Group items tagged

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

Reacting to recommendations from a UK-first independent review, the Department of Health and Social Care (DHSC) has outlined action to tackle potential bias in the design and use of medical devices. Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, was appointed to lead the review, which focused on three areas - optical devices such as pulse oximeters, AI-enabled devices, and polygenic risk scores (PRS) in genomics. The DHSC commissioned the medical devices review after concerns were raised that pulse oximeters - widely used during the COVID-19 pandemic to monitor blood oxygen levels - were not as accurate for patients with darker skin tones. There were worries that this could cause delays in treatment if dangerously low oxygen levels in such patients were missed. However, no evidence was found from NHS studies indicating that this differing performance had an impact on patient care. Accepting the report's conclusions, the DHSC has committed to several actions, such as ensuring the safe use of pulse oximeter devices across a range of skin tones within the NHS and eliminating racial bias from data sets employed in clinical studies.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."

Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA communicate with healthcare professionals to improve medicines and medical devices' safety'. Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. "We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients," said MHRA. "We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety."

Britain called on Sunday (November 21) for international action on the issue of medical devices such as oximeters that work better on people with lighter skin, saying the disparities may have cost lives of ethnic minority patients during the Covid-19 pandemic. Health secretary Sajid Javid said he had commissioned a review of the issue after learning that oximeters, which measure blood oxygen levels and are key to assessing Covid patients, give less accurate readings for patients with darker skin. "This is systemic across the world. This is about a racial bias in some medical instruments. It's unintentional but it exists and oximeters are a really good example of that," Javid said during an interview with the BBC. Asked whether people may have died of Covid-19 as a result of the flaw, Javid said: "I think possibly yes. I don't have the full facts." He said the reason for the discrepancies was that a lot of medical devices, drugs, procedures and textbooks were put together in white majority countries.

The Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of three international work-sharing partnerships. Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally. The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.

To complete the evaluations of Lateral Flow Device (LFD) test kits, the UK Health Security Agency (UKHSA) will approach pharmacies and send 15 combined kits to pharmacies in December. The combined kits will contain a standard LFD pack, one PCR test along with comprehensive instructions. For the evaluation, a part of meeting Medicines and Healthcare products Regulatory Agency (MHRA) obligations, UKSHA needs "dual swabbing through the community pharmacy Covid-19 lateral flow device distribution service." Pharmacies receiving these kits need to finish the current open carton of LFD packs and then open the next standard carton. Pharmacy negotiator PSNC has advised pharmacies to be mindful of "the expiration date of the kit and ensure these are handed out in sufficient time."

Viveca Biomed has launched an innovative and clinically-proven bladder support device that offers women immediate relief from stress urinary incontinence (SUI) and provides community pharmacy contractors with a way to build a new consumer base, customer loyalty and sales margins. The product, named 'Contrelle Activgard', has already recorded millions of sales in Scandinavia over a decade. The company behind the UK launch is female healthcare business Viveca Biomed, founded in 2019 by Andrew Tasker who has spent 30+ years in senior roles within the OTC and pharma industry. Contrelle is manufactured, packed and distributed in the UK at Viveca Biomed's factory near Newcastle, with no outsourcing, and thus offering the best possible continuity of supply. Ahead of the launch, the company commissioned a large consumer lifestyle survey with 500 women over 40 years of age who experience bladder leaks, to reveal the extent of its detrimental impact. Contrelle Activgard is a safe, discrete, easy-to-use and highly effective, single-use vaginal device, designed to immediately prevent SUI rather than just deal with the leakage.

The results of the Community Pharmacy IT Group's (CP ITG's) IT arrangements survey revealed that 83 per cent of the respondents support the goal of going paperless. The Pharmaceutical Services Negotiating Committee (PSNC) asked community pharmacy teams to complete the survey between late 2021 and October 2022. The survey was designed to gather information on frontline pharmacy teams' perspectives about community pharmacy IT and their pharmacies' IT arrangements. It was found that more than half of pharmacies experience at least one IT outage per month (lasting at least one hour). Over 40% reported poor mobile phone signal and limited internet connectivity options at their pharmacy. 80% agreed that mobile devices would help working within pharmacy, but most reported no laptop and no tablet device available for use in the pharmacy

The government on Wednesday (March 2) announced an investment of £260 million to support research, development and manufacturing of new drugs, devices and diagnostics. Of the total funding, up to £200m has been allocated for research to better access NHS data through Trusted Research Environments and digital clinical trial services, enabling availability of crucial data with the highest levels of privacy. This will allow the NHS to deliver new life-saving treatments to patients, tackle health inequalities and improve patient care, a government release stated. The remaining £60m will support commercial-scale manufacturing investments by companies at the leading-edge of innovation, from cell and gene therapies and earlier and better diagnostic technologies, to medical devices. The funding for manufacturing investments will be distributed through the new Life Sciences Innovative Manufacturing Fund (LSIMF), following the success of the earlier Medicines and Diagnostics Manufacturing Transformation Fund.

Five smart devices in healthcare starting with the most recently announced FingerReader.

NHS England has secured a deal for 'Dexcom ONE Real Time-Continuous Glucose Monitoring' device which will help type 1 diabetes patients to keep track of their glucose levels at all times without having to scan or take a finger prick test. Once the patients receive their starter pack - which will include information on the product and usage, a sensor and transmitter - from the hospital or GP surgery, they can go to the community pharmacy for their repeat prescription. The wearable arm gadget sends information to a mobile app and allows diabetes patients to keep track of their glucose levels. "Traditionally, continuous glucose monitors are more expensive than their flash monitor counterparts - which record glucose levels by scanning a sensor - but thanks to the NHS agreeing on a new cost-effective deal with manufacturers DEXCOM, they will now be available for NHS patients on prescription at a similar price," said NHS. Dexcom ONE Real Time-Continuous Glucose Monitoring, uses a sensor no bigger than a bottle cap that attaches to the arm for up to 10 days and measures glucose levels from just under the skin. The wider rollout of the technology will help diabetes patients manage their condition better - reducing hospitalisations and associated diabetic illnesses which will ultimately ease pressure off the NHS. Karen Baxter, vice president, UK & Ireland, Benelux, France and Spain at Dexcom: "The addition of Dexcom ONE to the NHS England drug tariff is enormous progress towards improving the choice of diabetes tech, providing an alternative to burdensome finger pricks and scanning.

Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines. Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential savings for the NHS, the consumer healthcare association highlighted during the event. Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process in 1983 to make them available over the counter - OTC. Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium (esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together (tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.

People who test positive for Covid-19 on rapid lateral flow tests will not need to confirm their results with a follow-up PCR test if they are not showing symptoms, the UK Health Security Agency said on Wednesday (January 5). Britain is reporting record daily case numbers, and the UKHSA said that the high prevalence meant the chance of a false positive from a lateral flow device (LFD) was low. The move could also reduce the burden on the testing system, and reduce confusion if the test results contradict each other. At current levels of prevalence, officials say a positive LFD result is likely to be accurate, even if a follow-up PCR were negative. "While cases of Covid continue to rise, this tried-and-tested approach means that LFDs can be used confidently to indicate Covid-19 infection without the need for PCR confirmation," said UKHSA chief executive Dr Jenny Harries.

Bas Vorsteveld has been elected as the new president of PAGB, the trade association representing the manufacturers of branded OTC medicines, self care medical devices and food supplements. Vorsteveld, who is vice president and general Manager of Haleon GB and Ireland, succeeds Neil Lister, managing director UK & Ireland and vice president at Perrigo. PAGB said the appointment comes at a crucial time for the consumer healthcare association as it looks to expand the role of self-care, secure a long-term favourable business environment for members, adapt to environmental challenges and continue to deliver excellent services for members. "We are so pleased to welcome Bas to the role of President. Bas has been actively involved with PAGB as a board member and we're looking forward to continuing our work with him. I have already seen from Bas's time on our Board that he combines great sector knowledge with drive, energy and genuine passion for what we do and we're so excited to have him as our President," Michelle Riddalls, chief executive of PAGB, said. "Bas's input and guidance as our strategy evolves over the coming years will be vital as we respond to new challenges as they emerge and make the most of the opportunities ahead."

The Medicines and Healthcare products Regulatory Agency (MHRA) is doubling down on its efforts to combat online pharmacy frauds, emphasising innovation, eradication of legacy systems, and cybersecurity in its updated technology roadmap. The online sale of medicines and medical devices is a "growing phenomenon offering convenience, anonymity, and lower prices " for the public. However the lack of robust cyber monitoring also "poses significant risks", as many online pharmacies are "unregulated, illegal, or fraudulent." According to the MHRA's recent report highlighting the impact of artificial intelligence on the regulation of medical products, the strategic themes of "fundamental to the successful deployment of AI" are essential for protecting consumers from fraudulent medical products.

Insights Care Magazine we bring you "Heart Care Special Edition." This magazine contains a listing of some of the most prominent and advanced heart care centers, hospitals, diagnostic centers with specialization in heart care and technology companies working on specialized medical devices to assist in monitoring heart health.

A news report suggests the Department of Health and Social Care is aiming to be ready to start charging for Covid-19 tests which are currently free at the end of June. Britain has been increasingly dependent on rapid testing to try to tackle the more-transmissible Omicron variant, which has spread rapidly through the population but is less severe. The government has previously said it will end the universal free provision of easy-to-use lateral flow devices (LFDs) at a "later stage", with individuals and businesses bearing the cost. The Department of Health has declined to say what the tests cost, citing commercial contracts. One source has told the Reuters news agency they can run to £30 for a pack of seven. Free pick up from pharmacies The tests have been made freely available to order online or pick up from local pharmacies since April. The UK Health Security Agency said that between December 30 and January 5 more than 8 million LFDs were conducted, the highest weekly figure on record.

The Pharmacy Collect team is now in position to supply additional stocks of lateral flow device (LFD) test kits to pharmacies that are still experiencing higher demand, Pharmaceutical Services Negotiating Committee (PSNC) said in an update. The team has informed the negotiator that LFD orders in some locations have reduced allowing them to work with Alliance Healthcare to facilitate extra deliveries. The UK Health Security Agency (UKHSA), which is continuing to deliver LFD stocks to Alliance Healthcare for onward delivery to pharmacies, distributed over 14.5 million tests to the company last week. Community pharmacy contractors can seek up to three additional cartons of test kits by emailing the Pharmacy Collect team. This will be in addition to one carton daily order that contractors are allowed to get through Alliance Healthcare.