scholarly journals MDUFA and its Impact on Medical Device Sector

2020 ◽  
Vol 11 (2) ◽  
pp. 2109-2116
Author(s):  
Anjana B ◽  
Naga Gouri T ◽  
Pramod Kumar T M ◽  
Venkatesh M P
Keyword(s):  
Medical Device ◽  
Review Process ◽  
Approval Process ◽  
Patient Health ◽  
Device User ◽  
User Fee ◽  
Set Up ◽  
Short Time ◽  
To Receive ◽  
The U.S

The U.S. Congress passed Medical Device User Fee Act (MDUFA), where FDA is required to assign and collect fees from manufacturers of medical devices to evaluate the functioning and the usage of the device.  for the purpose of fastening the analysis of the application of the drug. The Medical Device User Fee Modernization Act was first adopted in 2002. The act focussed on innovative review process and reviewing capabilities of experts. Every five years, MDUFA comes up with reauthorisation. The act was reauthorized in 2007 by reducing the application fee and introducing certain new fees such as the annual product fee and annual establishment fee which helped in pre-market evaluation. Few issues being raised in MDUFA II led the congress to enact an amendment. The next revision of the act made the review process more efficient and interactive with the applicant to meet the timelines. Recent amendment has set up several new performance goals and proposes certain changes to the previous amendments. The device manufacturers are currently in a position to receive regulatory approval in a short time compared to the pre-MDUFA period. MDUFA has helped in improving the patient health by streamlining the FDA’s approval process for application of new medical device, thereby allowing patient’s quicker access to potentially life changing therapies.

Rapid, Refined, and Robust Method for Expression, Purification, and Characterization of Recombinant Human Amyloid-beta M1-42

2019 ◽  
Author(s):  
Priya Prakash ◽  
Travis Lantz ◽  
Krupal P. Jethava ◽  
Gaurav Chopra
Keyword(s):  
Amyloid Beta ◽  
Western Blots ◽  
Force Microscopy ◽  
E Coli ◽  
Atomic Force ◽  
Set Up ◽  
Short Time

Amyloid plaques found in the brains of Alzheimer’s disease (AD) patients primarily consists of amyloid beta 1-42 (Ab42). Commercially, Ab42 is synthetized using peptide synthesizers. We describe a robust methodology for expression of recombinant human Ab(M1-42) in Rosetta(DE3)pLysS and BL21(DE3)pLysS competent E. coli with refined and rapid analytical purification techniques. The peptide is isolated and purified from the transformed cells using an optimized set-up for reverse-phase HPLC protocol, using commonly available C18 columns, yielding high amounts of peptide (~15-20 mg per 1 L culture) in a short time. The recombinant Ab(M1-42) forms characteristic aggregates similar to synthetic Ab42 aggregates as verified by western blots and atomic force microscopy to warrant future biological use. Our rapid, refined, and robust technique to purify human Ab(M1-42) can be used to synthesize chemical probes for several downstream in vitro and in vivo assays to facilitate AD research.

HAMMERING YAMMER

10.28945/3583 ◽  
2016 ◽  
Vol 1 ◽  
pp. 1-22
Keyword(s):  
Work Environment ◽  
Instant Messaging ◽  
Annual Conference ◽  
Online Environment ◽  
Remote Employees ◽  
Phone Calls ◽  
Set Up ◽  
Enterprise Social Network ◽  
Southeastern Region ◽  
The U.S

Chris Milan, Managing Director of Southeastern Region at Tribridge, Inc., was drumming away at the annual “Connect” conference with the company band called “The Bridge.” He enjoyed seeing everyone dancing, laughing, and jamming out to the music and making new friends with coworkers. Tribridge had quickly grown over fifteen years to more than 600 employees with most deployed to customer sites around the U.S. and Canada. The annual conference was a cultural staple designed to re-connect the company with employees and employees with each other. But how much longer could they continue to rely on a once a year event to keep the company together on both social and cultural levels? Chris reflected on a recent executive team meeting where the leaders asked themselves, “How can we keep all of these people, from all over the globe, feeling connected with each other?” The leadership was familiar with and had been discussing ways to keep the company connected through the deployment of an Enterprise Social Network (ESN)--sort of a Facebook for employees. They had been told that an ESN would allow for local employees and remote employees to connect more efficiently to help create an overall cohesive work environment. In theory, it would be a much less expensive approach than flying everyone in to Tampa. And, it was supposed to create a continuous--not just once a year--flow of interactions through an online environment. Plus, wasn’t everyone already familiar with the tool? After all, nearly everyone was on Facebook. Why not set up an ESN and they could join that too? At the same time, the decision to proceed wasn’t easy. There were many factors Milan and the leadership had to consider. Email, Instant Messaging (IM), phone calls and SharePoint were Tribridge’s current forms of communication and connectivity. Would connecting through an ESN replace those platforms? Would it be “in addition to” them? Also, Tribridge was a “Microsoft shop” using Office 365. Office 365 included the ESN platform called Yammer. Would using Yammer be more efficient than email for communication? Would it be as effective as a party for connectivity? Could it share and propagate a culture with a distributed workforce? Since Yammer seemed to be the inevitable choice at Tribridge, maybe the real questions would revolve around how to implement another system in the already busy world that was Tribridge.

scholarly journals Duodenoscope Medical Device Reports Associated with Patient Infection, Patient Exposure, or Device Contamination

2020 ◽  
Vol 41 (S1) ◽  
pp. s196-s197
Author(s):  
Jian Connell ◽  
Shanil Haugen ◽  
Ann Ferriter
Keyword(s):  
Medical Device ◽  
The United States ◽  
Risk Of Infection ◽  
Patient Exposure ◽  
Safety Issues ◽  
Device User ◽  
Infection Patient ◽  
Device Use ◽  
Serious Injuries ◽  
Patient Infection

Background: Each year, the FDA receives more than a million reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical device reports (MDRs) are submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers. The FDA uses MDRs to monitor device performance, including monitoring reports of infection or device contamination to detect potential device-related safety issues and to share this information in public communications. In this analysis, the FDA presents MDRs for duodenoscopes, which are a type of flexible endoscope that have been associated with infections in patients. Methods: For this analysis, we searched the MDR database for duodenoscope reports submitted between January 2015 and July 1, 2019. MDRs were classified into clinical risk categories based on the MDR’s text narratives as patient infection (indicated the presence of infection in patients potentially transmitted by the device), patient exposure (indicated a contaminated device has been used in a patient, but the MDR lacks clear mention of patient infection), or device contamination (indicated that the device was contaminated, but no mention of device use in patients or patient infection). Results: Overall, 1,115 duodenoscope reports related to a patient infection, patient exposure, or device contamination for devices marketed inside and outside the United States were received from January 2015 to mid-2019. Among them, 79 MDRs were received for deaths in patient infection, patient exposure, or device contamination reports. The number of reported infections decreased from 247 MDRs in 2015 to 55 MDRs in the first half of 2019. Furthermore, the number of reported deaths decreased from 25 MDRs in 2015 to 2 MDRs reported in the first half of 2019. Conclusions: The MDR data indicate a decrease in the number of reported infections. The decrease in infections suggests that efforts to reduce the risk of infection from duodenoscopes have yielded improvements; however, additional improvements are necessary to further decrease the risk of infection.Funding: NoneDisclosures: None

scholarly journals Environmental Engineering Techniques to Restore Degraded Posidonia oceanica Meadows

Water ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 661
Author(s):  
Luigi Piazzi ◽  
Stefano Acunto ◽  
Francesca Frau ◽  
Fabrizio Atzori ◽  
Maria Francesca Cinti ◽  
...  
Keyword(s):  
Large Scale ◽  
Natural Habitat ◽  
Cost Benefit ◽  
Cost Effective ◽  
Posidonia Oceanica ◽  
Environmental Engineering ◽  
Bottom Surface ◽  
Sessile Invertebrates ◽  
Set Up ◽  
Short Time

Seagrass planting techniques have shown to be an effective tool for restoring degraded meadows and ecosystem function. In the Mediterranean Sea, most restoration efforts have been addressed to the endemic seagrass Posidonia oceanica, but cost-benefit analyses have shown unpromising results. This study aimed at evaluating the effectiveness of environmental engineering techniques generally employed in terrestrial systems to restore the P. oceanica meadows: two different restoration efforts were considered, either exploring non-degradable mats or, for the first time, degradable mats. Both of them provided encouraging results, as the loss of transplanting plots was null or very low and the survival of cuttings stabilized to about 50%. Data collected are to be considered positive as the survived cuttings are enough to allow the future spread of the patches. The utilized techniques provided a cost-effective restoration tool likely affordable for large-scale projects, as the methods allowed to set up a wide bottom surface to restore in a relatively short time without any particular expensive device. Moreover, the mats, comparing with other anchoring methods, enhanced the colonization of other organisms such as macroalgae and sessile invertebrates, contributing to generate a natural habitat.

Any DNA to Declare? Regulating Offshore Access to Genetic Enhancement

2002 ◽  
Vol 28 (2-3) ◽  
pp. 179-213
Author(s):  
Maxwell J. Mehlman ◽  
Kirsten M. Rabe
Keyword(s):  
Law School ◽  
Genetic Enhancement ◽  
Basketball Player ◽  
Professional Basketball ◽  
The Government ◽  
Travel Abroad ◽  
To Receive ◽  
The U.S

Imagine a world in which parents can genetically enhance their child's height so that he becomes a professional basketball player. Or imagine a law school student preparing for the bar who takes out an extra loan to genetically enhance his intelligence. What if going to your physician for a routine physical included the option of genetically enhancing any trait you desired? And what if such a practice was expensive and, therefore, only available to the privileged members of society? Is this desirable or should the U.S. government ban genetic enhancement? What if the government bans it and citizens travel abroad to receive genetic enhancement treatments? Can the U.S. government do anything to prevent access to illegal genetic enhancement abroad?

A Most Active Customer

2014 ◽  
Vol 44 (5) ◽  
pp. 470-502 ◽  
Author(s):  
Simone Turchetti
Keyword(s):  
World War Ii ◽  
Nuclear Power ◽  
Atomic Energy Commission ◽  
Developed Countries ◽  
Atomic Energy ◽  
Peace Treaty ◽  
Research Committee ◽  
Energy Field ◽  
Set Up ◽  
The U.S

After World War II had ended, Italy, not unlike other developed countries, held the ambition to establish an atomic energy program. The Peace Treaty of 1947 forbade its administration from seeking to acquire atomic weaponry, but in 1952 a national research committee was set up to explore the peaceful uses of atomic energy, in particular with regard to building nuclear reactors. One of the committee’s goals was to use nuclear power to make the country less reliant on foreign energy provisions. Yet, this paper reveals that the atomic energy project resulted in actually increasing Italy’s dependence on overseas assistance. I explain the reasons for this outcome by looking at the unfolding of U.S.–Italy relations and the offers of collaboration in the atomic energy field put forth by the U.S. State Department and the U.S. Atomic Energy Commission. I argue that these offers undermined plans to shape the nuclear program as its Italian architects had envisioned, caused them to reconsider the goal of self-sufficiency in energy provisioning, and reconfigured the project to be amenable to the security and economic priorities of the U.S. administration. In this way, I conclude, the path for the Italian project to “de-develop” was set.

scholarly journals The European TeleCheck-AF project on remote app-based management of atrial fibrillation during the COVID-19 pandemic: centre and patient experiences

EP Europace ◽  
2021 ◽  
Author(s):  
Monika Gawałko ◽  
David Duncker ◽  
Martin Manninger ◽  
Rachel M J van der Velden ◽  
Astrid N L Hermans ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Care Delivery ◽  
Patient Characteristics ◽  
Patient Experiences ◽  
Af Ablation ◽  
District Hospitals ◽  
Inclusion Rate ◽  
Set Up ◽  
Time Required ◽  
Short Time

Abstract Aims TeleCheck-AF is a multicentre international project initiated to maintain care delivery for patients with atrial fibrillation (AF) during COVID-19 through teleconsultations supported by an on-demand photoplethysmography-based heart rate and rhythm monitoring app (FibriCheck®). We describe the characteristics, inclusion rates, and experiences from participating centres according the TeleCheck-AF infrastructure as well as characteristics and experiences from recruited patients. Methods and results Three surveys exploring centre characteristics (n = 25), centre experiences (n = 23), and patient experiences (n = 826) were completed. Self-reported patient characteristics were obtained from the app. Most centres were academic (64%) and specialized public cardiology/district hospitals (36%). Majority of the centres had AF outpatient clinics (64%) and only 36% had AF ablation clinics. The time required to start patient inclusion and total number of included patients in the project was comparable for centres experienced (56%) or inexperienced in mHealth use. Within 28 weeks, 1930 AF patients were recruited, mainly for remote AF control (31% of patients) and AF ablation follow-up (42%). Average inclusion rate was highest during the lockdown restrictions and reached a steady state at a lower level after easing the restrictions (188 vs. 52 weekly recruited patients). Majority (>80%) of the centres reported no problems during the implementation of the TeleCheck-AF approach. Recruited patients [median age 64 (55–71), 62% male] agreed that the FibriCheck® app was easy to use (94%). Conclusion Despite different health care settings and mobile health experiences, the TeleCheck-AF approach could be set up within an extremely short time and easily used in different European centres during COVID-19.

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