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Showing results for tags 'Medical device'.
Found 337 results
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Content Article
HSJ Roundtable: Ensuring safe vascular access
Patient Safety Learning posted an article in Patient management
Ensuring safe vascular access is a fundamental part of the care of many hospital patients with up to 90% of inpatients requiring intravenous access for delivery of fluids and medication or blood sampling. Historically vascular access has been carried out by anaesthetists, radiologists and medical consultants. But an HSJ roundtable heard that introducing specialist teams to assess patients for vascular access, and then insert, care and maintain devices has many advantages from both an organisational perspective and that of the patient. -
Content ArticleMedical device and drug safety recalls are on the up. But is there a way to predict which products will be recalled in the future?
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Content Article
Endoscopy safety: Staff attitudes survey
Patient Safety Learning posted an article in Medical devices (existing)
The Joint Advisory Group on GI Endoscopy (JAG) and Imperial College London are conducting a survey into the safety attitudes of all endoscopy staff across UK & Ireland endoscopy services. Your views are vital in understanding current safety practices across endoscopy nationally. This survey takes less than 7 minutes to complete. -
Content ArticleThis guide for people who inject insulin or GLP-1 to treat diabetes includes information on: how to correctly inject insulin where to inject to ensure insulin and GLP-1 medication enter the body correctly how to avoid ‘Lipos’ how to store medication correctly how to dispose of needles safely.
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Content ArticleThis checklist is for people who inject insulin or GLP-1 medication to treat their diabetes. It details the steps patients should take to ensure they inject their medication correctly and explains the impact of failing to take certain steps - such as moving injection sites and changing needles - on blood glucose control.
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Content Article
The operation that ruined my life (BBC Panorama, 29 November 2022)
Sam posted an article in Women's health
Women across the UK are suffering after an operation they were told would transform their lives. Instead, some of them say their lives have been ruined. For years women have been fitted with mesh-like devices to treat prolapse or incontinence - often caused by childbirth. Although it's been a successful treatment for many of them, thousands of women in the US, the UK and Australia are now suing, after finding themselves in agony or suffering other serious complications. -
Content ArticleBev Curtis, Medical Device Safety Officer (MDSO) at Harrogate & District NHS Foundation Trust, describes the role of the MDSO in this presentation.
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Content Article
In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that the UK regulatory systems for medicines and healthcare have not been fit for purpose for a number of years. Framed within the context of the Cumberlege Review, Kath uses evidence and personal insight to highlight flaws in the system, and to make the case for urgent reform. -
Content ArticlePatient safety alerts are issued to providers of NHS care to support them to take specific actions to keep patients safe. Although some content of past alerts is outdated, some of the actions from previously issued alerts continue to be relevant and remain valid beyond the timescales of the original alert. Over 140 alerts issued up to November 2019 (including ‘notices’ or ‘rapid response reports’) were recently clinically reviewed to identify which actions within those alerts remain valid and should be considered as ‘enduring standards’. The review covered alerts issued by the NHS England and NHS Improvement National Patient Safety Team and its predecessor organisation, the National Patient Safety Agency (NPSA). The review also summarised other content from the alerts identified as general principles that can be applied more widely to inform wider ongoing safety improvement. The key elements from the review are highlighted. The pages do not set out any new actions for organisations to implement, but act as an aid to support providers to confirm that ‘enduring standards’ from previously completed alerts have been embedded locally, and that the general principles are considered within ongoing patient safety improvement.
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Content ArticleThe purpose of this document from the Medicines and Healthcare products Regulatory Agency (MHRA) is to provide information and guidance to all involved with the purchase, management and use of non-invasive blood pressure measurement devices. It reviews the advantages and disadvantages of mercury, aneroid, electronic manual sphygmomanometers and automated blood pressure measuring devices. This should help to ensure the most appropriate technology is selected for use.
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News Article
New NHS model needed for adoption of innovative medical devices
Patient Safety Learning posted a news article in News
The system for introducing new medical technologies into the NHS remains complex, crowded, and difficult to manage, according to a new report by the Medical Technology Group (MTG). The paper also calls for innovative treatments with medical devices to be given the same support as new pharmaceutical medicines. Current NHS mechanisms to support the uptake and use of innovative technology are severely limited in scope and are focused on ‘picking winners’ rather than the broad system-wide adoption of new technology, the report states. It points to the Accelerated Access Pathway, for instance, which supports fewer than 10 technologies each year; and the lack of a clear mechanism to support the widespread uptake of innovative products across the NHS. And the absence of a broad, national commissioning policy means patients sometimes miss out on the benefits of established technology due to a regional variation in access. Read full story Source: BBH, 24 March 2021 -
Content Article
ECRI: Top 10 patient safety concerns 2021
Patient Safety Learning posted an article in International patient safety
ECRI Institute's Top 10 patient Safety concerns for 2021 report highlights patient safety concerns across the continuum of care because patient safety strategies increasingly focus on collaborating with other provider organisations, community agencies, patients or residents, and family members. Each patient safety concern on this list may affect more than one setting and involve a wide range of personnel. -
News ArticleDevices which measure blood oxygen levels could be giving “seriously misleading” results for Black and minority ethnic people, possibly contributing to increased Covid-19 mortality, experts have warned. Pulse oximeters attach a clip-like device to a person’s finger, toe or earlobe and send a beam of infrared light to measure oxygen levels in the blood. The resulting reading can be used to monitor oxygen levels of people with a variety of conditions, including by people at home with coronavirus, and to assess patients in hospital. At the moment, coronavirus patients who call an ambulance but are not yet deemed sick enough to go to hospital are being given new home oxygen monitoring kits to help spot those who may deteriorate earlier, and over 300,000 oximeters have been sent out by NHS England. But a new paper cites a “growing body of evidence” that pulse oximetry is less accurate in darker skinned patients. This could be contributing to health inequalities such as the increased COVID-19 mortality rates of ethnic minority patients, according to a review conducted for the NHS Race and Health Observatory. It is now calling for the Medicines and Healthcare products Regulatory Agency (MHRA) to urgently review pulse oximetry products for ethnic minority people used in hospitals and by the wider public. Read full story Source: The Independent, 27 March 2021
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Content ArticleThe first meeting of the Independent Medicines and Medical Device Safety Review (IMMDS) Patient Reference Group took place on Thursday 25th February. The website contains summaries of all the meetings.
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Content Article
Mesh: Denial, half-truths and the harms (March 2021)
Patient Safety Learning posted an article in Women's health
In this article, Sharon Hartles, a member of the Harm and Evidence Research Collaborative, critically discusses the harmful impacts of mesh medical devices against the backdrop of disempowerment, denial and half-truths. Surgical meshes have been in use since the late 19th century. In the mid-20th century the clinical usage of mesh increased. Now, in the early 21st century, procedures involving mesh implantation are common surgeries that are performed around the world. Despite the frequency and worldwide usage of mesh medical devices, the debate about whether or not the benefits outweigh the alleged harms remains highly contested. Read the full article Further recommended reading: Dangerous exclusions: The risk to patient safety of sex and gender bias Healing after harm: A restorative approach to incidents Analysing the Cumberlege Review: Who should join the dots for patient safety? Findings of the Cumberlege Review: informed consent Findings of the Cumberlege Review: patient complaints -
Content ArticleThe Medicines and Medical Devices Bill has received royal assent and has become law. The new Act will enable the Department of Health and Social Care (DHSC) to implement a number of policies to amend the existing regulatory frameworks, although generally regulations under the Act must first be introduced. The potential changes include: Supporting the availability of medicines: enabling hub and spoke arrangements between different legal entities, to ‘support wider use of automation to bring increased efficiencies’; requiring manufacturers to provide electronic patient information leaflets; and increasing the professions able to prescribe and supply certain medicines. Protecting the public: developing a UK medicines verification system; introducing a national registration scheme for online sellers of medicines; and facilitating supply of medicines and medical devices during non-pandemic public health emergencies.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
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Today, Patient Safety Learning stands with others around the world to celebrate International Women’s Day 2021. In light of this year’s campaign theme “choose to challenge” we are raising awareness of some of the ways in which male bias can negatively impact on patient safety. Drawing on case studies and quantitative research, this blog focuses on three key areas: Design – using examples to illustrate how male-centric design of equipment and medical devices affects patient safety. Data – discussing how data which does not account for differences between the sexes impacts on patient safety. Dismissal – considering the recurring theme from personal testimonials, and healthcare scandals in recent years, that women’s voices and patient safety concerns are being ignored or dismissed. We will reflect on the key patient safety issues and inequalities in each of these areas and offer our perspective on what needs to happen moving forward to prevent future avoidable harm. -
Content ArticleAt the First Do No Harm All Party Parliamentary Group (APPG) meeting on 26 January 2021 with the Minister for Patient Safety, Nadine Dorries MP, attendees asked a large number of questions, not all of which could be answered by the Minister due to time constraints. The unanswered questions were submitted to the Minister’s office at the Department for Health and Social Care for a written response. The Department has now provided answers.
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Content ArticleThe General Medical Council (GMC) has updated their ethical guidance on Good practice in prescribing and managing medicines and devices.
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Content ArticleRisk of complications following hernia repair is the key parameter to assess risk/benefit ratio of a technique. As mesh devices are permanent, their risks are life-long. Too many reports in the past assessed mesh safety prematurely after short follow-ups. Peterson et al. aimed to explore what length of follow up would reveal the full extent of complications. The authors concluded that follow-up of more than 15 years is needed to fully assess complications after mesh hernia repair. Especially longer periods are needed to detect mesh erosion into organs and complications in younger males. Presently, short observations and lack of reporting standard in the literature prohibit accurate assessment of complication risks.
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Content Article
Kate Pym, Managing Director of Pym's Consultancy, discusses the barriers involved in getting an innovative product into the NHS.- Posted
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Content ArticleA large proportion of the patient injuries or deaths attributable to medical device misuse can be eliminated and/or mitigated by adopting an effective human factors and ergonomics (HFE) approach. The implementation of a usability engineering process is now mandatory for medical devices manufacturers seeking to obtain the European Union’s CE Mark. In this article, Pelayo, Marcilly and Bellandi describe the European Union’s HFE regulation and highlight the challenges faced by (i) manufacturers implementing this regulation and (ii) regulatory bodies charged with assessing the compliance of usability files. In Europe, 95% of MD manufacturers are small- and medium-sized enterprises; compliance with the CE Mark regulations is a real challenge to their competitiveness. Levels of knowledge about HFE vary greatly from one regulatory organisation to another, which can sometimes lead to very different expectations. The authors also present the specific use-related risk management approach required by the HFE regulation. Lastly, they focus on the limitations of the HFE regulation for MDs and on future HFE challenges in further reducing and/or eliminating MD use errors. The main challenge is the need to go beyond technology design and the premarket assessment and to look at the postproduction stage; the coupling between an MD and a sociotechnical system can lead to consequences that were not predicted during the design process. This implies the need to consider the emerging properties of technologies in use by involving all the stakeholders.
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Content ArticleThis is a video recording of the All Party Parliamentary Group (APPG) for First Do No Harm meeting with Nadine Dorries MP, the Minister for Patient Safety, Suicide Prevention and Mental Health. The meeting took place on 26 January 2021 and is chaired by Baroness Cumberlege who is the Co-Chair of the APPG. The APPG was set up to raise awareness of and build support for the recommendations in 'First Do No Harm', the report of the Independent Medicines and Medical Devices Safety Review, and to ensure the implementation of the recommendations by the UK government and others.
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Content ArticleIn this written statement to Parliament, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, gives an update on the government’s response to the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review. Nadine Dorries concludes: "The report of the IMMDS Review powerfully demonstrates the importance of hearing the patient voice in patient safety matters. The actions outlined here demonstrate the government’s commitment to learning from this report, and will support vital work already underway to hear the voice of the patient as part of the NHS Patient Safety Strategy. We currently plan to respond further to the report of the IMMDS Review during 2021."
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