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certification01 · 10 months

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How to Get GMP certification in Netherlands?

Introduction to GMP certification in the Netherlands

GMP certification in Netherlands, is a European u. S . Positioned within the northwestern place of the continent. The Netherlands is understood for its tulips, windmills, and canals. The Netherlands is a founding member of the European Union and is domestic to the headquarters of many multinational organizations. The Netherlands has a sturdy financial system and is a main exporter of goods. The Netherlands is likewise a famous vacationer vacation spot.

The Netherlands is a signatory to the Pharmaceutical Inspection Convention and the Cooperation Scheme (PIC/S). The Netherlands is a member of the European Medicines Agency (EMA). The Netherlands has a nicely developed regulatory device for prescription drugs. The Netherlands is likewise a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The Netherlands has a national competent authority accountable for the law of prescribed drugs, clinical gadgets, and cosmetics. The Netherlands Medicines Evaluation Board (MEB) is the countrywide capable authority answerable for the assessment and supervision of drugs inside the Netherlands. The MEB is a systematic advisory board to the Dutch Minister of Health, Welfare, and Sport.

The MEB evaluates drugs for safety, efficacy, and great. The MEB also assesses the gain-danger balance of drug treatments. The MEB is accountable for the registration of drug treatments within the Netherlands. The MEB has problems with advertising authorization for medicines that are safe and effective.

The MEB video display units the protection of medicines after they’re legal for advertising. The MEB also gives facts to healthcare experts and patients on the secure and powerful use of medicines.

The Netherlands has a properly advanced device for the scientific testing of drugs. The Netherlands is a member of the European Medical Trials Directive. The Netherlands has a country wide able authority answerable for the authorization of medical trials. The Central Committee on Research regarding Human Subjects (CCMO) is the national competent authority chargeable for the authorization of clinical trials within the Netherlands.

The Netherlands has a national machine for the registration of scientific trials. The Netherlands has a countrywide registry of scientific trials. The Netherlands Clinical Trials Registry (NLCTR) is a national database of clinical trials which might be performed in the Netherlands. The NLCTR is maintained by using the MEB.

What are the advantages of GMP certification in the Netherlands?

The Netherlands is a small United States of America with a massive reputation for first-rate. That’s why increasingly more groups are searching for GMP certification so that you can do commercial enterprise there.

GMP certification is an important exceptional credential for pharmaceutical and clinical tool manufacturers. It demonstrates to clients and regulators that a company is following proper production practices and is capable of generating secure and powerful merchandise.

The Netherlands has a long history of quality production. In the early days of the Dutch pharmaceutical industry, corporations were already exporting their merchandise everywhere in the global. Today, the Netherlands is domestic to many multinational pharmaceutical and clinical tool businesses.

The Dutch government could be very supportive of the pharmaceutical and scientific device industries. There are several tax incentives and other monetary blessings available to companies doing business in the Netherlands.

The Dutch healthcare device is one of the first-class in the global. The U.S. Has a highly skilled staff and a properly-advanced infrastructure.

There are many motives why agencies searching for GMP certification must remember the Netherlands. The u . S . Has a verified tune record of great manufacturing, a supportive government, and a global-magnificence healthcare gadget.

How to get GMP certification in the Netherlands?

If you are trying to get your merchandise licensed with the aid of the Good Manufacturing Practices (GMP) in the Netherlands, there are a few things you want to realize:

The Netherlands is a member of the European Union (EU), and as such, products that are certified by means of the GMP inside the Netherlands may be bought for the duration of the EU.

The Netherlands has its personal certification manner for merchandise that meets the GMP standards, which is known as the CE Marking.

The Netherlands also has a separate method for merchandise that is not certified through the GMP, however, which still meets the requirements of the CE Marking.

The CE Marking is an obligatory requirement for all products which can be sold in the EU. It is a symbol that indicates that a product meets the minimal safety, fitness, and environmental requirements of the EU. Products which are licensed through the GMP within the Netherlands can be bought at some point in the EU without having to go through the CE Marking manner.

The Netherlands additionally has its very own method for products that the GMP does not license, however, which still meets the necessities of the CE Marking. These merchandise are called Non-GMP Certified Products (NGCPs). NGCPs can be sold in the Netherlands, but they can’t be offered in different EU nations.

If you’re seeking to get your products certified via the GMP within the Netherlands, step one is to contact a certification body. The Dutch authorities authorize this. There are some permitted certification bodies in the Netherlands, and you can find a list of them on the website of the Dutch Ministry of Economic Affairs.

Once you have located a certification body which you would really like to use, you’ll need to put up an application for certification. The software process will vary depending on the certification frame, but in general, you’ll want to offer records about your company, your merchandise, and your manufacturing technique.

After your software has been reviewed, the certification body will conduct an on-site audit of your centres. The purpose of the audit is to make certain that your manufacturing process meets the GMP requirements. If the certification body is satisfied that your method meets the requirements, they’ll problem you.

Why is GMP certification in the Netherlands critical?

GMP certification in the Netherlands is vital for several reasons:

It guarantees that synthetic products in the Netherlands meet worldwide pleasant standards. It is vital for Iteach Netherland-based companies that export their products and for foreign companies that import products from the Netherlands.

GMP certification in the Netherlands ensures that products are manufactured in a smooth and secure environment. It is critical for both the people who are employed within the manufacturing procedure and for the customers who purchase the goods.

GMP certification in the Netherlands guarantees that products are synthetic for the usage of the modern-day generation and system. It is essential for both the efficiency of the producing technique and for the fine of the goods.

GMP certification in the Netherlands guarantees that merchandise is synthetic in accordance with the very best ethical and environmental requirements.

It is essential for each of the workers who are hired within the manufacturing method and for the customers who buy the goods.

What are the requirements for GMP certification in the Netherlands?

GMP certification in the Netherlands is required for any organization that desires to manufacture, procedure, per cent or save medicinal merchandise. The necessities are laid down within the European Union (EU) Good Manufacturing Practice (GMP) hints. These pointers are harmonized across all EU member states, so a business enterprise that is GMP certified in a single u. S . A . Might be robotically certified in some other.

GMP certification isn’t mandatory in the Netherlands. However, it is particularly endorsed. Companies that aren’t GMP certified will discover it very tough to do commercial enterprise with different EU nations, as they may no longer be capable of exporting their merchandise. In addition, many pharmaceutical agencies will not do commercial enterprise with groups that are not GMP licensed, so it is important for businesses that need to fabricate medicinal products to have this certification.

The necessities for GMP certification in the Netherlands are very similar to those in other EU nations. Companies should have an exceptional control system in the area, and they need to be capable of exhibiting that they may be consistently producing exceptional products. They also need to have adequate centres and personnel, and they ought to follow strict manufacturing methods.

If you’re taking into consideration putting in place a medicinal production organization in the Netherlands, or if you are already running such an employer, it’s very important to make sure that you are GMP certified. It will give you a satisfactory danger of success in the fairly competitive EU market.

How to get GMP Certification in Netherlands?

You don’t need to worry about your management system or how you will meet the certification requirements if you are wondering how to obtain GMP certification in Netherlands because we are the ideal option. Send us an email at [email protected] or visit our official website at www.factocert.com to communicate with our help desk staff, who can assist in addressing your certification-related questions. You can register your phone number with our help desk staff, who are accessible around the clock, so they can set up a call back from a certified expert who can assist you in getting the best possible certification solution on the market.

For more information visit GMP certification in Nethrelands

Related link:

• ISO 9001 certification in Netherlands

• ISO 14001certification in Netherlands

• ISO 45001 certification in Netherlands

• ISO 27001 certification in Netherlands

• ISO 22000 certification in Netherlands

#GMP certification

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doonitedin · 3 years

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MedTech industry recommends MDTAG representation in Centre’s Committee to frame new drugs, medical devices act

The Union Health Ministry has formed a committee to frame the New Drugs, Cosmetics And Medical Devices Bill for the enactment of New Drugs, Cosmetics and Medical Devices Act. Medical device industry has asked for Medical Devices Technical Advisory Group (MDTAG) representation in Centre’s committee for framing of new drugs, cosmetics and medical devices act.The Drugs and Cosmetics (D&C) Act, 1940…

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#2017 #cosmetics #cosmetics and medical devices act #d&c act #distribution #drugs #drugs and cosmetics act #import #manufacture #mdtag #medical device #medical devices technical advisory group #new drugs #new md rules #sale #union health ministry

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k-young-audio · 4 years

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Non-creative applications in audio programming and processing.

The success of an audio processing application to be used in a creative success can be argued as subjective. In the world of plug-ins audio application has been programmed to have a purpose, but weather that purpose is successful depends on the individual using it. In some cases, an individual with a non-academic background can use the audio application in a musical sense, apply it to their music while not necessarily being able to describe what it does.

In this blog post, I want to focus on the other side of audio processing; audio applications that have been designed for a non-musical purpose. As well as delve into how we measure their success.

Audio processing for a medical use- Hearing Aids.

Within non-creative, non-musical audio devices, the hearing aid stands out as a simple design to forfill a medical need to help people who have been born with, or have developed hearing loss. Digital hearing aids are designed around and analogue/digital converter, a means to amplfy the signal, and finally a digital to analogue converter directed towards the ear drum.

Schneider. T, Brennan. R, Balsiger. P, Heubi. A (1999) An Ultra Low-power Programmable DSP System for Hearing Aids and Other Audio Applications (Online) ICSPAT’99 Proceedings, November 1-4, 1999, Orlando, FL. Available at

https://www.onsemi.jp/site/pdf/DSP_System.pdf (Accessed 18th Nov 2020)

This is a patent for technology used to describe an application specific signal processor suitable for hearing aids amongst other audio applications. This patent is particularly good at specifying the limitations of DSP in a real-time environment and offers solutions as how to conduct DSP with ultra low power. Section 3 lays out the fundamentals of the programming design. This source is dated and is not relevant to creating audio plug-ins specifically, and, although dated, the information provided is valuable as an insight into the fundamentals of DSP theory in audio as the hearing aid was a breakthrough in ultra low powered DSP.

Digital hearing aids are now the standard QUOTE, so we can see, objectively, that the development of the hearing aid as an audio device was a success.

Audio processing for support evidence -Audio forensics.

Audio forensics is a field where audio is used to obtain evidence through enhancing or processing an audio signal to gather information to support a criminal or civil case. This process is non-creative and non-musical, and should be approached with an objective mindset as the aim is not to make something sound good musically, but use audio as a means to support an investigation.

“Audio forensic evidence may come from a criminal investigation by law enforcement or as part of an official inquiry into an accident, fraud, accusation of slander, or some other civil incident. The primary aspects of audio forensics are establishing the authenticity of audio evidence, performing enhancement of audio recordings to improve speech intelligibility and the audibility of low-level sounds, and interpreting and documenting sonic evidence, such as identifying talkers, transcribing dialog, and reconstructing crime or accident scenes and timelines.” (Audio Forensics Expert, n.d.)

Upon investigating signal processing in audio forensics, I encountered this article, supporting the idea that audio forensics is an entirely different discipline to audio engineering. “Audio engineers can go with whatever feels good, without worrying about documenting their processes, but forensic analysts must only apply what can be referenced and proven to be an accepted technique, and have to write down everything. And with the implementation of the ISO 17025 guidelines making the transition to the audio forensics world infinitely more difficult, anyone who wants to get into the field in the future could find themselves jumping through a whole lot more hoops.“ (Zjalic, 2018)

I feel article relays an important message, especially within my professional practice of audio programming; understanding that audio isn’t just about producing audio for a creative means, and there is another side that requires objectivity and an understanding of the physics and inner workings of sound.

One notable case where audio was used as supporting evidence was the Watergate case, an example that shows not only that audio can be used as evidence, but “doctored” audio can be detected and used as supporting evidence too. Below I have included an extract from an article describing the audio tapes in the Watergate cover-up.

“In 1974, interest turned to a particular recording of a con- versation between President Nixon and his Chief of Staff H. R. Haldeman recorded in 1972 in the EOB. The investigators were suspicious that the recorded conversation included re- marks about the Watergate cover-up, but when the record- ing was examined, the investigators discovered that 181⁄2 minutes of the recording were obliterated by an unexplained gap consisting of audible buzz sounds but no discernable speech. Investigators suspected that someone had deliber- ately erased or recorded over that section of the tape to de- stroy the originally recorded conversation, perhaps with the intention of eliminating incriminating remarks.

John J. Sirica, Chief Judge of the US District Court for the District of Columbia, determined that the potentially altered tape required expert analysis beyond the routine capability of the court (McKnight and Weiss, 1976). He requested that the Watergate Special Prosecutor and the counsel for the president jointly nominate a group of six outside technical experts (including several ASA members) to form a special Advisory Panel on White House Tapes “...to study relevant aspects of the tape and the sounds recorded on it” (Advisory Panel on White House Tapes, 1974).

The Advisory Panel analysed the physical tape itself and the electrical signals observed on playback and, ultimately of greatest importance, performed magnetic development us- ing ferrofluid to reveal latent magnetic domain patterns on the tape and the magnetization signatures of the recording and erase heads installed in the tape recorders known to be present in the White House. The magnetic development of the tape led the Advisory Panel to the conclusion that the 181⁄2-minute gap consisted of several overlapping start-stop erasures performed with a specific tape recorder available in the White House but not the same device that was used to make the original recording (Advisory Panel on White House Tapes, 1974).” (The New York Times, 1974)

A piece of audio should be subjected to critical analysis when being used as evidence, the reliability of the audio can be questionable “Assessing the reliability of audio forensic opinions can be a challenge. Unlike DNA comparisons that can be expressed in a formal statistical sense, a forensic acoustics question such as “Is the utterance present in the evidentiary recording the voice of Suspect A?” (Maher, 2016)Especially if the audio is from a low quality source and noises can be difficult to determine.

Modern audio tools have been programmed to change the audio in order to help determine noise sources and allow for a clearer picture for the listener to make an informed critical analysis of what they are listening to. An example of these are some of the audio tools in Izotope RX. RX allows the user to see a detailed report of the audio, and then deconstruct the audio in order to enhance specific noise sources.

I have created the following example using Izotope RX.

youtube

Audio for speed detection- Speed cameras.

Kubera. E, Wieczorkowski. A, Kuranc. A, Słowik. T (2019) Discovering Speed Changes of Vehicles from Audio Data (Online) Advance in Sensors and Sensing Systems for Driving and Transportation. Available at https://www.mdpi.com/1424-8220/19/14/3067. (Accessed 18 Nov 2020.)

I have found further research into devices and methodology utilising non-musical audio processing. This is a piece of research with the aim of using audio to detect car driving speed. Viewing the research shows that the research was successful in detecting an fairly accurate speed audio data recorded from the vehicle. “The presented results show that even a simple feature vector, representing lines in a spectrogram, yields 90% accuracy, even though tracking these lines is difficult, and errors in these parameters are possible.” While the accuracy is high enough for the general research to be considered a success, using recorded audio to replace speed cameras in the modern world woulf be problematic and inpractical, as it is less accurate, leaving it far more open to legal disputes than speed cameras that have a lower margin of error, that are already often legally disputed for their accuracy. “Speed cameras are officially described as being calibrated to an accuracy of two per cent. However, in recent years some well-publicised court cases have hinged upon alleged inaccuracies in the speed camera evidence.” (nationalprobationservice, 2015)

Although this research at this time is not accurate enough to be used practically, one can question how this research can be expanded on to for the purpose of a practical need. In future, audio speed detectors could be used to detect speed in low visibility conditions.

Exploring these non-musical/creatives avenues has been especially useful for my practice as an audio programmer because they have shown the potential that audio signal processing can have in society, as well as show the benefits of approaching audio programming with an objective mindset. All of the devices I have found have been created for a practical use, and it is interesting to see where societal needs have been filled by audio programming and how this research can be taken further. To become a practitioner in creating audio devices for practical solutions, an understanding of audio from an objective viewpoint is fundamental. Approaching audio in this way is essential to my practice as programming is rooted in having a logical and objective discipline. Even if one is programming a tool for the purpose of creativity, as an audio programmer, one needs to understand exactly what is happening in the program.

References

Audio Forensics Expert. (n.d.). Retrieved 12 2020, from https://www.audioforensicexpert.com/what-is-audio-forensics/

Maher, R. C. (2016). Lending an Ear in the Courtroom: Forensic Acoustics. Retrieved 12 2020, from Acoustics Today: https://acousticstoday.org/wp-content/uploads/2015/08/Lending-an-Ear-in-the-Courtroom-Forensic-Acoustics-Forensic-acoustics-deals-with-acquisition-analysis-and-evaluation-of-audio-recordings-to-be-used-as-evidence-in-an-official-legal-inquiry..pdf

nationalprobationservice. (2015). nationalprobationservice. Retrieved 11 2020, from nationalprobationservice/speedcameras: https://www.nationalprobationservice.co.uk/speedcameras.html

The New York Times. (1974, 1). ext of Advisory Panel's Report to Judge Sirica on Tape Recording. Retrieved 12 2020, from The New York Times: https://www.nytimes.com/1974/01/16/archives/text-of-advisory-panels-report-to-judge-sirica-on-tape-recording.html

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lupine-publishers-tceia · 5 years

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Lupine publishers LLC | Lupine Publishers Review

Lupine Publishers LLC isa world’s leading Online Publishing repository, a genuine publisher with quality medical journals. Lupine Publishers LLC peer reviewed publisher is a multidisciplinary, scholarly Open Access publisher focused on Genetic, Biomedical and Remedial missions in relation with Technical Knowledge as well. Lupine Publishers LLC Online Open Access Publisher,craves to select ground- breaking research based on modernism, aptness, scientific connotation, prospective spectator’s interests, setc. Lupine Publishers LLC Online Open Access Publisher endeavor to provide by far and liberally accessible belvedere to researchers and practitioners in support of their novel and valuable ideas. Lupine Publishers LLCOnline Open Access Publisher already have 2000+ Editorial Board members along with 5000+ Published articles with them. Lupine Publishers LLC Online Open Access journals maintains a scrupulous, methodical, fair peer review System. Besides, quality control is riveted in each step of the publication process. Lupine Publishers LLC, strictly follows open access policy: Open access policies are part of rapidly growing researches in academia to enhance and encourage the new modes and techniques of scholarly publication by providing worldwide free access. Members of universities, schools and departments are establishing open access policies to make their research and scholarship more accessible to scholars, educators, policymakers, students and citizens worldwide. The only motto of Lupine Publishers LLC Open access Publisher is accelerating the scientific and technical research papers,considering the importance of technology and the human health in the advanced levels and several emergency medical and clinical issues associated with it, the key attention is given towards biomedical research. Thus, Lupine Publishers LLC asserting the requirement of a common evoked and enriched information sharing platform for the craving readers. Lupine Publishers LLC is such a unique platform to accumulate and publicize scientific knowledge on science and related discipline. Lupine Publishers LLC multidisciplinary open access publisher is rendering a global podium for the professors, academicians, researchers and students of the relevant disciplines to share their scientific excellence in the form of an original research article, review article, case reports, short communication, e-books, video articles, etc. Lupine Publishers LLC has quality journals which are self supporting, with no dependency on any other external sources (like universities, centers) for funds and strives for the best and enhanced quality publications competes the world wide open access publishing market. Lupine Publishers LLC always rely on the support from the members of the Lupine Publishers LLC family that is relevantly their Authors, Editorial Committee members, advisory board, Reviewers Board and all the technical support teams all over the globe. Lupine Publishers LLC trust in the reciprocated coordination and cooperation in terms of sharing the scientific knowledge of individuals and Groups of Research centers/areas will in turn educates and provokes in advanced researches. In this case Lupine Publishers LLC like to act as a media that anchors in the transformation of information in the form of global online publication.

2. Lupine Publishers LLC likes to bring world latest concept of open access video articles of research work at ease and cost-efficient manner. Lupine Publishers LLC aim to develop the integrated illustration approach to educational researchers and practitioners to encourage innovations and new research frontiers in scientific field. Lupine Publishers LLC provides advance platform for researchers for making their research work live and exemplify investigational visualization to the world. Lupine Publishers LLC also helps researchers to demonstrate their work by video to all young researchers, as this helps authors to get rapid acquaintance among their research community within short span of time. Lupine Publishers LLC invite video research articles in all diverse fields of Medical, Life Science, Health Care, Pharma, and other groups for publication in their Journals. Lupine Publishers LLC also accepts E-books that are written by scholars and influences the learning practice around the world. Lupine Publishers LLC, believes that E-books offer many potential benefits, to access when and where you want to read. Lupine Publishers LLC a great way to demonstrate knowledge in a creative way and is much more visually appealing than a white paper. The e-book has become the current standard form to have the research work available to the users. Lupine Publishers LLC offers high quality of PDF formats for their scholars to have their work available to the world. Lupine Publishers LLC, lightening fast lookup of the required information can now find through e-books as, it’s the hand library available of the users upon one button. Lupine Publishers LLC delivers high quality of e-prints that can be displayed in any electronic device. E-Books are the ones where every individual can afford, as they are freely available with Lupine Publishers LLC. In Lupine Publishers LLC, e-Books are embedded with a variety of multi- media elements which are not available with traditional books. Also, audio and video can be implanted to make reading comfortable while accessing the published articles. Lupine Publishers LLC provides article reprints with an aim to broadcast the research work in affordable and quality paper. Lupine Publishers LLC, indeed providing reprints is to explore the research work to the world in the format the user need. Lupine Publishers LLC reprints in two ways: Hard Copy: Lupine Publishers LLC, provide reprints with high quality & specially designed covers along with the journal name & logo on every page. Also, Lupine Publishers LLC provide customization option for cover Image. Or reprints will the mirror image of your articles. Electronic copy: E-prints of Lupine Publishers LLC are the electronic copies of article in PDF format. E-prints are print-enabled and allow users to print PDF for their use. The provided PDF link can be emailed or burned onto CD-ROMs.

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lupine-publishers-tooaj · 5 years

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Lupine publishers LLC | Lupine Publishers Review

Lupine Publishers LLC likes to bring world latest concept of open access video articles of research work at ease and cost-efficient manner. Lupine Publishers LLC aim to develop the integrated illustration approach to educational researchers and practitioners to encourage innovations and new research frontiers in scientific field. Lupine Publishers LLC provides advance platform for researchers for making their research work live and exemplify investigational visualization to the world. Lupine Publishers LLC also helps researchers to demonstrate their work by video to all young researchers, as this helps authors to get rapid acquaintance among their research community within short span of time. Lupine Publishers LLC invite video research articles in all diverse fields of Medical, Life Science, Health Care, Pharma, and other groups for publication in their Journals. Lupine Publishers LLC also accepts E-books that are written by scholars and influences the learning practice around the world. Lupine Publishers LLC, believes that E-books offer many potential benefits, to access when and where you want to read. Lupine Publishers LLC a great way to demonstrate knowledge in a creative way and is much more visually appealing than a white paper. The e-book has become the current standard form to have the research work available to the users. Lupine Publishers LLC offers high quality of PDF formats for their scholars to have their work available to the world. Lupine Publishers LLC, lightening fast lookup of the required information can now find through e-books as, it’s the hand library available of the users upon one button. Lupine Publishers LLC delivers high quality of e-prints that can be displayed in any electronic device. E-Books are the ones where every individual can afford, as they are freely available with Lupine Publishers LLC. In Lupine Publishers LLC, e-Books are embedded with a variety of multi- media elements which are not available with traditional books. Also, audio and video can be implanted to make reading comfortable while accessing the published articles. Lupine Publishers LLC provides article reprints with an aim to broadcast the research work in affordable and quality paper. Lupine Publishers LLC, indeed providing reprints is to explore the research work to the world in the format the user need. Lupine Publishers LLC reprints in two ways: Hard Copy: Lupine Publishers LLC, provide reprints with high quality & specially designed covers along with the journal name & logo on every page. Also, Lupine Publishers LLC provide customization option for cover Image. Or reprints will the mirror image of your articles. Electronic copy: E-prints of Lupine Publishers LLC are the electronic copies of article in PDF format. E-prints are print-enabled and allow users to print PDF for their use. The provided PDF link can be emailed or burned onto CD-ROMs.

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lupinepublishers-ojnbd · 5 years

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Lupine publishers LLC | Lupine Publishers Review

https://www.slideshare.net/LupinePublishers/lupine-publishers-llc-lupine-publishers-review

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astuteinsights · 2 years

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Enteral Food Devices Market Size, Share, 2022 Global Industry Growth, Trends, Emerging Factors, Demands, Key Players, Revenue Expectation, Research Report by Astute Analytica

Astute Analytica publishes a research report on the global Enteral food devices market. The analysis report contains in-depth data about demand, growth, opportunities, challenges, and restraints. In addition, it provides a thorough examination of the structure and possibility of global and regional industries.

The global Enteral food devices market study includes information from key firms on R&D, new product launches, and product responses from global markets. The analysis includes a graphical presentation and a diagrammatic examination of the global Enteral food devices market by region.

The global Enteral food devices market size was US$ $$$ billion in 2021 and is forecast to reach US$ $$$ billion by 2027, growing at a compound annual growth rate (CAGR) of $$% during the forecast period from 2021 to 2027.

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People and economies globally rely substantially on the healthcare business. It is one of the fastest-growing industries. There is a correlation between income levels and healthcare spending in different nations, with healthcare spending accounting for more than 10% of most industrialized countries' GDP.

The Centers for Medicare and Medicaid Services data calculates that the U.S. national healthcare expenditure reached US$ 4.1 trillion in 2020 and is forecast to surpass US$ 6.2 trillion by 2028. According to the Commonwealth Fund, the U.S. spent nearly 17% of gross domestic product (GDP) on healthcare in 2018. Switzerland was the second-highest-ranking country, spending 12.2%. In addition, New Zealand and Australia dedicate only 9.3%.

Regional Analysis:

According to the United States, Bureau of Labor Statistics, healthcare employment is likely to grow 16% from 2020 to 2030, much faster than the average for all occupations, with about 2.6 million new jobs. This projected increase is primarily due to an aging population, which indicates a higher demand for healthcare services. In May 2021, the median annual wage for healthcare practitioners and technical sectors (such as registered nurses, physicians and surgeons, and dental hygienists) was US$ 75,040, which was higher than the economy's median annual wage of US$ 45,760.

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The European legislature and decision-makers should be aware that EU health systems are facing challenges arising from an aging population, citizens' rising expectations, migration, and mobility of patients and health care professionals. Statista data shows the number of individuals employed in Europe's hospitals in 2019. In 2019, there were more than 1.5 million people employed in hospitals in the UK, the largest number in Europe.

Impact Analysis of COVID-19:

Global COVID-19 cases have climbed above 516 million as of May 2022, and the death toll has exceeded 6.25 million. COVID-19 has disproportionately impacted specific racial and ethnic minority groups, as well as underserved and marginalized communities, highlighting the persistent challenges of health equity and health outcomes.

COVID-19 is causing a great deal of emotional, physical, and professional stress among health care personnel. The changing attitudes and behaviors of consumers, the integration of life sciences and health care, fast-growing digital health technology, new talent, and care delivery models, and clinical innovation advanced by COVID-19.

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As sector players and the customers, they serve to adapt to a new world of remote working, virtual doctor visits, and a supply chain plagued by shortages of medical goods, employees, and services, the sector is reforming to become more customer-centric.

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SOURCE Astute Analytica

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chinasunsong · 3 years

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Zha Daojiong︱How is China's new crown vaccine used globally?

Recently, significant progress has been made in the use of the new crown vaccine produced by Chinese companies in overseas anti-epidemic efforts.

On July 12, the Global Alliance for Vaccines and Immunization announced that China National Pharmaceutical Group Co., Ltd. and Beijing Kexing Zhongwei Biotechnology Co., Ltd. have signed cooperation agreements with the "New Coronary Pneumonia Vaccine Implementation Plan" (COVAX) to supply vaccines. The "Plan" was initiated by the alliance and supported by the World Health Organization. According to the agreement, the two companies immediately began to provide COVAX with 110 million doses of the new crown vaccine.

The above two Chinese vaccines have been reviewed by the World Health Organization's immunization strategy advisory expert group in early June and have been included in the emergency use list of new crown vaccines approved by the WHO. These Chinese vaccines will be supplied through COVAX to self-funded participating countries and participating countries supported by the COVAX advance market commitment mechanism. By implementing the procurement agreement between UNICEF and the Pan American Health Organization, China's vaccines will benefit many low- and middle-income countries.

According to the procurement goals reached by COVAX, Sinopharm and Kexing, by the first half of 2022, up to 550 million doses of China's new crown vaccine will be distributed to participating countries through this multilateral mechanism. Previously, China had sent 423 million doses of vaccines abroad.

In addition, the new crown vaccine candidate of Shamrock Biopharmaceutical Co., Ltd., headquartered in Chengdu, is currently undergoing a global phase II/III clinical effectiveness trial covering four continents. The vaccine was developed from the beginning as a product of international cooperation and funded by the Epidemic Prevention Innovation Alliance (CEPI). Clover Bio has signed a pre-purchase agreement with the Global Immunization Alliance. Once its new crown vaccine candidate is approved for inclusion in the World Health Organization's emergency use list, the company will provide COVAX with up to 414 million doses of vaccine.

Due to the unpredictability of virus variants, the evolution of the new crown epidemic on a global scale is highly uncertain. In terms of vaccines, on the one hand, the imbalance between supply and demand on a global scale has not been effectively alleviated. On the other hand, some countries have put supplementary vaccination for the vaccinated population on the agenda. Demand for supply in the global vaccine market remains strong.

By July 2021, with the inclusion of two new crown vaccines developed by Japanese and Australian companies, there are 11 vaccines on the WHO emergency list. According to statistics from the World Health Organization, as of July 9, 2021, a total of 107 vaccines worldwide have entered the clinical trial stage, and 184 vaccines are in the preclinical development stage.

The international new crown vaccine supply pattern follows the principle of “national priority”-countries that have the ability to develop and produce on their own will give priority to self-produced vaccines, and supply vaccines on the premise of meeting domestic vaccination needs; countries that are unable to develop or produce on their own, according to According to our own needs, we will review and select vaccines to enter the international circulation in a "self-centered" manner. The “emergency use form” of the WHO is an admission ticket for products to enter the international circulation, but it is only used as a reference in the examination and approval process of specific countries.

The COVAX mechanism and bilateral vaccine supply arrangements are parallel. Most countries adopt the practice of national procurement and free vaccinations for residents. Therefore, the cross-border flow of vaccines is greatly affected by a country's financial capacity. Some countries reduce expenditures through joint production with foreign vaccine manufacturers. At present, 12 countries on four continents have reached joint production arrangements with Chinese vaccine companies.

For vaccine providers, the quality assessment of product effectiveness and safety after vaccination, especially the monitoring and handling of adverse reactions, and the timely and appropriate release and sharing of the above-mentioned information are essential to increase the public’s confidence in vaccines. At the same time, this is also related to product brand building and the image of related countries in the international arena.

Due to the shortage of COVID-19 infections, China's vaccine phase II or phase III clinical trials are mostly carried out abroad, and the partners and purchasers are mostly developing countries-different countries have different public health policies, different health systems, and uneven levels of infrastructure. This has somewhat caused difficulties in the collection of relevant medical data. In this regard, Chinese vaccine companies should pay attention and respond with professionalism to ensure the accuracy, comprehensiveness and transparency of relevant data. Whether the vaccine product provider’s work on information sharing is in place is of utmost importance.

As mentioned earlier, the demand for vaccines in the global market is still strong, but in practice, vaccine hoarding and vaccine waste coexist. Hoarding mainly refers to the fact that some countries have signed purchases with vaccine manufacturers by a large margin (several times) in excess of the total number of vaccinated populations, resulting in no vaccines to buy in other countries. Waste not only occurs in some countries with Miao, but also in some countries without Miao. Among these factors are the validity period of the vaccine, the hesitation of the population's willingness to vaccinate, whether the national public health agency's infrastructure and human resources are in place for vaccination, and so on.

For vaccine providers, whether it is market sales, subsidized sales, or gifts, striking a balance between the number of vaccines provided and effective vaccination is a matter of brand building and maintenance of domestic vaccine products. Improving the status of the domestic vaccine R&D and production industry in the international vaccine (and even drugs and devices) industry chain through diplomatic channels must be based on the stability of vaccine R&D and production capacity and the coherence and consistency of supply policies.

As the world enters the epidemic response link of gradually opening up borders while increasing the vaccination schedule, arrangements have been made for mutual recognition of vaccinated vaccines, which has been put on the agenda of various countries, and more and more countries are beginning to develop cross-border travel vaccination figures Certificate.

However, at present, "selective recognition" is the universal policy orientation adopted by countries for vaccinated vaccines. Although the World Health Organization has repeatedly urged member states not to treat certified vaccines differently, it is up to member states to decide whether to recognize vaccines vaccinated by other countries. The choice is based on technical considerations and non-technical factors, including geopolitics. Even racist factors.

In this regard, it is necessary for China to advocate consultations among countries from the perspectives of humanitarianism, internationalism and global equality, and formulate rules acceptable to all countries as soon as possible, so as to minimize the increase in travel costs due to discrimination by Chinese vaccine vaccinators ( Such as quarantine), so that the trade economy and personnel travel life can return to normal as soon as possible.

In general, whether it is China's vaccine entry into the WHO's emergency use list, or COVAX and two Chinese vaccine companies reached a supply implementation arrangement, it is a milestone achievement for China's vaccine industry to go global. As far as national diplomacy is concerned, the initiative to treat vaccines and other anti-epidemic products as global public goods has gradually been implemented.

At the same time, we must also realize that in terms of global vaccine supply and implementation, there is a gap between less internationalized manufacturers and mature manufacturers, and Chinese vaccine companies need to continue to improve their professional technology and after-sales service capabilities. In addition, the national medical and diplomatic mechanisms need to have sufficient understanding and effective management of the follow-up risks of vaccination.

This requires multi-sector cooperation to request and help vaccine companies, because any incident will have a huge impact on the country’s image and the entire vaccine industry’s going global under the current international political and public opinion environment. Especially when there is still room for efforts by Chinese vaccine companies to monitor adverse reactions in other countries, as well as more adequate and timely clinical data disclosure, effective communication is needed to promote understanding. As for the "vaccine passport" and other issues of transition to the post-epidemic period, strategies and tactics are needed to avoid the occurrence of differential and discriminatory treatment.

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gordonwilliamsweb · 3 years

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Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.

Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, according to government officials.

Yet SpineFrontier’s success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through “sham consulting fees” that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.

Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up health care spending and put patients at risk of serious harm, a KHN investigation has found. These payments come in various forms, from royalties for helping to design implants to speakers’ fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.

Health policy experts and regulators have focused for decades on pharmaceutical companies’ payments to doctors — which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.

Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.

“It is simply so much money that it is staggering,” said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and critic of the medical device industry’s influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.

Device makers say the long-established practice leads to higher-quality, safer products. “Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients’ lives,” said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry’s trade group.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Retton, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

The case of Chin’s company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers — from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.

The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Court filings named 35 spine surgeons who used SpineFrontier’s surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has pleaded guilty to criminal charges. It’s illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don’t face criminal prosecution.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

“There is a court date [for the DOJ case] as ordered by a judge,” Chin said via email. “If we get to that point the facts of the case will be litigated.”

Back Surgeries Under Scrutiny

The nation’s outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry report.

Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.

In one common spinal procedure, surgeons may replace damaged discs with an implant and screws and metal rods that hold it in place. The demand for surgery to replace worn-out knees and hips also has mushroomed as aging boomers and others seek relief from joint pain that restricts their movement.

Perhaps not surprisingly, the competition for sales of orthopedic devices is fierce: Some 250 companies proffer a dizzying array of products. Industry critics blame the Food and Drug Administration, which allows manufacturers to roll out new hardware that is substantially equivalent to what already is sold — though it often is marketed as more durable, or otherwise better for patients.

“The money is just phenomenal for this medical hardware,” said Dr. James Rickert, a spine surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group. He said most of the products are “essentially the same,” adding: “These are not technical instruments; [it’s often] just a screw.”

Hospitals can end up charging patients $20,000 or more for the materials, though they pay much less for them. Spine surgeons — who make upward of $500,000 a year — bill separately and may charge $8,000 to $20,000 for major procedures.

Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.

And it doesn’t stop there. Whistleblower cases filed under the federal False Claims Act allege a startling array of schemes to influence surgeons, including compensating them for joining a medical society created and financed by a device company. In other cases, companies bought billboard space or other advertising to promote medical practitioners, hired surgeons’ relatives, paid for hunting trips — even mailed checks to their homes.

Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.

These gigs are legal so long as they involve professional work done at fair market value. But they have drawn fire as far back as 2007, when four manufacturers that dominated the hip and knee implant market, including a J&J division, agreed to pay $311 million to settle charges of violating anti-kickback laws through their consulting deals.

KHN found at least 20 whistleblower suits, some settled, others pending, that have since accused device makers of camouflaging kickbacks as consulting work, including paying doctors to sit on suspect “advisory boards” or other activities that entailed little work to justify the fees.

In November 2019, device maker Life Spine and two of its executives admitted to paying consulting fees to induce dozens of surgeons to use Life Spine’s implants in the operating room. In all, 21 of the top 30 Life Spine adopters were paid and they accounted for about half its total device sales, according to the Justice Department. Life Spine and the executives paid a total of $6 million in penalties. The company did not respond to requests for comment.

Similarly, SpineFrontier received “the vast majority” of its sales, more than $100 million worth, from surgeons who were compensated, the Justice Department alleges. Often, they were paid by way of a “sham” company run by Chin’s wife, Vanessa, from a mail drop in Fort Lauderdale, according to the Justice Department. Vanessa Dudley Chin, a defendant in the DOJ civil case, had no comment.

Kingsley Chin told KHN via email that he takes no salary from SpineFrontier, based in Malden, Massachusetts. In 2013, Chin received $4.3 million in income from the company, according to court filings in a divorce case in Philadelphia from an earlier marriage. In 2018, SpineFrontier valued Chin’s interest in the company at $75 million, according to government records, though its current worth is unclear.

SpineFrontier’s management thought paying doctors was “the only reliable way to steadily increase its market share and stave off competition,” Charles Birchall, a former business associate of Chin’s, alleged in a whistleblower complaint. The case is one of two whistleblower suits filed against SpineFrontier that the DOJ has joined and consolidated. Chin has yet to file a response in court.

From March 2013 through December 2018, the company offered some surgeons $500 or more an hour for “consulting,” which could include the time they spent operating on patients — even though they already were being paid by Medicare or other health insurers. Other surgeons were paid repeatedly to “evaluate” the same products, though their feedback was “often minimal or nonexistent,” according to the DOJ complaint.

Patient Injuries Pile Up

While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.

Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered “phony” consulting deals to surgeons who had complained about alarming defects in one of its knee implants.

Their findings should have been forwarded to the FDA to protect the public, Fuentes and two former Exactech sales reps alleged in their suit. Instead, the company paid the surgeons “to retain their business and secure their silence” about patients needlessly undergoing a second operation to address the defects implanted in the first, according to the suit. Lawyer Thomas Beimers, who represents Exactech in the case, said the company “emphatically denies the allegations and looks forward to presenting the real facts to the court.” In a court filing, the company said the suit was “full of conclusory, vague and immaterial facts” and said it should be dismissed.

In Maryland, spine surgeon Dr. Randy F. Davis faces a lawsuit filed in early 2020 by 14 former patients who claim he implanted counterfeit hardware from a device distributor that had paid him hundreds of thousands of dollars in consulting fees and other compensation.

Davis used the hardware, which had not been FDA-approved, on about 250 patients at the University of Maryland Baltimore Washington Medical Center in Glen Burnie, Maryland, according to the suit. Several patients say screws or other implants failed and they sustained permanent injuries as a result. One woman said she was left with little feeling in her right foot and needs a cane or walker to get around. Others claim “extreme mental anguish” for fear the hardware inside them will fail, according to the suit.

The patients allege that Davis improperly disposed of defective screws and other hardware he removed rather than send the items for analysis or report the failures to authorities. Instead, the University of Maryland hospital sent “hush” letters to patients that falsely told them that no defects had been found, according to the suit. A spokesperson for the hospital, which also is a defendant in the suit, denied the allegations, noting: “We will vigorously defend this lawsuit and at its conclusion are quite confident we will prevail.” Davis and his lawyer didn’t respond to repeated requests for comment. The lawsuit is pending in Anne Arundel County state court.

Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.

That happened when three patients filed lawsuits in 2018 against Arthrex, a Florida device company. The patients argued they were forced to undergo repeat operations to replace defective Arthrex knee devices implanted by Pennsylvania orthopedic surgeon Dr. Thomas Meade.

Meade was not a defendant in the cases. But the patients accused him of misleading them about the product’s safety and a recall. One noted that Meade had served as a prominent consultant to Arthrex and had “participated in the design, testing, marketing, promotion and sales” of the knee implant. The patient alleged that Arthrex had paid Meade more than $250,000 for work that included “promotional speaking, travel, lodging, and consulting.”

In court filings, Arthrex admitted making payments to Meade for “consulting and royalties” but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.

Chin’s dual roles as SpineFrontier’s CEO and user of its hardware was called a “huge” conflict of interest by a judge in a pending malpractice case filed against him and the company in South Florida.

In that case, Miami resident Patrick Chapoteau alleges Chin performed back surgery in 2014 using SpineFrontier hardware even though it had little chance of success. According to the suit, a Chin-designed screw implanted to stabilize Chapoteau’s spine broke in half, causing him pain and disabling injuries.

In a legal brief, Chin’s lawyers argued that he regularly operates on people with disabling back problems, noting: “The surgery is sophisticated and challenging. On a few rare occasions, his patients have not obtained the relief they expected or experienced unanticipated complications that required additional care.”

Joseph Wooten, a former Chin patient and Florida power company employee, alleged in a 2014 lawsuit in Broward County Circuit Court that Chin had 15 previous malpractice claims that had ended in more than $8 million in settlements, an assertion Chin’s lawyers disputed.

“He never told me of his bad record injuring people,” Wooten, 64, wrote in a court filing. He and his wife, Kim, said the surgery caused “debilitating and life-altering injuries.” The case has since been settled. Chin acknowledged no wrongdoing and the terms are confidential.

KHN reviewed court pleadings in nine settled malpractice cases in Philadelphia, where Chin served on the faculty of the University of Pennsylvania Medical School from 2003 to 2007, and six in South Florida filed since 2012. Details of the settlements are confidential. Five of the six South Florida cases are pending, including one filed in December by the widow of a man who died shortly after spine surgery. In all the cases and settlements, Chin has denied negligence.

In her lawsuit pending against Chin in South Florida, Nancy Lazo of Hialeah Gardens, Florida, said she slipped and tumbled down the stairs outside her Miami office, landing on her back and arm. When the pain would not go away, she turned to Chin and had two operations, in 2014 and 2015. Her lawyers allege that a SpineFrontier screw Chin implanted in her spine in the second procedure caused nerve damage. Lazo, 51, a former billing clerk with two adult sons, said she can no longer work and remains in “constant” pain. “Based on what my doctors have told me,” she said, “I will never get back to normal.” Chin denied any negligence and the case is pending.

“Based on what my doctors have told me, I will never get back to normal.”

— Nancy Lazo

Government Struggles to Keep Pace

Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional hearings, in media exposés and in federal investigations. The recurring scandals led Congress to require that device makers and pharmaceutical companies report the payments, starting in August 2013, to a government-run website called Open Payments. That website shows that payments to all doctors have risen from $8.6 billion in 2014 to just over $10 billion last year. A recent study found payments by device makers exceeded those of pharmaceutical companies by a wide margin.

Both the North American Spine Society and the American Academy of Orthopaedic Surgeons told KHN that close ties with the industry, while seeming to generate huge payouts to some surgeons, lead to the design of safer and better implants. “These interactions are really essential for good outcomes in patient care and that needs to be preserved,” said Dr. Joshua J. Jacobs, who chairs the orthopedic surgery department at Rush University Medical Center in Chicago and the AAOS’ ethics committee.

Although more than 600,000 American doctors lap up industry largesse, most do so through small payments that cover the cost of food, drinks and travel to industry-sponsored events. When it comes to big money, however, orthopedists and neurosurgeons dominate, collecting 25% of the total — even though they represent only 5% of the doctors accepting payments, according to the KHN analysis of Open Payments data.

Dr. Charles Rosen, a spine surgeon and co-founder of the advocacy group Association for Medical Ethics, said he was once offered $2,000 just to show up and watch an industry-sponsored panel. “It was quite unbelievable,” he said.

Rosen said while he believes a “relatively small number” of surgeons cash whopping industry checks, many who do so are influential figures who can “help direct medical care.”

Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.

Federal officials recently signaled their displeasure with the hefty fees paid to doctors who promote their products to peers, especially at restaurants, entertainment or sports venues that feature free food and booze but little educational content. In November, the inspector general at the Department of Health and Human Services issued a special fraud alert that such gestures could violate anti-kickback laws.

Companies that ignore the reporting law can be fined up to $1 million, though no fines were levied from 2014 through spring 2020, according to a CMS report. That changed in October, when device giant Medtronic agreed to pay the government $9.2 million to settle allegations that it paid kickbacks to Sioux Falls, South Dakota, neurosurgeon Dr. Wilson Asfora to promote its goods. Officials said the company sponsored more than 100 events at a Brazilian restaurant owned by the surgeon to clinch the sales. Just over $1 million of the fine was assessed for failing to report the transactions. A Medtronic spokesperson said the company fired or took other disciplinary action against the sales employees involved and “remains committed to maintaining the highest standards of ethical conduct.”

KHN identified four spinal device makers — including SpineFrontier — that have been accused in whistleblower cases of scheming to hide consulting payments from the government.

Responding to written questions, a CMS spokesperson said the agency “has multiple formal compliance actions pending which it is unable to discuss further at this time.”

But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.

“Some people would say if you penalize companies enough, they won’t be making these offers,” said Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine. She said small fines may be chalked up to the “cost of doing business.”

The Federation of State Medical Boards does not keep data on how often its members discipline doctors for civil kickback offenses, according to spokesperson Joe Knickrehm. The federation has “long advocated for stronger reporting requirements,” Knickrehm said.

Justice Department officials would not discuss whether they are seeking fines from more surgeons. But in a statement in April 2020, then-U.S. Attorney for the District of Massachusetts Andrew E. Lelling noted that the government will investigate any doctor “who accepts money from a device manufacturer simply for using that company’s products.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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meeraoperon · 3 years

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MDCG Guidance for Class I Medical Devices

MDCG Guidance for Class I Medical Devices has now (finally) published its guidance MDCG 2020-2 on the subject, which confirms everything in that blog in terms of the mechanics of timing, but adds important procedural requirements for a class I manufacturer about how to actually document things, what the state of the technical file and QMS should be and what the declaration of conformity should look like, because these are things that manufacturers of class I devices often do not right.

MDCG Guidance for Class I Medical Devices The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to provide medical device manufacturers and other parties involved with recommendations regarding compliance with the applicable regulations in the context of MDR postponement.MDCG Guidance for Class I Medical Devices The MDCG enlists tasks to be carried out by a Class I manufacturer to ensure compliance with the MDR: Ensure that the device is accompanied by the information needed to identify it and its manufacturer, and any safety and performance information relevant to the user, or any other person, as appropriate.Implement a post-market surveillance system in accordance with Article 83 (Article 10(10)) proportional to the risk class and appropriate for the type of device, this includes additional aspects to be taken into account in case of devices placed on the market in sterile condition, with a measuring function or that are reusable surgical instruments. This system will be an integral part of the manufacturer’s quality management system based on a post-market surveillance plan.Implement a system for recording and reporting incidents and field safety corrective actions. Put measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC3 , without prejudice to more protective measures under national law. These measures will be proportional to the risk class, type of device and the size of the enterprise.“For devices which are currently certified with respect to the Directive 93/42/EC, and for which the available clinical data are not sufficient to demonstrate compliance with MDR, additional clinical data may be obtained by post-market clinical follow-up studies of the device. Sometimes, even data from the general post-market follow-up might suffice to close the gap.The MDCG Guidance for Class I Medical Devices says “duly justified and substantiated cases,” some Class I device manufacturers “may exceptionally demonstrate that the conformity with general safety and performance requirements based on clinical data is not deemed appropriate. Such a justification by the manufacturer must be based upon an evaluation of evidence in accordance with Article 61(10).Read More - MDCG Guidance for Class I Medical Devices Read More Article - 1. Orthopedic Implants Manufacturing 2. disposable syringe manufacturers 3. Dental Implants Manufacturing 4.Blood Collection Tubes Manufacturing Contact details – Phone no - 9325283428 Mail - [email protected] If You Want Medical Devices Services Consultation For Following. 1. Medical Device Manufacturing 2. CDSCO Registration 3. FDA 510 k clearance 4. Continuous Improvement Program 5. Design Control Requirements 6. QMS Certification Services 7. Manufacturing Plant Layout Design 8. Primary Packaging Consultant 9. Manufacturing Site Conceptualization 10. Combination Product 11. Medical Device Design And Development 12. Clean Room Design Consultant 13. ISO 13485 Certification 14. ISO 15378 certification 15. Medical Device Process Validation 16. 21 cfr part 820 17. 21 cfr part 210 and 211 18. DMF submission 19. CAPA Management 210. TURNKEY PROJECT CONSULTANT

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dannygoodwin · 4 years

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Selected Glossary of Acronyms from forthcoming book “Job Security: Security Workers Talk About the Parts of Their Jobs They Can Talk About and How They Feel About the Parts They Can’t Talk About”

● AS: Airborne Systems (thermal imaging)

● ATFP: US Navy Anti-Terrorism Force Protection

● BUDs: Basic Underwater Demolition/SEALs

● C2: Command and Control

● CBP: US Customs and Border Protection (DHS)

● CCDCE: Cooperative Cyber Defense Centre of Excellence

● CEHC: College of Emergency Preparedness, Homeland Security, and Cybersecurity at the University at Albany, State University of New York

● CETC: Current and Emerging Threats Center (DHS)

● CIA: US Central Intelligence Agency

● CIMC: Counterintelligence Mission Center (DHS)

● CISA: Cybersecurity and Infrastructure Security Agency

● CISM: Certified Information Security Manager

● CISSP: Certified Information Systems Security Professional

● COP: Common Operational Picture

● CTMC: Counterterrorism Mission Center (DHS)

● CYMC: Cyber Mission Center (DHS)

● DCS: US Defense Clandestine Services

● DEC: US Department of Environmental Conservation

● DEVGRU: Naval Special Warfare Development Group (Formerly “Seal Team 6”)

● DHS: US Department of Homeland Security

● DISA: US Defense Information Systems Agency

● DOD: US Department of Defense

● DOJ: Department of Justice

● EMS: Emergency Medical Services

● ERO: Enforcement and Removal Operations

● ESMC: Economic Security Mission Center (DHS)

● FBI: US Federal Bureau of Investigation

● FEMA: US Federal Emergency Management Agency (DHS)

● FLIR: Forward-Looking Infrared

● FOB: Forward Operating Base

● FOD: Field Operations Division (DHS)

● HIS: Homeland Security Investigations

● HITEC: Homeland Identities, Targeting and Exploitation Center (DHS)

● HOMSEC: Homeland Security

● HSIN: Homeland Security Information Network (DHS)

● HUMINT: Human Intelligence

● I&A: Office of Intelligence and Analysis (DHS)

● IC: Intelligence Community

● ICE: Immigration and Customs Enforcement (DHS)

● IED: Improvised Explosive Device

● IRADS: Infrared Acquisition Designation System

● ISTAR: Intelligence, Surveillance, Target Acquisition, and Reconnaissance

● JCU: US Joint Communications Unit

● JIATF-W: US Joint Interagency Task Force West

● JSOC: US Joint Special Operations Command

● KURIOT: Cryptonym for Technical Services Division (CIA)

● MOS: Military Occupational Specialty training/certification

● MP: Man-Portable (thermal imaging)

● NATO: North Atlantic Treaty Organization

● NCSP: National Center for Security and Preparedness

● NOC: Non-Official Cover

● NRO: US National Reconnaissance Office

● NSA: US National Security Agency

● NSWDG: US Naval Special Warfare Development Group (Formerly “Seal Team 6”)

● NTAS: National Terrorism Advisory System (DHS)

● NYDHSES: New York Department of Homeland Security and Emergency Services

● NYSPTC: New York State Preparedness Training Center

● ODNI: US Office of the Director of National Intelligence

● PAG: Political Action Group (CIA)

● PfP: NATO Partnership for Peace

● PNNL: Pacific Northwest National Laboratory

● ROTC: Reserve Officers’ Training Corps

● SAC: Special Activities Center (CIA)

● SCIF: Sensitive Compartmented Information Facility

● SEALs: US Navy Sea, Air, and Land teams

● SDI: Strategic Defense Initiative

● SFOD-D: US Special Forces Operational Detachment – Delta (AKA “Delta Force”)

● SIGINT: Signals Intelligence

● SME: Subject Matter Expert

● SO: Special Operations

● SOCOM: US Special Operations Command

● SOG: Special Operations Group (CIA)

● SR: Special Reconnaissance

● SWAT: Special Weapons and Tactics

● SWCC: US Naval Special Warfare Combatant-Craft Crewmen

● TI: Texas Instruments

● TOCMC: Transnational Organized Crime Mission Center (DHS)

● TSA: US Transportation Security Administration

● TSD: Technical Services Division (CIA)

● USCYBERCOM: US Cyber Command

● USO: United Service Organizations

● USREDCOM: US Readiness Command

● UXO: Unexploded Ordinance

● WARCOM: US Naval Special Warfare Command

● WMD: Weapons of Mass Destruction

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realyoungdarius · 4 years

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The O*NET® Content Model -- Occupational Requirements

Occupational Requirements

https://www.onetcenter.org/content.html

A comprehensive set of variables or detailed elements that describe what various occupations require.

This domain includes information about typical activities required across occupations. Task information is often too specific to describe an occupation or occupational group. The O*NET approach is to identify generalized work activities (GWAs) and detailed work activities (DWAs) to summarize the broad and more specific types of job behaviors and tasks that may be performed within multiple occupations. Using this framework makes it possible to use a single set of descriptors to describe many occupations. Contextual variables such as the physical, social, or structural context of work that may impose specific demands on the worker or activities are also included in this section.

Folder (open)Generalized Work ActivitiesWork activities that are common across a very large number of occupations. They are performed in almost all job families and industries.

Folder (open)Intermediate Work ActivitiesWork activities that are common across many occupations. They are performed in many job families and industries.

Folder (open)Detailed Work ActivitiesSpecific work activities that are performed across a small to moderate number of occupations within a job family.

Folder (open)Organizational ContextCharacteristics of the organization that influence how people do their work

Folder (open)Work ContextPhysical and social factors that influence the nature of work

Folder (open)Information InputWhere and how are the information and data gained that are needed to perform this job?

Folder (open)Mental ProcessesWhat processing, planning, problem-solving, decision-making, and innovating activities are performed with job-relevant information?

Folder (open)Work OutputWhat physical activities are performed, what equipment and vehicles are operated/controlled, and what complex/technical activities are accomplished as job outputs?

Folder (open)Interacting With OthersWhat interactions with other persons or supervisory activities occur while performing this job?

Folder (open)Looking for and Receiving Job-Related InformationHow is information obtained to perform this job?

Folder (open)Identify and Evaluating Job-Relevant InformationHow is information interpreted to perform this job?

Getting InformationObserving, receiving, and otherwise obtaining information from all relevant sources.

Monitor Processes, Materials, or SurroundingsMonitoring and reviewing information from materials, events, or the environment, to detect or assess problems.

Identifying Objects, Actions, and EventsIdentifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

Inspecting Equipment, Structures, or MaterialInspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.

Estimating the Quantifiable Characteristics of Products, Events, or InformationEstimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.

Folder (open)Information and Data ProcessingHow is information processed to perform this job?

Folder (open)Reasoning and Decision MakingWhat decisions are made and problems solved in performing this job?

Judging the Qualities of Things, Services, or PeopleAssessing the value, importance, or quality of things or people.

Processing InformationCompiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Evaluating Information to Determine Compliance with StandardsUsing relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.

Analyzing Data or InformationIdentifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Making Decisions and Solving ProblemsAnalyzing information and evaluating results to choose the best solution and solve problems.

Thinking CreativelyDeveloping, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.

Updating and Using Relevant KnowledgeKeeping up-to-date technically and applying new knowledge to your job.

Developing Objectives and StrategiesEstablishing long-range objectives and specifying the strategies and actions to achieve them.

Scheduling Work and ActivitiesScheduling events, programs, and activities, as well as the work of others.

Organizing, Planning, and Prioritizing WorkDeveloping specific goals and plans to prioritize, organize, and accomplish your work.

Folder (open)Performing Physical and Manual Work ActivitiesWhat activities using the body and hands are done to perform this job?

Folder (open)Performing Complex and Technical ActivitiesWhat skilled activities using coordinated movements are done to perform this job?

Performing General Physical ActivitiesPerforming physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling of materials.

Handling and Moving ObjectsUsing hands and arms in handling, installing, positioning, and moving materials, and manipulating things.

Controlling Machines and ProcessesUsing either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).

Operating Vehicles, Mechanized Devices, or EquipmentRunning, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or water craft.

Interacting With ComputersUsing computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.

Drafting, Laying Out, and Specifying Technical Devices, Parts, and EquipmentProviding documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used.

Repairing and Maintaining Mechanical EquipmentServicing, repairing, adjusting, and testing machines, devices, moving parts, and equipment that operate primarily on the basis of mechanical (not electronic) principles.

Repairing and Maintaining Electronic EquipmentServicing, repairing, calibrating, regulating, fine-tuning, or testing machines, devices, and equipment that operate primarily on the basis of electrical or electronic (not mechanical) principles.

Documenting/Recording InformationEntering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Folder (open)Communicating and InteractingWhat interactions with other people occur while performing this job?

Folder (open)Coordinating, Developing, Managing, and AdvisingWhat coordinating, managerial, or advisory activities are done while performing this job?

Folder (open)AdministeringWhat administrative, staffing, monitoring, or controlling activities are done while performing this job?

Interpreting the Meaning of Information for OthersTranslating or explaining what information means and how it can be used.

Communicating with Supervisors, Peers, or SubordinatesProviding information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Communicating with Persons Outside OrganizationCommunicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.

Establishing and Maintaining Interpersonal RelationshipsDeveloping constructive and cooperative working relationships with others, and maintaining them over time.

Assisting and Caring for OthersProviding personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.

Selling or Influencing OthersConvincing others to buy merchandise/goods or to otherwise change their minds or actions.

Resolving Conflicts and Negotiating with OthersHandling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Performing for or Working Directly with the PublicPerforming for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.

Coordinating the Work and Activities of OthersGetting members of a group to work together to accomplish tasks.

Developing and Building TeamsEncouraging and building mutual trust, respect, and cooperation among team members.

Training and Teaching OthersIdentifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Guiding, Directing, and Motivating SubordinatesProviding guidance and direction to subordinates, including setting performance standards and monitoring performance.

Coaching and Developing OthersIdentifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Provide Consultation and Advice to OthersProviding guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

Performing Administrative ActivitiesPerforming day-to-day administrative tasks such as maintaining information files and processing paperwork.

Staffing Organizational UnitsRecruiting, interviewing, selecting, hiring, and promoting employees in an organization.

Monitoring and Controlling ResourcesMonitoring and controlling resources and overseeing the spending of money.

Intermediate Work Activities ListList of intermediate work activities for each occupation

Detailed Work Activities ListList of detailed work activities for each occupation

Folder (open)Structural CharacteristicsA functional subsystem of organization structure subsuming constructs of (a) organizational structure, and (b) human resources systems and practices

Folder (open)Social ProcessesA functional subsystem of organization structure subsuming processes linking people (employees) to their work and to each other and includes elements such as values, goals, leadership, and roles

Folder (open)Organizational StructureThe architecture or anatomy of an organization, affecting the behavior of organizational members as well as the ability of organizations to adapt effectively to their environments. Elements of organizational structure include the hierarchy of the organization, the degree of centralization, and the nature of work groups used to accomplish organizational objectives

Folder (open)Human Resources Systems and PracticesOrganizational practices and policies designed to ensure that an organization has employees who are capable of meeting its goals

Folder (open)Decision Making SystemThe amount of autonomy and involvement in decision making that employees have

Folder (open)Job CharacteristicsIndicates the level of skill variety, task significance, task identity, autonomy, and feedback in this job

Folder (open)Job Stability and RotationThe amount of stability in the job and the extent of job rotation

Folder (open)Decentralization and Employee EmpowermentIndicates the degree to which employees are provided with different types of information and participate in decision-making

Individual versus Team StructureIdentifies the extent to which employees work in intact teams

Have Control Over Unit or DepartmentYou have a great deal of control over what happens in your unit or departmentData not collected

Have Influence Over DecisionsYou have a great deal of influence over decisions that are made in your unit or department.Data not collected

Monitor Data on Quality/Costs/Waste/etc.You monitor data on quality, costs, waste, and productivityData not collected

Determine Work Flow or Order of TasksYou determine work flow or the order in which tasks are performedData not collected

Invest in New Equipment and TechnologyYou invest in new equipment and technologyData not collected

Develop New Products, Services, and ProceduresYou develop new products, services, and proceduresData not collected

Percent of Time in Intact TeamApproximately what percentage of your time do you spend working in an intact team? By intact team we mean a group of 3 or more employees who are jointly responsible for whole work processes and work toward shared goals (e.g., production team; development team; project team).Data not collected

Folder (open)Skill VarietyThe variety of skills required of people in this job

Folder (open)Task SignificanceThe importance or significance of the tasks performed on this job, as reflected by its effect on the lives or well-being of others

Folder (open)Task IdentityThe extent to which tasks performed on this job can be perceived as contributing to the final product

Folder (open)AutonomyThe amount of freedom in the job, as reflected in a person being able to exercise personal initiative and judgment in task performance

Folder (open)FeedbackThe extent to which this job provides information about how well one is performing

Job VarietyHow much variety is there in your job? That is, to what extent does the job require you to do many different things at work, using a variety of your skills and talents?Data not collected

Complex or High Level Skills RequiredYour job requires you to use a number of complex or high-level skills.Data not collected

Variety of Tasks RequiredYour job requires you to perform a variety of tasks.Data not collected

Significance or Importance of JobIn general, how significant or important is your job? That is, are the results of your work likely to significantly affect the lives or well-being of other people?Data not collected

Job Quality Affects Lots of PeopleYour job is one where a lot of people can be affected by how well the work gets done.Data not collected

Job Itself Is Very SignificantYour job itself is very significant and important in the broader scheme of things.Data not collected

Job Involves Whole Piece of WorkTo what extent does your job involve doing a 'whole' and identifiable piece of work? That is, is the job a complete piece of work that has an obvious beginning and end? Or is it only a small part of the overall piece of work, which is finished by other people or automatic machines? (If your job involves many different tasks or pieces of work, try to think about your typical tasks or the tasks you spend the most time on.)Data not collected

Can Do Entire Piece of WorkYour job is arranged so that you can do an entire piece of work from beginning to end.Data not collected

Can Finish What You StartYour job provides you a chance to completely finish the piece of work you began.Data not collected

Autonomy and Freedom in JobHow much autonomy and freedom are there in your job? That is, to what extent does your job permit you to decide on your own how to go about doing your job?Data not collected

Chance for Initiative and JudgmentYour job gives you a chance to use your personal initiative and judgment in carrying out the work.Data not collected

Opportunity for Independence and FreedomYour job gives you considerable opportunity for independence and freedom in how you do your job.Data not collected

Extent of Feedback From Doing Job ItselfTo what extent does doing the job itself provide you with information about your work performance? That is, does the actual work itself provide clues about how well you are doing--aside from any 'feedback' co-workers or supervisors may provide?Data not collected

Doing Job Provides Chances for FeedbackJust doing the job provides many chances for you to figure out how well you are doing.Data not collected

After Finishing Job, Know Own PerformanceAfter you finish a job, you know whether you performed well.Data not collected

Number of Supervisors in Past YearHow many different supervisors have you had in the past year?Data not collected

Number of Work Teams in Past YearApproximately how many different work teams have you belonged to during the past year?Data not collected

Number of Work Group Reorganizations in Past YearIn the past year, how many times has your primary work group gone through some kind of reorganization?Data not collected

Number of Times Nature of Job ChangedIn the past year, how many times has the nature of your job duties changed dramatically?Data not collected

Job Rotation PracticesWhich statement best describes the job rotation practices in your job and your work group?Data not collected

Folder (open)Recruitment and SelectionOrganizational practices, decisions, and processes that affect (a) the capability of an organization to make hiring, promotion, and other personnel decisions, and (b) the number or types of individuals who are willing to apply for or accept a given vacancy

Folder (open)Training and DevelopmentThe systematic acquisition of attitudes, concepts, knowledge, roles, or skills that result in improved performance at work

Folder (open)Reward SystemMonetary compensation and monetary and non-monetary benefits organizations provide to their employees

Recruitment OperationsActivities involved in implementing recruitment plans (e.g., selecting sources, realistic job preview)

Selection Assessment Methods UsedThe methods used for selection or promotion of employees

Sources of People for Current JobWhich of the sources listed below are used to recruit people for your current job?Data not collected

Assessment Methods Used to Select for JobWhich of the following assessment methods are used to select people for your current job?Data not collected

Training MethodsThe methods used in training programs

Training Topics and ContentWhat trainers intend to teach trainees through training programs

Extent and Support of Training ActivitiesThe extent to which an organization makes training available to its employees and provides financial support for training activities

Training Methods Used in CompanyWhich of the following training methods have been used in company training courses you have attended in the last two years?Data not collected

Areas of Recent Formal TrainingIn which of the following content areas have you received formal training in the last two years?Data not collected

Recent Technical Skill TrainingIn the last two years, how often have you attended company sponsored job-related technical training (i.e., technical skill training)?Data not collected

Basis of CompensationThe extent to which organizations reward individuals based on: (a) their knowledge, skills, and performance, (b) seniority, (c) team performance, (d) organizational performance, and (e) job attributes

BenefitsThe extent to which employees' compensation includes benefits such as pensions, insurance, paid leave, awards and bonuses, pay for time not worked, etc.

Compensation Package ComponentsWhich of the following is part of your compensation package (i.e., pay)?Data not collected

Benefit ComponentsWhich of the following is part of your benefits?Data not collected

Folder (open)GoalsIndividual goal setting.

Folder (open)RolesCharacteristics of job incumbents' roles, such as the extent to which they involve conflict and overload

CulturePatterns of behaviors and social relationships reflecting the assumptions, values, norms, and artifacts shared by members of the organization

Folder (open)Supervisor RoleThe nature of supervisory leadership

Folder (open)Individual Goal CharacteristicsThe extent to which an individual's goal is made explicit, and the probability that an individual can attain the goal

Folder (open)Goal FeedbackThe extent to which an individual is given periodic feedback regarding his or her progress against a goal

Achieve Most Important Individual GoalRealistically, the probability that you will achieve your most important individual work goal this year is:Data not collected

How Many Quantitative Individual GoalsHow many of your individual work goals are quantitative (e.g., selling $100,000 worth of merchandise as opposed to selling as much merchandise as possible).Data not collected

How Many Specific Individual GoalsHow many of your individual work goals are specific -- that is, you will know exactly when you have achieved them?Data not collected

When Get Information on Individual GoalsHow often do you get information regarding how close you are to achieving your most important individual work goal (for example, an interim financial report or data on number of units sold)?Data not collected

Informal, Job-Relevant FeedbackTo what extent do you receive informal, job-relevant feedback from your supervisor?Data not collected

Meet One-on-One With Supervisor on Goals, Training, and DevelopmentDuring the past year, how often have you met one-on-one with your immediate supervisor to discuss issues such as your performance, goals, training and development?Data not collected

Folder (open)Role ConflictThe extent to which an individual has to deal with conflicting demands

Folder (open)Role NegotiabilityThe extent to which an individual can negotiate his/her role in an organization

Folder (open)Role OverloadA discrepancy between the job's demands and one's ability to meet those demands

Often Receive Conflicting RequestsYou often receive conflicting requests from two or more people at work.Data not collected

Work With Groups With Different FocusesYou work with two or more groups who want you to focus on different things.Data not collected

You and Your Supervisor Agree About JobYou and your supervisor agree about what your job should be.Data not collected

Supervisor Makes Conflicting RequestsYour supervisor often asks you to do two or more things that conflict (for example, save a large amount of money while at the same time dramatically increasing quality).Data not collected

Negotiate Changes in Role with SupervisorYou have negotiated changes in the nature of your role at work with your supervisor.Data not collected

Significant Input Into Way You Do JobYou have significant input into the way you do your job.Data not collected

Get Assignments without Adequate ResourcesYou receive assignments at work without adequate resources and materials to complete them properly.Data not collected

Given Enough Time to Do WorkYou are given enough time to do what is expected of you at work.Data not collected

Too Much for One Person to DoIt often seems like you have too much work for one person to do.Data not collected

Organizational ValuesIndicates the importance of different organizational values such as tradition, stability, innovation, and collaboration

Folder (open)Guiding Principles of OrganizationHow important are each of the following concepts, or values, as a guiding principle for your organization as a whole.

Taking Chances; Going Out on a LimbTaking chances; going out on a limbData not collected

Fairness; JusticeFairness; justiceData not collected

PrecisionPrecision; paying attention to even the smallest detailsData not collected

StabilityStability; keeping things on an even keelData not collected

Getting Things DoneGetting things done; taking decisive or quick actionData not collected

Caring About EmployeesCaring about employees; showing concern for their well-beingData not collected

InnovationInnovation; finding new and better ways of doing things; openness to new ideasData not collected

AggressivenessAggressiveness; forcefully going after what you wantData not collected

Valuing CustomersValuing customers; emphasizing customer serviceData not collected

Providing High Quality ProductsProviding high quality products or services; meeting high standards of excellenceData not collected

Openness and HonestyOpenness; honesty; keeping employees well informedData not collected

Flexibility, Adapting to ChangeFlexibility, adapting to changeData not collected

Supervisor Friendly and SupportiveTo what extent does your supervisor act in a friendly and supportive manner? For example, does he/she show concern for members of your work group and respect for your ideas?Data not collected

Supervisor Takes Active RoleTo what extent does your supervisor take an active role in directing your work group's activities by setting goals, planning and scheduling work, assigning tasks, and making sure that each person knows what he/she should be doing?Data not collected

Supervisor Provides Clear VisionTo what extent does your supervisor provide members of your work group with a clear vision of where the group is going and keep everyone fully committed to the work at hand?Data not collected

Supervisor Solves ProblemsTo what extent does your supervisor quickly and effectively solve problems, even difficult problems, that come up in your work group?Data not collected

Folder (open)Interpersonal RelationshipsThis category describes the context of the job in terms of human interaction processes

Folder (open)Physical Work ConditionsThis category describes the work context as it relates to the interactions between the worker and the physical job environment

Folder (open)Structural Job CharacteristicsThis category involves the relationships or interactions between the worker and the structural characteristics of the job

Folder (open)CommunicationTypes and frequency of interactions with other people that are required as part of this job.

Role RelationshipsImportance of different types of interactions with others both inside and outside the organization

Folder (open)Responsibility for OthersAmount of responsibility the worker has for other workers as a part of this job

Folder (open)Conflictual ContactAmount of conflict that the worker will encounter as part of this job

Folder (closed)Communication MethodsHow frequently does this job require the use of the following communication methods?

Contact With OthersHow much does this job require the worker to be in contact with others (face-to-face, by telephone, or otherwise) in order to perform it?

Folder (open)Job InteractionsHow important are interactions requiring the worker to:

Work With Work Group or TeamHow important is it to work with others in a group or team in this job?

Deal With External CustomersHow important is it to work with external customers or the public in this job?

Coordinate or Lead OthersHow important is it to coordinate or lead others in accomplishing work activities in this job?

Responsible for Others' Health and SafetyHow much responsibility is there for the health and safety of others in this job?

Responsibility for Outcomes and ResultsHow responsible is the worker for work outcomes and results of other workers?

Frequency of Conflict SituationsHow often are there conflict situations the employee has to face in this job?

Deal With Unpleasant or Angry PeopleHow frequently does the worker have to deal with unpleasant, angry, or discourteous individuals as part of the job requirements?

Deal With Physically Aggressive PeopleHow frequently does this job require the worker to deal with physical aggression of violent individuals?

Folder (open)Work SettingDescription of physical surroundings that the worker will face as part of this job

Environmental ConditionsDescription of extreme environmental conditions the worker will be placed in as part of this job

Folder (open)Job HazardsDescriptions of types of hazardous conditions the worker could be exposed to as part of this job. This includes the frequency of exposure, and the likelihood and degree of injury if exposed.

Body PositioningAmount of time the worker will spend in a variety of physical positions on this job

Work AttireDress requirements of this job

Folder (open)Frequency Required to Work:How frequently does this job require the worker to work:

Physical ProximityTo what extent does this job require the worker to perform job tasks in close physical proximity to other people?

Indoors, Environmentally ControlledHow often does this job require working indoors in environmentally controlled conditions?

Indoors, Not Environmentally ControlledHow often does this job require working indoors in non-controlled environmental conditions (e.g., warehouse without heat)?

Outdoors, Exposed to WeatherHow often does this job require working outdoors, exposed to all weather conditions?

Outdoors, Under CoverHow often does this job require working outdoors, under cover (e.g., structure with roof but no walls)?

In an Open Vehicle or EquipmentHow often does this job require working in an open vehicle or equipment (e.g., tractor)?

In an Enclosed Vehicle or EquipmentHow often does this job require working in a closed vehicle or equipment (e.g., car)?

Folder (open)Frequency in Environmental ConditionsHow often during a usual work period is the worker exposed to the following conditions:

Sounds, Noise Levels Are Distracting or UncomfortableHow often does this job require working exposed to sounds and noise levels that are distracting or uncomfortable?

Very Hot or Cold TemperaturesHow often does this job require working in very hot (above 90 F degrees) or very cold (below 32 F degrees) temperatures?

Extremely Bright or Inadequate LightingHow often does this job require working in extremely bright or inadequate lighting conditions?

Exposed to ContaminantsHow often does this job require working exposed to contaminants (such as pollutants, gases, dust or odors)?

Cramped Work Space, Awkward PositionsHow often does this job require working in cramped work spaces that requires getting into awkward positions?

Exposed to Whole Body VibrationHow often does this job require exposure to whole body vibration (e.g., operate a jackhammer)?

Folder (open)Frequency of Exposure to Job HazardsHow often does this job require the worker to be exposed to the following hazards?

Likelihood of Injury From Job HazardsWhat is the likelihood that the worker would be injured as a result of being exposed to the following hazards while performing this job?Data not collected

Degree of InjuryIf injury, due to exposure to the following hazards, were to occur while performing this job, how serious would be the likely outcome?Data not collected

Exposed to RadiationHow often does this job require exposure to radiation?

Exposed to Disease or InfectionsHow often does this job require exposure to disease/infections?

Exposed to High PlacesHow often does this job require exposure to high places?

Exposed to Hazardous ConditionsHow often does this job require exposure to hazardous conditions?

Exposed to Hazardous EquipmentHow often does this job require exposure to hazardous equipment?

Exposed to Minor Burns, Cuts, Bites, or StingsHow often does this job require exposure to minor burns, cuts, bites, or stings?

Folder (open)Time Spent in Body PositionsHow much time in a usual work period does the worker spend:

Spend Time SittingHow much does this job require sitting?

Spend Time StandingHow much does this job require standing?

Spend Time Climbing Ladders, Scaffolds, or PolesHow much does this job require climbing ladders, scaffolds, or poles?

Spend Time Walking and RunningHow much does this job require walking and running?

Spend Time Kneeling, Crouching, Stooping, or CrawlingHow much does this job require kneeling, crouching, stooping or crawling?

Spend Time Keeping or Regaining BalanceHow much does this job require keeping or regaining your balance?

Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or ControlsHow much does this job require using your hands to handle, control, or feel objects, tools or controls?

Spend Time Bending or Twisting the BodyHow much does this job require bending or twisting your body?

Spend Time Making Repetitive MotionsHow much does this job require making repetitive motions?

Folder (open)Frequency of Wearing Work AttireHow often does the worker wear:

Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life JacketsHow much does this job require wearing common protective or safety equipment such as safety shoes, glasses, gloves, hard hats or life jackets?

Wear Specialized Protective or Safety Equipment such as Breathing Apparatus, Safety Harness, Full Protection Suits, or Radiation ProtectionHow much does this job require wearing specialized protective or safety equipment such as breathing apparatus, safety harness, full protection suits, or radiation protection?

Folder (open)Criticality of PositionAmount of impact the worker has on final products and their outcomes

Folder (open)Routine versus Challenging WorkThe relative amounts of routine versus challenging work the worker will perform as part of this job

CompetitionAmount of competition that the worker will face as part of this job

Folder (open)Pace and SchedulingDescription of the role that time plays in the way the worker performs the tasks required by this job

Consequence of ErrorHow serious would the result usually be if the worker made a mistake that was not readily correctable?

Folder (closed)Impact of DecisionsThe frequency and nature of the impact of worker's decisions on the organization

Freedom to Make DecisionsHow much decision making freedom, without supervision, does the job offer?

Degree of AutomationHow automated is the job?

Importance of Being Exact or AccurateHow important is being very exact or highly accurate in performing this job?

Importance of Repeating Same TasksHow important is repeating the same physical activities (e.g., key entry) or mental activities (e.g., checking entries in a ledger) over and over, without stopping, to performing this job?

Structured versus Unstructured WorkTo what extent is this job structured for the worker, rather than allowing the worker to determine tasks, priorities, and goals?

Level of CompetitionTo what extent does this job require the worker to compete or to be aware of competitive pressures?

Time PressureHow often does this job require the worker to meet strict deadlines?

Pace Determined by Speed of EquipmentHow important is it to this job that the pace is determined by the speed of equipment or machinery? (This does not refer to keeping busy at all times on this job.)

Work SchedulesHow regular are the work schedules for this job?

Duration of Typical Work WeekNumber of hours typically worked in one week.

0 notes

khalilhumam · 4 years

Text

Making the $12 Billion Go Further: Four Things the World Bank Can Do in Support of COVID-19 Vaccination Efforts

New Post has been published on http://khalilhumam.com/making-the-12-billion-go-further-four-things-the-world-bank-can-do-in-support-of-covid-19-vaccination-efforts/

Making the $12 Billion Go Further: Four Things the World Bank Can Do in Support of COVID-19 Vaccination Efforts

This week, as part of the World Bank’s 2020 Annual Meetings, the World Bank announced approval of $12 billion for the purchase and distribution of COVID-19 vaccines, tests, and treatments. The funding would go a long way to meeting needs—the Access to COVID-19 Tools (ACT) Accelerator estimates a requirement of $35 billion for all COVID products, with $1.19 billion raised so far. The announcement mentions that, “In implementing the program, the World Bank will support multilateral efforts currently led by WHO and COVAX.” This is encouraging given that each country on its own would lack access to a large pool of potential vaccine candidates and may face higher prices or more limited volumes than would be optimal for population health impact. To maximise the impact of this badly needed investment to combat COVID and, most importantly, to avoid any perverse and potentially catastrophic implications of World Bank financing undermining current global efforts led by Gavi and CEPI, we propose that the World Bank commit to the four principles below. We also suggest it works with external partners and independent experts to operationalise these principles as part of the implementation of the funding.

1. Access to a diversified portfolio/product selection

To assure this access, the World Bank should link formally to the COVAX portfolio, by far the most diversified set of potential vaccines for purchase outside of the US Operation Warp Speed initiative (see CGD analysis). (COVAX is the vaccines pillar of the Access to COVID-19 Tools [ACT] Accelerator and is led by the Coalition for Epidemic Preparedness Innovations [CEPI]; Gavi, the Vaccine Alliance; and the World Health Organization [WHO].) Although the COVAX portfolio is reasonably diversified, the World Bank should push its portfolio towards further diversification by going from the current 9 to at least 12 vaccine candidates, thereby raising the chances of getting to a successful product from under 70 percent to over 80 percent. Operating outside of COVAX may not only deprive individual countries from access to a diversified portfolio but may well also reduce the chances of COVAX succeeding by encouraging additional bilateral deals between middle-income country governments and industry, and in so doing weakening the COVAX pool’s purchasing power. Formally joining COVAX and accessing its portfolio would empower the World Bank to seek stronger governance, transparency of process in selecting vaccine candidates, and broader diversification on behalf of country purchasers, and a discussion of country options should the COVAX portfolio fail to deliver. World Bank technical leadership and funding can also strengthen COVAX by shifting the emphasis from advocacy to analysis, enhancing transparency including sharing of contract offer design and terms, and an exposition of the legal framework for enforcing these, going beyond information currently available.

2. Regulatory standards and licensing

The World Bank must commit to WHO pre-qualification (PQ) as a regulatory and licensing standard for vaccine developer and manufacturing/fill and finish sites. Not including WHO PQ as an acceptable regulatory standard for the World Bank financing package risks insufficient manufacturing capacity or inadequate portfolio diversification, which could have knock-on effects for access. For example, part of the current manufacturing capacity (both fill and finish—when vials and syringes are filled and packed for transport—and bulk antigen production), particularly in middle-income countries, is WHO-pre-qualified, but not approved by a stringent regulatory authority. Further, relying only on high-income country stringent regulatory authorities only (e.g., the US Food and Drug Administration, the European Medicines Agency, Australia’s Therapeutic Drugs’ Administration, or Japan’s Pharmaceuticals and Medical Devices Agency) risks creating backlash from countries that would not recognize approval from these agencies for domestic political and legal reasons. While backing WHO PQ, the World Bank can also allocate resources and technical assistance for vaccine regulatory capacity strengthening (e.g. building on the projects such as its African Medicines Regulatory Harmonisation project) as part of this large financing package given that vaccine regulation in low- and middle-income countries (LMICs) is extremely weak. At the same time, there is a need for regulatory checks and balances in relation to products licensed without the completion of Phase 3 trials and/or without sufficient safety and efficacy data, which could be achieved through a coordinated WHO PQ effort.

3. Assure value for money in vaccine selection, procurement, and pricing negotiations

The World Bank should commit to launch Health Technology Assessment (HTA) in parallel to WHO PQ to assure that vaccine candidates that are ultimately purchased are as cost-effective as possible. As noted in some of our previous work, the likely efficacy and relative cost-effectiveness of the set of vaccine candidates is still mostly unknown and must be rigorously assessed using HTA to determine best value use of funds. HTA is a process already carried out by middle-income countries such as Thailand and the Philippines in relation to COVID-19 commodities and endorsed by WHO. The World Bank can commission analyses from WHO Strategic Advisory Group of Experts (SAGE), especially as comparative clinical and cost effectiveness are part of the SAGE scope and from international centres of excellence to inform product selection and tiered pricing as well as vaccine roll out. Outside COVAX, and on a country-by-country basis, product selection will likely be based on subjective criteria, which may or may not consider vaccine effectiveness or value for money and may allow for inappropriate practices, as we have seen so far in relation to COVID commodity procurement at much lower amounts of money. Encouraging (or indeed requiring) bilateral or bank-facilitated procurement could result in an uncoordinated, opaque, inefficient process, and generate competition for COVAX/CEPI in the process, undermining access for LMICs. Such an approach could also encourage what we are already seeing: MICs including large African nations directly negotiating with Chinese and Russian manufacturers. In addition to product selection, price negotiation will be hard to manage outside a multi-country platform such as COVAX (World Bank joining may also bring an end to current COVAX discussions on what we see as suboptimal ideas of cofinancing by LMICs and vaccine exchanges for wealthier countries). WB can introduce a transparent and well governed process for product selection and tiered pricing based on comparative product effectiveness and cost-effectiveness assessments ensuring some cash flow visibility and better accountability. Linking with the COVAX pool is consistent with the financing flowing directly from the country or the Bank Facilitated Procurement on behalf of the country, whilst the contract abides by COVAX rules. In the longer term, this level of investment in vaccine as well as treatment and test R&D and manufacturing can derisk the market and crowd in private investment to tackle this and the next outbreak.

4. Manufacturing capacity

The World Bank financing package should coordinate with the IFC facility to include a clear framework for managing manufacturing capacity globally, including know-how transfer and investing in high-quality developing country vaccine manufacturers (DCVM). Ensuring sufficient manufacturing capacity to meet global demand requires working with and expanding a globally distributed footprint of high-quality vaccine manufacturers. The challenge is not as much about intellectual property as about having the right manufacturing assets and technical know-how, especially for the novel platforms, e.g., nucleic acid vaccines, viral vectors. IFC’s COVID financing facility could be used to provide fixed and working for proven high-quality DCVM network vaccine manufacturers, but it needs to be connected much more closely with Bank financing for COVID-19 vaccines. Tech transfer is much more challenging here than it is for oral solids such as antiretroviral treatments. Existing voluntary licensing facilitation or pooling mechanisms may not have the required technical capacity to carry out such a role. Also, the new companies with COVID-19 vaccine candidates (e.g., Novavax, Moderna, Innovio, Curevac) have no experience of such tech transfer and don’t have in-house teams with the experience to think through voluntary or compulsory licensing, tiered pricing, tech transfer, and so on.

A Word Bank and COVAX partnership

It is not clear from the public release what safeguards have been put in place to shape implementation of the $12 billion package ex post and whether any of the above four points are included. The stakes are high and the risks significant, from undermining the COVAX efforts through allowing direct bilateral (country/industry) procurement and aggravating emerging markets by requiring approvals by high-income-country regulators to severely restricting manufacturing capacity for LMICs and allowing resources to be wasted through inefficient, bilateral, and at times corrupt national procurement practices. On the other hand, the World Bank money can inject data and contract and process transparency into the COVAX effort, require more active country engagement, and allow more flexibility and choice—all concerns voiced in relation with COVAX. Experiences of countries such as Mexico and Colombia, which considered going at it alone but ultimately joined COVAX, show that pooling expertise and resources makes sense for middle-income as well as low-income countries. The very real risks of nationalism, politics, and individual self-interest undermining the global race to get to a vaccine and which are already manifesting themselves in the vaccines arms race driven by high-income countries, are best confronted and addressed through the only existing multinational platform aimed at serving developing nations. The World Bank can be a force for good, forcing governance reforms whilst also boosting COVAX’s vaccine portfolio and enhancing its chances of success. And in making available to countries a wealth of technical expertise in procurement and manufacturing, a wide range of vaccine choices, as well as financial resources, a World Bank/COVAX partnership can appeal to middle-income countries already in bilateral discussions with China and Russia whilst also offering industry a badly needed single point of contact for negotiations. Will the World Bank rise to the challenge?

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ladystylestores · 4 years

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Coronavirus: Trump taking unproven drug hydroxychloroquine

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Media captionTrump taking hydroxychloroquine to prevent coronavirus

US President Donald Trump has said he is taking hydroxychloroquine to ward off coronavirus, even though health officials have warned it may be unsafe.

Speaking at the White House, he told reporters he started taking the malaria and lupus medication recently.

“I’m taking it for about a week and a half now and I’m still here, I’m still here,” was his surprise announcement.

There is no evidence hydroxychloroquine can fight off coronavirus, though clinical trials are under way.

What did Trump say?

The 73-year-old president was hosting a meeting devoted to the struggling restaurant industry on Monday, when he caught reporters unawares by revealing he was taking the drug.

“You’d be surprised at how many people are taking it, especially the frontline workers before you catch it, the frontline workers, many, many are taking it,” he told reporters. “I happen to be taking it.”

Asked what was his evidence of hydroxychloroquine’s positive benefits, Mr Trump said: “Here’s my evidence: I get a lot of positive calls about it.”

He added: “I’ve heard a lot of good stories [about hydroxychloroquine] and if it’s not good, I’ll tell you right I’m not going to get hurt by it.”

Though some people in the White House have tested positive for coronavirus, the president said again on Monday he had “zero symptoms” and was being tested frequently.

He added that he has been taking a daily zinc supplement and received a single dose of azithromycin, an antibiotic meant to prevent infection.

When asked whether the White House physician had recommended he start taking the disputed remedy, Mr Trump said he himself had requested it.

Dr Sean Conley, physician to the president, said in a statement issued through the White House later on Monday that Mr Trump was in “very good health” and “symptom-free”.

The US Navy officer added: “After numerous discussions he and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relative risks.”

Mr Trump’s most powerful elected adversary, the Democratic Speaker of the US House of Representatives, Nancy Pelosi, could not resist taking a dig at his age and weight when asked on CNN about him taking the malaria medication.

“He’s our president and I would rather he not be taking something that has not been approved by the scientists, especially in his age group and in his, shall we say, weight group – morbidly obese, they say,” she said.

Last year, the White House physician noted in Mr Trump’s annual medical exam that he weighed 243lb (110kg) and was 6ft 3in, which would score his body mass index at a technically obese 30.4.

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Media captionThe harmonica player uniting his locked down neighbours with concerts

What have US health officials said?

The US Food and Drug Administration (FDA) last month issued an advisory saying that hydroxychloroquine has “not been shown to be safe and effective”.

It cited reports that the drug can cause serious heart rhythm problems in Covid-19 patients.

The FDA warned against use of the medication outside hospitals, where the agency has granted temporary authorisation for its use in some cases.

The Centers for Disease Control (CDC) says there are no approved drugs or therapeutics to prevent or treat Covid-19, which is confirmed to have infected more than 1.5 million people in the US, killing over 90,000 patients.

Centre of attention again

Donald Trump knows how to drive a news cycle.

Going into his meeting with restaurant businesses, there were a lot of threads to the day’s events, including the stock market surging based on positive news about a possible coronavirus vaccine. Coming out of the meeting, all anyone in the media could talk about was Mr Trump’s announcement that he has been taking the anti-malarial drug hydroxychloroquine for more than a week now.

Some of the president’s critics will see this unprompted revelation as a nefarious effort to distract from bad news elsewhere. Some will see this as another instance of the president stepping on what should have been a good news day.

Or perhaps he was simply unwilling to acknowledge that his past trumpeting of the drug as a miracle cure wasn’t just premature, it was ill-advised.

Whatever the reason, Mr Trump has once again made himself the centre of attention – and there’s no doubt he’s perfectly happy with that.

What else did Trump say?

Dismissing reports of severe side effects from hydroxychloroquine, the president said: “All I can tell you is, so far I seem to be OK.”

He said the “only negative” he had heard was from a “very unscientific report” conducted by “people that aren’t big Trump fans”.

Mr Trump was apparently referring to a preliminary study from April of Covid-19 patients in US government-run hospitals for military veterans that suggested hydroxychloroquine had no benefit and may have even caused a greater rate of deaths.

“I get a lot of tremendously positive news on the hydroxy,” the president told reporters, adding: “What do you have to lose?”

According to doctors, the drug has the potential to cause symptoms including heart failure, suicidal thoughts and signs of liver disease.

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Media captionWhat’s it like to fast for Ramadan as a healthcare worker during the pandemic?

What’s the reaction?

Mr Trump’s most powerful elected antagonist, the Democratic Speaker of the US House of Representatives, Nancy Pelosi, could not resist taking a dig at his age and weight when asked on CNN about him taking the malaria medication.

Last year, the White House physician noted in Mr Trump’s annual medical exam that he weighed 243lb (110kg) and was 6ft 3in, which would score his body mass index at a technically obese 30.4.

What have other medical experts said?

Two recent studies, each involving around 1,400 Covid-19 patients in New York, did not find any benefits from hydroxychloroquine.

Another study by French researchers involved 84 hospital patients taking the drug and 97 others who received standard care. It concluded hydroxychloroquine had no impact for better or worse.

Last month, the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists issued a joint statement opposing the use of hydroxychloroquine for Covid-19 prevention.

Also in April, the former director of a federal vaccine agency claimed in a whistleblower complaint that he was removed for refusing to promote the drug.

Dr Rick Bright: US risks its ‘darkest winter in modern history’

The health department has rejected Dr Rick Bright’s complaint, and the president has called him a “disgruntled” employee.

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gordonwilliamsweb · 3 years

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Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Renner, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.

The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

“There is a court date [for the DOJ case] as ordered by a judge,” Chin said via email. “If we get to that point the facts of the case will be litigated.”

Back Surgeries Under Scrutiny

The nation’s outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry report.

Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.

Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.

Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.

Patient Injuries Pile Up

While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.

Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.

In court filings, Arthrex admitted making payments to Meade for “consulting and royalties” but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.

“Based on what my doctors have told me, I will never get back to normal.”

— Nancy Lazo

Government Struggles to Keep Pace

Rosen said while he believes a “relatively small number” of surgeons cash whopping industry checks, many who do so are influential figures who can “help direct medical care.”

Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.

KHN identified four spinal device makers — including SpineFrontier — that have been accused in whistleblower cases of scheming to hide consulting payments from the government.

Responding to written questions, a CMS spokesperson said the agency “has multiple formal compliance actions pending which it is unable to discuss further at this time.”

But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.

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alicecpacheco · 5 years

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American Hospital Association Concerned About Vulnerabilities in Health Care Sector

The American Hospital Association (AHA)has some serious concerns about the safety of patient data and also the security of legacy devices that become more and more vulnerable to hacks as time marches on. In February of 2019, Senator Mark Warner reached out to several healthcare organizations including the AHA and the AMA asking for their opinions on how to battle the security issues facing the industry which is now working on being totally digital and becoming a huge target for all kinds of nefarious hackers and ransomware.

The AHA responded with the letter below. Give it a read.

On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners – including more than 270,000 affiliated physicians, 2 million nurses and other caregivers – and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to respond to your letter regarding cybersecurity in the health care sector. Hospital and health system leaders recognize the information and resources held by health care organizations are highly sensitive and valuable, and they are taking cybersecurity challenges extremely seriously. They have implemented important security steps to safeguard clinical technologies and information systems while they continue to enhance their data protection capabilities. And hospitals and health systems have made great strides to defend their networks, secure patient data, preserve the efficient delivery of health care services and, most importantly, protect patient safety. The AHA has focused its efforts on providing up-to-date cybersecurity information – for both technical and non-technical audiences – to our member hospitals and health systems. This information assists hospitals and health systems as they face the continuing challenges of ensuring the privacy and security of patients’ health care data in an environment of increasingly networked technology and expanded connectivity that offers significant benefits for care delivery, but also increases the potential for exposure to possible additional cybersecurity threats. As the global WannaCry ransomware attack in 2017 underscored, the cybersecurity risks hospitals and health systems continue to face include the extent to which medical devices are vulnerable to threats and, in turn, can create serious risks for the security of hospitals’ overall information systems and the delivery of patient care. Below, we discuss our efforts to assist members with cybersecurity risk reduction and mediation, as well as federal government efforts to stimulate and promote additional cybersecurity risk reduction strategies to the health field. We also offer recommendations for reducing cybersecurity vulnerabilities in health care. AHA EFFORTS TO ADDRESS CYBERSECURITY Cyber threats are a major risk issue for hospitals and health systems. The AHA began raising awareness on cybersecurity issues in 2014 with resources directed at both hospital and health system leaders and trustees. In 2018, the AHA expanded on its provision of educational opportunities for members, and we now also provide them with targeted and customized information, including strategic cybersecurity and risk advisory services. Specifically, the AHA created a new role, senior advisor for cybersecurity and risk, to assist the field. We hired a nationally recognized health care cybersecurity expert who has nearly 30 years of highly- accomplished service with the Federal Bureau of Investigation (FBI). The AHA offers many cybersecurity education opportunities to hospital and health system leaders, including both in-person and web-based presentations discussing specific cybersecurity topics. We have prioritized raising awareness for board members, hospital leaders and staff, in addition to providing information to technical audiences. In addition, the AHA reviews government policy, regulation and legislation to provide analysis pertaining to cybersecurity and risk implications for hospital and health systems. We monitor pending criminal and national security investigations and liaise with law enforcement and the intelligence community, as needed. The AHA also offers support and advice to members during ransomware and extortion incidents, including communications and response to adversaries. The AHA has worked closely with federal government partners to help increase the coordination and sharing of information to identify possible vulnerabilities and prevent attacks on hospitals. The AHA serves as both a distribution channel to disseminate threat information, as well as a conduit to federal agencies and departments highlighting hospitals’ and health systems’ on-the-ground experiences. This was especially important during the WannaCry attack when the AHA provided critical information to many government partners regarding the impact on the health care sector. FEDERAL GOVERNMENT AND PRIVATE-SECTOR EFFORTS TO ADDRESS CYBERSECURITY The AHA offers many cybersecurity education opportunities to hospital and health system leaders, including both in-person and web-based presentations discussing specific cybersecurity topics. We have prioritized raising awareness for board members, hospital leaders and staff, in addition to providing information to technical audiences. Both Congress and the Administration have worked to address cybersecurity vulnerabilities in recent years. There are numerous efforts underway in several departments and agencies. The Administration has used executive orders to name 16 critical infrastructure sectors ─ including health care and public health ─ deemed essential to the security of the nation and directed federal agencies to prioritize securing federal systems. The Department of Health and Human Services (HHS) is designated as the liaison for the health care sector. More broadly, the FBI has been designated as the lead authority on investigating cybercrime. Other agencies, including the Department of Homeland Security (DHS) and the Secret Service, also play key roles in combatting cybercrime and providing guidance. Coordination across these federal agencies is critical to ensure threat intelligence and defensive strategies are shared widely, effectively and in a timely manner. In addition, these agencies must be given the resources to not only respond to attacks, but help vulnerable health care targets prevent attacks from occurring and succeeding. The Cybersecurity Information Sharing Act of 2015 (CISA) allowed for information sharing among private-sector and federal government entities and provided a safe harbor from certain liabilities related to that information sharing. Information sharing is a critical way to help prevent future attacks by allowing organizations to share real-time threat information. Several private-sector entities, such as the Health Information Sharing and Analysis Center (H-ISAC) and Health Information Trust Alliance (HITRUST), provide information-sharing opportunities for organizations. The Health Sector Coordinating Council Joint Cybersecurity Working Group, which the AHA participates in, also serves an important role in bringing stakeholders together and coordinating across public and private sectors. In addition, the federal government has provided information sharing resources through its cybersecurity initiatives, including health care and public health facilities. With that said, the goals of information sharing have yet to be fully realized. Expedited and tailored cyber threat information sharing from the federal government would benefit all health care and public health organizations. Providers need actionable information that identifies specific steps they can take to secure against new threats. Large volumes of more generalized information can prove challenging to interpret and even become a distraction. In September 2018, the Administration released the National Cyber Strategy to address the larger cyber ecosystem. Action is needed to address the cybersecurity challenges facing all sectors, including health care. As a nation, we must bolster the security of our cyber ecosystem, not just place the burden on individual institutions. The magnitude of the challenges and the growing sophistication of the attacks suggest that the federal government must provide additional resources. Department of Health and Human Services. Under CISA, HHS is directed to work with the private sector and other federal agencies to establish voluntary, consensus- based best practices. To carry out this directive, HHS convened the Health Care Industry Cybersecurity (HCIC) Task Force in March 2016 to examine the cybersecurity challenges in the health care sector and determine recommendations to address them. The following year, the Task Force released a report detailing six areas of focus along with recommendations for both public and private partners to increase security in the health care sector. In addition, in 2017, HHS convened the CISA 405(d) Task Group to align industry approaches by developing a common set of voluntary, consensus-based, and industry-led guidelines, practices, methodologies, procedures and processes that health care organizations can use to enhance cybersecurity. The group is comprised of more than 150 members from both the public and private sector, including the AHA. In January 2019, the task group released the Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients to help continue to raise awareness and provide best practices. The Health Industry Cybersecurity Practices provides essential guidance for organizations of varying size and resource level to mitigate cybersecurity threats. HHS also opened the Health Sector Cybersecurity Coordination Center (HC3) in October 2018 to coordinate activities across the sector and report threats, profiles and preventive strategies to DHS. Food and Drug Administration (FDA). The FDA provides oversight to ensure that medical devices are safe and effective. As a regulator, FDA has a leadership role in creating expectations that manufacturers proactively minimize risk by building security into products by design, providing security tools to their end-users, and updating and patching devices as new intelligence and threats emerge. Manufacturers must share with end-users the responsibility for safeguarding the confidentiality of patient data, maintaining data integrity, and ensuring the continued availability and functionality of the device system itself. While no actions can completely eliminate cybersecurity risks from health care, swift action by FDA to improve the security of legacy and new medical devices will aid in reducing significant sources of vulnerability. We were pleased to see FDA include cybersecurity steps in its May 2018 Medical Safety Action Plan and release a draft of new pre-market authority requiring manufacturers to build capability to update and patch device security into product design and providing a “Software Bill of Materials” that identifies the information technology solutions in a device so that end-users can better manage the devices. It also included consideration of new post-market authority to require manufacturers to adopt policies and procedures for coordinated disclosure of vulnerabilities when they are identified. In our comments to the agency, we noted that the outlined steps would make important improvements to FDA’s oversight of medical device manufacturers with respect to the security of their products and offered suggestions for improvement. The AHA also urged FDA to move as quickly as possible to implement these steps and make public its timeline for the benefit of all stakeholders. FDA also has worked collaboratively with the private sector to advance medical device security. In January 2019, the Healthcare and Public Health Sector Coordinating Councils released the Medial Device and Health IT Joint Security Plan as a result of the recommendation in the 2017 HCIC Task Force report. It will be important to continue this work. AHA RECOMMENDATIONS TO REDUCE CYBERSECURITY VULNERABILITIES IN THE HEALTH CARE SECTOR The AHA supports recommendations included in the HCIC report, particularly continuing to increase the security and resilience of medical devices and developing the health care cybersecurity workforce capacity. We also support the development of a safe harbor to protect HIPAA-covered entities that have complied with cybersecurity best practices and making sure victims of attacks receive support and resources while enforcement efforts are focused on investigating and prosecuting the attackers. Additional recommendations in certain areas follow. Medical Devices. A health system can have tens of thousands of devices from hundreds of manufacturers connected to its network, leading to significant security management challenges. Legacy devices remain a key vulnerability for hospitals and health systems. Given their useful lifespans, many legacy devices were not built with cybersecurity in mind and may use outdated or insecure software, hardware and protocols, leaving them vulnerable to attack. To remediate this problem, manufacturers must support end-users in providing a secure environment for safe patient care. This support should include wrapping security precautions around these devices, adding security tools and auditing capabilities where possible, conducting regular updates and patching all software, and communicating security vulnerabilities quickly through consistent channels. While FDA has released both pre- and post-market guidance to device manufacturers on how to secure systems, and released updated pre-market guidance for comment, there are still concerns surrounding legacy devices and supported lifetimes that have yet to be resolved. Given that legacy devices have already been sold, there is little incentive for manufacturers to address the security of their installed base of products. FDA must make clear that security measures to protect legacy devices are required, not optional. Last year, we provided detailed comments to the House Committee on Energy and Commerce with additional recommendations on the security of legacy medical devices. Workforce. Hospitals and health systems have emphasized the challenges they face in securing their information systems, given the limited financial resources they have to devote to cybersecurity and the current cybersecurity workforce shortages. These challenges are even more acute for smaller and rural facilities. As discussed earlier, recommendations to address this concern were included in the June 2017 HCIC Task Force report. These recommendations discuss the need for the Administration and Congress to provide resources and programs to increase and improve the cybersecurity workforce in health care and to address the challenges of small and rural facilities. The AHA would support developing and promoting workforce training programs specific to cybersecurity in health care, as well as funding for targeted internships or other programs to place cybersecurity professionals in small and rural facilities. Safe Harbor. Despite complying with HIPAA rules and implementing best practices, hospitals and health care providers will continue to be the targets of sophisticated cyberattacks, and some attacks will inevitably succeed. Whether exploiting previously unknown vulnerabilities or taking advantage of an organization with limited resources, attackers will continue to be successful. The AHA believes that victims of attacks should be given support and resources, and enforcement efforts should rightly focus on investigating and prosecuting the attackers. Merely because an organization was the victim of a cyberattack does not mean that the organization itself was in any way at fault or unprepared. Similarly, a breach does not necessarily equate to a HIPAA security rule compliance failure. Moreover, an aggressive regulatory enforcement approach could be counter-productive and hinder valued cooperation by the victims of cyberattack with other parts of the government, such as DHS, FBI and the intelligence community. Instead, successful attacks should be fully investigated, and the lessons learned should be disseminated widely to prevent successful similar future attacks. We urge the HHS Office of Civil Rights (OCR) to consider ways to develop a safe- harbor for HIPAA-covered entities that have shown, perhaps through a certification process, that they are in compliance with best practices in cybersecurity, such as those promulgated by HHS, in cooperation with the private sector, under section 405(d) of the CISA. Those best practices were developed through broad public/private collaboration after months of deliberation and development. A safe harbor would give covered entities clarity about the level of diligence they need to exercise, including when they agree to share and exchange protected health information with other systems/organizations through tools like health information exchanges, to avoid OCR enforcement when an attacker gains access. General Cyber Defenses. In addition to activities specific to the health care sector, the AHA supports efforts to bolster nationwide cyber defenses. These include building capacity and devoting federal resources to: Develop and disseminate coordinated national defensive measures, both within government and to the private sector. Identify and disrupt bad actors through law enforcement activities. Increase the consequences for those who commit cybercrimes. Identify and support best practices by the private sector.

Hospitals and health systems have made great strides to defend their networks, secure patient data, preserve the efficient delivery of health care services and, most importantly, protect patient safety. The AHA supports improving the cybersecurity of medical devices to help reduce vulnerabilities, increasing the cybersecurity workforce to ensure needed experts can help prevent attacks, and the developing of a safe harbor to give reassurance to facilities with exemplary cyber practices. The AHA is pleased to continue sharing information from the field to help the federal government effectively combat cyber threats. We look forward to working with you and others in Congress to reduce cybersecurity vulnerabilities in the health care sector. Thank you for the opportunity to comment and for your leadership on this issue. Please contact me if you have questions or feel free to have a member of your team contact Mark Seklecki, vice president of political affairs, at [email protected] or (202) 626- 2341. Sincerely, /s/

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