; Trotman, S.G

2009-01-01

226

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.  

PubMed

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. PMID:25255810

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

227

Microneedles for transdermal drug delivery  

Microsoft Academic Search

The success of transdermal drug delivery has been severely limited by the inability of most drugs to enter the skin at therapeutically useful rates. Recently, the use of micron-scale needles in increasing skin permeability has been proposed and shown to dramatically increase transdermal delivery, especially for macromolecules. Using the tools of the microelectronics industry, microneedles have been fabricated with a

Mark R Prausnitz

2004-01-01

228

Transdermal drug delivery: Microfabrication insights  

Microsoft Academic Search

The paper presented an enhancement solution for transdermal drug delivery using microneedles array with biodegradable tips. The microneedles array was fabricated by using deep reactive ion etching (DRIE) and the biodegradable tips were made to be porous by electrochemical etching process. The porous silicon microneedle tips can greatly enhance the transdermal drug delivery in a minimum invasion, painless, and convenient

Ciprian Iliescu; Bangtao Chen; Jiashen Wei; Zhilian Yue

2009-01-01

229

Current status and future potential of transdermal drug delivery  

Microsoft Academic Search

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

2004-01-01

230

Silicone surface with drug nanodepots for medical devices.  

PubMed

An ideal surface of poly(dimethylsiloxane) (PDMS) medical devices requires sustained drug release to combat various tissue responses and infection. At present, a noncovalent surface coating with drug molecules using binders possesses a detachment problem, while covalently linking drug molecules to the surface provides no releasable drug. Here, a platform that allows the deposition of diverse drugs onto the PDMS surface in an adequate quantity with reliable attachment and a sustained-release character is demonstrated. First, a PDMS surface with carboxyl functionality (PDMS-COOH) is generated by subjecting a PDMS piece to an oxygen plasma treatment to obtain silanol moieties on its surface, then condensing the silanols with (3-aminopropyl)triethoxysilane molecules to generate amino groups, and finally reacting the amino groups with succinic anhydride. The drug-loaded carriers with hydroxyl groups on their surface can then be esterified to PDMS-COOH, resulting in a PDMS surface covalently grafted with drug-filled nanocarriers so that the drugs inside the securely grafted carriers can be released. Demonstrated here is the covalent linking of the surface of a PDMS endotracheal tube with budesonide-loaded ethylcellulose nanoparticles. A secure and high drug accumulation at the surface of the tubes (0.025 mg/cm(2)) can be achieved without changes in its bulk property such as hardness (Shore-A), and sustained release of budesonide with a high release flux during the first week followed by a reduced release flux over the subsequent 3 weeks can be obtained. In addition, the grafted tube possesses more hydrophilic surface and thus is more tissue-compatible. The grafted PDMS pieces show a reduced in vitro inflammation in cell culture and a lower level of in vivo tissue responses, including a reduced level of inflammation, compared to the unmodified PDMS pieces, when implanted in rats. Although demonstrated with budesonide and a PDMS endotracheal tube, this platform of grafting a PDMS surface with drug-loaded particles can be applied to other drugs and other devices. PMID:25314005

Mokkaphan, Jiratchaya; Banlunara, Wijit; Palaga, Tanapat; Sombuntham, Premsuda; Wanichwecharungruang, Supason

2014-11-26

231

Varying the Wear Time of the Methylphenidate Transdermal System in Children with Attention-Deficit/Hyperactivity Disorder  

ERIC Educational Resources Information Center

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.

2008-01-01

232

Technology Advances and Challenges in Hermetic Packaging for Implantable Medical Devices  

Microsoft Academic Search

\\u000a Many implantable medical devices 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 medical device packaging\\u000a are discussed. Various testing methods applicable to the packaging of implantable medical

Guangqiang Jiang; David D. Zhou

2010-01-01

233

TOWARD FLUOROSCOPIC SHAPE RECONSTRUCTION FOR CONTROL OF STEERABLE MEDICAL DEVICES  

E-print Network

of a flex- ible, curved, medical robot. Such sensing represents an initial step towards closed-loop control surgery". The International Journal of Medical Robotics and Computer Assisted Surgery, 5(4), pp. 381.". Medical engineering & physics, 32(8), pp. 813�21. [10] Glozman, D., and Shoham, M., 2007. "Image

Simaan, Nabil

234

77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service  

Federal Register 2010, 2011, 2012, 2013

...RM-11404; FCC 11-176] Additional Spectrum for the Medical Device Radiocommunication...MedRadio devices to access 24 megahertz of spectrum in the 413-419 MHz, 426-432 MHz...MedRadio devices to access 24 megahertz of spectrum in the 413-419 MHz, 426-432...

2012-01-27

235

77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...  

Federal Register 2010, 2011, 2012, 2013

...Federal Register Volume 77, Number 169...National Medical Device Postmarket Surveillance...you need special accommodations due to a disability...and international device registries for selected...calling for the expansion of the postmarket...system to include devices. Key...

2012-08-30

236

Stanford University Significant Risk and Nonsignificant Risk GUI-7m Research Compliance Office Medical Device Studies  

E-print Network

Medical Device Studies File:GUI01007 rev2 09/10 1 of 2 (FDA Information Sheets October 1, 1995) The Investigational Device Exemption (IDE) regulations [21 CFR part 812] describe two types of device studies," a term utilized in the Institutional Review Board (IRB) regulations [21 CFR part 56] to identify certain

Puglisi, Joseph

237

Effective use of transdermal drug delivery in children.  

PubMed

Transdermal administration offers a non-invasive and convenient method for paediatric drug delivery. The competent skin barrier function in term infants and older children limits both water loss and the percutaneous entry of chemicals including drugs; but the smaller doses required by children eases the attainment of therapeutic concentrations. Transdermal patches used in paediatrics include fentanyl, buprenorphine, clonidine, scopolamine, methylphenidate, oestrogens, nicotine and tulobuterol. Some patches have paediatric labelling supported by clinical trials whereas others are used unlicensed. Innovative drug delivery methods, such as microneedles and sonophoresis are being tested for their safety and efficacy; needleless injectors are primarily used to administer growth hormone; and two iontophoretic devices were approved for paediatrics. In contrast, the immature and rapidly evolving skin barrier function in premature neonates represents a significant formulation challenge. Unfortunately, this population group suffers from an absence of approved transdermal formulations, a shortcoming exacerbated by the significant risk of excessive drug exposure via the incompletely formed skin barrier. PMID:24333231

Delgado-Charro, M Begoña; Guy, Richard H

2014-06-01

238

Use-related risk analysis for medical devices based on improved FMEA.  

PubMed

In order to effectively analyze and control use-related risk of medical devices, 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 medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described. PMID:22317712

Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

2012-01-01

239

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2010 CFR

...alternatives to labeling requirements for medical devices held by the Strategic National... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions...

2010-04-01

240

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2013 CFR

...alternatives to labeling requirements for medical devices held by the Strategic National... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions...

2013-04-01

241

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

...alternatives to labeling requirements for medical devices held by the Strategic National... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions...

2014-04-01

242

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2012 CFR

...alternatives to labeling requirements for medical devices held by the Strategic National... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions...

2012-04-01

243

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2011 CFR

...alternatives to labeling requirements for medical devices held by the Strategic National... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions...

2011-04-01

244

78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...  

Federal Register 2010, 2011, 2012, 2013

...Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...encourage public comments regarding standard content and format for medical device labeling...during the general session. Standard content and format of full labeling and a...

2013-01-07

245

Development and Implementation of a Medical Device Course.  

ERIC Educational Resources Information Center

A course for fifth-year baccalaureate students provides a structured introduction to many of the devices with which pharmacists are involved (contraceptives, convalescent aids, surgical appliances, etc.), and includes assigned readings, lectures, and hands-on experience with industry representatives. Lists of the lecture material, devices, reading…

Mendel, Philip A.

1982-01-01

246

A proposed framework to improve the safety of medical devices in a Canadian hospital context  

PubMed Central

Purpose Medical devices 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 medical devices in a hospital. Materials and methods The proposed medical device 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 medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-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 medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility. PMID:24876796

Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana

2014-01-01

247

Skin tolerability associated with transdermal drug delivery systems: an overview  

Microsoft Academic Search

As transdermal patches become more widely prescribed, it is important that clinicians understand: (a) the common causes of\\u000a skin reactions with these medications; (b) how to minimize these reactions; and (c) how to manage the signs and symptoms.\\u000a Here we review published data for skin reactions with patch medications approved within the past decade. Overall, the most\\u000a common application site

Iris Ale; Jean-Marie Lachapelle; Howard I. Maibach

2009-01-01

248

On-line integration of computer controlled diagnostic devices and medical information systems in undergraduate medical physics education for physicians.  

PubMed

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 medical devices 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

2013-01-01

249

Managing Complexity at the Boundaries of the Firm: A Knowledge-Based Examination in Medical Device Manufacturing  

E-print Network

. After medical devices are approved by the Food and Drug Administration (FDA) for their safetyManaging Complexity at the Boundaries of the Firm: A Knowledge-Based Examination in Medical Device solving; firm boundaries; medical devices. Abstract: This paper examines how the knowledge-based view (KBV

Sekhon, Jasjeet S.

250

AC 2012-3822: GENERATING INTEREST IN TECHNOLOGY AND MED-ICAL DEVICES THROUGH AN INTERACTIVE EDUCATIONAL GAME  

E-print Network

EDUCATIONAL GAME Mr. Devin R. Berg, Medical Devices Center, University of Minnesota - Twin Cities Devin R in Technology and Medical Devices Through an Interactive Educational Game Introduction The issue of motivating and educate them in the field of medical devices, a modified, life-sized version of the game Operation

Wu, Mingshen

251

Actuation of shape memory polymer using magnetic fields for applications in medical devices  

E-print Network

A novel approach to the heating and actuation of shape memory polymer using dispersed Curie temperature thermo-regulated particles is proposed. Such a material has potential applications in medical devices which are delivered ...

Buckley, Patrick Regan, 1981-

2004-01-01

252

76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices  

Federal Register 2010, 2011, 2012, 2013

...dedicated to identifying as many studies as possible that are relevant...information (e.g., details of studies conducted) from medical device industry stakeholders...solicitations. We are looking for studies that report on pressure...

2011-12-01

253

Developing an Asia-Pacific manufacturing footprint strategy in the medical device industry  

E-print Network

As medical device manufacturers operating in the Asia-Pacific region are planning for increased demand in the near future, they must evaluate their manufacturing footprint strategies to determine if they are getting the ...

Dev, Nishanth K. (Nishanth Krishna)

2013-01-01

254

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2013 CFR

... 2013-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2013-07-01

255

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2012 CFR

... 2012-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2012-07-01

256

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2011 CFR

... 2011-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2011-07-01

257

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2010 CFR

... 2010-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2010-07-01

258

They Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices  

E-print Network

Wireless communication has become an intrinsic part of modern implantable medical devices (IMDs). Recent work, however, has demonstrated that wireless connectivity can be exploited to compromise the confidentiality of IMDs' ...

Gollakota, Shyamnath

259

Preventive maintenance scheduling based on failure data in a medical device manufacturing facility  

E-print Network

This study was conducted at a medical device production facility where analysis was done on the reliability of Product S barrel molds for the purpose of predicting preventive maintenance (PM) schedule. Pareto Rule was ...

Mohd Fauzi, Mohammed Faizal B

2009-01-01

260

Inventory management strategy for the supply chain of a medical device company  

E-print Network

In the medical device industry, many companies rely on a high inventory strategy in order to meet their customers' urgent requirements, sometimes leading to excessive inventory. This problem is compounded when it involves ...

Tjhin, Poi Chung

2012-01-01

261

Systems Theoretic Accident Model and Process application : quality control in medical device manufacturing  

E-print Network

The goal of medical device industry is to provide patients and healthcare professionals effective, reliable, safe and affordable products. However, due to the dynamic and competitive operation and business environment, ...

Li, Tieyu

2013-01-01

262

77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period  

Federal Register 2010, 2011, 2012, 2013

...medical devices; and methods to overcome the pitfalls and data gaps, including statistical approaches and modeling...research data, and 3. The methods to overcome the pitfalls and data gaps, including statistical approaches and...

2012-01-25

263

U.S. women bullying women in the pharmaceutical/biotechnology/medical device industry.  

E-print Network

?? This empirical study investigated bullying among adult U.S. women in the Pharmaceutical/Biotechnology/Medical Device (PBMD) Industry. A concurrent triangulation mixed method was used. An online… (more)

Liu, Sharon L.

2012-01-01

264

Mergers & acquisitions in the medical device industry : an exploration of factors influencing valuation  

E-print Network

Valuing medical device companies and technologies is a complex process. Several different approaches and models are often used in combination to determine a transaction valuation. This research uses the Enterprise Value ...

Robins, Jason S

2008-01-01

265

Applying the interaction design approach to medical devices.  

PubMed

The medical industry is undergoing a radical transformation as increasingly powerful personal computers become the predominant user interface for both clinical and laboratory equipment. Accompanying this change is the introduction of a design discipline known as interaction design, which has given rise to a new breed of specialists whose role is to champion the end user--that is, the physician, scientist, or medical technician--at every stage of the product-development cycle. PMID:10147994

Smith, J; Leftwich, J

1991-04-01

266

A Phase 1 Trial of pharmacologic interactions between transdermal selegiline and a 4-hour cocaine infusion  

Microsoft Academic Search

BACKGROUND: The selective MAO-B inhibitor selegiline has been evaluated in clinical trials as a potential medication for the treatment of cocaine dependence. This study evaluated the safety of and pharmacologic interactions between 7 days of transdermal selegiline dosed with patches (Selegiline Transdermal System, STS) that deliver 6 mg\\/24 hours and 2.5 mg\\/kg of cocaine administered over 4 hours. METHODS: Twelve

Debra S Harris; Thomas Everhart; Peyton Jacob; Emil Lin; John E Mendelson; Reese T Jones

2009-01-01

267

76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop  

Federal Register 2010, 2011, 2012, 2013

...The Food and Drug Administration...Person: Carol Krueger, Food and Drug Administration...contributing factor in microbial transmission and subsequent...devices could reduce the incidence of HAIs associated with...Management (HFA-305), Food and Drug...

2011-05-02

268

Interconnections of basic science research and product development in medical device design.  

PubMed

The relationship between basic science research and product design/development are intertwined. This paper explores the definition of basic science and design as it relates to medical device development. It is intended to serve as a reference for both researchers and device developers to assist in trans-disciplinary collaborative efforts in improving patient care as each are of equal importance. The definition of a medical device is broad and varied. This paper is aimed towards those devices which interact with tissue and are rooted in the tenets of science. Both the scientific method and the design process are compared with similarities and opposites identified. The paper concludes identifying fundamental principles of medical device development and highlights the importance of both entities. PMID:19964135

Privitera, Mary Beth; Design, M; Johnson, Jeffrey

2009-01-01

269

Modeling and Simulation of SMA Medical Devices Undergoing complex Thermo-mechanical Loadings  

NASA Astrophysics Data System (ADS)

There are SMA medical applications which undergo complex thermo-mechanical loading paths to meet specific and accurate requirements. In this work, a 3D model and its implementation techniques are presented. This model is currently deployed to design and model SMA medical devices subjected to multi-axial loading in both isothermal and dynamic regimes. Some of these devices are introduced and studied as examples to show the efficiency of the proposed platform.

Taheri Andani, Masood; Elahinia, Mohammad

2014-07-01

270

78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...  

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel...public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel...disability, please contact James Clark, Conference Management Staff, at...

2013-02-27

271

78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...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,...

2013-11-07

272

75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...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...

2010-01-27

273

76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...  

Federal Register 2010, 2011, 2012, 2013

...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...

2011-06-24

274

Dosing considerations with transdermal formulations of fentanyl and buprenorphine for the treatment of cancer pain  

PubMed Central

Opioids continue to be first-line pharmacotherapy for patients suffering from cancer pain. Unfortunately, subtherapeutic dosage prescribing of pain medications remains common, and many cancer patients continue to suffer and experience diminished quality of life. A large variety of therapeutic options are available for cancer pain patients. Analgesic pharmacotherapy is based on the patient’s self-report of pain intensity and should be tailored to meet the requirements of each individual. Most, if not all, cancer pain patients will ultimately require modifications in their opioid pharmacotherapy. When changes in a patient’s medication regimen are needed, adequate pain control is best maintained through appropriate dosage conversion, scheduling immediate release medication for withdrawal prevention, and providing as needed dosing for breakthrough pain. Transdermal opioids are noninvasive, cause less constipation and sedation when compared to oral opioids, and may improve patient compliance. A relative potency of 100:1 is recommended when converting the patient from oral morphine to transdermal fentanyl. Based on the limited data available, there is significant interpatient variability with transdermal buprenorphine and equipotency recommendations from oral morphine of 75:1–110:1 have been suggested. Cancer patients may require larger transdermal buprenorphine doses to control their pain and may respond better to a more aggressive 75–100:1 potency ratio. This review outlines the prescribing of transdermal fentanyl and transdermal buprenorphine including how to safely and effectively convert to and use them for those with cancer pain. PMID:25170278

Skaer, Tracy L

2014-01-01

275

Medical devices; immunology and microbiology devices; classification of tryptase test system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). 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:25233536

2014-09-18

276

77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD...first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these...

2012-03-28

277

Clinical use of medical devices in the 'Bermuda Triangle'.  

PubMed

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

2004-01-01

278

Biologically inspired artificial haircell sensors Today's engineering systems, such as machines, vehicles, robots, medical devices, home  

E-print Network

, such as machines, vehicles, robots, medical devices, home appliances and entertainment devices, are often sensor) by allowing easier integration of sensors in systems; and (4) by developing technologies to utilize sensor of polymer MEMS to enable simple sensor packaging and sensor-electronics integration. Short Bio: Chang Liu

Valero-Cuevas, Francisco

279

BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.  

PubMed

In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners. PMID:23494126

Bruzzi, M S; Linehan, J H

2013-09-01

280

Healthcare, medical support and consultancy applications and services for mobile devices  

Microsoft Academic Search

While thinking about potential new user groups for mobile devices one can notice that the world largest clusters with low penetration of devices are people from developing countries. In the developed countries the largest groups are children and older generation people. Driven by different factors the healthcare and medical applications might create real breakthrough in demand for the new mobile

Alexandra Reyss; Sergey Balandin

2010-01-01

281

MD-Adapt: A Proposed Architecture for Open-Source Medical Device Interoperability  

Microsoft Academic Search

MD-adapt is an architecture for shamble common interfaces for medical devices in support of the goals of MDPnP. This paper proposes an architecture for enabling an open source, community-based effort to create a pool of reusable device interface implementations. The MD-adapt architecture consists of a standardized API (application programming interface) and a device metadata format, and supports building modular and

J. Hotchkiss; J. Robbins; M. Robkin

2007-01-01

282

An Open-Source Medical Device Coordination Framework  

E-print Network

, as illustrated by the following tragic clinical event reported in 2005 in the Anesthesia Patient Safety data streaming directly into patient electronic health records (EHRs), integration of information from multiple devices in a clinical context (e.g., hospital room) into a single tailorable composite display

Huth, Michael

283

Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology  

PubMed Central

Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, 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 medical devices, 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 medical devices 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. PMID:24760423

Rome, Benjamin N.; Kramer, Daniel B.

2014-01-01

284

Integration of human factors and ergonomics during medical device design and development: it's all about communication.  

PubMed

Manufacturers of interactive medical devices, 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 medical device 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 medical devices. 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

2014-05-01

285

Laser direct writing of micro- and nano-scale medical devices.  

PubMed

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 medical devices. 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 medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Gittard, Shaun D; Narayan, Roger J

2010-05-01

286

Medical devices; gastroenterology-urology devices; classification of the implantable transprostatic tissue retractor system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the implantable transprostatic tissue retractor 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. 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:25118368

2014-07-25

287

Medical devices; general and plastic surgery devices; classification of the absorbable lung biopsy plug. Final order.  

PubMed

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

2014-03-10

288

Medical device procurement in low- and middle-income settings: protocol for a systematic review  

PubMed Central

Background Medical device procurement processes for low- and middle-income countries (LMICs) are a poorly understood and researched topic. To support LMIC policy formulation in this area, international public health organizations and research institutions issue a large body of predominantly grey literature including guidelines, manuals and recommendations. We propose to undertake a systematic review to identify and explore the medical device procurement methodologies suggested within this and further literature. Procurement facilitators and barriers will be identified, and methodologies for medical device prioritization under resource constraints will be discussed. Methods/design Searches of both bibliographic and grey literature will be conducted to identify documents relating to the procurement of medical devices in LMICs. Data will be extracted according to protocol on a number of pre-specified issues and variables. First, data relating to the specific settings described within the literature will be noted. Second, information relating to medical device procurement methodologies will be extracted, including prioritization of procurement under resource constraints, the use of evidence (e.g. cost-effectiveness evaluations, burden of disease data) as well as stakeholders participating in procurement processes. Information relating to prioritization methodologies will be extracted in the form of quotes or keywords, and analysis will include qualitative meta-summary. Narrative synthesis will be employed to analyse data otherwise extracted. The PRISMA guidelines for reporting will be followed. Discussion The current review will identify recommended medical device procurement methodologies for LMICs. Prioritization methods for medical device acquisition will be explored. Relevant stakeholders, facilitators and barriers will be discussed. The review is aimed at both LMIC decision makers and the international research community and hopes to offer a first holistic conceptualization of this topic. PMID:25336161

2014-01-01

289

Implantable Glucose BioFuel Cells for Medical Devices  

NASA Astrophysics Data System (ADS)

An Implantable BioFuel Cell (IBFC) is a device that produces power only from the chemicals that are naturally occurring inside the body. We have been working on two approaches to creating an IBFC. The first approach is to use chemicals such as glucose and oxygen to provide the fuel for an enzymatic IBFC. The second approach is to use electrolytes such as sodium to provide the fuel for a biomimetic IBFC.

Cinquin, P.; Cosnier, S.; Belgacem, N.; Cosnier, M. L.; Dal Molin, R.; Martin, D. K.

2013-12-01

290

Transferosomes - A vesicular transdermal delivery system for enhanced drug permeation  

PubMed Central

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.

2011-01-01

291

Sumatriptan iontophoretic transdermal system for the acute treatment of migraine.  

PubMed

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

2014-03-01

292

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...  

Federal Register 2010, 2011, 2012, 2013

...General and Plastic Surgery Devices; Classification...Federal Food, Drug, and Cosmetic Act (FD&C Act...Federal Food, Drug, and Cosmetic Act and under authority...GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority...from minimally invasive surgery, and simple,...

2010-11-10

293

76 FR 71045 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062...rule which, if made final, would make CES devices Class III requiring premarket approval...will include the existing data to support CES safety and effectiveness and whether...

2011-11-16

294

75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System  

Federal Register 2010, 2011, 2012, 2013

...digital x-ray images of the entire breast. This generic type of device may...Digital Versus Film Mammography for Breast- Cancer Screening,'' New England Journal...digital x-ray images of the entire breast. This generic type of device...

2010-11-05

295

78 FR 24426 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex...Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The...

2013-04-25

296

SMPTE Test Pattern For Certification Of Medical Diagnostic Display Devices  

NASA Astrophysics Data System (ADS)

Since the invention of x-rays by Wilhelm Conrad Roentgen, rapid advances have been made in the radiological detection of body abnormalities. This was very evident in the 1960's and 70's when the marriage of computers to radiology gave birth to a new generation of imaging modalities such as computerized tomography, ultrasound, digital radiographic imaging, nuclear medicine, and nuclear magnetic resonance. Many of these devices employ digital computer techniques for signal manipulation, and the resultant analog diagnostic images are displayed on television monitors for viewing and on imaging cathode-ray tubes for a photographic hard copy.

Lisk, Kenneth G.

1984-08-01

297

Microneedle-mediated transdermal bacteriophage delivery  

PubMed Central

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 × 106 PFU/ml (plaque forming units per ml) was detected in the receiver compartment when delivered across dermatomed skin and 4.0 × 103 PFU/ml was detected in the receiver compartment when delivered across full thickness skin. An in vivo study resulted in 4.13 × 103 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 24 h, 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.

2012-01-01

298

[Assessment of the benefit of medical devices in surgical practice. Problems and possible solutions].  

PubMed

The market approval of medical devices 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 medical devices 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 medical devices 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 medical devices 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

2014-05-01

299

Current state of medical device nomenclature and taxonomy systems in the UK: spotlight on GMDN and SNOMED CT  

PubMed Central

A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices 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 medical devices 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 medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices. PMID:23885299

White, Judith; Carolan-Rees, Grace

2013-01-01

300

78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing...

2013-08-13

301

76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...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...

2011-02-07

302

77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice...to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning device, sponsored by U-Systems,...

2012-02-28

303

78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug  

Federal Register 2010, 2011, 2012, 2013

...Administration Ophthalmic Devices Panel Meeting, January 22, 1996. 2. Chang, Stanley, ``LXII Edward Jackson Lecture: Open Angle Glaucoma After Vitrectomy,'' American Journal of Ophthalmology, vol. 141(6): pp. 1033-1043, June 2006, available at...

2013-01-25

304

The transdermal delivery of fentanyl.  

PubMed

The fentanyl patch is one of the great commercial successes in transdermal drug delivery. The suitability of this molecule for delivery through skin had been identified in the 1970s, and subsequently, a number of transdermal formulations became available on the market. This article reviews the development of fentanyl patch technology with particular emphasis on the pharmacokinetics and disposition of the drug when delivered through the skin. The various patch designs are considered as well as the bioequivalence of the different designs. The influence of heat on fentanyl permeation is highlighted. Post-mortem redistribution of fentanyl is discussed in light of the reported discrepancies in serum levels reported in patients after death compared with therapeutic levels in living subjects. Finally, alternatives to patch technology are considered, and recent novel transdermal formulations are highlighted. PMID:23419814

Lane, Majella E

2013-08-01

305

Medical devices and conflict of interest: unique issues and an industry code to address them.  

PubMed

Development of medical devices requires interaction between physicians and industry that is considerably more intimate than that in pharmaceutical development. Progress in procedure-based medicine would be stalled if this collaboration were eliminated. This degree of interaction, however, creates conflicts of interest that must be managed to avoid compromising trust, credibility, and patient care. AdvaMed, a trade association for the medical device industry, has developed a code of ethics to manage many of these conflicts and to guide its members' interactions with health care professionals. This article reviews the rationale for the AdvaMed code and provides a brief in terms of c overview of the code itself.onflict-of-interest cons iderations, the world of medical devices is significantly dif- PMID:17469470

LaViolette, Paul A

2007-03-01

306

Examples Of Holographic Testing Versus State-Of-The-Art In The Medical Device Industry  

NASA Astrophysics Data System (ADS)

The medical device industry has seemed rather reluctant to integrate holographic technology into their product lines. While independent researchers have demonstrated the great potential for holography in imaging and display, it appears that holographic techniques may have the greater potential to solve some of the in-vitro testing and quality and process control problems peculiar to the medical device industry. Examples of these techniques include in-vitro testing of strain distributions surrounding bone plates, contouring for wear properties of artificial joints, and rapid nondestructive determination of leak rates in implantable electronics packages. With new advances in optics and electro-optics comes the hope that these and similar techniques may soon become integral parts of medical device manufacturing.

Wagner, James W.

1986-01-01

307

MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 121 Biological, Medical Devices  

E-print Network

.................................................................................................................................123 A Portable Bioimpedance Spectroscopy Measurement System for Managing Congestive Heart Failure ....................................................................................................................125 An Electronically Steered, Wearable Transcranial Doppler Ultrasound System Biological & Medical 123 Vital signs such as heart rate, blood pressure, blood ox- ygenation, cardiac output

Reif, Rafael

308

A bioinspired omniphobic surface coating on medical devices prevents thrombosis and biofouling.  

PubMed

Thrombosis and biofouling of extracorporeal circuits and indwelling medical devices cause significant morbidity and mortality worldwide. We apply a bioinspired, omniphobic coating to tubing and catheters and show that it completely repels blood and suppresses biofilm formation. The coating is a covalently tethered, flexible molecular layer of perfluorocarbon, which holds a thin liquid film of medical-grade perfluorocarbon on the surface. This coating prevents fibrin attachment, reduces platelet adhesion and activation, suppresses biofilm formation and is stable under blood flow in vitro. Surface-coated medical-grade tubing and catheters, assembled into arteriovenous shunts and implanted in pigs, remain patent for at least 8 h without anticoagulation. This surface-coating technology could reduce the use of anticoagulants in patients and help to prevent thrombotic occlusion and biofouling of medical devices. PMID:25306244

Leslie, Daniel C; Waterhouse, Anna; Berthet, Julia B; Valentin, Thomas M; Watters, Alexander L; Jain, Abhishek; Kim, Philseok; Hatton, Benjamin D; Nedder, Arthur; Donovan, Kathryn; Super, Elana H; Howell, Caitlin; Johnson, Christopher P; Vu, Thy L; Bolgen, Dana E; Rifai, Sami; Hansen, Anne R; Aizenberg, Michael; Super, Michael; Aizenberg, Joanna; Ingber, Donald E

2014-11-01

309

Josephson junction devices: Model quantum mechanical systems and medical applications  

NASA Astrophysics Data System (ADS)

In this dissertation, three experiments using Josephson junction devices are described. In Part I, the effect of dissipation on tunneling between charge states in a superconducting single-electron transistor (sSET) was studied. The sSET was fabricated on top of a semi-conductor heterostructure with a two-dimensional electron gas (2DEG) imbedded beneath the surface. The 2DEG acted as a dissipative ground plane. The sheet resistance of the 2DEG could be varied in situ by applying a large voltage to a gate on the back of the substrate. The zero-bias conductance of the sSET was observed to increase with increasing temperature and 2DEG resistance. Some qualitative but not quantitative agreement was found with theoretical calculations of the functional dependence of the conductance on temperature and 2DEG resistance. Part II describes a series of experiments performed on magnesium diboride point-contact junctions. The pressure between the MgB2 tip and base pieces could be adjusted to form junctions with different characteristics. With light pressure applied between the two pieces, quasiparticle tunneling in superconductor-insulator-superconductor junctions was measured. From these data, a superconducting gap of approximately 2 meV and a critical temperature of 29 K were estimated. Increasing the pressure between the MgB2 pieces formed junctions with superconductor-normal metal-superconductor characteristics. We used these junctions to form MgB2 superconducting quantum interference devices (SQUIDS). Noise levels as low as 35 fT/Hz1/2 and 4 muphi 0/Hz1/2 at 1 kHz were measured. In Part III, we used a SQUID-based instrument to acquire magnetocardiograms (MCG), the magnetic field signal measured from the human heart. We measured 51 healthy volunteers and 11 cardiac patients both at rest and after treadmill exercise. We found age and sex related differences in the MCG of the healthy volunteers that suggest that these factors should be considered when evaluating the MCG for disease. We also defined a spatio-temporal MCG parameter, the repolarization stabilization interval, which successfully discriminated our patients from our healthy controls.

Chen, Josephine

310

Application of a Temporal Reasoning Framework Tool in Analysis of Medical Device Adverse Events  

PubMed Central

The Clinical Narrative Temporal Relation Ontology (CNTRO)1 project offers a semantic-web based reasoning framework, which represents temporal events and relationships within clinical narrative texts, and infer new knowledge over them. In this paper, the CNTRO reasoning framework is applied to temporal analysis of medical device adverse event files. One specific adverse event was used as a test case: late stent thrombosis. Adverse event narratives were obtained from the Food and Drug Administration’s (FDA) Manufacturing and User Facility Device Experience (MAUDE) database2. 15 adverse event files in which late stent thrombosis was confirmed were randomly selected across multiple drug eluting stent devices. From these files, 81 events and 72 temporal relations were annotated. 73 temporal questions were generated, of which 65 were correctly answered by the CNTRO system. This results in an overall accuracy of 89%. This system should be pursued further to continue assessing its potential benefits in temporal analysis of medical device adverse events. PMID:22195199

Clark, Kimberly K.; Sharma, Deepak K.; Chute, Christopher G.; Tao, Cui

2011-01-01

311

Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states  

PubMed Central

With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC’s abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states.

Howard, Jason J

2014-01-01

312

Concordance of Adherence Measurement Using Self-Reported Adherence Questionnaires and Medication Monitoring Devices  

Microsoft Academic Search

The primary objective of this review was to identify and examine the literature on the association between medication adherence self-reported questionnaires (SRQs) and medication monitoring devices. The primary literature search was performed for 1980-2009 using PubMed, PubMed In Process and Non-Indexed, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO (EBSCO), CINAHL (EBSCO), Ovid HealthStar, EMBASE (Elsevier) and Cochrane Databases and using the

Lizheng Shi; Jinan Liu; Yordanka Koleva; Vivian Fonseca; Anupama Kalsekar; Manjiri Pawaskar

2010-01-01

313

Designing a program to assess potential induced radioactivity in electron beam sterilization of medical devices  

NASA Astrophysics Data System (ADS)

ISO 11137-1:2006 requires that the potential for induced radioactivity be evaluated for medical devices irradiated with electrons with energy more than 10 MeV. For a manufacturing operation where new devices are being developed, a practical program for making such an evaluation needs to be engrained in the process. A program was developed such that the induced radioactivity evaluation is imbedded in the development of the irradiation process.

Smith, Mark; Logar, John; Vrain, Olivier

2014-12-01

314

Medical devices; ophthalmic devices; classification of the eyelid weight. Final rule.  

PubMed

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

2014-04-21

315

Biodegradable polymer microneedles: Fabrication, mechanics and transdermal drug delivery  

E-print Network

Biodegradable polymer microneedles: Fabrication, mechanics and transdermal drug delivery Jung the skin's barrier properties that block transdermal delivery of most drugs, arrays of microscopic needles; Transdermal drug delivery; Biodegradable polymer; Failure force 1. Introduction Most drugs are administered

316

Rosemarie Hunziker, Ph.D. is the Director of Tissue Engineering and Regenerative Medicine, Biomaterials, and Medical Devices at the  

E-print Network

, Biomaterials, and Medical Devices at the National Institute of Biomedical Imaging and Bioengineering (NIBIB engineering, biomaterials, and technology transfer. Rosemarie's professional career in the research laboratory

317

Trial Registration for Public Trust: Making the Case for Medical Devices  

PubMed Central

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 medical device 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. PMID:18095047

2007-01-01

318

A service protocol for post-processing of medical images on the mobile device  

NASA Astrophysics Data System (ADS)

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.

He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

2014-03-01

319

Ultrasound and transdermal drug delivery  

Microsoft Academic Search

Transdermal drug delivery offers an attractive alternative to the conventional drug delivery methods of oral administration and injection. However, the stratum corneum acts as a barrier that limits the penetration of substances through the skin. Application of ultrasound to the skin increases its permeability (sonophoresis) and enables the delivery of various substances into and through the skin. This review presents

Ilana Lavon; Joseph Kost

2004-01-01

320

Product development of a device for manufacturing medical equipment for use in low-resource settings  

E-print Network

The objective of this paper is to describe the product design of a device that can be used to create medical supplies on-site in clinics in low-resource settings. The machine uses purely mechanical elements to cut and fold ...

Schlecht, Lisa (Lisa Anne)

2010-01-01

321

Laser welding assembling of an implantable bio-medical device: investigation of temperature field  

Microsoft Academic Search

Laser welding is a commonly used process to assemble medical devices. The heat produced during the laser welding process may have an adverse effect on the mechanical integrity of the case assembly and the functionality of heat sensitive electronic components. In order to maintain the mechanical integrity of the case assembly and to protect the subcomponents, it is important to

Yaomin Lin; Guangqiang Jiang; Joseph L. Calderon

2011-01-01

322

Design and test of a miniature 2.45 GHz antenna for implantable medical devices  

Microsoft Academic Search

A miniature 2.45 GHz microstrip antenna based on the short pin technique is presented. The antenna is designated for implantable medical devices which have extreme stringent requirements on componentspsila sizes. Theoretical analysis and implementation details of the antenna are presented in this paper. Direct measurement results show that the antenna achieves an impedance bandwidth of 104 MHz and a maximum

Xueyi Yu; Guolin Li; Lingwei Zhang; Zhihua Wang

2008-01-01

323

edical devices are essential for performing mod-ern-day clinical functions. Traditionally, medical  

E-print Network

in patient care, such as patient context awareness, reduced medical errors, and im- proved patient safety of the patient's health, much more so than any individual device can provide. Moreover, such information can.937905 view for a job The interview Communication Security Issues By K.K.Venkatasubramanian, S.K.S. Gupta, R

Hu, Fei

324

Assuring the Safety, Security, and Reliability of Medical-Device Cyber-  

E-print Network

to understand software fault tolerance � Numerous problems with radiation treatment (http://www.nytimes.com/2010 pump recalls to address safety problems � The most common types of problems � Software Defect � UserAssuring the Safety, Security, and Reliability of Medical-Device Cyber- Physical Systems (MDCPS

Hu, Fei

325

In vitro and in vivo studies on wireless powering of medical sensors and implantable devices  

Microsoft Academic Search

This paper investigates wireless electricity (witricity) and its application to medical sensors and implantable devices. Several coupling scenarios of resonators are analyzed theoretically. In vitro experiments are conducted in open air and through an agar phantom of the human head. An in vivo animal experiment is also carried out. Our studies indicate that witricity is a suitable tool for providing

Fei Zhang; Xiaoyu Liu; Steven A. Hackworth; Robert J. Sclabassi; Mingui Sun

2009-01-01

326

A survey of success factors in New Product Development in the medical devices industry  

Microsoft Academic Search

This study of the factors that are correlated with success in new product development (NPD) is based on 68 responses to a survey of medical device companies in the UK and Ireland. It was found that the degree of technological innovation, the involvement of end users in the development process, the dissemination of NPD priorities to staff, and the use

Alan Brown; Dorian Dixon; Julie Eatock; Brian J. Meenan; Terry Young

2008-01-01

327

Department of Mechanical Engineering Spring 2013 3D Printed Medical Device  

E-print Network

PENNSTATE Department of Mechanical Engineering Spring 2013 3D Printed Medical Device Overview This project aimed to develop a 3D-printed everting structure for use in conjunction with current endosurgical/concept and that our main form of manufacturing revolved around 3D-printing, which allowed us to quickly make

Demirel, Melik C.

328

Heart-to-Heart (H2H): Authentication for Implanted Medical Devices  

E-print Network

patients to over-the-air attack and physical harm. H2H makes use of ECG (heartbeat dataHeart-to-Heart (H2H): Authentication for Implanted Medical Devices Masoud Rostami Rice University Rice University Houston, TX farinaz@rice.edu ABSTRACT We present Heart-to-Heart (H2H), a system

329

Impact of sanctions on procurement of medicine and medical devices in Iran; a technical response.  

PubMed

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 medical devices. Problems with money transfer have made it extremely lengthy in time to import medicine and medical devices 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 medical devices and certain financial institutions are assigned for this purpose. It is also suggested that defining a white list of Iranian pharmaceuticals and medical device 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

Hosseini, Seyed Alireza

2013-12-01

330

Plasma Sterilization: Opportunities and Microbial Assessment Strategies in Medical Device Manufacturing  

Microsoft Academic Search

Non-thermal gas discharge plasmas have significant potential as novel sterilization\\/decontamination agents in medical device manufacturing, and such agents may well be accepted by regulatory agencies. A number of aspects of plasma technology are currently under active investigation by many institutions and companies in order to obtain a thorough understanding of plasma sterilization as an alternative to conventional sterilization methods for

Ozlem Yardimci; Peter Setlow

2010-01-01

331

Department of Bioengineering Spring 2011 ISO 80369-Compliant Design of Medical Device Connectors/Standards  

E-print Network

will have competitive ideas to contribute for the ISO 80369 standard development #12;PENNSTATE Department of Bioengineering Spring 2011 ISO 80369- Compliant Design of Medical Device Connectors/Standards Overview The universal Luer standard adapters that have been used for years are giving

Demirel, Melik C.

332

[Analysis of the status and countermeasures of sales supervision on medical devices].  

PubMed

This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference. PMID:25330610

Zhang, Xintao; Shi, Xian; Hao, Qing; Zhu, Jiong; Bai, Rongqing

2014-07-01

333

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels  

E-print Network

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels Systems Division Education Committee #12;2 A Method for Analysis of Expert Committee Decision-Making in Technology, Management, and Policy ABSTRACT Committees of experts are critical for decision-making

de Weck, Olivier L.

334

A medical game changer New device shows early promise for detecting heart disease  

E-print Network

Fall 2012 A medical game changer New device shows early promise for detecting heart disease It as a functional test for people at high risk of developing heart disease, the leading cause of death in the United heart disease became Johnson's mission. After finishing three postdoctoral fellowships, she returned

Minnesota, University of

335

Disability, Technology, and Place: Social and Ethical Implications of Long-Term Dependency on Medical Devices  

Microsoft Academic Search

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

2007-01-01

336

Modular reservoir concept for MEMS-based transdermal drug delivery systems  

NASA Astrophysics Data System (ADS)

While MEMS-based transdermal drug delivery device development efforts have typically focused on tightly-integrated solutions, we propose an alternate conception based upon a novel, modular drug reservoir approach. By decoupling the drug storage functionality from the rest of the delivery system, this approach seeks to minimize cold chain storage volume, enhance compatibility with conventional pharmaceutical practices, and allow independent optimization of reservoir device design, materials, and fabrication. Herein, we report the design, fabrication, and preliminary characterization of modular reservoirs that demonstrate the virtue of this approach within the application context of transdermal insulin administration for diabetes management.

Cantwell, Cara T.; Wei, Pinghung; Ziaie, Babak; Rao, Masaru P.

2014-11-01

337

Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application  

SciTech Connect

This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. 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 medical devices. 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)

1995-09-01

338

Relative risk analysis of the use of radiation-emitting medical devices: A preliminary application  

SciTech Connect

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 medical devices. 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.

Jones, E.D.

1996-06-01

339

Microneedle-based drug delivery systems for transdermal route.  

PubMed

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

2014-03-01

340

Chitosan microneedle patches for sustained transdermal delivery of macromolecules.  

PubMed

This paper introduces a chitosan microneedle patch for efficient and sustained transdermal delivery of hydrophilic macromolecules. Chitosan microneedles have sufficient mechanical strength to be inserted in vitro into porcine skin at approximately 250 ?m in depth and in vivo into rat skin at approximately 200 ?m in depth. Bovine serum albumin (BSA, MW=66.5 kDa) was used as a model protein to explore the potential use of chitosan microneedles as a transdermal delivery device for protein drugs. In vitro drug release showed that chitosan microneedles can provide a sustained release of BSA for at least 8 days (approximately 95% of drugs released in 8 days). When the Alexa Fluor 488-labeled BSA (Alexa 488-BSA)-loaded microneedles were applied to the rat skin in vivo, confocal microscopic images showed that BSA can gradually diffuse from the puncture sites to the dermal layer and the fluorescence of Alexa 488-BSA can be observed at the depth of 300 ?m. In addition, encapsulation of BSA within the microneedle matrix did not alter the secondary structure of BSA, indicating that the gentle nature of the fabrication process allowed for encapsulation of fragile biomolecules. These results suggested that the developed chitosan microneedles may serve as a promising device for transdermal delivery of macromolecules in a sustained manner. PMID:23116140

Chen, Mei-Chin; Ling, Ming-Hung; Lai, Kuan-Ying; Pramudityo, Esar

2012-12-10

341

An Evaluation of a Distributed Medical Device Safety Surveillance System: The DELTA Network Study  

PubMed Central

Background Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication. Purpose To review the design of the DELTA (Data Extraction and Longitudinal Trend Analysis) network study of the medical device safety surveillance. Methods This is a multicenter prospective observational study designed to evaluate the safety of new cardiovascular devices used during percutaneous coronary intervention (PCI) performed through continuous analysis of the routinely collected American College of Cardiology- National Cardiovascular Data Registry (ACC-NCDR) data elements. The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices, including drug eluting coronary stents, embolic protection devices, and vascular closure devices in patients undergoing PCI. Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis, overall sensitivity, specificity, positive predictive value and negative predictive value of the DELTA network surveillance system. Results The details of the study are described including system design, eligibility criteria, methods and components of data collection, data security and statistical methods. In addition, the methods of adjudication and verification following an adverse event alert, overall study outcomes, end points, limitations and potential advantages are discussed. Conclusion This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices. PMID:21356331

Vidi, Venkatesan D.; Matheny, Michael E.; Donnelly, Sharon; Resnic, Frederic S.

2011-01-01

342

Absorption of transdermally delivered ketorolac acid in humans.  

PubMed

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

Roy, S D; Manoukian, E; Combs, D

1995-01-01

343

Security Risks, Low-tech User Interfaces, and Implantable Medical Devices: A Case Study with Insulin Pump Infusion Systems  

SciTech Connect

Portable implantable medical device 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 device 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] [ORNL; Kohno, Tadayoshi [University of Washington, Seattle] [University of Washington, Seattle

2012-01-01

344

Book review of "Joining and assembly of medical materials and devices" edited by Y. (Norman) Zhou and Mark D. Breyen  

PubMed Central

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 medical device design and education are discussed in this invited review.

2013-01-01

345

Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.  

PubMed

Regulatory bodies weighing market approval for novel medical devices 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

2014-01-01

346

The psychosocial impact of home use medical devices on the lives of older people: a qualitative study  

PubMed Central

Background Increased life expectancy and the accompanying prevalence of chronic conditions have led to the focus and delivery of health care migrating from the hospital and into people’s homes. While previous studies have investigated the integration of particular types of medical devices into the home, it was our intention to describe how medical devices are integrated into the lives of older people. Methods Adopting a qualitative study design, 12 older people, who used medical devices in the home, took part in in-depth, semi structured interviews. In 7 of the interviews participants and their partners were interviewed together. These interviews were recorded, transcribed and analysed thematically. Results Two themes were constructed that describe how medical devices that are used in the home present certain challenges to older people and their partners in how the device is adopted and the personal adaptations that they are required to make. The first theme of 'self-esteem’ highlighted the psychological impact on users. The second theme of 'the social device' illustrated the social impact of these devices on the user and the people around them. Conclusions We found that these devices had both a positive and negative psychosocial impact on users’ lives. An improved understanding of these psychological and social issues may assist both designers of medical devices and the professionals who issue them to better facilitate the integration of medical devices into the homes and lives of older people. PMID:24195757

2013-01-01

347

Real-time volume rendering of digital medical images on an iOS device  

NASA Astrophysics Data System (ADS)

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.

Noon, Christian; Holub, Joseph; Winer, Eliot

2013-03-01

348

Influence of Mobile Phones on the Quality of ECG Signal Acquired by Medical Devices  

NASA Astrophysics Data System (ADS)

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, medical devices 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.

2013-10-01

349

Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment  

PubMed Central

Introduction The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device 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 medical devices are subject to comparable scrutiny. Objective To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices? Conclusions Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes. PMID:18095046

Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.

2007-01-01

350

Harmonized Medical Device Regulation: Need, Challenges, and Risks of not Harmonizing the Regulation in Asia.  

PubMed

Medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. Despite the fact that Asia has 60% of the world population providing large market potential, Asian healthcare expenditure constitutes only 15% of the global healthcare expenditure. The accelerated ageing population and increasing prevalence of chronic disease are the key drivers that contribute toward the increase in the total healthcare expenditure on medical devices in the region. Several policies clearly showed the eagerness of the government to provide better healthcare infrastructure with better medical devices and facilities. The fundamental objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt to change and remain competitive. After the era of liberalization and globalization, the desires of developing economies is to ensure safety and performance of the product brought to their markets and for this harmonized regulation is an important tool for strengthening the same. If we talk about the industry need, then this approach will eliminate redundant requirements that do not contribute to safety and effectiveness. In addition, Asia is diverse in many respects and with it come the various challenges to harmonizing the regulation which includes diversity in culture, politics, economy, historical issues, etc. If, by any reason, the regulation of medical devices is not harmonized and consequently, the harmonized regulation is not adopted, then it leads to serious concerns like delayed or absent access to innovative technology, continued rise in the cost of medical therapies, etc. So this issue is written to attract all stakeholders to move toward the concept of harmonization, keeping in mind their need, challenges, and risks of not harmonizing the regulation as well. PMID:21331201

Kaushik, A; Saini, Ks; Anil, B; Rambabu, S

2010-01-01

351

Harmonized Medical Device Regulation: Need, Challenges, and Risks of not Harmonizing the Regulation in Asia  

PubMed Central

Medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. Despite the fact that Asia has 60% of the world population providing large market potential, Asian healthcare expenditure constitutes only 15% of the global healthcare expenditure. The accelerated ageing population and increasing prevalence of chronic disease are the key drivers that contribute toward the increase in the total healthcare expenditure on medical devices in the region. Several policies clearly showed the eagerness of the government to provide better healthcare infrastructure with better medical devices and facilities. The fundamental objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt to change and remain competitive. After the era of liberalization and globalization, the desires of developing economies is to ensure safety and performance of the product brought to their markets and for this harmonized regulation is an important tool for strengthening the same. If we talk about the industry need, then this approach will eliminate redundant requirements that do not contribute to safety and effectiveness. In addition, Asia is diverse in many respects and with it come the various challenges to harmonizing the regulation which includes diversity in culture, politics, economy, historical issues, etc. If, by any reason, the regulation of medical devices is not harmonized and consequently, the harmonized regulation is not adopted, then it leads to serious concerns like delayed or absent access to innovative technology, continued rise in the cost of medical therapies, etc. So this issue is written to attract all stakeholders to move toward the concept of harmonization, keeping in mind their need, challenges, and risks of not harmonizing the regulation as well. PMID:21331201

Kaushik, A; Saini, KS; Anil, B; Rambabu, S

2010-01-01

352

Real-time signal processing of accelerometer data for wearable medical patient monitoring devices.  

PubMed

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

Van Wieringen, Matt; Eklund, J

2008-01-01

353

US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?  

PubMed Central

Although radiation therapy is highly safe and effective in treating cancer, recent reports of dangerous radiation-related errors have focused a national spotlight on the field of radiation oncology and, more specifically, on the rapidly evolving and complex nature of radiation devices and how they are regulated. The purpose of this review is to explore the issues involved in medical device regulation in radiation oncology. We start with a general review of federal medical device regulation, including explanations of the legal and regulatory framework, and then discuss issues specific to radiation oncology with real-world examples. We also provide our thoughts on potential solutions and reforms to the current system, including better reporting of radiation-related errors in a centralized database, well-defined criteria for establishing substantial equivalence of a new device, and standard postmarket surveillance of radiation devices. Modern radiation therapy is a powerful tool that can help cure many patients' cancers and alleviate others' suffering with limited adverse effects. We must ensure that this promise is never compromised by avoidable mistakes. PMID:22548012

Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

2012-01-01

354

Quantifying opportunities for hospital cost control: medical device purchasing and patient discharge planning.  

PubMed

Objectives To quantify the potential reduction in hospital costs from adoption of best local practices in supply chain management and discharge planning. Study Design We performed multivariate statistical analyses of the association between total variable cost per procedure and medical device price and length of stay, controlling for patient and hospital characteristics. Methods Ten hospitals in 1 major metropolitan area supplied patient-level administrative data on 9778 patients undergoing joint replacement, spine fusion, or cardiac rhythm management (CRM) procedures in 2008 and 2010. The impact on each hospital of matching lowest local market device prices and lowest patient length of stay (LOS) was calculated using multivariate regression analysis controlling for patient demographics, diagnoses, comorbidities, and implications. Results Average variable costs ranged from $11,315 for joint replacement to $16,087 for CRM and $18,413 for spine fusion. Implantable medical devices accounted for a large share of each procedure's variable costs: 44% for joint replacement, 39% for spine fusion, and 59% for CRM. Device prices and patient length-of-stay exhibited wide variation across hospitals. Total potential hospital cost savings from achieving best local practices in device prices and patient length of stay are 14.5% for joint replacement, 18.8% for spine fusion;,and 29.1% for CRM. Conclusions Hospitals have opportunities for cost reduction from adoption of best local practices in supply chain management and discharge planning. PMID:25364878

Robinson, James C; Brown, Timothy T

2014-01-01

355

Fentanyl Transdermal Patch  

MedlinePLUS

... TAO) (not available in the United States); and verapamil (Calan, Covera, Verelan). Your doctor may need to ... patch is exposed to extreme heat, it may release too much medication into your body at once. ...

356

Case studies of innovative medical device companies from India: barriers and enablers to development  

PubMed Central

Background Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered. Methods Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources. Results In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market. Conclusions Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products. PMID:23721110

2013-01-01

357

Synergistic Effect of Enhancers for Transdermal Drug Delivery  

Microsoft Academic Search

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

Samir Mitragotri

2000-01-01

358

Definition of Information Technology Architectures for Continuous Data Management and Medical Device Integration in Diabetes  

PubMed Central

The growing availability of continuous data from medical devices 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 medical devices and decision support tools to extract all the relevant knowledge to support diabetes care. PMID:19885276

Hernando, M. Elena; Pascual, Mario; Salvador, Carlos H.; Garcia-Saez, Gema; Rodriguez-Herrero, Agustin; Martinez-Sarriegui, Inaki; Gomez, Enrique J.

2008-01-01

359

The New (Challenging) Role of Academia in Biomaterial Translational Research and Medical Device Development  

PubMed Central

With the ever-changing landscape of translational research, the medical device and pharmaceutical industries increasingly license technologies with the added value of clinical and/or pre-clinical data rather than those in earlier stages of development. Universities have the potential to fill the gap in product development from academic laboratories through enhanced student training and increased implementation of some development and manufacturing activities that are traditionally found only in the private sector. A development roadmap is described from initial product feasibility through commercialization in the context of efficient development practices. The specific challenges in the design and development of biomaterial-based medical devices are described in the context of this development path with an emphasis on unique challenges for academic laboratories. PMID:22589055

Kleinbeck, Kyle; Anderson, Edward; Ogle, Matthew; Burmania, Jeanine

2013-01-01

360

Potential GPRS 900\\/180MHz and WCDMA 1900MHz Interference to Medical Devices  

Microsoft Academic Search

This study compared the potential for interference to medical devices 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

Steve Iskra; Barry W. Thomas; Ray McKenzie; Jack Rowley

2007-01-01

361

Efficacy of a Methylphenidate Transdermal System versus t.i.d. Methylphenidate in a Laboratory Setting  

ERIC Educational Resources Information Center

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.

2011-01-01

362

Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.  

PubMed

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 medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices 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 medical devices to consumers without thorough or sufficient examination of evidence. PMID:22032398

Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

2013-01-01

363

Visualization analysis of research hotspots based on CiteSpace II: taking medical devices as an example  

PubMed Central

Biomedical engineering has been one of the hottest fields in biology and engineering. As an important branch, the medical device has achieved significant progress in the past decades. As a useful method in evaluative bibliometrics, mapping knowledge has been used to explore the trend of one field. In the present study, we retrieve literatures about the medical device from the Web of Science™ (2004–2013), and acquire 26,793 related records, then analyze time range, region distribution, and main research directions of the literatures, and try to use keywords combined with mapping knowledge to explore the main trends of the medical device, and then aim to provide more information for medical device research. Through the study, we discover: 1) the publications regarding medical devices show an upward trend over the past decade in general; 2) the percentage of publications in the USA (38.49%) is the highest all over the world; 3) engineering (20.64%) is the hottest research direction, and takes up about one-fifth of the total publications; 4) the Journal of the American Medical Association and The New England Journal of Medicine are among the two journals that are the most highly cited, followed by Science and The Lancet; and 5) keywords of the medical device include in vitro, quality-of-life, outcomes, management, mortality, depression, and so on. With the help of mapping knowledge, we dig out some hot topics of medical devices and provide more information through trend analysis, and we discover that our findings are related to previous research and further research can enlarge the number of records and optimize the algorithm. We provide a systematic approach for researchers to keep abreast of the development and state of the research of medical devices. PMID:25368536

Liu, Dong-Dong; Liu, Sheng-Lin; Zhang, Jia-Hua

2014-01-01

364

Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness  

NASA Astrophysics Data System (ADS)

Public safety can be enhanced through the development of a comprehensive medical device 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 medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device 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 medical devices 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 medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.

Hughes, Allen A.

1994-12-01

365

[Better medical devices regulations for better health care: enlightenment for medical devices regulatory reform in China, from experiences of the E.U. and the U.S.A].  

PubMed

The expansion of applications of medical devices has attracted the increased attention of government regulatory bodies around the world to the safety and effectiveness of these products. Most developed countries, such as the United States and European Union, have developed well-established regulatory systems for medical devices, which have also consistently been amended to accommodate the changing requirements of safety and the trend of globalization.The current "Regulations for the Supervision and Administration of Medical Device (China)", established in 2000, has brought about great improvements for the safety and effectiveness of products, safeguarding public health. But there are still, at present, a lot of counterfeit and poor quality devices and device-related adverse events for lack of powerful post -market and in-use regulatory controls for products. It is therefore very urgent for the Chinese government to reform its medical device administration and management. This research paper analyses and compares the different requirements and executions of medical devices regulations in the EU, the US and China, to draw some experiences of the EU and US regimes that are very useful to China's regulatory reform. It is suggested that when developing a new scheme of medical devices regulatory reform in China, two prominent aspects have to be considered by policy makers and regulators. Firstly, the global trend of medical devices regulations has to be taken into account. Secondly, the experiences learned from the EU and US systems should be applied to the Chinese regulatory reform in combination with the concrete practice of China. PMID:16646425

Sun, Qin; Yan, Liang

2006-01-01

366

Automatic mobile device synchronization and remote control system for high-performance medical applications.  

PubMed

The field of telemedicine is in need of generic solutions that harness the power of small, easily carried computing devices to increase efficiency and decrease the likelihood of medical errors. Our study resolved to build a framework to bridge the gap between handheld and desktop solutions by developing an automated network protocol that wirelessly propagates application data and images prepared by a powerful workstation to handheld clients for storage, display and collaborative manipulation. To this end, we present the Mobile Active Medical Protocol (MAMP), a framework capable of nigh-effortlessly linking medical workstation solutions to corresponding control interfaces on handheld devices for remote storage, control and display. The ease-of-use, encapsulation and applicability of this automated solution is designed to provide significant benefits to the rapid development of telemedical solutions. Our results demonstrate that the design of this system allows an acceptable data transfer rate, a usable framerate for diagnostic solutions and enough flexibility to enable its use in a wide variety of cases. To this end, we also present a large-scale multi-modality image viewer as an example application based on the MAMP. PMID:18002576

Constantinescu, L; Kim, J; Chan, C; Feng, D

2007-01-01

367

Design and development of low-loss transformer for powering small implantable medical devices.  

PubMed

Small implantable medical devices, such as wireless capsule endoscopes, that can be swallowed have previously been developed. However, these devices cannot continuously operate for more than 8 h because of battery limitations; moreover, additional functionalities cannot be introduced. This paper proposes a design method for a high-efficiency energy transmission transformer (ETT) that can transmit energy transcutaneously to small implantable medical devices using electromagnetic induction. First, the authors propose an unconventional design method to develop such a high-efficiency ETT. This method can be readily used to calculate the exact transmission efficiency for changes in the material and design parameters (i.e., the magnetic material, transmission frequency, load resistance, etc.). Next, the ac-to-ac energy transmission efficiency is calculated and compared with experimental measurements. Then, suitable conditions for practical transmission are identified. A maximum efficiency of 33.1% can be obtained at a transmission frequency of 500 kHz and a receiving power of 100 mW for a receiving coil size of ¿5 mm × 20 mm. Future design optimization is possible by using this method. PMID:23853315

Shiba, K; Morimasa, A; Hirano, H

2010-04-01

368

Security Mechanism Based on Hospital Authentication Server for Secure Application of Implantable Medical Devices  

PubMed Central

After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance.

2014-01-01

369

IR and green femtosecond laser machining of heat sensitive materials for medical devices at micrometer scale  

NASA Astrophysics Data System (ADS)

In medical device 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

2014-03-01

370

Security mechanism based on hospital authentication server for secure application of implantable medical devices.  

PubMed

After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance. PMID:25276797

Park, Chang-Seop

2014-01-01

371

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...  

Federal Register 2010, 2011, 2012, 2013

...continue to make home healthcare more common. With these trends, a significant number of medical devices, including infusion pumps, ventilators, and wound care therapies, are now being used in the home. Home healthcare can provide...

2010-04-21

372

78 FR 6825 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...  

Federal Register 2010, 2011, 2012, 2013

...SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction AGENCY: Food and Drug Administration, HHS. ACTION:...

2013-01-31

373

78 FR 17934 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of...  

Federal Register 2010, 2011, 2012, 2013

...SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

2013-03-25

374

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.  

...2013-07-01 true Routine checking of hearing aids and external components of surgically implanted...300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure...

2014-07-01

375

Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies  

E-print Network

The aim of this thesis was to look at the impact of acquiring the CE marking approval on the outcome of early stage medical device companies, specifically its impact on strategic acquisition opportunities and on valuation. ...

Kothari, Ashish (Ashish Shrikant)

2011-01-01

376

Feasibility results of an electromagnetic compatibility test protocol to evaluate medical devices to radio frequency identification exposure  

PubMed Central

Background The use of radio frequency identification (RFID) systems in healthcare is increasing, and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have demonstrated that RFID systems can interfere with medical devices; however, the majority of past studies relied on time-consuming and burdensome test schemes based on ad hoc test methods applied to individual RFID systems. Methods This paper presents the results of using an RFID simulator that allows for faster evaluation of RFID-medical device EMC against a library of RFID test signals at various field strengths. Results The results of these tests demonstrate the feasibility and adequacy of simulator testing and can be used to support its incorporation into applicable consensus standards. Conclusions This work can aid the medical device community in better assessing the risks associated with medical device exposure to RFID. PMID:25086451

2014-01-01

377

Development and in vitro evaluation of chitosan-based transdermal drug delivery systems for the controlled delivery of propranolol hydrochloride  

Microsoft Academic Search

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

D. Thacharodi; K. Panduranga Rao

1995-01-01

378

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review  

PubMed Central

Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices 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 medical device 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. PMID:22912563

Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

2012-01-01

379

Transdermal Insulin Delivery Using Microdermabrasion  

Microsoft Academic Search

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

380

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance  

PubMed Central

Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

2012-01-01

381

Optimised design and development of a bio-medical healthcare device through quality function deployment (QFD).  

PubMed

Technology is major stimulus for change and is imbibed in various forms; especially in the field of medical devices 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

Sharma, Jitendra

2012-01-01

382

Toxicity testing of medical device materials tested in human tissue cultures.  

PubMed

Rubber and plastic parts of medical devices were applied to human cell monolayers either directly or as aqueous extracts made at different time/temperature conditions. Thirteen rubber and twelve plastic samples were tested. The cultures were observed and photographed by use of a microscope with a camera before and after treatment with the test materials. The toxicity of the specimens was evaluated by comparison of the photographs. Alterations or disappearance of the cells or inhibited growth were interpreted as toxic effects of the materials. Twelve of the rubber and six of the plastic samples were evaluated as toxic in one or more of the systems. PMID:6722251

Haustveit, G; Torheim, B; Fystro, D; Eidem, T; Sandvik, M

1984-03-01

383

A 10.5 cm Ultrasound Link for Deep Implanted Medical Devices.  

PubMed

A study on ultrasound link for wireless energy transmission dedicated to deeply implanted medical devices is presented. The selection of the frequency to avoid biological side effects (e.g., cavitations), the choice of the power amplifier to drive the external transducers and the design of the rectifier to maximize the energy extraction from the implanted transducer are described in details. The link efficiency is characterized in water using a phantom material for a transmitter-receiver distance of 105 mm, transducers active area of 30 mm × 96 mm and 5 mm × 10 mm, respectively, and a system efficiency of 1.6% is measured. PMID:25388881

Mazzilli, Francesco; Lafon, Cyril; Dehollain, Catherine

2014-10-01

384

Preliminary results for the use of sensitive devices to assess the effect of medication on attentional demands  

E-print Network

1 Preliminary results for the use of sensitive devices to assess the effect of medication was to examine the effects of medication on the attentional demands of precision (Pre) and power (Pow) grips attentional demands of the motor task, participants performed an auditory analogue of the Stroop test while

Matsuoka, Yoky

385

Take Two Software Updates and See Me in the Morning: The Case for Software Security Evaluations of Medical Devices  

E-print Network

& Radiation Emitting Device Recalls--finding that between 2002­2010, there were 537 recalls of softwareTake Two Software Updates and See Me in the Morning: The Case for Software Security Evaluations--Medical devices used for critical care are becoming increasingly reliant on software; however, little

Song, Dawn

386

What do you mean you can't sterilize it? The reusable medical device matrix.  

PubMed

Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices 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 Medical Device (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 medical devices (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 medical device 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

Stephens, Anne; Assang, AnnMarie

2010-12-01

387

Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study  

PubMed Central

Background Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors. Methods and Findings Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty–industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50–2.00] versus 1.77 [1.50–2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r?=?0.28, 95% CI 0.11–0.44; marketing representative access policies, r?=?0.51, 95% CI 0.36–0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19–0.72; IMAP score, OR 0.45, 95% CI 0.19–1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15–0.69; IMAP score, OR 0.37, 95% CI 0.14–0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis. Conclusions As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions. Please see later in the article for the Editors' Summary PMID:25314155

Yeh, James S.; Austad, Kirsten E.; Franklin, Jessica M.; Chimonas, Susan; Campbell, Eric G.; Avorn, Jerry; Kesselheim, Aaron S.

2014-01-01

388

[Usability first : Model-based approach for the use-oriented risk analysis of medical devices].  

PubMed

Due to increasing automation, the number and complexity of technical components have increased in the medical context (e.g., in the clinic or in the home care sector) in recent years. Besides new effective and efficient therapeutic and diagnostic options, these devices entail a wide range of functions and very complex (often computer-based) user interfaces that may lead to human-induced risk potential. A systematic and early human risk analysis and a usability evaluation allow medical device manufacturers to identify and control risks within the human-machine interaction very efficiently. At the Department of Medical Engineering in the Helmholtz Institute for Biomedical Engineering at the RWTH Aachen University, a formal-analytical methodology and a corresponding software tool for prospective human-risk analysis and model-based usability evaluation has been developed. Based on a twofold approach, user interactive process sequences and their potential impacts on the overall process are identified and the resulting use-related risks are assessed. For this, the tasks are categorized (in system and user tasks) and modeled and temporally related within the framework of a high-level task analysis. Within a subsequent cognitive low-level task analysis, potentially critical parallel process sequences are then tested in order to detect a potential resource overload of the user. The subsequent corresponding human-risk analysis is developed according to a knowledge base (checklist) of taxonomies related to human error. The HiFEM (human-function effect modeling) methodology is universally applicable and can be used for the evaluation of human-computer interfaces as well as for the analysis of purely mechanical control interfaces and simple hand-held instruments (such as a scalpel and implant). In a comparative study, the HiFEM method clearly outperforms the classic FMEA (failure modes and effects analysis) process with regard to effectiveness, efficiency, learnability, and user satisfaction. Especially small and medium-sized enterprises that constitute the medical device industry can be supported by the new methodology in the context of risk management according to ISO 14971 as well as usability engineering in accordance with IEC 62366 and IEC 60601-1-6 as well as EN ISO 9241. PMID:25367174

Janß, A; Radermacher, Klaus

2014-12-01

389

Transdermal Systems for Overactive Bladder: Principles and Practice  

PubMed Central

The transdermal system for delivery of medication to treat overactive bladder may provide an improved efficacy-to-tolerability ratio by regulating serum drug levels; avoiding gastrointestinal and hepatic metabolism, which is important when the metabolite has a lesser therapeutic index than the parent drug; and achieving clinical efficacy with a lower total drug burden. Additional advantages may include increased compliance and obviation of the need for oral drug administration, which is especially beneficial for the patient who is taking multiple oral medications or is caregiver-dependent. An efficient patch system must preserve the physical integrity of the drug layer, provide adequate adhesion, store and release the drug and permeation-enhancing agent in a predictable manner, promote consistent absorption through the skin regardless of location or skin or subcutaneous tissue differences, demonstrate dose proportionality, maintain skin integrity during product use and removal, and be cosmetically acceptable. A novel transdermal delivery system that incorporates an occlusive layer covering an acrylic adhesive containing the active agent oxybutynin and a skin permeation enhancer has been demonstrated in clinical trials to achieve these goals. PMID:16985986

Staskin, David R

2003-01-01

390

Terahertz Imaging System for Medical Applications and Related High Efficiency Terahertz Devices  

NASA Astrophysics Data System (ADS)

A terahertz (THz) imaging system and high efficient terahertz sources and detectors for medical applications were developed. A fiber laser based compact time domain terahertz tomography system was developed with a high depth resolution of less than 20 ?m. Three-dimensional images of porcine skin were obtained including some physical properties such as applied skin creams. The discrimination between healthy human tissue and tumor tissue has been achieved using reflection spectra. To improve the THz imaging system, a ridge waveguide LiNbO3 based nonlinear terahertz generator was studied to achieve high output power. A ridge waveguide with 5-7 ?m width was designed for high efficiency emission from the LiNbO3 crystal by the electro-optic Cherenkov effect. Terahertz electronic sources and detectors were also realized for future imaging systems. As electronic source devices, resonant tunneling diode (RTD) oscillators with a patch antenna were fabricated using an InGaAs/InAlAs/AlAs triple barrier structure. On the other side, Schottky barrier diode (SBD) detectors with a log-periodic antenna were fabricated by thin-film technology on a Si substrate. Both devices operate above 1 THz at room temperature. This electronic THz device set could provide a future high performance imaging system.

Ouchi, Toshihiko; Kajiki, Kousuke; Koizumi, Takayuki; Itsuji, Takeaki; Koyama, Yasushi; Sekiguchi, Ryota; Kubota, Oichi; Kawase, Kodo

2013-07-01

391

[Safe reprocessing of medical devices with a view of the entire process chain : Recommendations of the VDI 5700 guidelines].  

PubMed

The reprocessing of medical devices for low pathogen or sterile use is in itself potentially risky even though the aim of reprocessing is the avoidance of hygienic or technically functional risks. The methodological principles of risk management for medical devices are described in the standard DIN EN ISO 14971. The recommendations of the Commission for Hospital Hygiene and Infectious Disease Prevention (Kommission für Krankenhaushygiene und Infektionsprävention KRINKO) of the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (Bundesinstituts für Arzneimittel und Medizinprodukte BfArM) "hygiene requirements for the reprocessing of medical devices" clarify numerous reprocessing-specific risks and are structured with reference to the different steps of reprocessing. The aim was a practical combination of the normative risk management methodology with the process-oriented KRINKO/BfArM recommendations, which has provided an interdisciplinary group of experts moderated by the Association of German Engineers (VDI). The main contents of the VDI 5700 guidelines on "hazards associated with the reprocessing-risk management in the reprocessing of medical devices-measures for risk control" and the process of the development of these guidelines is described. PMID:25348217

Kraft, Marc; Wille, F; Attenberger, J; Müller, U

2014-12-01

392

Promoting interdisciplinary project-based learning to build the skill sets for research and development of medical devices in academia.  

PubMed

The worldwide need for rapid expansion and diversification of medical devices and the corresponding requirements in industry pose arduous challenges for educators to train undergraduate biomedical engineering (BME) students. Preparing BME students for working in the research and development (R&D) in medical device industry is not easily accomplished by adopting traditional pedagogical methods. Even with the inclusion of the design and development elements in capstone projects, medical device industry may be still experience a gap in fulfilling their needs in R&D. This paper proposes a new model based on interdisciplinary project-based learning (IDPBL) to address the requirements of building the necessary skill sets in academia for carrying out R&D in medical device industry. The proposed model incorporates IDPBL modules distributed in a stepwise fashion through the four years of a typical BME program. The proposed model involves buy-in and collaboration from faculty as well as students. The implementation of the proposed design in an undergraduate BME program is still in process. However, a variant of the proposed IDPBL method has been attempted at a limited scale at the postgraduate level and has shown some success. Extrapolating the previous results, the adoption of the IDPBL to BME training seems to suggest promising outcomes. Despite numerous implementation challenges, with continued efforts, the proposed IDPBL will be valuable n academia for skill sets building for medical device R&D. PMID:24110394

Krishnan, Shankar

2013-01-01

393

A medical application integrating remote 3D visualization tools to access picture archiving and communication system on mobile devices.  

PubMed

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

He, Longjun; Ming, Xing; Liu, Qian

2014-04-01

394

In vivo characterization of transdermal drug transport by microdialysis  

Microsoft Academic Search

The aim of the present study was to evaluate the scope and limitations of the microdialysis technique as a tool for pharmacokinetic studies of transdermal therapy systems (TTS) and for characterization of the transdermal diffusion process in man. Nicotine (TTS; 21 mg\\/24 h) or estradiol (TTS; 100 ?g\\/24 h) were administered transdermally to 15 healthy volunteers. Microdialysis probes were inserted

Markus Müller; Rainer Schmid; Oswald Wagner; Bettina v. Osten; Houshang Shayganfar; Hans G Eichler

1995-01-01

395

Interfacial kinetics effects on transdermal drug delivery: a computer modeling  

E-print Network

Interfacial kinetics effects on transdermal drug delivery: a computer modeling Malcolm M. Q. Xing1 a transdermal drug delivery process. A more realistic multilayer structure, including the patch, SC and viable words: transdermal drug ­ interphase barrier ­ multi- layer finite-element model ­ contact transfer

Pan, Ning

396

An average enumeration method of hyperspectral imaging data for quantitative evaluation of medical device surface contamination  

PubMed Central

We propose a quantification method called Mapped Average Principal component analysis Score (MAPS) to enumerate the contamination coverage on common medical device surfaces. The method was adapted from conventional Principal Component Analysis (PCA) on non-overlapped regions of a full frame hyperspectral image to resolve the percentage of contamination from the substrate. The concept was proven by using a controlled contamination sample with artificial test soil and color simulating organic mixture, and was further validated using a bacterial system including biofilm on stainless steel surface. We also validate the results of MAPS with other statistical spectral analysis including Spectral Angle Mapper (SAM). The proposed method provides an alternative quantification method for hyperspectral imaging data, which can be easily implemented by basic PCA analysis. PMID:25360377

Le, Hanh N. D.; Kim, Moon S.; Hwang, Jeeseong; Yang, Yi; Thainual, Paweena U; Kang, Jin U.; Kim, Do-Hyun

2014-01-01

397

Laser welding assembling of an implantable bio-medical device: investigation of temperature field  

NASA Astrophysics Data System (ADS)

Laser welding is a commonly used process to assemble medical devices. The heat produced during the laser welding process may have an adverse effect on the mechanical integrity of the case assembly and the functionality of heat sensitive electronic components. In order to maintain the mechanical integrity of the case assembly and to protect the subcomponents, it is important to control the temperature in the assembling process, the investigation of the temperature distribution in the assembly during laser welding is thus necessary. In this paper, we report an experimental method and a numerical simulation for the investigation of the temperature field in the process of laser welding the eyelet to the case subassembly of the Functional Electrical Battery Powered Microstimulator (FEBPM). A pulsed 1064nm Nd:YAG laser is used as an example in this paper.

Lin, Yaomin; Jiang, Guangqiang; Calderon, Joseph L.

2011-03-01

398

Research and development of metals for medical devices based on clinical needs  

NASA Astrophysics Data System (ADS)

The current research and development of metallic materials used for medicine and dentistry is reviewed. First, the general properties required of metals used in medical devices are summarized, followed by the needs for the development of ? + ? type Ti alloys with large elongation and ? type Ti alloys with a low Young's modulus. In addition, nickel-free Ni-Ti alloys and austenitic stainless steels are described. As new topics, we review metals that are bioabsorbable and compatible with magnetic resonance imaging. Surface treatment and modification techniques to improve biofunctions and biocompatibility are categorized, and the related problems are presented at the end of this review. The metal surface may be biofunctionalized by various techniques, such as dry and wet processes. These techniques make it possible to apply metals to scaffolds in tissue engineering.

Hanawa, Takao

2012-12-01

399

[Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].  

PubMed

Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. PMID:25066351

Lang, Achim

2014-01-01

400

Study of a smart polymer medical device, product development obstacles and innovative solutions  

NASA Astrophysics Data System (ADS)

The concept is simple, within the pump a pH responsive polymer actuator swells in volume under electrically controlled stimulus. As the actuator swells it presses against a drug reservoir, as the reservoir collapses the drug is metered out to the patient. From concept to finished product, engineering this smart system entailed integration across multiple fields of science and engineering. Materials science, nanotechnology, polymer chemistry, organic chemistry, electrochemistry, molecular engineering, electrical engineering, and mechanical engineering all played a part in solutions to multiple technical hurdles. Some of these hurdles where overcome by tried and true materials and component engineering, others where resolved by some very creative out of the box thinking and tinkering. This paper, hopefully, will serve to encourage others to venture into unfamiliar territory as we did, in order to overcome technical obstacles and successfully develop a low cost smart medical device that can truly change a patient's life.

Banister, Mark; Clark, Ray; Coiner, Eric; Geronov, Yordan; McWilliams, Mark; Sias, Ralph; Walters, Gary; McGrath, Dominic

2012-04-01

401

An average enumeration method of hyperspectral imaging data for quantitative evaluation of medical device surface contamination.  

PubMed

We propose a quantification method called Mapped Average Principal component analysis Score (MAPS) to enumerate the contamination coverage on common medical device surfaces. The method was adapted from conventional Principal Component Analysis (PCA) on non-overlapped regions of a full frame hyperspectral image to resolve the percentage of contamination from the substrate. The concept was proven by using a controlled contamination sample with artificial test soil and color simulating organic mixture, and was further validated using a bacterial system including biofilm on stainless steel surface. We also validate the results of MAPS with other statistical spectral analysis including Spectral Angle Mapper (SAM). The proposed method provides an alternative quantification method for hyperspectral imaging data, which can be easily implemented by basic PCA analysis. PMID:25360377

Le, Hanh N D; Kim, Moon S; Hwang, Jeeseong; Yang, Yi; Thainual, Paweena U; Kang, Jin U; Kim, Do-Hyun

2014-10-01

402

Examining the link between cash flow, market value, and research and development investment spending in the medical device industry.  

PubMed

Unlike the pharmaceutical industry, no empirical research has focused on the factors influencing research and development (R&D) spending in the medical device industry. To fill that gap, this study examines how R&D spending is influenced by prior year cash flow and corporate market value using multiple regression analysis and a panel data set of medical device companies over the period 1962-2008. The empirical findings suggest that the elasticities of R&D spending with respect to cash flow and corporate market value equal 0.58 and 0.31, respectively. Moreover, based upon these estimates, simulations show that the recently enacted excise tax on medical devices, taken alone, will reduce R&D spending by approximately $4 billion and thereby lead to a minimum loss of $20 billion worth of human life years over the first 10?years of its enactment. PMID:23303706

Schmutz, Bryan P; Santerre, Rexford E

2013-02-01

403

Corruption in the health care sector: A barrier to access of orthopaedic care and medical devices in Uganda  

PubMed Central

Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher wages and benefits for workers could be important and initial steps in improving access orthopaedic care and OMDs, and managing the global injury burden. PMID:22554349

2012-01-01

404

New use cases for remote control and configuration of interoperable medical devices.  

PubMed

The newest branch of the ISO/IEEE 11073 (X73) standard for Personal Health Devices (X73PHD), allow the development of interoperable personal health ecosystems. At the moment of this writing, more than 11 specializations have been successfully published by the Personal Health Device (PHD) Working Group (PHD WG). Nevertheless, some recent specializations at draft stage show the need for a procedure to control configuration parameters. As a solution, some ad-hoc methods have been elaborated to deal with it, but, the aim of the PHD WG is to standardize a general procedure, valid for longer term. Then it is needed to identify use cases requiring remote configuration services. This work identifies and studies new use cases that employ remote configuration services. The resulting use cases, discussed within the PHD WG to get the maximum consensus, are within the scope of the Basic Electrocardiograph (X73-10406), the Sleep Apnea Breathing Therapy Equipment (X73-10424), and the Medication Monitor (X73-10472) specializations. In addition, a classification of the findings is proposed for each use case. These findings could be the basis for the new remote configuration extension. PMID:24110805

Barrón-González, H G; Martínez-Espronceda, M; Led, S; Serrano, L; Fischer, Christoph; Clarke, M

2013-01-01

405

Automatic alignment of a high-performance interferometric medical imaging device  

NASA Astrophysics Data System (ADS)

For optimal performance of a high-precision optical system, careful and stable alignment is necessary. To achieve robust alignment in a commercial system, performance tradeoffs or significant redesigns are often made. We have developed subsystems that allow us to automatically monitor and control the optical system alignment, allowing us to minimize the changes necessary between high-performance research systems and practical commercial designs. In addition, this can allow ruggedization of systems that would be too unstable otherwise. We have implemented such an alignment system in a high-performance medical interferometric imaging device with a focus on maintaining high throughput and allowing for significant system customization. The system is able to maintain near-optimal alignment without any user interaction over a large thermal range and can compensate for misalignments during initial system construction or resulting from shock events. With careful planning, the cost of such a system can be kept reasonably low and it requires minimal interruption to a normal user's workflow. We will discuss the basic principles and necessary considerations for the implementation of such a system, using the developed system as a case study. Similar technology can be used in many optical devices and is especially relevant if access by a trained technician is difficult or costly.

Cenko, Andrew T.; Behr, Bradford B.; Christensen, Peter B.; Hajian, Arsen R.; Hendrikse, Jan; Meade, Jeff T.; Sweeney, Frederic D.; van der Vecht, Paul

2011-03-01

406

Simultaneous transdermal extraction of glucose and lactate from human subjects by reverse iontophoresis  

PubMed Central

This study investigated the possibility of simultaneously extracting glucose and lactate from human subjects, at the same skin location, using transdermal reverse iontophoresis. Transdermal monitoring using iontophoresis is made possible by the skin’s permeability to small molecules and the nanoporous and microporous nature of the structure of skin. The study was intended to provide information which could be used to develop a full, biosensor-based, monitoring system for multiple parameters from transdermal extraction. As a precursor to the human study, in vitro reverse iontophoresis experiments were performed in an artificial skin system to establish the optimum current waveforms to be applied during iontophoresis. In the human study, a bipolar DC current waveform (with reversal of the electrode current direction every 15 minutes) was applied to ten healthy volunteers via skin electrodes and utilized for simultaneous glucose and lactate transdermal extraction at an applied current density of 300 ?A/cm2. Glucose and lactate were successfully extracted through each subject’s skin into the conducting gel that formed part of each iontophoresis electrode. The results suggest that it will be possible to noninvasively and simultaneously monitor glucose and lactate levels in patients using this approach and this could have future applications in diagnostic monitoring for a variety of medical conditions. PMID:18686780

Ching, Tak S; Connolly, Patricia

2008-01-01

407

Medical devices; clinical chemistry and clinical toxicology devices; classification of hemoglobin A1c test system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test 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:25167593

2014-08-25

408

7 Themes for guiding situated ergonomic assessments of medical devices: a case study of an inpatient glucometer.  

PubMed

There is relatively little guidance on the situated ergonomic assessment of medical devices, and few case studies that detail this type of evaluation. This paper reports results of a detailed case study that focuses on the design and use of a modern blood glucose meter on an oncology ward. We spent approximately 150 h in-situ, over 11 days and 4 nights, performing observations and interviews with users. This was complemented by interviews with two staff with oversight and management responsibility related to the device. We identified 19 issues with the design and use of this device. These issues were grouped into 7 themes which can help guide the situated study of medical devices: usability, knowledge gaps and mental models, workarounds, wider tasks and equipment, the patient, connection between services, and policy. PMID:24953286

Furniss, Dominic; Masci, Paolo; Curzon, Paul; Mayer, Astrid; Blandford, Ann

2014-11-01

409

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study  

NASA Astrophysics Data System (ADS)

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

410

An integrated robotics and medical control device to quantify atheromatous plaques: experiments on the arteries of a patient  

Microsoft Academic Search

We study the income of an integrated robotics and medical device, using a force-control law to measure arterial distensibility and to reconstruct in 3D the atheromatous plaques in the arteries. During the medical control, sonographer holds the ultrasound probe attached on the end-effector of the robot and brings it onto the skin of the patient. Then, he can simply get

S. Boudet; J. Gariepy; S. Mansour

1997-01-01

411

Abstract--Transdermal drug delivery through microneedles is a minimally invasive procedure causing little or no pain, and  

E-print Network

Abstract--Transdermal drug delivery through microneedles is a minimally invasive procedure causing little or no pain, and is a potentially attractive alternative to intramuscular and subdermal drug-dimensional (2D) and three-dimensional (3D) microneedle devices for drug delivery applications have been reported

412

A Transdermal Drug Delivery System Based on LIGA Technology and Soft Lithography  

NASA Astrophysics Data System (ADS)

This report presents a transdermal drug delivery system based on LIGA fabricated microparts. It is a portable device combining a magnetically actuated micro gear pump with a microneedle array. The fluidic behaviour of the system is analyzed in order to predict its performance according to the dimension of the microparts and then compared to experimental data. The manufacturing process of both micropump and microneedle array are described.

Matteucci, Marco; Perennes, Frederic; Marmiroli, Benedetta; Di Fabrizio, Enzo

2007-01-01

413

Water-activated, pH-controlled patch in transdermal administration of timolol  

Microsoft Academic Search

The feasibility of the water-activated, pH-controlled silicone reservoir devices for transdermal administration was investigated using timolol maleate as a model drug. Timolol patches were applied to the arm of 12 volunteers for 81 h, two patches per subject. Timolol absorption from patches was compared to that from a peroral timolol tablet formulation (Blocanol® 10 mg). Furthermore, in vivo plasma levels

Riitta Sutinen; Petteri Paronen; Veijo Saano; Arto Urtti

2000-01-01

414

Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies  

Microsoft Academic Search

Propensity score analysis is a versatile statistical method used mainly in observational studies for improving treatment comparison by adjusting for up to a relatively large number of potentially confounding covariates. Recently, there has been an increased interest in applying this method to nonrandomized medical device clinical studies. In the application of the methodology, some statistical and regulatory issues arise in

Lilly Q. Yue

2007-01-01

415

Light insensitive silver(I) cyanoximates as antimicrobial agents for indwelling medical devices.  

PubMed

Ten silver(I) cyanoximates of AgL composition (L = NC-C(NO)-R, where R is electron withdrawing groups: -CN, -C(O)NR(2), -C(O)R' (alkyl), -C(O)OEt, 2-heteroaryl fragments such as 2-pyridyl, 2-benzimidazolyl, 2-benzoxazolyl, 2-benzthiazolyl) were synthesized and characterized using spectroscopic methods and X-ray analysis. Crystal structures of four complexes were determined and revealed the formation of two-dimensional (2D) coordination polymers of different complexity in which anions exhibit bridging or combined chelate and bridging binding modes. In these compounds, anions are in the nitroso form. All studied AgL complexes are sparingly soluble in water and are thermally stable to 150 °C. Synthesized compounds demonstrated remarkable insensitivity toward visible light and UV-radiation, which was explained based on their polymeric structures with multiple covalent bonds between bridging cyanoxime ligands and Ag(I) centers. All 10 silver(I) cyanoximates were tested in vitro on the subject of their antimicrobial activity against both Gram-positive and Gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus sp., Pseudomonas aeruginosa, Enterococcus hirae, Streptococcus mutans, Staphylococcus aureus, and Mycobacterium fortuitum as well as against Candida albicans in solutions, and in the solid state as pressed pellets and dried filter paper disks presoaked with solutions of AgL in DMF. Results showed pronounced antimicrobial activity for all investigated complexes. A combination of five factors: (1) light insensitivity, (2) poor water solubility, (3) high thermal stability, (4) lack of toxicity of organic ligands, and (5) in vitro antimicrobial activity allows development of silver(I) cyanoximates for medical applications. These include antimicrobial additives to acrylate glue, cured by UV-radiation, used in introduction of prosthetic joints and dental implants, and prevention of biofilm formation on several types of indwelling medical devices. PMID:20873734

Gerasimchuk, Nikolay; Gamian, Andrzej; Glover, Garrett; Szponar, Bogumila

2010-11-01

416

Anodizing color coded anodized Ti6Al4V medical devices for increasing bone cell functions  

PubMed Central

Current titanium-based implants are often anodized in sulfuric acid (H2SO4) for color coding purposes. However, a crucial parameter in selecting the material for an orthopedic implant is the degree to which it will integrate into the surrounding bone. Loosening at the bone–implant interface can cause catastrophic failure when motion occurs between the implant and the surrounding bone. Recently, a different anodization process using hydrofluoric acid has been shown to increase bone growth on commercially pure titanium and titanium alloys through the creation of nanotubes. The objective of this study was to compare, for the first time, the influence of anodizing a titanium alloy medical device in sulfuric acid for color coding purposes, as is done in the orthopedic implant industry, followed by anodizing the device in hydrofluoric acid to implement nanotubes. Specifically, Ti6Al4V model implant samples were anodized first with sulfuric acid to create color-coding features, and then with hydrofluoric acid to implement surface features to enhance osteoblast functions. The material surfaces were characterized by visual inspection, scanning electron microscopy, contact angle measurements, and energy dispersive spectroscopy. Human osteoblasts were seeded onto the samples for a series of time points and were measured for adhesion and proliferation. After 1 and 2 weeks, the levels of alkaline phosphatase activity and calcium deposition were measured to assess the long-term differentiation of osteoblasts into the calcium depositing cells. The results showed that anodizing in hydrofluoric acid after anodizing in sulfuric acid partially retains color coding and creates unique surface features to increase osteoblast adhesion, proliferation, alkaline phosphatase activity, and calcium deposition. In this manner, this study provides a viable method to anodize an already color coded, anodized titanium alloy to potentially increase bone growth for numerous implant applications. PMID:23319862

Ross, Alexandra P; Webster, Thomas J

2013-01-01

417

Transdermal Insulin Delivery Using Microdermabrasion  

PubMed Central

Purpose Transdermal insulin delivery is an attractive needle-free alternative to subcutaneous injection conventionally used to treat diabetes. However, skin’s barrier properties prevent insulin permeation at useful levels. Methods We investigated whether microdermabrasion can selectively remove skin’s surface layers to increase skin permeability as a method to administer insulin to diabetic rats. We further assessed the relative roles of stratum corneum and viable epidermis as barriers to insulin delivery. Results Pretreatment of skin with microdermabrasion to selectively remove stratum corneum did not have a significant effect on insulin delivery or reduction in blood glucose level (BGL). Removal of full epidermis by microdermabrasion significantly reduced BGL, similar to the positive control involving subcutaneous injection of 0.1U insulin. Significant pharmacokinetic differences between microdermabrasion and subcutaneous injection were faster time to peak insulin concentration after injection and larger peak insulin concentration and area-under-the-curve after microdermabrasion. Conclusions Microdermabrasion can increase skin permeability to insulin at levels sufficient to reduce BGL. Viable epidermis is a barrier to insulin delivery such that removal of full epidermis enables significantly more insulin delivery than removal of stratum corneum alone. PMID:21499837

Andrews, Samantha; Lee, Jeong Woo; Choi, Seong-O

2011-01-01

418

Ultrasound-Mediated Transdermal Protein Delivery  

NASA Astrophysics Data System (ADS)

Transdermal drug delivery offers a potential method of drug administration. However, its application has been limited to a few low molecular weight compounds because of the extremely low permeability of human skin. Low-frequency ultrasound was shown to increase the permeability of human skin to many drugs, including high molecular weight proteins, by several orders of magnitude, thus making transdermal administration of these molecules potentially feasible. It was possible to deliver and control therapeutic doses of proteins such as insulin, interferon ?, and erythropoeitin across human skin. Low-frequency ultrasound is thus a potential noninvasive substitute for traditional methods of drug delivery, such as injections.

Mitragotri, Samir; Blankschtein, Daniel; Langer, Robert

1995-08-01

419

Failure or success of search strategies to identify adverse effects of medical devices: a feasibility study using a systematic review  

PubMed Central

Background Research has indicated that adverse effects terms are increasingly prevalent in the title, abstract or indexing terms of articles that contain adverse drug effects data in MEDLINE and Embase. However, it is unknown whether adverse effects terms are present in the database records of articles that contain adverse effects data of medical devices, and thus, to what extent the development of an adverse effects search filter for medical devices may be feasible. Methods A case study systematic review of a medical device was selected. The included studies from a systematic review of the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion were used in the analysis. For each included study, the corresponding database record on MEDLINE and Embase was assessed to measure the presence or absence of adverse effects terms in the title, abstract or indexing. The performance of each potential adverse effects search term was also measured and compared. Results There were 82 publications (49 studies) included in the systematic review with 51 of these indexed on MEDLINE and 55 on Embase. Ninety-four percent (48/51) of the records on MEDLINE and 95% (52/55) of the records on Embase contained at least one adverse effects related search term. The wide variety of adverse effects terms included in the title, abstract or indexing of bibliographic records, and the lack of any individual high-performing search terms suggests that a combination of terms in different fields is required to identify adverse effects of medical devices. In addition, the most successful search terms differed from the most successful terms for identifying adverse drug effects. Conclusions The search filters currently available for adverse drug effects are not necessarily useful for searching adverse effects data of medical devices. The presence of adverse effects terms in the bibliographic records of articles on medical devices, however, indicates that combinations of adverse effects search terms may be useful in search strategies in MEDLINE and Embase. The results, therefore, suggest that not only a search filter for the adverse effects of medical devices is feasible, but also that it should be a research priority. PMID:25312884

2014-01-01

420

BULK TITANIUM MICRONEEDLES WITH EMBEDDED MICROFLUIDIC NETWORKS FOR TRANSDERMAL DRUG DELIVERY  

E-print Network

BULK TITANIUM MICRONEEDLES WITH EMBEDDED MICROFLUIDIC NETWORKS FOR TRANSDERMAL DRUG DELIVERY E. R, robust platform for transdermal drug delivery applications. 1. INTRODUCTION Microfabrication techniques for low-cost transdermal drug delivery and diagnostic applications. Owing to its biocompatibility

MacDonald, Noel C.

421

76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...  

Federal Register 2010, 2011, 2012, 2013

...Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems...developers and manufacturers of transdermal drug delivery systems...

2011-08-17

422

Using mobile devices to support communication between emergency medical responders and deaf people  

Microsoft Academic Search

Fast and effective communication is crucial during medical emergencies, but patients' disabilities can make it a challenging task for emergency medical responders. This paper proposes a mobile system to deal with the communication barrier between medical responders and deaf patients. The system allows medical responders to quickly browse a collection of emergency-related sentences, and show videos of the corresponding translations

Fabio Buttussi; Luca Chittaro; Elio Carchietti; Marco Coppo

2010-01-01

423

Evaluation of reprocessing medical devices in 14 German regional hospitals and at 27 medical practitioners‘ offices within the European context – consequences for European harmonization  

PubMed Central

Safe reprocessing of medical devices through cleaning, disinfection, and sterilization is essential for the prevention of health care associated infections (HAI) and to guarantee patient safety. Several studies detected residual contamination and even severe infections of patients, despite carrying out reprocessing. To develop appropriate solutions, the existing situation in Germany and selected European countries was analyzed. Additionally, in 27 medical practitioners’ offices and 14 hospitals, the true practice of reprocessing was analyzed using a questionnaire, a checklist, and inspection on site. A structured analysis of potential alternatives to the internal reprocessing was conducted within the German and European context. The results indicate that the conditions for the execution of the reprocessing process in the analyzed health facilities in southern Hesse (Germany) do not satisfy legal requirements. The detected deficiencies were consistent with other reports from Germany and Europe. The analysis gave insight into several reasons for the detected deficiencies. The three main reasons were the high costs for proper implementation, the subjective value assigned to the reprocessing unit in health care facilities, and deficits in monitoring by the health authority. Throughout the European Union, a similar regulatory framework for the performance of the reprocessing process exists, while the environment, structures of the health systems and administrative supervision vary significantly. The German states as well as selected European countries are currently discussing the challenges of increased quality-assured execution of the reprocessing process. For instance, the same supervisory system for hospitals and medical practitioners should be established at an equal standard. Alternatives such as the use of single-use medical devices, outsourcing the decontamination processes, or the cooperation of health facilities may be considered. This paper also discusses economic and ecological aspects. Finally, different options are recommended to ensure the exclusive use of reliable medical devices for surgical procedures that guarantee an adequate standard of patient safety within economic constraints. PMID:24327946

Thiede, Birgit; Kramer, Axel

2013-01-01

424

Preparation and characterization of an advanced medical device for bone regeneration.  

PubMed

Tridimensional scaffolds can promote bone regeneration as a framework supporting the migration of cells from the surrounding tissue into the damaged tissue and as delivery systems for the controlled or prolonged release of cells, genes, and growth factors. The goal of the work was to obtain an advanced medical device for bone regeneration through coating a decellularized and deproteinized bone matrix of bovine origin with a biodegradable, biocompatible polymer, to improve the cell engraftment on the bone graft. The coating protocol was studied and set up to obtain a continuous and homogeneous polylactide-co-glycolide (PLGA) coating on the deproteinized bone matrix Orthoss® block without occluding pores and decreasing the scaffold porosity. The PLGA-coated scaffolds were characterized for their morphology and porosity. The effects of PLGA polymer coating on cell viability were assessed with the 3-(4,5-dimethyl-2-thiazolyl)-2,5 diphenyl-2H-tetrazolium assay. The polymer solution concentration and the number of polymeric layers were the main variables affecting coating efficiency and porosity of the original decellularized bone matrix. The designed polymer coating protocol did not affect the trabecular structure of the original decellularized bone matrix. The PLGA-coated decellularized bone matrix maintained the structural features, and it improved the ability in stimulating fibroblasts attachment and proliferation. PMID:24146118

Dorati, Rossella; Colonna, Claudia; Genta, Ida; Bruni, Giovanna; Visai, Livia; Conti, Bice

2014-02-01

425

Analytical methods for the determination of DEHP plasticizer alternatives present in medical devices: a review.  

PubMed

Until 2010, diethylhexylphthalate (DEHP) was the plasticizer most commonly used to soften PVC medical devices (MDs), because of a good efficiency/cost ratio. In flexible plasticized PVC, phthalates are not chemically bound to PVC and they are released into the environment and thus may come into contact with patients. The European Directive 2007/47/CE, classified DEHP as a product with a toxicity risk and restricted its use in MDs. MD manufacturers were therefore forced to quickly find alternatives to DEHP to maintain the elasticity of PVC nutrition tubings, infusion sets and hemodialysis lines. Several replacement plasticizers, so-called "alternative to DEHP plasticizers" were incorporated into the MDs. Nowadays, the risk of exposure to these compounds for hospitalized patients, particularly in situations classified "at risk", has not yet been evaluated, because migrations studies, providing sufficient exposure and human toxicity data have not been performed. To assess the risk to patients of DEHP plasticizer alternatives, reliable analytical methods must be first developed in order to generate data that supports clinical studies being conducted in this area. After a brief introduction of the characteristics and toxicity of the selected plasticizers used currently in MDs, this review outlines recently analytical methods available to determine and quantify these plasticizers in several matrices, allowing the evaluation of potential risk and so risk management. PMID:25127563

Bernard, L; Décaudin, B; Lecoeur, M; Richard, D; Bourdeaux, D; Cueff, R; Sautou, V

2014-11-01

426

Embrittlement phenomenon of Ag core MP35N cable as lead conductor in medical device.  

PubMed

Ag core MP35N (Ag/MP35N) wire has been used in lead electric conductor wires in the medical device industry for many years. Recently it was noticed that the combination of silver and MP35N restricts its wire drawing process. The annealing temperature in Ag/MP35N has to be lower than the melting temperature of pure Ag (960 °C), which cannot fully anneal MP35N. The lower annealing temperature results in a highly cold worked MP35N, which significantly reduces Ag/MP35N ductility. The embrittlement phenomenon of Ag/MP35N cable was observed in tension and bending deformation. The effect of the embrittlement on the wire flex fatigue life was evaluated using a newly developed flex fatigue testing method. The Ag/MP35N cable fatigue results was analyzed with a Coffin-Manson approach and compared to the MP35N cable fatigue results. The root causes of the Ag/Mp35N embrittlement phenomenon are discussed. PMID:23231759

Wang, Ling; Li, Bernie; Zhang, Haitao

2013-02-01

427

The effect of transdermal scopolamine for the prevention of postoperative nausea and vomiting.  

PubMed

Postoperative nausea and vomiting (PONV) is one of the most common and undesirable complaints recorded in as many as 70-80% of high-risk surgical patients. The current prophylactic therapy recommendations for PONV management stated in the Society of Ambulatory Anesthesia (SAMBA) guidelines should start with monotherapy and patients at moderate to high risk, a combination of antiemetic medication should be considered. Consequently, if rescue medication is required, the antiemetic drug chosen should be from a different therapeutic class and administration mode than the drug used for prophylaxis. The guidelines restrict the use of dexamethasone, transdermal scopolamine, aprepitant, and palonosetron as rescue medication 6 h after surgery. In an effort to find a safer and reliable therapy for PONV, new drugs with antiemetic properties and minimal side effects are needed, and scopolamine may be considered an effective alternative. Scopolamine is a belladonna alkaloid, ?-(hydroxymethyl) benzene acetic acid 9-methyl-3-oxa-9-azatricyclo non-7-yl ester, acting as a non-selective muscarinic antagonist and producing both peripheral antimuscarinic and central sedative, antiemetic, and amnestic effects. The empirical formula is C17H21NO4 and its structural formula is a tertiary amine L-(2)-scopolamine (tropic acid ester with scopine; MW = 303.4). Scopolamine became the first drug commercially available as a transdermal therapeutic system used for extended continuous drug delivery during 72 h. Clinical trials with transdermal scopolamine have consistently demonstrated its safety and efficacy in PONV. Thus, scopolamine is a promising candidate for the management of PONV in adults as a first line monotherapy or in combination with other drugs. In addition, transdermal scopolamine might be helpful in preventing postoperative discharge nausea and vomiting owing to its long-lasting clinical effects. PMID:24782768

Antor, María A; Uribe, Alberto A; Erminy-Falcon, Natali; Werner, Joseph G; Candiotti, Keith A; Pergolizzi, Joseph V; Bergese, Sergio D

2014-01-01

428

Overactive Bladder: OTC Oxybutynin Transdermal Patch for Women.  

PubMed

The prevalence and burden of overactive bladder (OAB) in the population is remarkable. An estimated 20 million adult women in the United States have symptoms of OAB. Despite the negative impact on their health-related quality of life, many do not seek treatment. Antimuscarinic agents for OAB have long been available only with a prescription. However, the Food and Drug Administration approved an over-the-counter (OTC) oxybutynin transdermal patch for use in women in 2013, and the product recently came to market. The availability of an OTC antimuscarinic medication for OAB introduces the opportunity for females to self-treat the condition. Prior to the prescription-to-OTC switch, the efficacy and safety data for the prescription product were evaluated. Consumer research studies guided the development of the drug label. PMID:25275392

Molnar, Christin; Fusco, Julie

2014-10-01

429

A skin-contact-actuated micropump for transdermal drug delivery.  

PubMed

In this paper, a skin-contact-actuated dispenser/micropump for transdermal drug delivery applications is presented. The micropump consists of stacked polydimethylsiloxane layers mounted on a silicon substrate and operates based on the evaporation and condensation of a low-boiling-point liquid. Therefore, there is no need for a heater and a power source, since only the thermal energy provided by skin contact is required for the actuation. A prototype device with overall dimensions of 14 mm × 14 mm × 8 mm is fabricated and characterized. For a perfluoro compound working fluid (3M FC-3284), a flow rate of 28.8 ? L/min and a maximum back pressure of 28.9 kPa is measured. PMID:21317070

Mousoulis, Charilaos; Ochoa, Manuel; Papageorgiou, Demetrios; Ziaie, Babak

2011-05-01

430

Transdermal microneedles for drug delivery applications  

Microsoft Academic Search

Transdermal drug delivery (TDD) has many advantages, the main one being the ability to maintain the prolonged release of drugs to attain optimal blood concentrations. Unfortunately, nature has provided a very effective protective barrier, the stratum corneum (sc), which limits TDD to certain types of drugs with specific properties. In order to enhance TDD, the idea of using microneedles to

Ai Ling Teo; Christopher Shearwood; Kian Chye Ng; Jia Lu; Shabbir Moochhala

2006-01-01

431

Transdermal Delivery of Metoprolol by Electroporation  

Microsoft Academic Search

Electroporation, i.e., the creation of transient “pores” in lipid membranes leading to increased permeability, could be used to promote transdermal drug delivery. We have evaluated metoprolol permeation through full thickness hairless rat skin in vitro following electroporation with an exponentially decaying pulse. Application of electric pulses increased metoprolol permeation as compared to diffusion through untreated skin. Raising the number of

Rita Vanbever; Nathalie Lecouturier; Véronique Préat

1994-01-01

432

Transdermal Drug Delivery: Penetration Enhancement Techniques  

Microsoft Academic Search

There is considerable interest in the skin as a site of drug application both for local and systemic effect. However, the skin, in particular the stratum corneum, poses a formidable barrier to drug penetration thereby limiting topical and transdermal bioavailability. Skin penetration enhancement techniques have been developed to improve bioavailability and increase the range of drugs for which topical and

Heather A. E. Benson

2005-01-01

433

Electrically-Assisted Transdermal Drug Delivery  

Microsoft Academic Search

Electrically-assisted transdermal delivery (EATDD) is the facilitated transport of compounds across the skin using an electromotive force. It has been extensively explored as a potential means for delivering peptides and other hydrophilic, acid-labile or orally unstable products of biotechnology. The predominant mechanism for delivery is iontophoresis, although electroosmosis and electroporation have also been investigated. The focus of this review is

Jim E. Riviere; Mark C. Heit

1997-01-01

434

Subjective Effects of Transdermal Nicotine Among Nonsmokers  

Microsoft Academic Search

The subjective experience of nicotine, which may be influenced by personality traits as well as environmental factors, may be important for understanding the factors associated with the initiation and maintenance of nicotine dependence. The present study examined the effects of 7 mg transdermal nicotine among a relatively large sample (n = 91; 44 women) of college-aged nonsmokers. Using a placebo

Rebecca L. Ashare; Joseph S. Baschnagel; Larry W. Hawk

2010-01-01

435

Immune modulation using transdermal photodynamic therapy  

NASA Astrophysics Data System (ADS)

The photosensitizer benzoporphyrin derivative monoacid ring A (VerteporfinR or BPD) has maximum absorption characteristics (690 nm) and biodistribution characteristics which permit activation of the drug in capillaries of the skin without causing skin photosensitivity (transdermal PDT). This permits targeting of cells in the circulation for selective ablation. Since BPD has been shown to accumulate preferentially in activated lymphocytes and monocytes, studies have been undertaken to determine the effect of transdermal PDT on murine models for rheumatoid arthritis (the MRL/lpr adjuvant enhanced model) and multiple sclerosis (the experimental allergic encephalomyelitis (EAE) model in PL mice). Localized transdermal PDT with BPD was found to be completely successful in preventing the development of adjuvant enhanced arthritis in the MRL/lpr mouse as well as improving the underlying arthritic condition of these animals. In the EAE model, in which an adoptive transfer system was used, it was found that transdermal PDT of recipients was effective in preventing EAE if treatments were implemented up to 24 hours after cell transfer but was not effective if given later, indicating the requirement for circulating T cells for effective treatment.

Levy, Julia G.; Chowdhary, R. K.; Ratkay, Leslie G.; Waterfield, Douglas; Obochi, Modestus; Leong, Simon; Hunt, David W. C.; Chan, Agnes H.

1995-01-01

436

Aceclofenac ethosomes for enhanced transdermal delivery  

Microsoft Academic Search

The oral administration of aceclofenac has often resulted in side effects with chronic use. Using the transdermal route eliminates these side effects. Aceclofenac ethosomes were prepared and incorporated into a gel to enhance the skin permeability of aceclofenac. Ethosomal system comprised of phospholipids, ethanol, propylene glycol and lecithin. Different formulations were prepared with varying concentrations of lecithin and ethanol. The

Shaila Lewis; Vivek Dave

2009-01-01

437

Placing a Price on Medical Device Innovation: The Example of Total Knee Arthroplasty  

PubMed Central

Background Total knee arthroplasty (TKA) is common, effective, and cost-effective. Innovative implants promising reduced long-term failure at increased cost are under continual development. We sought to define the implant cost and performance thresholds under which innovative TKA implants are cost-effective. Methods We performed a cost-effectiveness analysis using a validated, published computer simulation model of knee osteoarthritis. Model inputs were derived using published literature, Medicare claims, and National Health and Nutrition Examination Survey data. We compared projected TKA implant survival, quality-adjusted life expectancy (QALE), lifetime costs, and cost-effectiveness (incremental cost-effectiveness ratios or ICERs) of standard versus innovative TKA implants. We assumed innovative implants offered 5–70% decreased long-term TKA failure rates at costs 20–400% increased above standard implants. We examined the impact of patient age, comorbidity, and potential increases in short-term failure on innovative implant cost-effectiveness. Results Implants offering ?50% decrease in long-term TKA failure at ?50% increased cost offered ICERs <$100,000 regardless of age or baseline comorbidity. An implant offering a 20% decrease in long-term failure at 50% increased cost provided ICERs <$150,000 per QALY gained only among healthy 50–59-year-olds. Increasing short-term failure, consistent with recent device failures, reduced cost-effectiveness across all groups. Increasing the baseline likelihood of long-term TKA failure among younger, healthier and more active individuals further enhanced innovative implant cost-effectiveness among younger patients. Conclusions Innovative implants must decrease actual TKA failure, not just radiographic wear, by 50–55% or more over standard implants to be broadly cost-effective. Comorbidity and remaining life span significantly affect innovative implant cost-effectiveness and should be considered in the development, approval and implementation of novel technologies, particularly in orthopedics. Model-based evaluations such as this offer valuable, unique insights for evaluating technological innovation in medical devices. PMID:23671626

Suter, Lisa G.; Paltiel, A. David; Rome, Benjamin N.; Solomon, Daniel H.; Thornhill, Thomas S.; Abrams, Stanley K.; Katz, Jeffrey N.; Losina, Elena

2013-01-01

438

A systems theoretic application to design for the safety of medical diagnostic devices  

E-print Network

In today's environment, medical technology is rapidly advancing to deliver tremendous value to physicians, nurses, and medical staff in order to support them to ultimately serve a common goal: provide safe and effective ...

Balgos, Vincent H

2012-01-01

439

Transdermal rivastigmine in the treatment of Alzheimer's disease: current and future directions.  

PubMed

Despite the fact that the prevalence of Alzheimer's disease (AD) is exponentially increasing, we have not yet been able to develop a new treatment to modify the course of the disease. This vacuum makes the traditional cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonist the only accessible pharmacotherapy options for the treatment of this disease. Among these medications, the only available transdermal patch at this time is the rivastigmine patch. This patch provides significantly lower gastrointestinal adverse effects. A higher tolerability rate provides the option for physicians to continue treatment with higher doses of rivastigmine in advanced stages of AD. Moreover, ease of use, easy-to-follow schedule, less administration time spent by the caregiver result in greater adherent to the treatment. This article aims to provide a comprehensive drug profile for transdermal rivastigmine, to review currently available treatment options, and to try to anticipate future treatment directions for AD. PMID:25201245

Amanatkar, Hamid Reza; Grossberg, George Thomas

2014-10-01

440

76 FR 22805 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities  

Federal Register 2010, 2011, 2012, 2013

...Federal Food, Drug, and Cosmetic Act (the FD&C Act...the General and Plastic Surgery Devices Panel (GPS Panel...Federal Food, Drug, and Cosmetic Act and under authority...GENERAL AND PLASTIC SURGERY DEVICES 0 1. The...

2011-04-25

441

Premarket Assessment of Pediatric Medical Devices: Guidancwe Industry and Food and Drug Administration Staff.  

National Technical Information Service (NTIS)

FDA reviews pediatric devices through all of its premarket pathways, including premarket notification (510(k)), premarket approval (PMA), biological license application (BLA), and humanitarian device exemption (HDE). A manufacturer may show substantial eq...

2014-01-01

442

78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices  

Federal Register 2010, 2011, 2012, 2013

...premarket approval, banned devices, records and reporting requirements, good manufacturing practice requirements, and requirements relating to the use of color additives in devices. Under section 520(g) of the FD&C Act, the procedures...

2013-02-25

443

A medical device for prefabrication of large bone grafts in modern medicine.  

PubMed

Translating advances in the laboratory into sound clinical practice presents a series of formidable conceptual and technical challenges. One of them is our inability to maintain large grafts of living cells upon transfer from in vitro conditions into the host in vivo. This is due mainly to diffusion limitations within the grafting material. We embrace the well-known hypothesis of the "Diamond Concept" in bone tissue regeneration, which includes four key factors. Based on the understanding of basic elements of tissue engineering constructs, prefabrication and conditioning techniques and the nano-vascularisation of the scaffold, we furthermore hypothesize that combinations of cells, solid multipolymeric scaffold as the "core element" working as the extracellular matrix (ECM), growth factors and nano-vascularisation setting may eventually generate a large "ready-to-use"in vitro/in vivo graft. We are confident and think that growth factors will help in the construction of a step-by-step organisation of the bone tissue engineering construct (BTEC). A medical device, named in vitro/in vivo Bone Bioreactor Tissue Engineering Construct (IV2B2TEC), is proposed to fulfil the hypothesis. Soon, we hope to test the above hypothesis on a non-union bone defect in an animal model. This novel strategy will likely open new options for reconstructing extended bone defects and facilitate clinical translation of bone tissue engineering. As compared with conventional reconstructive methods, the strategy has four key advantages and might prove to be a novel armamentarium for clinicians in regenerative medicine. PMID:21183285

Laflamme, Claude; Rouabhia, Mahmoud

2011-04-01

444

Challenges and opportunities in dermal/transdermal delivery  

PubMed Central

Transdermal drug delivery is an exciting and challenging area. There are numerous transdermal delivery systems currently available on the market. However, the transdermal market still remains limited to a narrow range of drugs. Further advances in transdermal delivery depend on the ability to overcome the challenges faced regarding the permeation and skin irritation of the drug molecules. Emergence of novel techniques for skin permeation enhancement and development of methods to lessen skin irritation would widen the transdermal market for hydrophilic compounds, macromolecules and conventional drugs for new therapeutic indications. As evident from the ongoing clinical trials of a wide variety of drugs for various clinical conditions, there is a great future for transdermal delivery of drugs. PMID:21132122

Paudel, Kalpana S; Milewski, Mikolaj; Swadley, Courtney L; Brogden, Nicole K; Ghosh, Priyanka; Stinchcomb, Audra L

2010-01-01

445

Analysis of role-play in medical communication training using a theatrical device the fourth wall  

Microsoft Academic Search

BACKGROUND: Communication training is a central part of medical education. The aim of this article is to explore the positions and didactic functions of the fourth wall in medical communication training, using a role-play model basically similar to a theatrical performance. METHOD: The empirical data stem from a communication training model demonstrated at an international workshop for medical teachers and

Torild Jacobsen; Anders Baerheim; Margret Rose Lepp; Edvin Schei

2006-01-01

446

Medical devices; performance standards for dental and mammographic X-ray devices; amendment--FDA. Proposed rule.  

PubMed

The Food and Drug Administration (FDA) is proposing to exempt panoramic dental x-ray units from the requirement that they be manufactured with exposure timers which automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subjected to unnecessary radiation due to repeat radiographs. FDA also proposes five changes to align the performance standard with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (MQSA). First, the agency proposes to remove any reference to the use of equipment not specifically designed for mammography from the performance requirements for mammography equipment. Second, FDA proposes that the mammographic field alignment requirements restrict the irradiation beam to less than 2 percent of the source-image receptor distance (SID) beyond the image receptor edges. Third, it is proposed that the definition of an image receptor support device be amended to specify that it must provide a primary protective barrier for any orientation of the x-ray tube and image receptor support device assembly. Fourth, it is proposed that the useful beam must be confined to the dimensions of the primary barrier provided by the image receptor support device (except on the chest wall side). Fifth, it is proposed that exposures not be permitted without the primary barrier in place. PMID:10185846

1998-10-29

447

Fundamental study of an electric power transmission system for implanted medical devices using magnetic and ultrasonic energy.  

PubMed

In this paper, the authors propose a novel electric power supply system for implanted medical devices. The system is noninvasive and uses two kinds of energy, magnetic and ultrasonic. The system can provide high power levels harmlessly. The energies are obtained by two types of vibrator, i.e., piezo and magnetostriction devices. A prototype was built and it was verified experimentally that the system is basically able to provide power. At high frequencies, such as 100 kHz, the output power was higher than the conventional system using a transformer. The normalized output power per unit volume also exceeded the transformer system. PMID:14598116

Suzuki, Shin-nosuke; Katane, Tamotsu; Saito, Osami

2003-01-01

448

Poly-4-hydroxybutyrate (P4HB): a new generation of resorbable medical devices for tissue repair and regeneration.  

PubMed

Poly-4-hydroxybutyrate (P4HB) is a thermoplastic, linear polyester, produced by recombinant fermentation, that can be converted into a wide range of resorbable medical devices. P4HB fibers are exceptionally strong, and can be designed to provide prolonged strength retention in vivo. In 2007, the FDA cleared a monofilament suture made from P4HB for general soft tissue approximation and/or ligation. Subsequently, surgical mesh devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery have been introduced for clinical use. This review describes the unique properties of P4HB, its clinical applications, and potential uses that are under development. PMID:23979121

Williams, Simon F; Rizk, Said; Martin, David P

2013-10-01

449

21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?  

... false Where can I find the reporting codes for adverse events that I use with medical...803.21 Where can I find the reporting codes for adverse events that I use with medical...The MEDWATCH Medical Device Reporting Code Instruction Manual contains adverse...

2014-04-01

450

Non-Contact Heart and Respiratory Monitoring Technology Mind2Market is a medical-device company producing a respiratory monitor that uses radar sensor tech-  

E-print Network

Non-Contact Heart and Respiratory Monitoring Technology Mind2Market is a medical-device company regular alerts initiates needed medical attention immediately. Market Potential The technology has great medical information. Animals often need to be isolated, quarantined and sedated in order to monitor vital

Jawitz, James W.

451

75 FR 61494 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013

...Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional...Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional...Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for...

2010-10-05

452

Biocompatibility analysis of an electrically-activated silver-based antibacterial surface system for medical device applications.  

PubMed

The costs associated with the treatment of medical device and surgical site infections are a major cause of concern in the global healthcare system. To prevent transmission of such infections, a prophylactic surface system that provides protracted release of antibacterial silver ions using low intensity direct electric current (LIDC; 28 ?A system current at 6 V) activation has been recently developed. To ensure the safety for future in vivo studies and potential clinical applications, this study assessed the biocompatibility of the LIDC-activated interdigitated silver electrodes-based surface system; in vitro toxicity to human epidermal keratinocytes, human dermal fibroblasts, and normal human osteoblasts, and antibacterial efficacy against Staphylococcus aureus and Escherichia coli was evaluated. The study concluded that the technological applications of the surface system for medical devices and surgical tools, which contact human tissues for less than 1.5 h, are expected to be self-sterilizing without causing toxicity in vivo. PMID:23242768

Samberg, Meghan E; Tan, Zhuo; Monteiro-Riviere, Nancy A; Orndorff, Paul E; Shirwaiker, Rohan A

2013-03-01

453

Identification and quantification of 14 phthalates and 5 non-phthalate plasticizers in PVC medical devices by GC-MS.  

PubMed

A GC/MS method was developed for the identification and quantification of 14 phthalates: 8 phthalates classified H360 (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP and DiBP), 3 phthalates proposed to be forbidden in medical devices (DnOP, DiNP and DiDP) and 3 other phthalates none regulated (DMP, DCHP and DEP) which may interfere with hormone function. In order to identify and quantify other plasticizers that are commonly used in PVC medical devices such as DEHP substitute, 5 non-phthalate plasticizers (ATBC, DEHA, DEHT, TOTM, and DINCH) were included in this study. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of plasticizers is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30m×0.25mm (i.d.)×0.25?m film thickness using a gradient temperature. Compounds quantification is performed by external calibration using an internal standard. Validation elements on standard solutions were determined using the ISO 12787 standard approach. Plasticizers are extracted from PVC medical devices using THF for dissolving the PVC part of the sample followed by precipitation of the PVC by addition of ethanol. The supernatant is injected into a GC/MS system after dilution in ethanol. Different validation elements, including extraction recoveries for all compounds or for DEHP a cross-validation of the extraction process using the European pharmacopoeia monograph 3.1.14 as reference method, are discussed. Results obtained on 61 medical devices in PVC and 12 raw materials used as plasticizers are given. PMID:24480330

Gimeno, Pascal; Thomas, Sébastien; Bousquet, Claudine; Maggio, Annie-Françoise; Civade, Corinne; Brenier, Charlotte; Bonnet, Pierre-Antoine

2014-02-15

454

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good  

PubMed Central

• Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations. PMID:16569240

Faunce, Thomas Alured

2006-01-01

455

Multiscale modeling of transdermal drug delivery  

NASA Astrophysics Data System (ADS)

This study addresses the modeling of transdermal diffusion of drugs, to better understand the permeation of molecules through the skin, and especially the stratum corneum, which forms the main permeation barrier of the skin. In transdermal delivery of systemic drugs, the drugs diffuse from a patch placed on the skin through the epidermis to the underlying blood vessels. The epidermis is the outermost layer of the skin and can be further divided into the stratum corneum (SC) and the viable epidermis layers. The SC consists of keratinous cells (corneocytes) embedded in the lipid multi-bilayers of the intercellular space. It is widely accepted that the barrier properties of the skin mostly arises from the ordered structure of the lipid bilayers. The diffusion path, at least for lipophilic molecules, seems to be mainly through the lipid bilayers. Despite the advantages of transdermal drug delivery compared to other drug delivery routes such as oral dosing and injections, the low percutaneous permeability of most compounds is a major difficulty in the wide application of transdermal drug delivery. In fact, many transdermal drug formulations include one or more permeation enhancers that increase the permeation of the drug significantly. During the last two decades, many researchers have studied percutaneous absorption of drugs both experimentally and theoretically. However, many are based on pharmacokinetic compartmental models, in which steady or pseudo-steady state conditions are assumed, with constant diffusivity and partitioning for single component systems. This study presents a framework for studying the multi-component diffusion of drugs coupled with enhancers through the skin by considering the microstructure of the stratum corneum (SC). A multiscale framework of modeling the transdermal diffusion of molecules is presented, by first calculating the microscopic diffusion coefficient in the lipid bilayers of the SC using molecular dynamics (MD). Then a homogenization procedure is performed over a model unit cell of the heterogeneous SC, resulting in effective diffusion parameters. These effective parameters are the macroscopic diffusion coefficients for the homogeneous medium that is "equivalent" to the heterogeneous SC, and thus can be used in finite element simulations of the macroscopic diffusion process.

Rim, Jee Eun

456

[Transdermal opioid administration: the pain plaster].  

PubMed

A new method of administration of an opioid was recently registered: fentanyl transdermal (brand name: Durogesic), intended particularly for the indication range 'pain in cancer'. Fentanyl is lipid-soluble so that deposition in the skin takes place and the biological half-life is approximately 20 hours after removal of the plaster. It is safe to start on a basis of an equianalgesic conversion of 100:1 in relation to oral morphine, although this may entail some risk of fentanyl under dosage. The dose adjustment time is 12-24 hours before a constant fentanyl level is reached; therefore, after attaching the first sticking plaster, the original morphine dose should be continued for another 12 hours. In addition, the patient may, if necessary, be given supplementary morphine preferably as a short-acting drug. There seems to be no clear indication for transdermal fentanyl either in neuropathic pain or in chronic benign pain. PMID:9221362

Vecht, C J; Sillevis Smitt, P A

1997-04-26

457

Microsecond thermal ablation of skin for transdermal drug delivery Jeong Woo Lee a  

E-print Network

Microsecond thermal ablation of skin for transdermal drug delivery Jeong Woo Lee a , Priya Gadiraju ablation Transdermal drug delivery Thermal ablation is a promising mechanism to increase permeability for transdermal drug delivery. © 2011 Elsevier B.V. All rights reserved. 1. Introduction Transdermal drug delivery

458

MICRO-ABLATION OF SKIN BY ARC-DISCHARGE JET EJECTION FOR TRANSDERMAL DRUG DELIVERY  

E-print Network

MICRO-ABLATION OF SKIN BY ARC-DISCHARGE JET EJECTION FOR TRANSDERMAL DRUG DELIVERY Priya D is a significant advance for transdermal drug delivery. Keywords: Transdermal drug delivery, Arc-discharge, jet ejection, Micro-ablation 1. INTRODUCTION Transdermal drug delivery [1] has gained importance recently

459

Radiological safety of medical devices sterilized with X-rays at 7.5 MeV  

NASA Astrophysics Data System (ADS)

The induced radioactivity in medical devices when sterilized with 7.5 MeV X-rays has been investigated theoretically and verified by dedicated experiments. The experimental setup has been chosen to simulate closely the situation in a commercial irradiation facility. The purpose of this study is twofold: compare activation of medical devices with regulatory limits and evaluate corresponding dose exposure of persons in contact with those devices. Samples of medical devices, classified in several test groups, were located in a stack of low-density material at the position of the highest photoneutron fluence and irradiated to X-ray doses between 25 and 30 kGy. The induced activities were measured with high purity germanium (HPGe) gamma ray spectrometers. The X-rays were generated in a tantalum target using a 7.3 MeV electron beam with a narrow energy spread during the first experiment and with a broad energy spectrum for a second one. Results have been scaled to 50 kGy and compared with theoretical estimates. In addition, the radiation exposure of four categories of persons (logistics personnel in the irradiation facility, truck drivers, doctors and patients) has been calculated from the measured activities. The measured activities are higher than theoretical expectations but still below governmental regulations. The annual dose received by the person category with the highest exposure is about 1% of the worldwide average environmental exposure, and for other categories it is negligible. The paper concludes that provided some precautions are considered, sterilization with X-rays from 7.5 MeV electrons can be regarded safe from the standpoint of public health and personal safety.

Grégoire, O.; Cleland, M. R.; Mittendorfer, J.; Vander Donckt, M.; Meissner, J.

2003-06-01

460

The report analyses the total disposable medical device market with focus on syringes. It compares syringes segments, RTF and bulk syringes by value and volume. The report also analyzes major markets such as US, Germany, UK, Italy, and Russia  

Microsoft Academic Search

Disposable medical device is a very important part of the total medical device industry. For the last few years disposable market is growing continuously and showing a bright growth trend in near future. Needles and syringes are most on-demand product segment of disposable medical device market. Other segments of the market are also showing positive growth trends like disposable gloves,

461

ORIGINAL ARTICLE Visualization of Oleic Acid-induced Transdermal Diusion  

E-print Network

£uores- cence and the transdermal £uorescent model drug spatial distributions were imaged simultaneously overORIGINAL ARTICLE Visualization of Oleic Acid-induced Transdermal Di¡usion Pathways Using Two-based model drug intensity emission at a di¡erent wavelength range of the £uorescence emission spectrum

So, Peter

462

Transdermal Drug Delivery Using Low-Frequency Sonophoresis  

Microsoft Academic Search

Purpose. Application of therapeutic ultrasound (frequency: 1–3 MHz and intensity: 0–2 W\\/cm2) enhances transdermal drug transport, although typically by a factor of less than 10. In this paper, we show that application of ultrasound at 20 KHz induces transdermal transport enhancements of up to 1000 times higher than those induced by therapeutic ultrasound.

Samir Mitragotri; Daniel Blankschtein; Robert Langer

1996-01-01

463

The effects of dimenhydrinate, cinnarizine and transdermal scopolamine on performance  

Microsoft Academic Search

We assessed the influence of dimenhydrinate, cinnarizine and transdermal scopolamine on the ability to perform simulated naval crew tasks. The effect of single doses of dimenhydrinate, 100 mg, cinnarizine, 50 mg, and one transdermal scopolamine patch on psychomotor performance was evaluated using a double-blind, placebo-controlled, randomized, crossover design in three separate studies. A total of 60 young naval crew (20

C. R. Gordon; A. Gonen; Z. Nachum; I. Doweck; O. Spitzer; A. Shupak

2001-01-01

464

76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...2011, meeting of the panel to discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims. FDA is reopening the comment period to update comments and to receive any new...

2011-04-01

465

77 FR 24716 - Scientific Information Request on Medical Devices To Treat Otitis Media With Effusion  

Federal Register 2010, 2011, 2012, 2013

...socioeconomic status groups d. Patients with comorbidities such as craniofacial abnormalities (e.g., cleft palate), Down syndrome, and existing speech, language, and hearing problems e. Patients with a medical history of AOM or OME (with...

2012-04-25

466

The traditional method of oral as-needed pain medication delivery compared to an oral patient-controlled analgesia device following total knee arthroplasty.  

PubMed

As-needed (PRN) oral pain medication is an essential part of multimodal pain therapy. Medication delivery is often delayed because of multiple demands upon nursing time in a busy postoperative nursing unit. Postoperative pain control was compared using either the manual delivery of PRN oral pain medication or a bedside oral patient-controlled analgesia device. Thirty patients in each group completed a survey on the day of discharge, and additional data were collected by chart reviews. Device patients had significantly better pain scores than the usual care group on postoperative Day 2 and within the last 24 hours prior to discharge. The device group reported statistically less pain interference overall with general activity, mood, physical therapy, sleep, and appetite. Use of an oral patient-controlled analgesia device may improve pain management and patient function following total knee arthroplasty compared to the traditional delivery of oral PRN pain medication. PMID:25058727

Lambert, Teresa L; Cata, Denise M

2014-01-01

467

2.782J / 3.961J / 20.451J / HST.524J Design of Medical Devices and Implants, Spring 2003  

E-print Network

Solution of clinical problems by use of implants and other medical devices. Systematic use of cell-matrix control volumes. The role of stress analysis in the design process. Anatomic fit: shape and size of implants. Selection ...

Yannas, Ioannis V.

468

Ultra-low-power circuits and systems for wearable and implantable medical devices  

E-print Network

Advances in circuits, sensors, and energy storage elements have opened up many new possibilities in the health industry. In the area of wearable devices, the miniaturization of electronics has spurred the rapid development ...

Yip, Marcus

2013-01-01

469

[Study on preparation of testosterone undecanoate ethosomes and its in vitro transdermal penetration].  

PubMed

Ethosomes, as a new vector for transdermal drug delivery, could obviously improve the transdermal penetration of drugs. In this study, we prepared testosterone undecanoate ethosomes, with TU ethosomes as the basic remedy, to determine its appearance, particle size, entrapment efficiency (EE) and membrane fluidity. Meanwhile, a transdermal test was conducted in mice, in order to determine the permeability characteristics of ethosomes as a vector for transdermal drug delivery, and compare transdermal behaviors of TU ethosomes, liposomes and their ethanol solutions. PMID:23944071

Meng, Shu; Yang, Li-Qun; Ma, Li-Ying; Guo, Jing; Li, Miao; Yang, Dan

2013-05-01

470

Rapid and low-cost prototyping of medical devices using 3D printed molds for liquid injection molding.  

PubMed

Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications. PMID:24998993

Chung, Philip; Heller, J Alex; Etemadi, Mozziyar; Ottoson, Paige E; Liu, Jonathan A; Rand, Larry; Roy, Shuvo

2014-01-01

471

[Safety of use assessment in a radio-frequency medical device].  

PubMed

The authors assessed the operating safety physical parameters of a bipolar radiofrequency device for aesthetic purposes. According to both Italian and EU guidelines, the authors considered: magnetic field environmental emission levels, electricity induced in the opertator's limbs, operator's exposure and radiofrequency specific absorbance rate (SAR) in treated tissues. Measurements were carried out with isotropic sensors and an inductive current indicator. Results pointed out excellent safety levels regarding environment, operators and patients as well, although such radiofrequency equipment cannot be used on patients with pacemakers, neurostimulators and other vital function controlling devices. PMID:25369715

Nicoletti, Giovanni; Coppola, Antonio; Di Liberto, Riccardo; Faga, Angela; Scevola, Silvia

2014-01-01

472

oving a new drug or medical device from the laboratory to  

E-print Network

, the country and globally. The hoped-for result--a new and better medical therapy -- is the end point of a long animals and human cells, and finishes with large-scale human trials to prove the value and safety of mouth keeps students coming here," says Ratkowski, who is an assistant professor of clinical trial

Garfunkel, Eric

473

Analysis of role-play in medical communication training using a theatrical device the fourth wall  

PubMed Central

Background Communication training is a central part of medical education. The aim of this article is to explore the positions and didactic functions of the fourth wall in medical communication training, using a role-play model basically similar to a theatrical performance. Method The empirical data stem from a communication training model demonstrated at an international workshop for medical teachers and course organizers. The model involves an actress playing a patient, students alternating in the role of the doctor, and a teacher who moderates. The workshop was videotaped and analyzed qualitatively. Results The analysis of the empirical material revealed three main locations of the fourth wall as it moved and changed qualities during the learning session: 1) A traditional theatre location, where the wall was transparent for the audience, but opaque for the participants in the fiction. 2) A "timeout/reflection" location, where the wall was doubly opaque, for the patient on the one side and the moderator, the doctor and the audience on the other side and 3) an "interviewing the character" location where the wall enclosed everybody in the room. All three locations may contribute to the learning process. Conclusion The theatrical concept 'the fourth wall' may present an additional tool for new understanding of fiction based communication training. Increased understanding of such an activity may help medical teachers/course organizers in planning and evaluating communication training courses. PMID:17040575

Jacobsen, Torild; Baerheim, Anders; Lepp, Margret Rose; Schei, Edvin

2006-01-01

474

Real-time signal processing of accelerometer data for wearable medical patient monitoring devices  

Microsoft Academic Search

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

Matt Van Wieringen; J. Mikael Eklund

2008-01-01

475

The Use of Solid States Ionic Materials and Devices in Medical Applications  

NASA Astrophysics Data System (ADS)

Electrolyte materials used in solid state polymer batteries can also be utilised in a special type of drug delivery system called an iontophoretic device. This review will describe the history, applications and limitations of iontophoretic and related systems and also the use of batteries and biofuel cells in medicine.

Linford, R. G.

2006-06-01

476

Model for a web based communication system between clinical engineers and medical device companies  

E-print Network

that can be accessed for information related to their services, and clinical engineers commonly have Web access. The missing link in this scenario is a Web site that could act as a central point of coned between the clinical engineers and the device...

Misri, Sandeep

2012-06-07

477

Oxybutynin and its new transdermal application for the treatment of overactive bladder.  

PubMed

It has long been accepted that antimuscarinic agents are the backbone of the pharmacological treatment of overactive bladder. Oxybutynin has been the gold standard of these medications for years due to its efficacy, but suffers from a lack of selectivity for the bladder, and extensive metabolism and lipophilicity result in significant side-effect issues. The transdermal delivery of oxybutynin turns this disadvantage of lipophilicity into an advantage. This, in turn, bypasses gastrointestinal absorption and metabolism by the cytochrome P450 system and reduces the breakdown into metabolites responsible for many of the side effects, while providing equivalent efficacy to the immediate-release oral formulation. PMID:19803893

Appell, Rodney A

2006-03-01

478

Effect of Inclusion Size and Distribution on the Corrosion Behavior of Medical-Device Grade Nitinol Tubing  

NASA Astrophysics Data System (ADS)

Nonmetallic inclusions in Nitinol, such as carbides (TiC) and intermetallic oxides (Ti4Ni2O x ), are known to be triggers for fatigue failure of Nitinol medical devices. These mechanically brittle inclusions are introduced during the melting process. As a result of hot and cold working in the production of Nitinol tubing inclusions are fractionalized due to the mechanical deformation imposed. While the role of inclusions regarding Nitinol fatigue performance has been studied extensively in the past, their effect on Nitinol corrosion behavior was investigated in only a limited number of studies. The focus of the present work was to understand the effect of inclusion size and distribution on the corrosion behavior of medical-device grade Nitinol tubing made from three different ingot sources during different manufacturing stages: (i) for the initial stage (hollow: round bar with centric hole), (ii) after hot drawing, and (iii) after the final drawing step (final tubing dimensions: outer diameter 0.3 mm, wall thickness 0.1 mm). For one ingot source, two different material qualities were investigated. Potentiodynamic polarization tests were performed for electropolished samples of the above-mentioned stages. Results indicate that inclusion size rather than inclusion quantity affects the susceptibility of electropolished Nitinol to pitting corrosion.

Wohlschlögel, Markus; Steegmüller, Rainer; Schüßler, Andreas

2014-07-01

479

Fiber-optic Fourier transform infrared spectroscopy for remote label-free sensing of medical device surface contamination  

NASA Astrophysics Data System (ADS)

As a potential major source of biochemical contamination, medical device surfaces are of critical safety concerns in the clinical practice and public health. The development of innovative sensing methods for accurate and real-time detection of medical device surface contamination is essential to protect patients from high risk infection. In this paper, we demonstrate an alternative fiber-optic Fourier Transform Infrared (FTIR) spectroscopy based sensing approach for remote, non-contact, and label-free detection of biochemical contaminants in the mid-infrared (mid-IR) region. The sensing probe is designed using mid-IR hollow fibers and FTIR measurements are carried out in reflection mode. Bovine Serum Albumin (BSA) and bacterial endotoxin of different concentrations under thoroughly dry condition are used to evaluate the detection sensitivity. The devised system can identify ?0.0025% (?4 × 1011 molecules) BSA and 0.5% (0.5 EU/ml) endotoxin concentration. The developed sensing approach may be applied to detect various pathogens that pose public health threats.

Hassan, Moinuddin; Tan, Xin; Welle, Elissa; Ilev, Ilko

2013-05-01

480

75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...  

Federal Register 2010, 2011, 2012, 2013

...Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems...developers and manufacturers of transdermal drug delivery systems...

2010-08-03

481

Machine learning study for the prediction of transdermal peptide.  

PubMed

In order to develop a computational method to rapidly evaluate transdermal peptides, we report approaches for predicting the transdermal activity of peptides on the basis of peptide sequence information using Artificial Neural Network (ANN), Partial Least Squares (PLS) and Support Vector Machine (SVM). We identified 269 transdermal peptides by the phage display technique and use them as the positive controls to develop and test machine learning models. Combinations of three descriptors with neural network archi