Preventing medical-device–borne outbreaks: High-level disinfection policy for duodenoscopes

2020 ◽  
pp. 1-4
Author(s):  
Preeti Mehrotra ◽  
David J. Weber ◽  
Ameet Sarpatwari
Keyword(s):  
Medical Device ◽  
High Level

Adopting Identification Standards in the Medical Device Supply Chain

2020 ◽  
Vol 13 (1) ◽  
pp. 1-14 ◽  
Author(s):  
Yousef Abdulsalam ◽  
Dari Alhuwail ◽  
Eugene S. Schneller
Keyword(s):  
Supply Chain ◽  
Medical Device ◽  
Medical Devices ◽  
Business Intelligence ◽  
Return On Investment ◽  
Survey Methods ◽  
Device Identification ◽  
Medical Device Manufacturers ◽  
High Level ◽  
The U.S

The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.

Cultural Barriers to the Transition from Product to Product Service in the Medical Device Industry

2014 ◽  
Vol 5 (2) ◽  
pp. 36-50 ◽  
Author(s):  
Linda Ryan ◽  
David Tormey ◽  
Perry Share
Keyword(s):  
Medical Device ◽  
Value Chain ◽  
Service Provision ◽  
Cultural Barriers ◽  
Manufacturing Companies ◽  
Regulatory Requirements ◽  
Product Service ◽  
High Level ◽  
Product Service Systems ◽  
Service Transition

Manufacturing companies are increasingly moving up the value chain by expanding their value offering to include service components, namely Product Service Systems (PSS). Due to the fundamental differences between the provision of products and services, many struggle to effectively integrate the two into a single cohesive offering. This is particularly true of companies operating in the medical device field as, due to the high level of regulatory requirements and controls, implementation of the ‘soft' components of service provision is difficult. The aim of the research is to facilitate companies to move up the value chain from product to product-service provision. Once identified, barriers can then be directly addressed and overcome, thereby allowing the development of a cohesive PSS offering. This will be achieved by identifying existing cultural barriers in relation to the application of PSS strategy within a product-orientated business. This information can be used to facilitate the application of PSS models with produc-orientated companies. This paper details qualitative research, undertaken with eight product-orientated medical device companies and two service practitioners, which establishes, details and analyses the primary cultural barriers in relation to product to product-service transition. These cultural barriers are further extrapolated through a supporting literature research.

An Agent-Based Fault Tolerance Mechanism for Dependable Medical Systems

2015 ◽  
Vol 6 (1) ◽  
pp. 47-75
Author(s):  
Meriem Zaiter ◽  
Salima Hacini ◽  
Zizette Boufaida
Keyword(s):  
Distributed Systems ◽  
Fault Tolerance ◽  
Medical Device ◽  
Home Monitoring ◽  
Medical System ◽  
Medical Systems ◽  
Tolerance Mechanism ◽  
Agent Based ◽  
High Level ◽  
Domestic Medical

The use of distributed systems and IT is growing, with automation being used more and more to facilitate our daily tasks. The need to remotely monitor a patient has driven one of important results of this growth: domestic medical systems. The latter are able to follow and maintain the condition of a patient in the patient's home. Monitoring is important in terms of saving time and also money. However, the critical nature of this task requires a high level of dependability. The aim of dependability is to satisfy the user's goal, which is that whatever the state and context of the overall system, its ability to control the operation of the medical device and to transmit files reporting the patient's condition (normal, critical, alert, etc.) must be continuously assured. This can be ensured by fault tolerance techniques. The authors' objective in this paper is to present a technique for fault tolerance in a domestic medical system. Briefly, their proposal integrates a smart concept into the system: agents for controlling the operation of the medical system and tolerating the faults that can occur.

Training Decay Selection for Usability Validation

2016 ◽  
Vol 5 (1) ◽  
pp. 76-83
Author(s):  
Shannon E. Clark
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Validation Studies ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Selection For ◽  
The Moment ◽  
High Level ◽  
First Time ◽  
Validation Testing

When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves. The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.

Transcription factor/DNA interactions visualized by electron spectroscopic imaging

1992 ◽  
Vol 50 (1) ◽  
pp. 450-451
Author(s):  
David P. Bazett-Jones ◽  
Mark L. Brown
Keyword(s):  
Transcription Factor ◽  
Dna Sequences ◽  
Transcription Initiation ◽  
Molecular Mechanisms ◽  
Phosphorus Content ◽  
Spectroscopic Imaging ◽  
Electron Spectroscopic Imaging ◽  
Dna Backbone ◽  
Two Parameters ◽  
High Level

A multisubunit RNA polymerase enzyme is ultimately responsible for transcription initiation and elongation of RNA, but recognition of the proper start site by the enzyme is regulated by general, temporal and gene-specific trans-factors interacting at promoter and enhancer DNA sequences. To understand the molecular mechanisms which precisely regulate the transcription initiation event, it is crucial to elucidate the structure of the transcription factor/DNA complexes involved. Electron spectroscopic imaging (ESI) provides the opportunity to visualize individual DNA molecules. Enhancement of DNA contrast with ESI is accomplished by imaging with electrons that have interacted with inner shell electrons of phosphorus in the DNA backbone. Phosphorus detection at this intermediately high level of resolution (≈lnm) permits selective imaging of the DNA, to determine whether the protein factors compact, bend or wrap the DNA. Simultaneously, mass analysis and phosphorus content can be measured quantitatively, using adjacent DNA or tobacco mosaic virus (TMV) as mass and phosphorus standards. These two parameters provide stoichiometric information relating the ratios of protein:DNA content.

Advances in Stem Instrumentation for Biology

1990 ◽  
Vol 48 (1) ◽  
pp. 362-363
Author(s):  
J. S. Wall
Keyword(s):  
Scanning Transmission Electron Microscope ◽  
Carbon Films ◽  
Specimen Preparation ◽  
Material Deposition ◽  
Active User ◽  
Percent Improvement ◽  
Scanning Transmission ◽  
The Moment ◽  
Film Substrate ◽  
High Level

The forte of the Scanning transmission Electron Microscope (STEM) is high resolution imaging with high contrast on thin specimens, as demonstrated by visualization of single heavy atoms. of equal importance for biology is the efficient utilization of all available signals, permitting low dose imaging of unstained single molecules such as DNA.Our work at Brookhaven has concentrated on: 1) design and construction of instruments optimized for a narrow range of biological applications and 2) use of such instruments in a very active user/collaborator program. Therefore our program is highly interactive with a strong emphasis on producing results which are interpretable with a high level of confidence.The major challenge we face at the moment is specimen preparation. The resolution of the STEM is better than 2.5 A, but measurements of resolution vs. dose level off at a resolution of 20 A at a dose of 10 el/A2 on a well-behaved biological specimen such as TMV (tobacco mosaic virus). To track down this problem we are examining all aspects of specimen preparation: purification of biological material, deposition on the thin film substrate, washing, fast freezing and freeze drying. As we attempt to improve our equipment/technique, we use image analysis of TMV internal controls included in all STEM samples as a monitor sensitive enough to detect even a few percent improvement. For delicate specimens, carbon films can be very harsh-leading to disruption of the sample. Therefore we are developing conducting polymer films as alternative substrates, as described elsewhere in these Proceedings. For specimen preparation studies, we have identified (from our user/collaborator program ) a variety of “canary” specimens, each uniquely sensitive to one particular aspect of sample preparation, so we can attempt to separate the variables involved.

A Questionnaire Survey of Current Rehabilitation Practices for Adults With Normal Hearing Sensitivity Who Experience Auditory Difficulties

2020 ◽  
Vol 29 (4) ◽  
pp. 738-761
Author(s):  
Tess K. Koerner ◽  
Melissa A. Papesh ◽  
Frederick J. Gallun
Keyword(s):  
Hearing Aids ◽  
Questionnaire Survey ◽  
Patient Population ◽  
Clinical Care ◽  
Normal Hearing ◽  
Auditory Training ◽  
Training Methods ◽  
Hearing Sensitivity ◽  
Considerable Benefit ◽  
High Level

Purpose A questionnaire survey was conducted to collect information from clinical audiologists about rehabilitation options for adult patients who report significant auditory difficulties despite having normal or near-normal hearing sensitivity. This work aimed to provide more information about what audiologists are currently doing in the clinic to manage auditory difficulties in this patient population and their views on the efficacy of recommended rehabilitation methods. Method A questionnaire survey containing multiple-choice and open-ended questions was developed and disseminated online. Invitations to participate were delivered via e-mail listservs and through business cards provided at annual audiology conferences. All responses were anonymous at the time of data collection. Results Responses were collected from 209 participants. The majority of participants reported seeing at least one normal-hearing patient per month who reported significant communication difficulties. However, few respondents indicated that their location had specific protocols for the treatment of these patients. Counseling was reported as the most frequent rehabilitation method, but results revealed that audiologists across various work settings are also successfully starting to fit patients with mild-gain hearing aids. Responses indicated that patient compliance with computer-based auditory training methods was regarded as low, with patients generally preferring device-based rehabilitation options. Conclusions Results from this questionnaire survey strongly suggest that audiologists frequently see normal-hearing patients who report auditory difficulties, but that few clinicians are equipped with established protocols for diagnosis and management. While many feel that mild-gain hearing aids provide considerable benefit for these patients, very little research has been conducted to date to support the use of hearing aids or other rehabilitation options for this unique patient population. This study reveals the critical need for additional research to establish evidence-based practice guidelines that will empower clinicians to provide a high level of clinical care and effective rehabilitation strategies to these patients.

805: High-Level Cyclin D1 is Associated with High Gleason Grade and Predicts Worse Biochemical-Free Survival in Prostate Cancer

2006 ◽  
Vol 175 (4S) ◽  
pp. 260-260
Author(s):  
Rile Li ◽  
Hong Dai ◽  
Thomas M. Wheeler ◽  
Anna Frolov ◽  
Gustavo Ayala
Keyword(s):  
Prostate Cancer ◽  
Cyclin D1 ◽  
Gleason Grade ◽  
Free Survival ◽  
High Level
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