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Showing results for tags 'Medical device / equipment'.
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Content ArticleMedical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries. This Reuters Special Report investigates some of the hazards associated with AI-enabled medical devices, including errors in a navigation system integrated into a medical device used in ENT surgery, AI software used for prenatal ultrasound scans that misidentified fetal body parts and AI assisted heart monitors that failed to recognise abnormal rhythms. Issues with the capacity of the U.S. Food and Drug Administration (FDA) to review the flood of new AI-enabled medical devices are also raised, as well as concerns that the FDA's traditional approach to regulating medical devices may no longer be fit for purpose.
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News Article
Baby sling safety warning as experts urge better guidance for new parents
Patient Safety Learning posted a news article in News
New parents require enhanced guidance on the safe use of baby slings, according to new research. Baby sleep experts at Durham University are advocating for improved education for parents, both pre-purchase and at the point of sale. A survey of 1,470 parents with infants under one year old revealed that nearly nine out of ten acquired their sling or carrier online. Of these, a mere three per cent received assistance from a virtual sales assistant or chat function, highlighting a significant gap in direct support. Researchers stress the need for more accessible and comprehensive safety information to prevent potential misuse. The survey found that even experienced parents had difficulty with positioning the baby in a sling, creating comfort for the carrier and securing the infant safely. Unsafe use of baby slings has been linked to accidental deaths from suffocation or falls. In 2023, six-week-old James Alderman died in a carrier during hands-free breastfeeding, leading a coroner to issue a warning. With incorrect sling or carrier fitting, a baby’s nose or mouth can be pressed against the parent’s body or blocked by fabric. In other cases, the baby can slump down in the carrier and their windpipe can become pinched. Read full story Source: The Independent, 4 June 2026 -
News Article
‘Catastrophic’ gaps in tech regulation plans
Patient Safety Learning posted a news article in News
Proposed amendments to UK medical device regulations are “a disgrace” and risk creating the lowest barrier to entry for high-risk AI devices in the developed world, sector experts have told HSJ. Under the draft rules, which have been submitted to the World Trade Organisation ahead of being laid before Parliament, software designed to diagnose a condition can face greater regulatory scrutiny than software designed to treat one. This means a company could deploy an AI chatbot designed to treat patients with severe mental health problems without independent regulatory scrutiny by self-certifying its own safety in the same category as a walking stick. The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the market. This was the most significant update to the UK Medical Device Regulations (MDR) 2002 since Brexit, when the UK left the EU MDR. However, regulatory leaders have aired concerns about the draft amendments, particularly around the risk classification of software. Read full story (paywalled) Source: HSJ, 18 May 2026 -
Content ArticleThis case study is one in a set of patient safety ‘how we acted on patient safety issues you recorded’ case studies which show the direct action taken in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm. As part of its core work to review recorded patient safety events, the National Patient Safety Team carried out a thematic review of incidents where patients were entrapped in beds, bed rails and ancillary devices. The review identified emerging risks that could lead to these incidents happening, because of issues including changes to ways of working due to COVID-19, patient flow and capacity, and new devices and equipment coming to market. Incident reports described fatal asphyxiation and other injuries associated with the use of bed rails and the interface between beds (including extra width beds) and: trolley frames mattresses automatic turning devices bed levers specialist sleep equipment The Medicines and Healthcare Products Regulatory Agency used the insight from reported cases to update guidance and support a National Patient Safety Alert issued in August 2023. This included giving staff additional guidance on risk assessment, selection and suitability of appropriate equipment and ongoing monitoring.
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Content ArticleSummary of the latest safety advice for medicines and medical device users from the Medicines and Healthcare Regulatory products Agency (MHRA). This month's Safety Roundup includes: Letters, medicines recalls and device notifications sent to healthcare professionals in April 2026. News and guidance on: EMA recommends withdrawal of marketing authorisations for levamisole medicines following safety review. Publication of RSV vaccine factsheet.
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Content ArticleThis case study is one in a set of patient safety ‘how we acted on patient safety issues you recorded’ case studies which show the direct action taken in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm. The National Patient Safety Team were notified by a trust Medical Device Safety Officer (MDSO) of an incident where a baby ingested the cap off a purple colostrum syringe. The baby was being fed expressed colostrum by the parent who was unaware of the presence of the cap when the feed started . Colostrum is the first breast milk the mother produces providing important nutritional benefits for newborns. When pressure was placed on the syringe plunger accidental cap dislodgement occurred and the baby required surgery to remove the cap. Despite the purple colour, the syringe was not licenced for the administration of colostrum. Collaboration with the MHRA resulted in the issuing of a device safety information alert. Working with key midwifery and neonatal stakeholders, a safety communication on reducing the risk of choking was issued to maternity and neonatal units. When advised of the safety issue, the manufacturer ceased production of the syringe and have introduced a new licenced colostrum collection and administration syringe. The new syringe does not have a cap and is available to order from the NHS Supply Chain. This intervention should reduce the risk of accidental ingestion of syringe caps.
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News Article
‘Only two weeks of stock’ at key supplier after Iran-linked cyber attack
Mark Hughes posted a news article in News
NHS England believes there is only two weeks’ stock of crucial surgical equipment and other products following an Iran-linked cyber-attack on a major medical technology supplier. The centre is urgently working to understand the actual extent of supplies currently held by trusts and the potential risks to patient safety of the supply disruption. Read full article (paywalled). Source: Health Service Journal, 19 March 2026 -
News Article
Iran-linked attack hits trusts’ supplies
Patient Safety Learning posted a news article in News
At least two trusts have declared incidents after a cyber attack on a key supplier, HSJ understands. An Iran-linked group appears to have claimed responsibility for the attack on medical device supplier Stryker, saying it was a response to a bombing that killed dozens of children in the town of Minab. The US firm was attacked on Wednesday evening and local NHS procurement teams spent Thursday determining what the impact would be on trusts that buy orthopaedic implants, defibrillators, ambulance trolleys and other products from the company. Sources at two acute trusts confirmed they had declared incidents due to the supply concerns, but they did not want to be identified. So far trusts have been able to obtain equipment needed urgently from elsewhere after implementing their business continuity plans. National NHS bodies have set up an incident team to manage supply disruption, but have not declared a national critical incident. The company, whose UK and Ireland branches turned over nearly £500m sales last year, said the incident had “caused disruptions to order processing, manufacturing and shipping”. Stryker said the disruption stems from a cybersecurity attack targeting its Microsoft environment but that it has no indication of ransomware or malware and believes the incident has been contained. The American Hospital Association said it has not identified any direct disruptions to U.S. hospital operations. John Riggi, the AHA’s national adviser for cybersecurity and risk, told Becker’s on the 12 March the organisation is actively exchanging information with hospitals and the federal government as the situation develops. Read full story (paywalled) Source: HSJ, 13 March 2026 -
News Article
Hospitals must update 100,000 pacemakers after safety fault
Patient Safety Learning posted a news article in News
Hospitals are having to update more than 100,000 patients’ pacemakers – and replace hundreds of the devices – after the manufacturer discovered their batteries run down years early, HSJ has learned. Medical device manufacturer Boston Scientific issued a field safety notice to trusts in December 2024, which stated that around 13% of its Accolade pacemakers manufactured before September 2018 have a battery flaw. It means they are more likely to suddenly switch into a limited, back-up “safety mode”, which can be fatal for some patients who are fully reliant on their pacemaker. Estimates of the numbers affected in the UK have never been issued, but the Medicines and Healthcare products Regulatory Agency has now told HSJ that 13,969 devices affected by the flaw were sold to 153 hospitals in the UK. In addition, last autumn, Boston Scientific issued a software update for the problem, which it said should be made via in-person appointments. The MHRA said this means a further 97,557 devices across 308 UK hospitals, in addition to the initial 13,969, should be updated. Acute trusts are now in the process of calling in the patients affected, HSJ has learned. Read full story (paywalled) Source: HSJ, 26 February 2026 -
Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Falsified Mounjaro KwikPen 15mg pre-filled pens Drug Safety Update on Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Drug Safety Update on IXCHIQ Chikungunya vaccine: updates to restrictions of use following safety review Drug Safety Update on GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases Letters, medicines recalls and device notifications sent to healthcare professionals in February 2026 News and guidance on: UKHSA and MHRA issue reminder to healthcare professionals regarding use of non-sterile alcohol-free wipes Updates to instructions for use (IFUs) of Cardinal Health Chest Drainage Units & accessories Respiratory tube connector: risk of patient harm due to manufacturing defect Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Isotretinoin – changes to prescribing guidance and additional risk minimisation measures Drug Safety Update on Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs Device Safety Information on M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001) Letters, medicines recalls and device notifications sent to healthcare professionals in January 2026 News and guidance on: Statins: update to product information on the role of the nocebo effect in muscle-related events. Increased semaglutide dose for adults with obesity – prescribing advice. Epimax Ointment and Epimax Paraffin-Free Ointment: reports of ocular surface toxicity and ocular chemical injury. MMRV vaccine factsheet published. New MHRA guidance for healthcare professionals and the public on the use of mental health apps and technologies.
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News ArticleCancer patients are being denied access to cutting-edge treatments on the NHS because of a “deadly postcode lottery” in access, doctors have warned. Patients in England are missing out on two innovative forms of radiotherapy that are known to be effective against several forms of the disease and are widely available in other countries, due to “red tape” and lack of funding. The Royal College of Radiologists (RCR) and Radiotherapy UK want Wes Streeting to use the government’s new cancer plan, being published this week, to make them widely available. They are urging the health secretary to end what they say are “bureaucratic hurdles” that NHS England imposes, through its complex funding and commissioning policies, on hospitals that want to provide stereotactic ablative body radiotherapy (SABR) and molecular radiotherapy (MRT). Unlocking the potential of the novel treatments would help improve cancer survival, which is poor in Britain by international standards, both organisations said. Dr Nicky Thorp, the RCR’s vice-president for clinical oncology, said: “A number of innovative cancer treatments exist and are known by cancer doctors to be effective, but they are in only limited use in the NHS in England. “This means that some cancer patients are missing out on treatments that cancer specialists know are effective and which could treat their cancer in fewer doses with fewer side effects. “Doctors want to do our best for our patients, so it is incredibly frustrating for us to be in a situation where some patients aren’t getting access to the full range of treatments that are proven to help tackle cancer.” Read full story Source: The Guardian, 1 February 2026
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Event
Seating Masterclass (Northeast Scotland)
Patient Safety Learning posted an event in Community Calendar
Seating Matters’ in-person Seating Masterclasses are the ideal chance to refresh and enhance your knowledge of effective sitting, pressure care management, and the seating assessment process. Stay up to date with the latest innovations in seating and gain practical insights from leading experts. Our resident OT, Kirsty Ryan, will share her expertise on conducting thorough seating assessments, managing pressure, and supporting posture. Whether you’re an occupational therapist, healthcare professional, caregiver, or simply passionate about seating solutions, this masterclass offers a valuable opportunity to connect with peers and explore new approaches to practice. Don’t miss out—register today using the promo code PATIENTSAFETYLEARNING to secure your free place! Register -
Event
Seating Masterclass (Dublin)
Patient Safety Learning posted an event in Community Calendar
Seating Matters’ in-person Seating Masterclasses are the ideal chance to refresh and enhance your knowledge of effective sitting, pressure care management, and the seating assessment process. Stay up to date with the latest innovations in seating and gain practical insights from leading experts. Our resident OT, Kirsty Ryan, will share her expertise on conducting thorough seating assessments, managing pressure, and supporting posture. Whether you’re an occupational therapist, healthcare professional, caregiver, or simply passionate about seating solutions, this masterclass offers a valuable opportunity to connect with peers and explore new approaches to practice. Don’t miss out—register today using the promo code PATIENTSAFETYLEARNING to secure your free place! Register -
Event
Seating Masterclass (Bristol)
Patient Safety Learning posted an event in Community Calendar
Seating Matters’ in-person Seating Masterclasses are the ideal chance to refresh and enhance your knowledge of effective sitting, pressure care management, and the seating assessment process. Stay up to date with the latest innovations in seating and gain practical insights from leading experts. Our resident OT, Kirsty Ryan, will share her expertise on conducting thorough seating assessments, managing pressure, and supporting posture. Whether you’re an occupational therapist, healthcare professional, caregiver, or simply passionate about seating solutions, this masterclass offers a valuable opportunity to connect with peers and explore new approaches to practice. Don’t miss out—register today using the promo code PATIENTSAFETYLEARNING to secure your free place! Register -
Event
Seating Masterclass (London)
Patient Safety Learning posted an event in Community Calendar
Seating Matters’ in-person Seating Masterclasses are the ideal chance to refresh and enhance your knowledge of effective sitting, pressure care management, and the seating assessment process. Stay up to date with the latest innovations in seating and gain practical insights from leading experts. Our resident OT, Kirsty Ryan, will share her expertise on conducting thorough seating assessments, managing pressure, and supporting posture. Whether you’re an occupational therapist, healthcare professional, caregiver, or simply passionate about seating solutions, this masterclass offers a valuable opportunity to connect with peers and explore new approaches to practice. Don’t miss out—register today using the promo code PATIENTSAFETYLEARNING to secure your free place! Register -
Content ArticleCommissioned by the Department of Health and Social Care (DHSC) in November 2024, this research by National Voices explores patient experience of the medical devices prescribed under Part IX of the NHS Drug Tariff. The project aimed to understand the features patients value most, so these insights can inform future categorisation and assessment of devices. Between November 2024 and March 2025, National Voices collected 679 survey responses and held interviews or focus groups with 66 people with lived experience of using medical devices. The report brings together patient feedback across seven device categories, spanning areas such as wound and skin care, respiratory care, diabetes and glucose monitoring, sexual and pelvic health, and oral, eye and ear care. The findings have been used by DHSC and National Voices to identify clear next steps for the Department, alongside actions for medical device manufacturers and local decision makers within Integrated Care Systems, helping ensure patient voice shapes decisions about device availability and choice.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Mesalazine and idiopathic intracranial hypertension Drug Safety Update on Rybelsus ® (semaglutide tablets): transition to new formulation and risk of medication error Letters, medicines recalls and device notifications sent to healthcare professionals in December 2025 News and guidance on: Patient and family experiences inform antidepressant safety information review Vaccine factsheet published Call for evidence: Regulation of AI in Healthcare MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices MHRA host workshop to improve Patient Information Leaflets
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Letters, medicines recalls and device notifications sent to healthcare professionals in November 2025 News and guidance on: Reported Cases of Patient Deaths Among Duchenne Muscular Dystrophy Patients Receiving Duvyzat®▼ (givinostat) and reminder of risk mitigation measures Tamoxifen: update to product information on QT prolongation and monitoring recommendations for high-risk patients MHRA begins hosting Patient Safety Commissioner
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News Article
Revealed: Home monitoring operating under lowest level of regulation
Patient Safety Learning posted a news article in News
Several technologies in use in the NHS are operating under a low-risk form of regulation, despite being advertised for remote monitoring of patients’ vital signs, HSJ can reveal. An HSJ analysis of registrations with the Medicines and Healthcare products Regulatory Agency (MHRA) has found wide variation in the classification of remote monitoring systems – with some complex software operating on the same level of risk assessment as a bandage or needleless syringe. The systems use wearable devices to track vital signs, blood sugar levels, medicine adherence and other health observations outside hospital, with the aim of triggering an intervention when patients are at risk. Between November 2020 and January 2023, over 487,000 people were supported at home using the technologies, and the government is pledging a big expansion. Some of the most widely used platforms are listed with the MHRA as “Class I” devices – the category for devices with the ”lowest risk”, which can be self-certified by manufacturers, and is subject to minimal external oversight. Suppliers said cost and a shortage of “notified bodies”, which can review applications, held them back from obtaining higher accreditation. Read full story (paywalled) Source: HSJ, 11 November 2025 -
Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Isotretinoin – updates to prescribing guidance and survey of services. Device Safety Information on BD BodyComm™ version 3.3 software used for BodyGuard infusion pumps, BodyGuard-T and T34 syringe drivers: Important steps to manage transition to Windows 11. Drug Safety Update on #MedSafetyWeek (3-9 November 2025): A call to action to improve patient safety. Letters, medicines recalls and device notifications sent to healthcare professionals in October 2025. News and guidance on: Reminder of the risk of incorrect dosing when switching between different drug formulations Patient safety essay writing competition 2025 for medical students and foundation doctors now open Side effects from drug interactions to be predicted by AI before reaching patients.
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Content ArticleThis case study is one in a set of patient safety ‘how we acted on patient safety issues you recorded’ case studies which show the direct action taken in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm. The Incident Reporting and Investigation Centre (IRIC) in Scotland contacted NHS England to share an incident where a patient’s body-worn continuous insulin patch pump device was incorrectly identified by their healthcare team as a glucose sensor, when admitted to hospital with a severe hypoglycaemic event and loss of consciousness. As a result, the pump continued to infuse insulin during treatment therefore prolonging, rather than correcting, the hypoglycaemia. Insulin pumps can be identified by on-device marking and NHS England's review of the National Reporting and Learning System (NRLS) did not indicate this to be a widespread safety issue. However, they used this case to signpost Medical Device Safety Officers, Medication Safety Officers and the National Association of Medical Device Educators and Trainers (NAMDET) networks to guidance available from the Association of British Clinical Diabetologists to raise awareness of the potential for this error. In addition, the Royal College of Emergency Medicine highlighted this issue in a Safety Flash to ensure healthcare staff were aware of the risk.
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Content ArticleThis article by BD looks at the the risks related to irritants and vesicants when medications are administered to patients via vascular access (into their blood vessels through a cannula). It highlights the immediate risks of vein irritation, pain, discomfort and potential tissue damage during an infusion, as well as looking at the impact of damage to vascular endothelial cells caused by irritants and vesicants. It offers guidance on selecting the right vascular access device (VAD) and includes a Vascular Access Device Assessment Decision Tree, which is free to download.
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Content ArticleThis roadmap sets out the government’s ambition to transition away from all avoidable single-use medical technology (medtech) products towards a functioning circular system by 2045 that maximises reuse, remanufacture and recycling. Circularity in medtech means designing, procuring and processing medical products in a way that enables them to be reused, remanufactured or recycled, preserving their value for as long as possible. The benefits of a circular economy in the health sector are vast and increasingly well-understood, but are rarely put into practice and are difficult to scale. Unlocking these benefits across the UK medtech sector will bring many opportunities for innovation and growth, while improving patient care and value for money and supporting the transition to a net zero NHS. This document sets out a plan of 30 actions to deliver our 2045 vision, which will involve: driving positive behavioural change exploring new commercial incentives to provide circular medtech creating new standards to enable innovative products and services planning the decontamination and recycling infrastructure of the future establishing new collaborations to accelerate the emergence of transformative science.
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News Article
Obsolete imaging equipment raises concerns in NI hospitals
Patient Safety Learning posted a news article in News
A report from the Northern Ireland Audit Office has found that 16% of imaging equipment used in healthcare settings is “effectively obsolete”. Comptroller and Auditor General Dorinnia Carville has raised concerns over the “substantial proportion of out-of-date equipment” and a growing gap between demand and capacity. Northern Ireland’s Department of Health said that while some of the equipment base “would ideally be replaced at a quicker rate”, it remains “safe and fit for purpose”. The report noted that around 90% of all hospital patients have images taken and interpreted. It said that increasing recognition of the benefits of imaging services has resulted in a “growing demand for them”. The report added: “Combined with changing patient demographics, and an absence of sustainable funding and resources, capacity has been unable to keep pace.” The report found that between 2018 and 2024, the health service delivered a total of 350,000 fewer scans (MRI, CT, and non-obstetric ultrasound scans) than what was required to meet demand. Similarly, waiting lists and waiting times for imaging services have risen in that period. The report said that timely replacement of imaging equipment is one of the “key components to service delivery and quality”. It said: “Currently 16% of all HSC imaging equipment is over 10 years old and is effectively obsolete. Older equipment can result in increased downtime and maintenance costs. It can also be potentially slower, reducing the number of patients which can be scanned, and may produce lower quality images meaning an increased risk of missed disease.” Read full story Source: Medscape, 31 March 2025
