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As part of my quality improvement study at university, I developed and introduced an oxygen reference card that was shown to improve newly qualified clinical staffs' knowledge and confidence when using an oxygen cylinder. The project's literature review captured that clinical staff may not have the memory recall to support them in clinical practice and, therefore, a lack of embedded knowledge, which could compromise care. It is paramount that users of oxygen cylinders have the knowledge to understand how to use a cylinder safely and to understand how to assess the remedial gas in the cylinder to support oxygen administration. The study found that there is minimal training accessed to support staffs' knowledge and skill foundations for using cylinders. The outcome of the study recommended that there needs to be better support for clinical staff to use cylinders within their pre/post training to be able to using the device correctly. Introducing a oxygen reference card that they could keep on them whilst at work is a useful tool to support decision-making when using the cylinder. You can download the card from the attachment below. Both NAMDET – National Association of Medical Device Educators and Trainers and Northumbria Healthcare Facilities Management - NHS FOUNDATION supported the QI project.- Posted
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The Yellow Card scheme is a system for reporting adverse drug reactions (ADRs) from medicines or adverse incidents with medical devices in the UK, ensuring that these products are safe for both healthcare professionals and patients. Reporting these issues helps the MHRA to identify new safety concerns, review products and take action to minimise risks. Despite the role of the Yellow Card reporting system in pharmacovigilance in the UK, understanding and uptake of the scheme remains limited. The authors designed a survey to explore healthcare professionals’ awareness, usage and perceptions of the Yellow Card Scheme for reporting ADRs. It was aimed at identifying current levels of engagement, perceived barriers to reporting, confidence in identifying ADRs and opportunities for improving reporting practices within the East London NHS Foundation Trust. The survey results showed that 84% were aware of the Yellow Card scheme, with 52% selecting that they were ‘fully aware’. A total of 16% of those asked had never heard of the scheme. Despite awareness of the scheme, actual usage is very low — 76% have never reported and 12% were unsure if they had reported, suggesting underutilisation of the scheme. Reporting is infrequent: no respondents report regularly; 12% report a few times a year and 20% have only reported one or twice in total. When asked about barriers to reporting, participants selected: Lack of awareness. Uncertainty about what qualifies as reportable. Lack of time. . Belief that someone else is responsible.- Posted
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Millions in compensation could be owed to women with mesh implants
Patient Safety Learning posted a news article in News
Mesh implants returned to the national spotlight as Sling the Mesh campaigners appeared on Good Morning Britain to highlight the devastating impact of surgical mesh procedures—and the urgent need for compensation and systemic reform. Campaign founder Kath Sansom was joined by Sharron Mahoney – who suffered severe autoimmune complications and chronic pain following rectopexy mesh surgery. Remarkably, Sharron’s symptoms began to clear within days of mesh removal -powerfully underscoring the direct link between these devices and the serious harm they can cause. Sharron’s story highlights the critical work of researchers such as Nicholas Farr from Sheffield University who recently published this study showing the plastic particles of surgical mesh can trigger autoimmune diseases – even after removal. Watch interview- Posted
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No adverse event should ever occur anywhere in the world if the knowledge exists to prevent it from happening. However, such knowledge is of little use if it is not put into practice. Translating knowledge into practical solutions is the ultimate foundation of the safety solutions action area of the World Alliance for Patient Safety. In April 2007, the International Steering Committee approved nine solutions for dissemination: Look-Alike, Sound-Alike Medication Names (PDF) Confusing drug names is one of the most common causes of medication errors and is a worldwide concern. With tens of thousands of drugs currently on the market, the potential for error created by confusing brand or generic drug names and packaging is significant. Patient Identification (PDF) The widespread and continuing failures to correctly identify patients often leads to medication, transfusion and testing errors; wrong person procedures; and the discharge of infants to the wrong families. Communication During Patient Hand-Overs (PDF) Gaps in hand-over (or hand-off) communication between patient care units, and between and among care teams, can cause serious breakdowns in the continuity of care, inappropriate treatment, and potential harm for the patient. Performance of Correct Procedure at Correct Body Site (PDF) Considered totally preventable, cases of wrong procedure or wrong site surgery are largely the result of miscommunication and unavailable, or incorrect, information. A major contributing factor to these types of errors is the lack of a standardized preoperative process. Control of Concentrated Electrolyte Solutions (PDF) While all drugs, biologics, vaccines and contrast media have a defined risk profile, concentrated electrolyte solutions that are used for injection are especially dangerous. Assuring Medication Accuracy at Transitions in Care (PDF) Medication errors occur most commonly at transitions. Medication reconciliation is a process designed to prevent medication errors at patient transition points. Avoiding Catheter and Tubing Mis-Connections (PDF) The design of tubing, catheters, and syringes currently in use is such that it is possible to inadvertently cause patient harm through connecting the wrong syringes and tubing and then delivering medication or fluids through an unintended wrong route. Single Use of Injection Devices (PDF) One of the biggest global concerns is the spread of Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV), and the Hepatitis C Virus (HCV) because of the reuse of injection needles. Improved Hand Hygiene to Prevent Health Care-Associated Infection (HAI) (PDF) It is estimated that at any point in time more than 1.4 million people worldwide are suffering from infections acquired in hospitals. Effective hand hygiene is the primary preventive measure for avoiding this problem.- Posted
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Vaginal mesh particles ‘could trigger autoimmune response even after removal’
Patient Safety Learning posted a news article in News
Microscopic particles left behind by vaginal mesh could continue to trigger the immune system to attack healthy tissue even after the material has been removed, according to researchers. Experts suggest allergy testing patients before they are fitted with mesh may help to better understand why complications happen in some cases. Campaign group Sling the Mesh said the majority of its members have developed a reaction they believe is down to the material, including autoimmune diseases, unexplained rashes and chronic fatigue. Transvaginal mesh (TVM) implants are made from synthetic materials such as polypropylene, a type of thermoplastic, and have been used to treat pelvic organ prolapse and incontinence after childbirth. However, they can cause serious harm to some women, with side effects including infection, pelvic pain, and incontinence. The NHS restricted its use of TVM implants in 2018 and they are now used only as a last resort through a high-vigilance programme of restricted practice. A new article led by Dr Nicholas Farr, published in the journal Nature Reviews Urology, analysed studies which suggest polypropylene is a material which causes autoimmune/inflammatory syndrome induced by adjuvants (Asia). Asia arises following exposure to substances that enhance the immune response in the likes of vaccines, silicone implants, or other foreign materials. Symptoms can vary widely, but include chronic fatigue and chronic pain. Read full story Source: The Independent, 6 June 2025 Related reading on the hub: Read a blog Dr Nicholas Farr wrote for the hub on medical device safety- Posted
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Evidence of polypropylene mesh degradation has revealed particle accumulation in surrounding tissues, raising concerns about potential local and systemic immune responses. Associations between polypropylene degradation and autoimmune/autoinflammatory syndrome induced by adjuvants-like symptoms have been made, and vigilant clinical assessment is important, especially in patients with a predisposition for allergy or autoimmune diseases. Related reading on the hub: Read a blog author Dr Nicholas Farr wrote for the hub on medical device safety- Posted
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In 2015, few people had even heard of pelvic mesh implants, let alone the devastating complications they could cause. Women were told their pain was “normal,” their concerns dismissed, their injuries hidden behind a wall of medical gaslighting. But what began as a small group of women raising their voices against an invisible epidemic turned into one of the UK’s most powerful grassroots campaigns for patient safety and medical justice. As Sling The Mesh marks its 10th anniversary, it celebrates a decade of courage, compassion, and relentless campaigning that has changed lives – and policy – forever. Over the next decade, Sling The Mesh will: Demand proper aftercare and support for all mesh-injured patients. Push for accountability from manufacturers and regulators. Campaign for awareness around hernia and other less-recognised mesh complications. Advocate for safer alternatives and patient-centred decision-making. Empower the next generation of campaigners to keep raising their voices. Push for tougher regulations and oversight of medical devices. Lobby for Sunshine legislation for transparency around funding from industry to the healthcare sector which can bias prescribing and affect research integrity.- Posted
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Boston Scientific Corp. will have to pay a total of $26.7 million in damages to four women in a court ruling related to its vaginal mesh product. Following a federal court trial in Miami, jurors found that the company’s Pinnacle pelvic floor replacement kit had a faulty design and the company failed to effectively warn patients and doctors about the possible risks associated with the device. Pelvic organ implants are used to treat female patients experiencing major discomfort due to pelvic organ prolapse. This was the first federal trial related to Pinnacle. Others lawsuits are pending. Pelvic organ prolapse occurs when a pelvic organ—such as the bladder—drops (prolapses) from its normal place and pushes against the walls of the vagina. This can happen when the muscles that hold pelvic organs in place are weakened or stretched from childbirth or surgery. Many women will have some kind of pelvic organ prolapse. It can be uncomfortable or painful, but isn’t usually a big health problem. It doesn’t always get worse. And in some women, it can get better with time. Boston Scientific officials told Reuters that they disagree with the verdict and have a strong case for post-trial motions and appeal. Marlborough, Mass.-based Boston Scientific is one of seven companies, including Johnson & Johnson’s Ethicon division and C.R. Bard, faced with lawsuits over similar mesh products. Officials with Endo International plc said in September it the company has set aside $1.6 billion to settle “substantially all” the cases against it and its American Medical Systems unit. Read full story Source: Medical Product Outsourcing- Posted
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A surgeon found to have left patients in "agony" after using artificial mesh to treat prolapsed bowels faces allegations he falsified medical notes. Tony Dixon was suspended after the surgery was found to have caused harm to hundreds of patients at two hospitals in Bristol. Now, a new hearing will examine Dr Dixon's records. He is accused of dishonestly creating patient records long after he was involved in their care, something he "strongly denies". The Medical Practitioners Tribunal Service (MPTS) will begin Monday. It will examine claims medical records for seven patients contained false information, and were not created at the correct time. A spokesperson for Dr Dixon said: "[He] always endeavoured to provide the highest standard of care to his patients. "He strongly disputes falsifying any medical records and will provide his detailed evidence about those serious allegations to the tribunal, initially by way of a detailed witness statement which he has provided to the General Medical Council." Read full story Source: BBC News, 12 May 2025- Posted
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The rapid evolution of digital health technologies offers new opportunities for healthcare systems while also increasing pressure on public budgets. Governments and insurers face growing challenges in determining what to fund and at what price. Health technology assessment (HTA) remains a critical tool for informing these decisions, and several OECD countries are exploring ways to adapt their approaches to the fast-changing and diverse landscape of digital medical devices. The absence of a common taxonomy, coupled with the rapid pace of technological advancement, further complicates evaluation, prompting interest in more harmonised HTA approaches. This paper explores how France, Germany, Israel, Korea, Spain, and the United Kingdom are adapting HTA to evaluate certain types of digital medical devices for coverage and pricing decisions. Through desk research and interviews, it describes HTA approaches, focusing on relevant pathways, technology remits, and evaluation methods. Drawing on practical experiences, it highlights key challenges and potential learning opportunities. The findings contribute to ongoing discussions on adapting HTA frameworks to improve the assessment and integration of digital medical devices into healthcare systems.- Posted
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Fake weight loss injections with dirty needles being sent to NI
Patient Safety Learning posted a news article in News
Illegal weight loss injections with dirty needles are being sold over social media and sent to people in Northern Ireland, a BBC investigation has found. BBC News NI made test purchases of syringes which claimed to contain semaglutide, a prescription-only drug, via Facebook from sellers based in England. When tested, the liquid was not semaglutide but did contain carnitine – a supplement that can be bought on the high street. The Police Service of Northern Ireland (PSNI) said it was working at an international level to root out criminal gangs selling illicit jabs manufactured in unhygienic labs. So-called skinny jabs are prescribed weight loss injections that work by making you feel fuller and less hungry. In Great Britain, semaglutide is available on the NHS as part of a weight management programme. However, in Northern Ireland it is not as there is no specialist weight management service, but it is available on private prescription. The Department of Health in Northern Ireland said people were putting themselves at serious risk buying from sellers on social media sites. Read full story Source: BBC News, 14 April 2025- Posted
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Almost 1.7 million hernia mesh implanted in NHS in 20 years
Patient Safety Learning posted a news article in News
Almost 1.7 million people have had hernia mesh surgery in the NHS since 2004, figures released by the NHS have revealed. The statistics do not include people who’ve had hernia mesh in private hospitals. Nobody can say how many are now suffering complications – because patients are not tracked for their lifetime. Yet campaigners and academics globally say it can take many years for mesh to cause problems- so the scale of suffering falls into a black hole of missing data. Moreover, support groups show that patients are being implanted with hernia mesh in their thousands ever year – but nobody is being given fully informed consent of the potential risks such as pain, loss of mobility, loss of sex life and losing the ability to have children. Also autoimmune diseases and allergies caused by the plastic mesh material. The figures came to light thanks to a Written Parliamentary Question asked by MP Sharon Hodgson, chair of the All Party Parliamentary Group for First Do No Harm. In its response, The Department of Health say: “Clinicians are expected to inform patients about risks associated with recommended treatments, including reasonable alternatives, to enable informed consent and a balanced patient decision.” But campaign group Sling The Mesh says that the majority of people are told hernia mesh is ‘not the mesh in the media’, or it is a new mesh, or that this is a gold standard treatment and that mesh receives undeserved negative attention. Read full story Source: Sling the Mesh, 25 March 2025- Posted
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Patients with vision or hearing loss frequently encounter difficulties accessing vital health information, medication instructions, and effectively using medical devices. This report for the Patient Safety Commissioner for England, commissioned from Professor Margaret Watson, highlights serious gaps and deficiencies in the way that people with visual and/or hearing impairment or loss (referred to as sensory impairment) are able to access and use medicines and medical devices safely. This report presents the results of a short-term study to explore the challenges experienced by patients with sensory impairment in relation to their safe and effective access to and use of medicines and medical devices. This study was conducted from September to December 2024. The primary data that were generated were derived from three sources: Focus groups involving individuals with visual impairment or loss, including people with diabetes. Key Informant responses to an electronic survey. Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card reports. Patients reported distressing experiences due to inaccessible packaging, unreadable patient information, inadequate communication about medication changes and a lack of suitable reporting mechanisms for issues. The report makes the following recommendations: The MHRA needs to review – working alongside patients – whether their current guidance and regulations for the licencing and packaging of medicines goes as far as is possible to enable their safe use by those with sensory impairment. The Association of the British Pharmaceutical Industry (ABPI), MHRA and Department of Health and Social Care (DHSC) should work together to restart work – alongside published milestones – to digitise paper-based patient information leaflets via the existing UK Electronic Patient Information Task Force (ePIL). As part of this restart, ePIL – working with patients – should examine how to maximise the benefits of this work for patients with sensory impairment. NHS England’s Diabetes Programme Team should launch a patient reference group to assess, understand and mitigate the barriers and enablers to the safe and effective roll-out of medical devices and other education programmes for the management of diabetes (such as DAFNE) for those with sensory impairments. DHSC and NHS England need to ensure the work announced to improve and expand the NHS App in ‘Reforming elective care for patients’ includes an assessment – conducted with the input of patients – to determine whether further accessibility improvements are required, especially for people with visual impairment. In a number of other areas, the report states that the Patient Safety Commissioner wants to make observations to a number of bodies – highlighting the outcome without specifying the solutions, in keeping with the ethos of the recent Health Services Safety Investigations Body (HSSIB) report ‘Recommendations but no action: improving the effectiveness of quality and safety recommendations in healthcare.’ The report makes the following observations: A patient’s medical record needs to include a prominent flag of accessibility needs and detailed information about these needs to ensure that the healthcare professional can provide any required reasonable adjustments. All relevant healthcare professionals – including community pharmacists – must have sufficient access to these patient records and flags. Healthcare professionals, particularly community pharmacy personnel and others involved in the direct supply of medicines and medical devices, must have sufficient funding to support the additional time and resources required by to undertake assessments of patient needs and provide the required ‘reasonable adjustments’ for medicines and medical devices. With the anticipated increase in prevalence of sensory impairment amongst the general population, further guidance is required to promote evidence-based practice by health and social care professionals in terms of the medicine journey of people with sensory impairment. It is also crucial that there is provision of training to healthcare professionals (ideally within the undergraduate curricula) regarding the needs of people with sensory impairment. People with experience of sensory impairment should be included in the design of medical devices, as well as user information and instructions to accompany their supply and use. Manufacturers need to provide more resources to facilitate the demonstration of the effective use of medical devices, especially for people with visual impairment.- Posted
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This is a brief summary of a Westminster Hall debate in the House of Commons on the 27 March 2025 concerning the first anniversary of The Hughes Report on valproate and pelvic mesh. What is a Westminster Hall Debate Westminster Hall debates give Members of Parliament (MPs) an opportunity to raise local or national issues and receive a response from a government minister. Any MP can take part in a Westminster Hall debate. The Hughes Report The Independent Medicines and Medical Devices Safety Review, published in July 2020, highlighted the scale of avoidable harm related to three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One of the Review’s key recommendations was that separate redress schemes should be established for patients adversely affected by these interventions. Published on the 7 February 2024, the Patient Safety Commissioner for England set out options for redress for two of these interventions, pelvic mesh and sodium valproate in The Hughes Report. It recommends the government creates a two-stage financial redress scheme – an interim scheme to enable the identification of all those harmed ensuring patients receive financial redress quickly – and a main scheme. You can find Patient Safety Learning’s reflections on the first anniversary of this report’s publication here. House of Commons debate In the discussion MPs highlighted individual cases from their constituents relating to pelvic mesh and sodium valproate and also discussed: The need to confirm a timeline for the Government's response to The Hughes Report. Considering whether there is scope to implement a sunshine-style piece of legislation to ensure the transparency of payments made by industry to the healthcare sector. The difficulties of getting financial redress outside of a Government scheme. On mesh, it was noted that of the 1,252 legal cases initiated between 2014 and 2024, only 356 were settled in or out of court with damages, but 678 were concluded without any such damages being awarded. Concerns about specialist mesh removal centres being run by clinicians who have inserted mesh. Considering whether the initial interim payment of £25,000, proposed by the report, could be prioritised ahead of finalising arrangements for the main payment. Responding on behalf of the Government to this debate was Ashley Dalton MP, Parliamentary Under-Secretary of State for Public Health and Prevention. She noted that: The previous Government had held a consultation on the principle of mandatory reporting for industry payments made to the health sector. The Department of Health and Social Care was now considering options regarding payment reporting, with an aim to publish a response later this year. The Government is still considering all the options and the associated costs before responding to The Hughes Report’s recommendations. She stated that she would write to Baroness Marron to clarify timescales around this.- Posted
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Almost 1.7 million hernia mesh implanted in NHS in 20 years
Patient Safety Learning posted a news article in News
Almost 1.7 million people have had hernia mesh surgery in the NHS since 2004, figures released by the NHS have revealed. The statistics do not include people who’ve had hernia mesh in private hospitals. Nobody can say how many are now suffering complications – because patients are not tracked for their lifetime. Yet campaigners and academics globally say it can take many years for mesh to cause problems- so the scale of suffering falls into a black hole of missing data. Moreover, support groups show that patients are being implanted with hernia mesh in their thousands ever year – but nobody is being given fully informed consent of the potential risks such as pain, loss of mobility, loss of sex life and losing the ability to have children. Also autoimmune diseases and allergies caused by the plastic mesh material. The figures came to light thanks to a Written Parliamentary Question asked by MP Sharon Hodgson, chair of the All Party Parliamentary Group for First Do No Harm. In its response, The Department of Health say: “Clinicians are expected to inform patients about risks associated with recommended treatments, including reasonable alternatives, to enable informed consent and a balanced patient decision.” Read full story Source: Sling the Mesh, 25 March 2025- Posted
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In traditional infusion processes, issues such as untimely medication replacement and patients’ difficulty in continuously monitoring their medication levels are prevalent. This study presents the design of a smart infusion automatic medication replacement device aimed at automating infusion management through three key modules: high-precision liquid level monitoring, automated medication replacement, and a smart control system. By monitoring liquid levels in real time, the system eliminates the need for patients to constantly check their medication levels, accurately controlling the amount of medication dispensed and transmitting monitoring signals within safe thresholds. By replacing repetitive manual adjustments with automated processes, healthcare professionals can focus more on patient care rather than the cumbersome medication replacement procedures. The smart infusion automatic medication replacement device enhances the quality of infusion therapy for patients and alleviates the repetitive workload of medical staff.- Posted
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Surgical airway securement: A standardised approach is needed
Dawn Stott posted an article in Surgery
This blog from Pentland Medical and Dawn Stott Associates highlights the findings from their report ‘Surgical airway securement: A report analysing responses to a survey, focus groups and freedom of information requests’.[2] The aim of the work is to look at patient harm from surgical airway securement in critical care environments and, ultimately, to underscore the importance of continuous learning, a culture of transparency and collaboration across disciplines to sustain improvements in patient safety. Background Securing an airway device is a critical component of patient safety, particularly in situations where airway management is essential to life support, such as during surgery, emergency care or critical illness. The airway device, typically an endotracheal tube or laryngeal mask airway, ensures that a patient’s airway remains open for adequate oxygenation and ventilation. The WHO Guidelines for Safe Surgery states that “Securing the airway of a patient undergoing general anaesthesia is the single most critical event during induction.”[1] As all healthcare professionals working in the anaesthetic environment will know, properly securing the device is paramount as any displacement or dislodgement can lead to life-threatening complications like hypoxia, aspiration or airway obstruction. Ensuring that the airway stays in place for the time needed is an equally important part of this process. Currently, this is often done with the use of off-label materials, such as tape and ties, which can cause facial damage ranging from minor redness to severe tissue damage. This tape can also pose an infection risk, but, perhaps more pertinently, any off-label methods are not fit for purpose. Although they are embedded in healthcare practice and are used world over, tape and ties were never designed to perform airway securement. Consultation on airway device securement Following an inaugural round table discussion meeting led by Dawn Stott Associates, a ‘cross sector’ Short Life Working Group (SLWG) was formed to consult on the way an airway device is currently secured when a patient is undergoing a surgical intervention. The group’s goals were to identify systemic barriers to the standardisation of airway management and to develop guidance to support a more robust and consistent way of securing the airway device. The group’s mission was to: review current policy, guidance and legislation to help interpret and apply them to daily anaesthetic practice to support healthcare facilities and personnel with materials and resources on airway device securement and management to help ensure compliance with policy to establish an environment where standardisation of approach is accepted to make guidance available to support healthcare professionals ensure that the patient is safe. The group also reviewed the broader issues around patient safety and the cultural challenges around change management in securing an airway device with tapes. Current guidance What has been astonishing for the SLWG is that no guidance exists from any recognised bodies in the UK on securing an airway device. The Difficult Airway Society (DAS) is generally regarded as the leading authority on anything airway related, not just in the UK but also internationally. However, while the DAS guidance states that healthcare professionals should secure the airway device, it does not go beyond this to advise on best techniques or materials that should be used. This absence of national guidance has resulted in an inconsistent approach to securing an airway device within UK hospitals, and with it the risk of facial harm, infections and more serious incidents that are entirely preventable. Until now there has not been any solution designed and risk-assessed to secure an airway device in the theatre environment, leaving a vacuum where healthcare professionals worldwide are forced to improvise by developing their own techniques and by using off-label generic materials such as tape and ties. There are also a huge number of varying circumstances encountered involving the use of different airway products and surgical positions that further complicates matters when it comes to a standardised approach to airway device securement. It is the opinion of the SLWG that the report we have produced provides compelling evidence for an urgent review of the existing practices for airway securement and for guidelines to be established, which include the requirement for dedicated medical devices to perform airway device securement. The study We used three approaches to gather information: A survey for healthcare practitioners was developed to explore whether there is a standardised approach to securing an airway device in their hospital. The intention was to use the findings to support ongoing work around safer patient care and better clinical outcomes. Focus groups were held to provide insight into how things are currently being done. Freedom of Information (FOI) requests were sent to NHS Foundation Trusts. The information requested was for the period between the 1 January 2020 to 31 December 2023. The FOI requests were designed to define how patient safety is delineated around securing an airway device and how standardisation can be improved to ensure the reduction of current incidents of failure and infection to patients. What we found The responses from the FOI requests show that a substantial number of trusts have experienced inadequate patient outcomes because of poor airway management (see the tables below). It also highlighted that many trusts do not report these patient safety incidents. This is sometimes due to the normalisation of the process and that the incidents are so ‘small’ it is not felt necessary to report them. Feedback from one Trust suggested that many professionals involved in the management of airway did not want to change their practices. Several Trusts stated that they did not routinely record this type of information and would therefore only be able to fulfil the FOI request if they were paid to do so under Section 12 of the FOI Act, underlining the lack of normal visibility of this data. Total responses to the FOI questions Five hospitals were unable to provide the information in the format requested but responded as follows: Key findings from the survey 23% of the people surveyed were aware of incidents of poor patient care resulting from their airway securement techniques. How people currently secured an airway: - 57% used tapes and ties - 20.16 % used elastoplast or similar - 4.3% used a fit for purpose device (not specified) - 8.7% used a mixture of methods depending on procedure - 9.4% didn’t respond. 56.5% of the respondents were aware of the infection risks associated with using tapes. However, they continued to use this as a method of securing the airway device even though it is an unlicenced and unhygienic way of managing the securement. 95.7% of the respondents were aware that the airway may migrate during the intervention and could cause serious harm to the patient but continued to use the same methods of securement. During the focus groups we asked about communication. The responses below showed that there wasn’t always an open and honest culture within the operating department. Infection Prevention and Control guidance The National Infection Prevention and Control Manual, Chapter one, Standard Infection Control Precautions (SICPs) states that care equipment can be easily contaminated with blood and other bodily fluids and infectious agents.[3] They classify care equipment as either: Single use – equipment which is used once on a single patient then discarded. Must never be reused even on the same patient. Single patient use – equipment which can be reused on the same patient. Reusable invasive equipment – used once then decontaminated e.g. surgical instruments. Reusable non-invasive equipment (often referred to as communal equipment) – reused on more than one patient following decontamination e.g. commode, patient transfer trolley. Multi-patient rolls of tape are, by definition, classified as ‘non-invasive re-usable equipment’, which by reason of the SICPs above, must be decontaminated to adhere to the National Infection Control Standards. As findings from our surveys/focus groups made clear, this is not happening because rolls of tape by their structure cannot be decontaminated. Education Ongoing education is one of the most crucial elements of managing the securement of the patient airway. Many organisations have integrated crisis management training, including human factors education into their anaesthesia and airway management programmes.[4] Simulated learning offers a dynamic and risk-free environment where learners can apply theoretical knowledge to practical scenarios, enhancing understanding and retention. By mimicking real-world situations, it allows individuals to develop critical skills, problem-solving abilities and confidence without the consequences of real-life errors. Encouraging innovation and change There is a continuing desire to make airway management safer. Innovations and new equipment continue to be developed to support safer anaesthetic practices; however, if healthcare professionals were to put forward the suggestions of tapes and ties to the regulatory bodies that manage new innovations, they would not pass the scrutiny and rigor and endure the processes in place to get the product to market. This speaks volumes about the archaic way of securing an airway device – but how do we encourage change within an environment that is entrenched in history and a ‘this is the way we have always done it’ mentality? New regulatory systems and sometimes political unawareness can cause pressures on the industry due to their often single-minded need to cut headline costs. Only recently, the Association for British Healthcare Industries announced that £50k worth of registration projects have been withdrawn due to the costs associated with compliance. This will have a catastrophic impact on much needed healthcare innovation and products that are designed to support patient safety.[5] How collaboration can make things happen This project has highlighted the importance of a team approach when trying to develop a standardised approach to different parts of the critical care environment. Another issue the project group discussed was how standardisation of certain practices made things much easier. However, it was thought that all approaches for standardisation should be backed up by rationale and be evidence based. Those involved in the discussions felt that training of new members of the team would be much easier if certain ways of working were standardised. Conclusion Effective airway device securement is a critical component of patient safety in clinical settings. Proper securement techniques reduce the risk of unplanned extubation, displacement, infection risks, facial tissue harm and compromising the airway, which can lead to life-threatening complications. Healthcare providers must be well-trained in securing airway devices and remain vigilant in monitoring their stability throughout patient care. Standardised protocols, high-quality materials and evidence-based practices are essential for ensuring the reliability of airway device securement. Regular assessments, interdisciplinary collaboration and the use of checklists further enhance safety by promoting consistency and reducing errors. In their WHA 72.6 Resolution (2019), WHO Health Ministers mandated for the global patient safety action plan 2021-2030 to be implemented.[6] Within the resolution at 5.3 they suggest they will make available guidance on how to create cultures that operate transparently and encourage speaking up.[7] Unfortunately, through the research we have undertaken and discussions we have had with individuals throughout this project, we have witnessed a damaging culture that exists within the healthcare environment. We believe that this is leading to a nation of healthcare professions who feel let down, devalued and unable to speak up and speak out to support better patient results. We did meet and talk to some professionals who worked in an environment of support and nurture, but sadly the majority of individuals felt unheard in a massive environment of ‘noise’. It has become evident that trusts generally only change their practices following an incident which is costing them more than it would have done to use a product that is designed for purpose. Failure to see the impact of such obstinacy on the patient and their wellbeing is a very blinkered approach to improvement and innovation. By prioritising proper securement practices, healthcare teams can improve patient outcomes, prevent adverse events and reinforce a culture of safety in airway management. Ongoing research and innovation in device design and securement techniques will continue to advance this critical aspect of patient care. Despite its contributions, this study is not without limitations and future research is needed with larger and more diverse samples, refining methodology and exploring additional variables. However, the outputs do highlight the issue that the project is championing for change. We are pleased to report that our work has garnered international interest, prompting efforts to replicate the exercise in both the USA and Europe. This global recognition underscores the significance of our findings and highlights the potential for broader applications in enhancing safety standards worldwide. These strategies, combined with continuous education and integration of innovative technologies, demonstrate the potential for significant improvement in patient safety related to airway device management. References World Health Organization. Guidelines for Safe Surgery 2009. Safe Surgery Saves Lives, 2009. Pentland Medical and Dawn Stott Associates. Surgical airway securement: A report analysing responses to a survey, focus groups and freedom of information requests, November 2024. NIPCM. National Infection Prevention and Control Manual, Chapter one; Standard Infection Control Precautions (SICPs). Tankard K, Sharifpour M, Chang MG, Bittner EA. Design and Implementation of Airway Response Teams to Improve Patient Safety. J Clin Med 2022; 11(21): 6336. https://doi.org/10.3390/jcm11216336. Fick M. Insight: Medical device makers drop products as EU law sows chaos. Reuters, 19 December 2022. World Health Organization. WHO Global Patient Safety Action Plan 2021 – 2030. Towards eliminating available harm in healthcare, 3 August 2021. World Health Organization. Consensus statement: Role of policy-makers and health care leaders in implementation of the Global Patient Safety Action Plan 2021–2030, 13 July 2022. You can read the full report of this study here or by scanning the QR code below:- Posted
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The Food and Drug Administration released an alert notifying patients of a safety concern using diabetes devices such as continuous glucose monitors, insulin pumps and automated insulin dosing systems that rely on a smartphone for delivering alerts. The agency said it received medical device reports in which users reported alerts were not being delivered or heard in situations where the users thought they configured the alerts to be delivered. Some instances may have contributed to serious harm, including severe hypoglycaemia, severe hyperglycaemia, diabetic ketoacidosis and death. The FDA issued recommendations for users and said it is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations are evaluated prior to use. It is also working with manufacturers to ensure settings for smartphones and mobile medical applications are continuously tested and that updates are communicated quickly and clearly to users. Read full story Source: US Food and Drug Administration, 5 February 2025- Posted
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Last September Emma-Louise Lucas, a mother of one from Manchester, at just 31 received the shocking news that she had a rare type of cancer, caused by her breast implants. Called breast-implant associated anaplastic large-cell lymphoma (BIA-ALCL), it’s a form of Non-Hodgkin’s Lymphoma, which affects immune cells. The disease has been linked to implants manufactured by Allergan. While the US medical company has made no admission of liability, in 2019 it issued a voluntary global recall of these types of implants. Now Emma, a manager of a civil-engineering company, is facing not just a shocking diagnosis, but learning she is the latest victim of a vast legal injustice. Emma had her implants inserted in March 2014. That time gap, of just over a decade, means that under UK rules she is barred from taking a legal case against the makers. This is because there is a ten-year limit on making medical-device injury claims, even though it often takes more than ten years for patients to start suffering symptoms of harm. It is a different situation in Europe, where the legal limit for such claims is being raised to 25 years. This unfairness is highlighted by the fact that last August, in a landmark case, 140 women in the UK won an undisclosed sum from three companies, Johnson & Johnson, Boston Scientific and Bard after suffering years of misery caused by mesh, or transvaginal tape (TVT). The total sum is expected to run into millions of pounds. But thanks to the ten-year legal snare, thousands of other UK women such as Gail McCourt, who have the exact same type of injuries caused by the same mesh, aren’t allowed to pursue the same claims. In a similar scenario, hundreds of British women are now pursuing compensation for harm they say was caused by a contraceptive implant called Essure. Read full story Source: The Daily Mail, 11 February 2025- Posted
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Beware ill-fitting menstrual cups, warn doctors
Patient Safety Learning posted a news article in News
Doctors are advising women to take care using menstrual cups, after one user developed temporary kidney problems because the cup was misaligned. The patient, in her 30s, had been experiencing intermittent pelvic pain and blood in her urine for months, but had not linked the symptoms to the menstrual cup, which is used to catch monthly blood flow. Although exceedingly rare, a poorly positioned cup inside the vaginal passage can press on other nearby structures, such as ureters - tubes carrying urine to the bladder, according to Danish doctors quoted in the British Medical Journal, external. Selecting the appropriate size cup is important, as well as inserting it properly, doctors have stressed. The patient made a complete recovery, but doctors have warned: "Correct positioning, along with choosing the correct cup shape and size, is important to prevent negative effects on the upper urinary tract. "Menstrual cups can be bought and used without clinical advice from a health professional, which emphasises the importance of detailed and clear patient information material." Read full story Source: BBC News, 11 February 2025- Posted
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A year ago today the Patient Safety Commissioner for England published The Hughes Report, which set out options for redress for those who have been harmed by valproate and pelvic mesh. In this blog, Patient Safety Learning reflects on the failure to act on its recommendations 12 months on. The Independent Medicines and Medical Devices Safety (IMMDS) Review published its report, First Do No Harm, on 8 July 2020. It examined how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices, focusing on three medical interventions: hormone pregnancy tests (HPTs) sodium valproate pelvic mesh. The report outlined how these interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades. It made nine recommendations as part of this, two of which specifically concerned redress options for patients: “Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals. Recommendation 4: Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.”[1] Though the Government initially rejected both these recommendations, patients and family members harmed by these medical interventions continued to tirelessly campaign for appropriate redress.[2] Responding to this, in early 2023 the then Minister for Mental Health and the Women’s Health Strategy, Maria Caulfield MP, signalled that the Government would be willing to look again at the issue of redress. She commissioned the Patient Safety Commissioner for England to explore redress options for those who have been harmed by two of the interventions covered by the IMMDS Review: sodium valproate and pelvic mesh. The Hughes Report Published on the 7 February 2024, the Patient Safety Commissioner set out options for redress for those harmed by pelvic mesh and sodium valproate in The Hughes Report.[3] At the core of its recommendations is a proposal to create a two-stage financial redress scheme. Responding at the time, we set out our support for these recommendations.[4] Patient Safety Learning believes, like many individual patients and patient groups, that there must be redress options for patients harmed by the interventions covered by the IMMDS Review. There is considerable evidence that for many patients the clinical negligence route is simply not viable and, in the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need. We also believe that this should extend to those affected by hormone pregnancy tests, who fell outside of the scope of The Hughes Report’s recommendations. Excluding patients and family members affected by hormone pregnancy tests from redress is not acceptable or in keeping with the spirit of the IMMDS Review’s recommendations. Commenting on this, our Chief Executive Helen Hughes said: “It is now over four and a half years on from the redress schemes first being recommended by the IMMDS Review. We think that it is unacceptable that there has been no response to The Hughes Report, over a year after its publication. Patients and their families are suffering unacceptably without redress schemes. The Government must respond to this report promptly and take steps to deliver redress for all those affected by pelvic mesh, sodium valproate and hormone pregnancy tests as a matter of urgency.” References The IMMDS Review. First Do No Harm, 8 July 2020. Department of Health and Social Care. Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021. Patient Safety Commissioner for England. The Hughes Report: options for redress for those harmed by valproate and pelvic mesh, 7 February 2024. Patient Safety Learning. Reflections on The Hughes Report: Pelvic mesh, sodium valproate, hormone pregnancy tests and options for redress, 20 February 2024.- Posted
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Mesh victims still wait for financial compensation
Patient Safety Learning posted a news article in News
Women harmed by pelvic mesh implants are still waiting for government compensation a year after a major report, external called for urgent action. Patient safety commissioner Dr Henrietta Hughes, who made that recommendation, called it "an injustice" for the thousands of lives destroyed. Some women were left in permanent pain, unable to walk, work or have sex, after the surgery to treat incontinence and pelvic organ prolapse. The government says it remains "fully focused" on how best to support patients and prevent harm. A Department of Health and Social Care official said: "Our sympathies are with those affected. "This is a complex area of work and Health Minister Baroness Gillian Merron met with some of those affected before Christmas, and has committed to providing an update to the patient safety commissioner at the earliest opportunity." Dr Hughes said: "It is very disappointing that women who have suffered so much harm are still waiting for redress. "They need redress now and the government must act immediately." Read full story Source: BBC News, 7 February 2025- Posted
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MHRA issues guidance on medical device surveillance regulation
Mark Hughes posted a news article in News
The MHRA has published new guidance to medical device manufacturers on upcoming requirements around post-market surveillance New Post-market surveillance regulation for medical devices comes into force across England, Scotland and Wales on 16 June 2025 and introduces key new requirements around the monitoring of medical devices after they’ve entered the market. This includes more comprehensive data collection; shorter timeframes for reporting serious incidents and summary reporting to identify safety issues; and clearer obligations around risk mitigation and communication to protect user safety. Read full story. Source: Digital Health, 22 January 2025- Posted
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This was a debate in the House of Commons on the 16 January 2025 discussing the performance of the Medicines and Healthcare products Regulatory Agency (MHRA), the body responsible for the regulation of medicines and medical devices in the UK. The motion debated focused on the MHRA’s performance in relation to patient safety matters, including: the agency’s work on the hormone pregnancy tests, the Yellow Card System and safety monitoring, funding and the influence of the pharmaceutical industry and the implementation of recommendations made by the Independent Medicines and Medical Devices Safety review.- Posted
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Patient advocates Sling The Mesh will tomorrow (17 December) meet with Baroness Gillian Merron, the Minister for Patient Safety, to discuss financial redress options for women injured by pelvic mesh implants. The meeting marks a significant step forward in recognising the profound harm suffered by thousands of women across the UK and the urgent need for redress to address the physical, mental, and financial toll of their injuries. Pelvic mesh implants, including rectopexy mesh, were widely used to treat conditions such as pelvic organ prolapse and stress urinary incontinence, but have left many women with debilitating pain, organ damage, autoimmune disease and other life-altering complications. Despite years of campaigning for justice, affected women have faced mounting medical costs, lost income, lost pensions, and faced a diminished quality of life - with little financial support. Kath Sansom, founder of Sling The Mesh, said: “The government must act with speed to provide financial redress. Many women have their PIP applications turned down even though they are severely injured, hundreds have lost relationships, their jobs, their pensions. Some have had to sell their homes to live with family as they can’t afford mortgage payments anymore.” She added: “We were all innocent players in this appalling story which has taken a heavy toll on women, including financially. We trusted in a medical system that should have protected us. Instead, women have lost so much. Women harmed by mesh implants deserve financial redress to help rebuild their lives and gain some measure of justice for the suffering they’ve endured.” The meeting will focus on potential pathways for redress and hear of the urgency in addressing the issue, with many struggling to afford ongoing medical treatment and getting trapped in cycles of financial worry due to their injuries. One of the leading voices in Parliament supporting the cause, MP Sharon Hodgson, whose mam had had her life changed forever due to mesh, underscored the importance of the financial redress initiative. Sharon said: “It is crucial that women who have been harmed by pelvic mesh implants receive the compensation they so desperately need and deserve. These women’s lives have been shattered, through no fault of their own. It is our duty to ensure that they are not left to shoulder the burden alone. I fully support the bringing this issue to light and pushing for meaningful redress.” Rt Hon. Sir Julian Lewis, MP for New Forest East, who supports women in his local area who have been harmed by mesh, said: “The female mesh implant scandal is an ongoing NHS disaster. Constituents have been seriously injured, left permanently in pain, and forced to spend thousands of pounds on remedial surgery, with at best only partial success. They deserve substantial compensation and a serious research effort by the NHS to find new ways of safely removing these dreadfully damaging implants." Rt Hon. Sir Alec Shelbrooke MP, who has also supported women in Parliament for many years, added: “Medical misogyny plays a key part in this horrific scandal. Women were butchered, through no fault of their own. Most were not given fully informed consent. It is vital they are compensated financially and as soon as possible. They must not wait as the victims of the Thalidomide, infected blood and Post Office scandals have been forced to.” MP Sarah Green, who has supported her local constituents for years, said: "It is past time that mesh victims receive the redress they need and deserve. In February the Hughes Report by the Patient Safety Commissioner outlined how such a scheme could work. The Government now just need to deliver it" It is hoped the meeting will conclude with a commitment to further discussions and collaboration between the government and campaign groups to explore viable financial redress models and ensure no woman is left behind. In a recent Westminster debate about pelvic mesh held on 5 December, 2024, the Parliamentary Under Secretary of State for Health and Social Care, MP Andrew Gwynne, closed by making a commitment to move financial redress forward at pace. He said: "The previous Government were too slow on that (redress). It is a priority for this Government. We are working at pace, and we remain focused on making meaningful progress."- Posted
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