Tag: Government

Government pushes to set international standards for medical devices < Policy < Article

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The Korea Disease Control and Prevention Agency (KDCA) will establish the “National Standard Implementation Plan for Medical Devices in 2023” to lead international standards and help domestic medical equipment makers advance overseas.

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Government pushes to set international standards for medical devices < Policy < Article&#13
(Credit: Getty Images)
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The main content of the implementation plan includes a push to win the final approval from the International Organization for Standardization (ISO) for two existing international standard plans suggested by Korea, three new international standard plans, and Korea’s hosting of international assemblies for electrical medical products, the agency said Wednesday.

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“We are doing our best to ensure that medical device technology in which Korea has strengths can be enacted as the ISO standards,” the KDCA said.

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The agency noted that it is continuously participating in ISO’s general assembly and working-group meetings and positively presenting its opinions so that ISO approves the two international standards in dentistry it had submitted this year, adding that it would suggest three new international standard plans this year to lead making international standards in medical devices.

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More specifically, KDCA is promoting to get the ISO’s final nods for “general requirements for non-hinged dental handhelds” and “frontal apparatus – part 4: auxiliary apparatus” as international standards in dentistry. In addition, it will push to make three new standards — general requirements for hinged hand tools for dentistry,” “focused tube equipment – part 8: precision of electronic root tube length meter,” and the “classification of dental equipment and devices according to reprocessing – as international standards.

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Besides, the agency is pushing to streamline 144 Korea Standards in various areas — 22 standards related to electric and electronic medical devices, 110 related to dental, surgical, and in vitro diagnostic areas, and 12 related to individual medical devices and those used by the vulnerable class.

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Meanwhile, the agency plans to hold an international assembly of electric medical devices to be attended by about 150 experts from 20 countries in September to heighten Korea’s status in the international community regarding this field.

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The international meetings planned by the agency are the general assembly of the International Electro-technical Commission (IEC) and its technological group, TC (Technical Committee) 62, which deals with electric and mechanical safety, risk management, validation, and data security.

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In these meetings, participants will discuss and decide on making and revising international standards regarding electrical medical products’ safety and essential function, including diagnostic imaging devices and radiation devices, the agency said.

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“We will communicate with relevant experts based on regulatory expertise and maintain national standards (KS) continuously to ensure that the public can use high-quality medical devices with confirmed safety and high performance,” the KDCA said. “In addition, by reflecting Korea’s strong technical standards in the field of medical devices in international standards, we will actively support to enhance the status of the domestic medical device industry and help K-medical devices advance into overseas markets.

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Big food companies slam government proposal for regulating “healthy” food labeling

As the federal government moves to change rules for what foods can sport “healthy” labels, manufacturers are pushing back.

Some of the biggest makers of cereals, frozen and packaged food have submitted dozens of claims to the Food and Drug Administration objecting to new rules that would exclude food with high amounts of added sugar and salt from being labeled as “healthy” on packaging. Some manufacturers have even called the regulations unconstitutional, saying they violate companies’ First Amendment rights. 

The FDA last fall moved to update its requirements around what foods can use the word “healthy” on packaging — the first change since the rule was implemented in the 1990s. The proposed changes would leave out high-sugar, low-fat products that currently are allowed to use the healthy label today, such as fruit-flavored low-fat yogurts and Raisin Bran cereal.

That’s unfair, many food companies gripe, complaining that the more rigorous nutritional standards would wrongly malign a range of popular foods. The rule “automatically disqualifies entire categories of nutrient dense foods,” Kellogg’s wrote in a February 16 comment on the agency’s proposal. 

General Mills goes further, arguing that the FDA’s “overly restrictive” rule violates companies’ rights to free speech.

“[T]he Proposed Rule precludes many objectively healthy products, including those promoted by the Dietary Guidelines, from engaging in truthful, nonmisleading commercial expression — and these overly restrictive boundaries for ‘healthy’ violate the First Amendment,” the packaged-food giant writes. 

General Mills has a slew of well-known brands, including Annie’s, Betty Crocker, Cascadian Farm, Pillsbury and Yoplait, as well as cereals Chex, Cheerios, Choco Puffs, Cinnamon Toast Crunch, Raisin Nut Bran and Wheaties.

The window for submitting public comments on the proposed rules closed earlier this month. The FDA will now review the feedback, though the timing of a final rule is uncertain.


FDA proposes new rules for plant-based milks

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The Consumer Brands Association, whose members include Coca-Cola, PepsiCo, Hain Celestial and the Campbell Soup Company, took a similar tack, writing that “consumers have a First Amendment right to receive truthful information about products and manufacturers have a First Amendment right to provide it to them.” The group estimated that 95{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of foods currently on the market would not qualify for a “healthy” label under the government’s new requirements. 

KIND, the granola bar company, took issue with the FDA’s proposed limits on added sugars in foods, saying they “created a barrier for fruit, vegetable, and protein food innovation” and would lead to more companies using artificial sweeteners in their products to mimic the taste of sugar-sweetened food.

“Criteria for use of ‘healthy’ should not be so restrictive that they allow only a very limited number of foods to qualify, because this could lead consumers to conclude that other nutrient dense food choices are ‘unhealthy,'” the company added.

No label, no customers?

Conagra Brands, creator of the “Healthy Choice” brand of frozen meals, offered a blunt assessment: If it reinvents “Healthy Choice” to comply with the new rules, people won’t buy it, the company said. 

“Conagra cannot continue to invest in ‘healthy’ innovation if we are not able to meet the necessary taste, eating trends and affordability our consumers expect. If the food does not taste good, people will not buy it,” Conagra said. 


FDA hasn’t reviewed some food additives in decades

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Many “Healthy Choice” items have been criticized for their high amount of sugar or salt. For instance, the “Healthy Choice Sweet and Sour Chicken” meal contains 21 grams of added sugar — 42{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the current recommended daily value — while providing just 390 calories. 

“Meeting people where they are”

The American Frozen Food Institute said that restrictions on sodium would result in “nutritious frozen items being excluded due to a small amount of sauce that makes the item much more likely to be consumed.” 

“Consumers already know that whole fruits and vegetables are healthy and may not be consuming such products for a variety of reasons,” the Institute said, adding that the FDA should be “meeting people where they are.”

The Consumer Brand Association echoed this comment, writing: “Many consumers are constrained from preparing meals and snacks from ‘plain’ ingredients due to limited time, affordability, easy access to stores that sell these ingredients, kitchen resources, and cooking skills. And most consumers do not typically eat foods in a plain, unflavored form.”

Despite this industry’s grousing, many nutrition experts have come out in favor of the FDA’s revised guidelines. Requirements for the “healthy” label haven’t changed in the 28 years since it was first created, even as the public understanding of what’s nutritious has evolved. 

“We want to use policies that advocate for a healthier diet than we currently have, and that’s why we believe the healthy claims should be allowed only for foods that are truly healthy,” said Eva Greenthal, senior policy scientist at the Center for Science in the Public Interest. The CSPI mostly supports the new rules but says they allow too much refined grain and processed fruit.

Powerful marketing 

Under the FDA’s proposed rules, foods high in sugar, sodium or refined grains won’t be banned; rather, food makers won’t be allowed to label such products as “healthy,” which can be a powerful marketing claim.

“There are currently some products labeled ‘healthy’ that contain insane amounts of sugars,” Greenthal said. 

That’s a remnant of the low-fat craze of the early nineties, when processed-food manufacturers created a slew of supposedly low-fat snacks that contained high amounts of sugar and salt to compensate for the loss of taste. Since then, research has overturned the belief that all fat is bad for health while demonstrating the harmful effects of high sugar consumption. 

Greenthal sees the revised FDA guidelines as mostly positive, although she doubts it will have much impact on Americans’ eating habits.

“What we really need are mandatory labels that force companies to disclose information they otherwise conceal,” she said. “Companies are very quick to tell us if a product is high in fiber or vitamin C, but not when a product is high in saturated fat, sodium, or sugar. These are the products that are linked to heart disease, high blood pressure and diabetes.”

The CSPI recently petitioned the FDA to require food makers to prominently label these ingredients on the front of a food package.

“The FDA just needs to consider its mission, to protect public health, and use that as its guiding star as it faces industry pressure to prioritize industry interests over public health,” Greenthal said.

Regulatory Horizons Council report on medical devices: government response

Executive summary

The Regulatory Horizons Council (RHC) report on medical devices comes at an opportune time. Following the UK’s withdrawal from the EU and the Medicines and Healthcare products Regulatory Authority’s (MHRA) consultation on the future regulation of medical devices, the government is well placed to take forward the report’s recommendations and deliver a world-leading regulatory framework.

This response addresses the report’s recommendations in 4 key areas:

1. Patient outcomes and safety

By building greater patient engagement into the regulatory framework and enhancing the reporting of safety risks, we will ensure a system that is centred on the needs and safety of patients.

2. International leadership and engagement

Positioning the MHRA as a world-leading regulator, the new framework will expand international engagement and establish the UK as a pioneer in the regulation of emerging technology, including software as a medical device and in-vitro diagnostics (IVD).

3. Investment in regulatory capacity

We will maximise the opportunities offered by the transition to UK Conformity Assessed (UKCA) marking – not only increasing the number of UK approved bodies to meet capacity, but also exploring opportunities to increase UK-based regulatory expertise.

4. Unlocking innovation and emerging technology

The MHRA is committed to supporting responsible innovation while minimising risk to patients and the public. Across government, we will continue to explore pathways to bring the most transformative emerging technologies to market and to the NHS, and attract investment in innovative devices.

Introduction

The RHC is an independent expert committee that identifies the implications of technological innovation, and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction. The RHC is supported by civil servants from the Better Regulation Executive (BRE) in the Department for Business, Energy and Industrial Strategy (BEIS)

The RHC published its report on medical devices on 19 August 2021, in response to rising complexity of medical technology and the opportunities for global leadership that EU exit has enabled. It sought to answer the following question: ‘How can the UK encourage international investment and innovation and improve safety in the medical devices area through regulatory and non-regulatory changes?’. The RHC engaged with industry experts and across government, and commissioned evidence.

The government has considered each of the report’s 11 recommendations and this response focusses on the actions being taken in response.

This response builds on the government’s response to the MHRA’s consultation on the future regulation of medical devices, published on 26 June 2022, which confirms the direction of travel for medical devices regulation in the UK. Having left the EU, we have been given a substantive opportunity to update and improve the UK’s medical devices regulatory landscape, supporting the growth of the UK life sciences sector. Full details of the future regulatory framework for medical devices can be found in the government’s response and appropriate references are included in this document.

Summary of the government response to each of the report’s recommendations

Building a regulatory system for medical devices that works for patients

Recommendation 1

The regulation of medical devices should be centred on the needs of patients, informed by patients, record outcomes that matter to patients, and provide evaluations that are understandable to patients.

Government response – accept

The government recognises and supports the MHRA’s delivery plan 2021 to 2023 Putting patients first: a new era for our agency, which sets out the MHRA’s roadmap for the future, centred on better public and patient involvement throughout their work.

This delivery plan has initiated a substantial programme of work to:

  • improve how it listens and responds to patients and the public
  • develop a more responsive system for reporting adverse incidents
  • strengthen the evidence to support timely and robust decisions that protect patient safety

This emphasis has already had an impact on how the MHRA works with patients in tangible ways. For example, the MHRA actively engaged with patient representatives in the development of the policies for the future regulatory framework for medical devices, during the public consultation that ran in autumn 2021, with over 300 attendees joining a public engagement session in October 2021.

The MHRA will continue to actively engage stakeholders, including patient representatives, in a series of planned focus groups. The focus groups will commence in January 2023 and will meet regularly to provide guidance around the chapters of the government response. A series of one-to-one meetings with patient representatives is also planned and will feed into all focus groups to gather patient input across a total of 20 topics for the guidance and other support materials necessary to aid transition to the amended regulatory system.

The government will continue to monitor the impact of the MHRA’s delivery plan and ensure that patient-centred regulation becomes embedded in the MHRA’s ways of working.

Increasing capacity to address present needs and emerging opportunities

Recommendation 2

Strengthen and increase funding to the MHRA to significantly expand their capacity in medical devices, including in emerging technologies.

Government response – accept in principle

The government continues to support the appropriate funding required for the operation of the MHRA, taking into account all of its functions. The MHRA’s regulatory functions for medical devices are primarily funded by the Department of Health and Social Care (DHSC), with the remaining revenue from fees charged for services.

In August 2022, the MHRA launched a consultation on proposals for changes to their statutory fees. The proposals are intended to ensure the MHRA is adequately resourced, including in areas of technological progress in medical devices where increased resource is required.

Recommendation 3

Address bottlenecks in the approval of medical devices, notably the shortage of UK approved bodies for conformity assessment.

Government response – accept

The MHRA focuses on ensuring conformity assessments are carried out consistently and robustly by UK approved bodies (ABs), which must effectively assess medical devices to assure their safety, quality and performance. View a list of UK approved bodies for medical devices.

The MHRA is currently reviewing several applications from organisations that have applied for designation as a UK approved body (AB). The MHRA is also actively working with organisations that are preparing to apply for UK AB designation either through new applications or extending their existing scope for conformity assessment.

Further information on mitigations for bottlenecks in the approval of medical devices is detailed in the response to recommendation 4 below.

Recommendation 4

Prepare mitigations that supplement AB capacity to ensure supply of devices after transition to UKCA.

Government response – accept

The MHRA has been exploring options to mitigate AB capacity issues, and will continue to communicate with industry for views to ensure there is a smooth transition to any regulatory changes, recognising that the medical devices sector requires time to make changes.

To address anticipated challenges relating to AB capacity, the future regulatory framework for medical devices will set out the government’s plans for a phased introduction of the proposed requirements to ensure there is a considered approach to implementation. This will allow manufacturers to leverage certification under the existing UKCA and CE marking processes.

Devices that are UKCA marked under the existing UK regulations prior to the new regime taking effect will be permitted to continue to be placed onto the GB market for 3 years for general medical devices and 5 years for in-vitro diagnostic (IVD) medical devices or until their current certifications expire, whichever is sooner. This will allow for the upscaling of the approved body capacity.

Devices that are CE marked under EU legislation will be permitted similar transition timescales and these will run from 1 July 2024, when the new regime is planned to come into effect. For devices CE marked under the EU directives (former EU legislation), these timescales will be 5 years for IVD medical devices and 3 years for other medical devices, or until their certifications have expired, whichever is sooner. For devices CE marked under the new EU regulations (EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)), it will be permitted to place these devices onto the GB market for up to 5 years from 1 July 2024.

It is not anticipated that an extension of this provision will be required, as the intervening period will be used to support an increase in AB capacity to ensure the UK has sufficient capacity to transition all medical devices to the UKCA marking system. The MHRA will also be working to build the UKCA marking for medical devices on a global standing.

These approaches have been designed specifically to alleviate pressure on ABs, given current capacity restraints. The phased implementation of the new regime has also been developed to prioritise patient safety and minimise the risk of critical supply issues, ensuring the continued safe supply of medical devices to the UK market.

International leadership and partnership in medical devices

Recommendation 5

Support the MHRA to increase UK visibility, international engagement and leadership.

Government response – accept

The government’s response to the MHRA’s consultation outlines the future regulatory framework for medical devices, which includes proposed changes that will position the MHRA as a world-leading regulator.

The future regulatory framework will be unique, innovative and ambitious in areas such as software as a medical device, artificial intelligence as a medical device, and IVDs, while maintaining a focus on patient safety. This leading regulatory model will put the MHRA in a leadership position among international peers in addressing challenges such as proportionate regulation of software as a medical device, ensuring that the UK attracts a world-class life sciences industry. Through the coronavirus (COVID-19) pandemic, the MHRA has shown itself to be one of the world’s foremost regulators – and true innovators.

The MHRA has recently gained full membership of the International Medical Devices Regulators Forum (IMDRF), a group of 10 regulatory authorities focussing on accelerating international medical device regulatory convergence. As a full IMDRF member, the MHRA will be able to take a greater international role in promoting an efficient and effective regulatory model for medical devices, responding to emerging challenges while protecting and maximising public health and patient safety.

The MHRA is also an official observer of the Medical Device Single Audit Programme (MDSAP). MDSAP is a way in which manufacturers can seek a single assessment of conformity of their quality management systems against the regulatory requirements for any of the 5 full member states: Australia, Brazil, Canada, Japan and the US.

More specifically, the MHRA has worked with the US Food and Drug Administration (FDA) and Health Canada to publish an agreed list of 10 Good Machine Learning Practice Principles (October 2021). This document is intended to ensure aligned thinking between the regulators and is the first step of collaborative work in this area between regulators. Building on this collaboration, the MHRA continues to strengthen their relations and are working together to deliver further documents to ensure internationally aligned thinking on artificial intelligence (AI) and machine learning-enabled medical devices. In addition, through participation of the IMDRF, the MHRA is developing AI-specific guidance that will set the global standards for regulatory compliance.

More widely, the MHRA has collaborated with the NHS Transformation Directorate on the G7 health track digital health proposal on AI governance as part of the UK delegation (paragraphs 40 and 41, G7 Health Ministers Declaration). Through this work we are contributing to the international dialogue on digital health and providing recommendations on how countries can work together to ensure their citizens can benefit from digital health technologies.

The MHRA is working closely with the British Standards Institute (BSI) in its roles as the UK national standards body and a global standards promoter in partnership with their US counterpart, the Association for the Advancement of Medical Instrumentation (AAMI). The MHRA contributes to several standards committees in this space, namely: BS30440 Validation Framework for the use of AI in Health and Care, and Committees: CH/62/2 Diagnostic Imaging Equipment, CH/62/3 Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry, and IST/35 Health Informatics. Additionally, the MHRA also provides input on many of the major reporting guideline variants for AI, such as CONSORT-AI, SPIRIT-AI, and DECIDE-AI, increasing the MHRA’s international engagement and leadership in developing regulatory guidelines.

This international work is a key component in ensuring alignment and the long-term success of MHRA’s domestic legislative and regulatory guidance plans for the future regulation of software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD).

Recommendation 6

Invest in the UK as a global centre for regulatory science and the training of regulatory professionals with expertise in medical devices, including in emerging technologies.

Government response – accept in principle

The government’s current focus for medical devices is to implement changes to the regulatory framework that increase patient safety and promote innovation, thereby growing the life sciences sector in the UK. Alongside this, we are interested in the opportunities posed by a UK centre of excellence in regulatory science and innovation (CERSI). This was also a recommendation of the Taskforce on Innovation, Growth and Regulatory Reform report 2021, and we will continue to work with stakeholders to explore options for this.

While the activities related to the future medical devices regulations do not bring additional direct investment, they do provide a robust and positive environment in which the UK can build its reputation in all areas of life sciences, and in particular a supportive UK regulatory environment for the safe and rapid development of innovative medical devices.

In addition to the new regulatory framework, the government’s ambition to ensure the UK is a leading global hub for all aspects of life sciences is being driven by the Life Sciences Vision, published by the Office for Life Sciences in July 2021. On skills, the vision makes commitments to:

  • welcoming and advocating the free flow of life sciences talent globally, underpinned by the UK’s new immigration system
  • boosting the proportion of the apprenticeship levy recovered by the life sciences sector
  • building links between life sciences university courses and industry
  • exploring how the sector can effectively meet emerging skills demands

The vision also sets out its aims to deliver a progressive UK regulatory offer with the capacity to unleash innovation in regulatory processes. This includes a specific funding allocation to the MHRA and the National Institute for Health and Care Excellence (NICE) to develop a new access and licensing pathway for medical devices, similar to that which exists for medicines.

To further support this work, the MHRA’s future regulatory framework for medical devices will actively address the safety and availability of medical devices, and the favourability of the UK as a place to research, develop, manufacture and supply medical devices. The government has outlined intentions for requirements for a Qualified Person within the response to the MHRA’s consultation on the regulatory changes for medical devices. This proposal will require that manufacturers have available within their organisation (or in the case of small and medium-sized enterprises (SMEs), at their disposal) at least one Qualified Person with qualifications or regulatory experience that meets minimum standards that would be set out in the UK medical devices regulations in the field of medical devices and IVDs. This commitment will provide a strong incentive for increased training of regulatory professionals with expertise in medical devices.

Recommendation 7

Build international partnership through mutual recognition and reliance or assurance where this may lead to overall efficiencies while preserving safety.

Government response – accept

The MHRA delivery plan 2021 to 2023 outlines commitments to building excellent international relationships that:

  • deliver high standards of patient protection
  • prompt access to innovation products
  • keep the UK as an attractive market for developers and manufacturers

The government sees international partnership as vital to deepen co-operation, exchange information and encourage the adoption of international standards and best practice.

The government also intends to use both certificates from the Medical Device Single Audit Program (MDSAP) and domestic assurance as alternative routes to market in the UK, which will make it easier for manufacturers to bring medical devices to the UK market while retaining strong regulatory oversight of their safety and performance.

The UK will require UK approved bodies to consider MDSAP assessments. However, adoption will be optional for manufacturers. Domestic assurance routes will allow an abridged assessment with the appropriate scrutiny, and UK approved bodies will hold the capacity to reject applications under the domestic assurance route if they do not consider the evidence provided to be sufficiently robust to undergo assessment through this route.

In 2019, the UK signed a mutual recognition agreement (MRA) with Australia that contains conditions under which each country will accept conformity assessment results from the other. This means that UK goods can be tested in the UK against Australia’s regulations, and then sold in the respective country without additional testing. This also applies for goods tested in Australia to the UK regulations.

We are in ongoing discussions to expand existing MRAs to include medical devices, and to build new MRAs that provide for a mutual acceptance of conformity assessment results with other countries. The UK-Canada Trade Continuity Agreement highlighted that the medical devices sector is a priority for mutual recognition of the acceptance of conformity assessment results, and further expansion will be explored in the future.

Through bilateral engagement, the government is encouraging other countries to join and adhere to multilateral medical device regulatory forums, which produce best practice guidelines for regulators and reduce the discrepancies between regulatory systems. Through further international collaboration and regulatory harmonisation, we will promote an efficient and effective global market for placing medical devices on the market, which is responsive to emerging challenges while maximising patient safety.

Using medical devices as a template to help enable regulatory innovation that improves patient safety, system efficiency and UK growth

Recommendation 8

Identify and resource areas where regulatory innovation within the medical device sector may attract inward investment and growth.

Government response – accept

The MHRA’s future regulatory framework outlines plans to create new routes to market to support innovation in medical devices. This will ensure the UK remains an excellent place to launch new medical devices and avoid repeat assessments, while maintaining robust safety standards.

Following the UK’s departure from the European Union, the MHRA now has direct responsibility for the regulation of medical devices in the UK. One of the freedoms that come with this is the ability to reform medical device regulation to ensure it better fits software and AI.

The regulation of AIaMD is an area where regulatory innovation will attract inward growth and investment. The MHRA has an opportunity to become a global leader in the regulation of AIaMD and to demonstrate the MHRA’s capacity to support responsible innovation while minimising risk to patients and the public.

The MHRA has embarked upon an ambitious Software and AIaMD Change Programme to help achieve this, reforming medical devices regulation as it applies to software and AI, and introducing new guidance and support packages. This work programme will deliver bold change to bring a high degree of protection for patients and the public, while also making sure that the UK is the home of responsible innovation for medical device software.

As mentioned in the response to recommendation 6 above, the MHRA and NICE also have plans to establish a pathway for medical devices that is similar to the Innovative Licensing Access Pathway that is currently in place for medicines. This pathway will allow for increased MHRA and NICE support for products that meet a critical unmet need, thereby attracting growth and investment in this sector.

To further explore pathways for innovative devices, the government is working to explore options to increase access and adoption of medical technologies. This will accelerate the work already in motion as part of the Life Sciences Vision, the MHRA’s new regulatory framework and the upcoming MedTech strategy by finding opportunities to increase market access and adoption of medical technology. As a result, we will seek to increase investment by making the UK a more attractive regulatory environment for companies bringing new products to market.

Recommendation 9

Develop a UK patient safety database that collects key details of all medical devices and monitors patient safety and wellbeing moving forward.

Recommendation 9A

Strengthen existing safety reporting through digital tools and the use of comprehensive data collection from health systems, patients and carers to a central MHRA-held UK patient safety database.

Recommendation 9B

When medical devices are used, their unique device identifier (UDI) should be recorded as standard within a patient’s health record, and this should be returned to a central MHRA-led UK patient safety database.

Government response – accept in principle

The MHRA has recently launched improvements to its Yellow Card scheme, which collects and monitors information from the public on suspected safety concerns involving healthcare products, including medical devices. The scheme helps the MHRA monitor the safety of medical devices along with all healthcare products in the UK, and reports through the scheme are used to help the MHRA identify any trends in the safety or efficacy of a medical device and take action accordingly.

The scheme’s improved website went live on 7 February 2022 with new functionality for reporters, such as a single reporting form, and further enhancements to the reporting journey will be made in coming months. One technology platform for incident management and signal detection across medicines and devices is being developed for the MHRA’s use, which will allow improved analysis and faster signal detection, and enable the MHRA to proactively respond to safety concerns.

Another key focus of current work in improving the safety of patients using medical devices is in the area of implantable devices. Following several high-profile failures of implanted medical devices, the government has recognised the need for greater, systematic information to be captured and shared on these interventions. The need for better data on patient outcomes and device traceability was highlighted by the Independent Medicines and Medical Devices Safety (IMMDS) Review, which recommended a system be established that would capture key information on implanted devices at the time of the operation and linked to specifically created registers to research and audit the outcomes both in terms of device safety and patient-reported outcome measures. The government accepted that recommendation in its response to the IMMDS Review on 21 July 2021.

In 2021 to 2022, a scoping exercise was undertaken that provided substantial learnings for how best to deliver on these traceability and patient outcome objectives. The government sets out more detail on how this work is progressing in the IMMDS implementation update. It is envisaged that the data collected as part of this programme will be shared with the MHRA for post-market surveillance purposes and therefore we do not accept that part of the recommendation.

Building resilience and preparing for future threats

Recommendation 10

Pandemic preparedness should include fast-track evaluation of new IVDs.

Government response – accept

The MHRA’s future regulatory framework intends to reform IVD regulation to update classification and include an extended patient risk review, recognising the central role that diagnostic devices have played in our response to the COVID-19 pandemic.

While stronger regulation is needed, the diagnostics sector needs to be sufficiently responsive. The 100 Days Mission to Respond to Future Pandemic Threats (June 2021), announced at the G7 Summit in Cornwall – proposed to build a framework for fast pandemic threat response and related work – will be taken forward through this strand. This framework will include plans for enabling prioritisation of clinical trials for diagnostic products (as well as vaccines and therapeutics) and faster approvals from regulators.

The 100 Days Mission for diagnostics, therapeutics and vaccines was welcomed by G7 and G20 leaders respectively. The first implementation report was published by the G7 Chief Scientific Advisers in December 2021, which outlined progress to date and a roadmap for achieving the mission by 2026. As part of the 100 Days Mission, the MHRA and the US FDA will collaborate with their G7 counterparts to implement proposals to streamline regulatory processes over 2022 to 2026. This could include a streamlined process for new product applications, and will explore the possibility of reciprocal agreements on regulatory approval to negate the need for the same product to be approved in multiple jurisdictions.

The lessons from the COVID-19 pandemic are being considered, and the government intends to enable a fast-track route for IVDs, as part of the ambition outlined in the 100 Days Mission, that is proportionate and workable for industry should future threats emerge, while maintaining quality and performance.

Recommendation 11

Reporting of diagnostic tests should be transparent and standardised.

Government response – accept in principle

The MHRA’s future regulatory framework intends to address the recommendation to increase the level of scrutiny applied to IVD devices. The new framework for IVDs will amend the classification rules to increase the level of scrutiny applied to IVDs. This will mean a higher proportion of IVDs will undergo an assessment by a UK approved body prior to being placed on the UK market. The proposed regulatory changes will take into account the intended purpose of the medical device and will reflect relevant international systems of regulation, driving greater patient safety.

The new regulatory framework will bring significant improvements in patient safety and ensure more robust pre and post-market requirements are introduced for IVDs, aligning with the international set of standards set by the IMDRF, rather than the Standards for Reporting of Diagnostic Accuracy Studies Framework. This will provide clarity and ensure that performance studies for IVDs are carried out in a consistent way. The government aims to set out in detail the specific requirements for any performance study, and to publish detailed guidance to accompany the regulatory requirements.

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Extra than seven in 10 of Democrats — 72 {bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} — support the strategy of a authorities-operate well being-treatment process.

The study outcomes clearly show the complicated situation most persons in the U.S. hold on the country’s wellbeing-treatment technique. Balancing the responsibilities of the government in overall health-treatment protection whilst also protecting a private protection method has been a juggling act faced by lawmakers and successive presidential administrations for many years.

Democrats have floated a amount of different policy tips to locate a way to ensure larger overall health protection through the electric power of the federal governing administration. The Obama administration’s Inexpensive Treatment Act expanded wellness coverage, but relied primarily on a private wellness-care program. Progressive lawmakers, like Sen. Bernie Sander (I-Vt.), have pushed the ball even more, advocating for a federal government-run, common health-care process that assures protection for every man or woman. The Medicare-for-all system turned well-known with progressive and youthful voters, but has nonetheless to turn into the plan desire of get together leaders.

For their component, Republicans have prioritized enabling the private sector to dominate the wellbeing-care field, functioning and campaigning for a long time to strike down or repeal essential sections of the Cost-effective Care Act.

The Gallup survey of 1,020 adults in November by means of December had a margin of error of 4 percentage factors.

People With Long Covid Face Barriers to Government Disability Benefits

When Josephine Cabrera Taveras was contaminated with covid-19 in spring 2020, she didn’t anticipate that the virus would knock her out of perform for two decades and set her loved ones at hazard for eviction.

Taveras, a mom of two in Brooklyn, New York, mentioned her bout with lengthy covid has meant working with debilitating indicators, ranging from respiration problems to arthritis, that have prevented her from returning to her task as a nanny. Not able to perform — and without the need of entry to Social Stability Incapacity Coverage or other authorities help — Taveras and her relatives confront a looming pile of charges.

“We are in the midst of probably getting rid of our condominium because we’re behind on hire,” stated Taveras, 32. Her software for Social Stability incapacity aid, submitted very last tumble, was turned down, but she is captivating.

Like quite a few other individuals with extended covid, Taveras has fallen via the cracks of a technique that was time-consuming and complicated to navigate even right before the covid pandemic. Persons are facing decades-lengthy wait around instances, inadequate authorized aid, and a lack of clear advice on how to show they are disabled — compounded by the problems of a clinical procedure that does not have a uniform process for diagnosing long covid, in accordance to wellness gurus and disability attorneys.

The Biden administration promised guidance to individuals with long covid, but affected person advocates say lots of are battling to get govt enable.

The Centers for Ailment Manage and Avoidance defines very long covid broadly, as a “range of ongoing overall health problems” that can last “weeks, months, or longer.” This description incorporates people, like Taveras, who simply cannot get the job done, as properly as individuals with much less intense symptoms, such as a extensive-term decline of smell.

The Social Security Administration has recognized about 40,000 disability claims that “include indication of a covid an infection at some position,” spokesperson Nicole Tiggemann mentioned. How a lot of people with prolonged covid are amid the much more than 1 million disability claims awaiting processing by Social Security is unknown.

In latest months, about 5{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of new disability promises filed by Allsup, an Illinois-primarily based firm that aids persons use for Social Security, involved men and women dealing with covid, said T.J. Geist, a director at the company. Other companies report equivalent figures.

The extensive waits for incapacity assistance usually finish in denial, in aspect because prolonged covid people don’t have the significant healthcare proof that federal officers require, Geist said. There is no regular course of action for diagnosing long covid. Equally, Social Security “has however to give particular assistance on how to assess covid claims” for the governing administration officials who assessment applications, he mentioned.

A modern report from the Brookings Establishment estimates that 2 million to 4 million folks are out of work due to the fact of extended covid. A examine revealed in September by the Nationwide Bureau of Economic Investigate places the quantity at 500,000.

Advocates suggest that a lot of men and women with extensive covid have nonetheless to recognize their need for authorities gains and could start off implementing soon.

“I did not recognize that I was disabled for 4 a long time since my capability would fluctuate so substantially,” explained Alison Sbrana, a individual-advocate with the prolonged covid support group Human body Politic. She has a long-term sickness whose signs and symptoms are equivalent to prolonged covid’s in several situations and has been given Social Safety disability payments for a number of years.

“If you apply my timeline to individuals with long covid, even people who obtained unwell in early 2020, we’re not going to know the entire extent of their ability to function or not till 2024,” she claimed.

In July 2021, the Office of Overall health and Human Services formally acknowledged long covid as a disability. Increasing on the recognition, the section and the White Household printed a report in August 2022 that summarizes the “services and supports” offered for individuals with prolonged covid and some others who have experienced prolonged-term impacts from the pandemic.

But accessing help is not as basic as White Dwelling announcements may possibly counsel. First, the July 2021 guidance regarded long covid beneath the Americans with Disabilities Act but did not extend to the Social Safety Administration, which runs advantage systems.

Below the ADA, extended covid sufferers who can even now perform might ask their employers for lodging, this kind of as a house to relaxation or a additional flexible timetable, said Juliana Reno, a New York law firm who specializes in employee added benefits. Social Stability, having said that, has much more stringent standards: To acquire incapacity insurance policies, persons must confirm their prolonged covid signs or symptoms are so debilitating that they can’t get the job done.

“The software procedure is really demanding, incredibly confusing for people,” Sbrana explained. “It also completely depends on you possessing this considerable breadcrumb trail of health care proof.”

Most purposes are denied in the to start with spherical, according to Sbrana and other advocates. Individuals commonly attraction the selection, often top to a 2nd denial. At that issue, they can ask for a court docket listening to. The entire process can consider a calendar year or extra and commonly involves authorized help.

The pandemic prolonged these wait around situations, as Social Protection workplaces shut and did not rapidly shift to remote operations. Furthermore, typical indicators these as brain fog can make filling out on-line programs or shelling out several hours on the phone with officers difficult.

Lengthy covid patients who had been hospitalized with serious indicators can submit paperwork from those people clinic stays and are extra very likely to obtain advantages, Geist mentioned. But for the persons who experienced gentle scenarios at first, or who have “invisible-type symptoms” like brain fog and tiredness, Geist mentioned, documentation is extra challenging. Obtaining a health practitioner who understands the problem and can indicator off on indications may perhaps get months.

Amanda Martin, a lengthy covid individual and advocate, is one particular of all those lost employees. Martin bought covid in April 2020 when working as a subcontractor for the U.S. Navy and dropped that occupation when they were unable to get well swiftly.

At to start with, unemployment rewards delivered guidance, but Martin’s signs or symptoms — like intense fatigue and mind fog — continued. Extra than two yrs following the first infection, Martin is still “on bed rest 90{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the time,” they explained. Martin gets meals stamps and Medicaid but doesn’t have support having to pay for other necessities, this sort of as fuel. Their application for federal incapacity advantages has been denied twice.

“I am now a 12 months into the [application] method I have eight to 11 months remaining,” Martin explained. “I have $50 in my price savings account.”

Lots of individuals with lengthy covid do not have the monetary means to employ the service of a law firm — or access to a medical professional who can help with their documentation, which helps make the scenario even tougher.

Patient advocacy organizations are pushing for a a lot more efficient software course of action, specific steerage for officials who consider very long covid conditions, and more rapidly eligibility for Medicare coverage just after a incapacity software is approved. (The regular wait is two years.)

The corporations also provide as guidance groups for people today with lengthy covid, sharing resources and delivering reassurance that they are not alone. Some organizations, these kinds of as the nonprofit Blooming Magnolia, even obtain resources for immediate distribution to persons with very long covid. But clients say these endeavours don’t appear shut to the scale of funding wanted.

Taveras, the Brooklyn mom, claimed she is familiar with quite a few other folks who are grappling with very similar concerns. “We’re trying to get support from the authorities, and we’re not receiving it,” she explained. Taveras established up a GoFundMe web site to request support for her family.

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