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Showing results for tags 'Medical device / equipment'.
Found 218 results
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Content ArticleWhen was the last time your board discussed procurement and its role in your strategy for improving health outcomes? It’s been four months since Heather Tierney-Moore took over as interim chair of NHS Supply Chain and in this blog she reflects on the world of NHS procurement, where it has come from and where it might be going.
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News Article
Scots mum considered ending her life due to mesh hell after suffering hernia
Patient Safety Learning posted a news article in News
A mum says her life has been destroyed following a hernia repaired with a mesh implant – with pain so severe she considered ending her life. Roseanna Clarkin, 38, has suffered excruciating pain since medics used mesh products to repair the issue. Now she wants the use of mesh in hernia operations to be suspended, as it has for vaginal mesh following years of suffering by thousands of women. Revealing her own hell, Roseanna told how she was in so much pain last month she asked for guidance about how to legally end her own life. She added: "When I was going to the doctor's after my op, I wasn't believed. They told me it was all in my head and even told my husband Brendan 'Don't get roped into this'". Roseanna said: "I suspect the mesh has moved. But even the other week one of the GPs at my practice was suggesting it was in my head." Roseanna launched a petition calling for the suspension of mesh in hernia ops. It is going through the public petitions committee at Holyrood. To date, more than 70 patients or their families have written to the committee about their experiences with hernia mesh implants. Labour's health spokeswoman, Jackie Baillie, who campaigned for vaginal mesh ops to be suspended, called for an urgent review of the uses of mesh for other procedures. She said: "It has taken years for the serious problems caused for women who had transvaginal mesh used in their surgical treatment to be resolved but it appears to be affecting other conditions too." She warned: "We can't repeat the mistakes of the past." Read full story Source: Daily Record, 31 January 2022 -
News Article
HeartWare gadget was a ticking time bomb for our daughter
Patient Safety Learning posted a news article in News
At the age of 36, Nola Borcherds could hardly walk ten steps without gasping for breath. A viral infection years earlier had weakened her heart and left her with a constant wheezy chest. Her heart was failing and she needed a new one. No transplant was available, but the next best thing was an implant called HeartWare. Unlike pacemakers, which send an electrical pulse to keep it beating regularly, the device would attach to Nola’s heart and keep her alive by taking over its function, continuously pumping blood around the body. Brochures promised the gadget could be life changing. It was smaller, safer and more effective than others, and designed to last up to ten years, raising her chance of a transplant. When Nola’s pump was implanted in December 2018 it made a tremendous difference. “Two to three months after she had it fitted, she could virtually run up the stairs,” her mother, Jenny Kiddie said. But on 21 May 2021, two and a half years after the device went in, it stopped working. Doctors at Harefield Hospital in Hillingdon, west London, were carrying out maintenance when it failed to turn back on, cutting the supply of blood to her brain. “The hospital called and said, ‘Nola’s become very unwell. How quickly can you get here?’” her mother said. “By the time we arrived, she was already in the morgue.” What her family believe Nola did not know, and what the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), failed to react to, was that HeartWare pumps had already been linked to hundreds of deaths globally. As early as 2011 some doctors switched to alternatives. Yet the UK regulator allowed them to stay on the market — and they continued to be implanted on the NHS until last year. Some patients are still living with the pieces of equipment, because surgery to remove them is so risky. Families, medical experts and lawyers want to know why the MHRA failed to take firm action despite repeated warnings about the devices, which they believe could have contributed to patients dying. By Nola’s death last year, the health regulator had passed on at least 16 safety alerts to doctors warning of problems identified by the manufacturer. Read full story Source: The Sunday Times, 23 January 2022 -
News ArticleThe Irish Cabinet has approved general indemnity cover and product liability cover for claims to two public sector bodies relating to transvaginal mesh products and the Gardasil HPV vaccine. The Health Minister Stephen Donnelly brought forward a proposal to Cabinet Wednesday for the provision of this cover to the Irish Blood Transfusion Service (IBTS) and the Mental Health Commission (MHC) for claims relating to the mesh products or Gardasil. Gardasil is a type of vaccine used to protect against HPV. Vaginal mesh devices have been used in operations to treat stress urinary incontinence and pelvic organ prolapse; two conditions that can impact women after natural childbirth or in their later years. Including the bodies in the State’s general indemnity scheme for these claims will eliminate the requirement for them to carry private insurance. The State Claims Agency was consulted and indicated that it supports the inclusion of both bodies under the scheme. The clinical indemnity scheme indemnifies hospitals but is confined to clinical acts and/or omissions and doesn’t cover product liability matters. Current legal cases around transvaginal mesh products involve allegations in relation to the product itself and allegations of clinical negligence. It has now been proposed to delegate the product liability claims for mesh products to the State Claims Agency to ensure hospitals aren’t exposed to uninsured liability. Thousands of women across the world have suffered complications after having a vaginal mesh device implanted. These complications include chronic pain and recurrent urinary tract infections and have been life-changing in many cases. Read full story Source: thejournal.ie, 19 January 2022
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Content Article
The bleeding edge (2018)
Patient-Safety-Learning posted an article in Medical devices (new)
This documentary takes a look at the fast-growing medical device industry and reveals how the rush to innovate can lead to devastating consequences for patients. -
Content ArticleWhen the pandemic began, many nations’ emergency stockpiles came into the spotlight—and were found wanting. Twenty months later, Jane Feinmann asks what happened, and if procurement has got any better.
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Content ArticleIn this episode of BBC Panorama, Reporter Deborah Cohen investigates how medical devices can cause harm to patients, and the lack of support and redress available when things go wrong.
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Content Article'Kicking the Hornet’s Nest' is a documentary that looks at power morcellation, a popular gynaecologic procedure used to perform hysterectomies. The documentary demonstrates how the practice has been inadvertently spreading cancer in patients for decades. It includes first-person testimonies and archival footage and follows two married, Harvard-affiliated whistle-blowers who have been personally impacted by the procedure, as they campaign to expose the controversial practice and prevent future needless deaths.
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Content ArticleThis article explores the use of infrared thermometers to screen for fever to detect Covid-19, and how they are not accurate enough alone to support a medical diagnosis.
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Content ArticleThis article looks at a safety issue around the initiation of humidified oxygen treatment. It examines an incident which resulted in a patient's death when they did not receive oxygen.
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Content ArticleThis report looks at an incident where a neonate suffered an oesophageal perforation following endotracheal and nasogastric tube insertion.
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Content ArticleWhere a new or under-recognised risk identified through the NHS England's review of patient safety events doesn’t meet the criteria for a National Patient Safety Alert, NHS England look to work with partner organisations, who may be better placed to take action to address the issue. To highlight this work and show the importance of recording patient safety events, they publish regular case studies. These case studies 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.
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Content ArticleColette Longstaffe, a registered nurse working in NHS Supply Chain in the Clinical and Product Assurance Team (CaPA), discusses how medical device design can impact on usability and patient safety, and the importance of embedding human factor principles into product specifications for the NHS procurement frameworks.
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Content ArticleTCC-CASEMIX has created a unique infrastructure to provide total traceability of medical device performance. This infrastructure is supported by The Association of British HealthTech Industries [ABHI]. We refer to it as an 'Open Registry Infrastructure' for medical devices. It is 'open', because unlike existing clinically focused registries, which are 'closed', we enable wide searches across the registries connected into it. It is 'open' because registries will 'declare the content' (I don't know what I don't know, so how can I search for what I don't know?) Access to this infrastructure is through a Data Access Portal which is being configured for the specific needs of each stakeholder group. We are seeking interest from patient groups who would like to join an Advisory Board to help specify how data should be presented to patients in a way that is relevant and meaningful. Our vision is to link this portal into an enhanced pre-operative assessment process, and to transform patient informed consent.
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Content ArticleThis article in BMC Health Services Research looks at a range of macro, meso and micro factors influencing eHealth innovation in the English NHS. eHealth is a broad term which encompasses e-health, m-health, telemedicine and telecare, public health surveillance, personalised medicine/patient engagement, health and medical platforms, self-tracking, medical imaging, healthcare information systems, mobile connectivity, social networking, sensors and wearables, gamification, electronic health records, big data, health information technology, health analytics, digitised health systems, robotics and active assistive living. The study found that the fragmentation of the NHS is the most significant factor limiting the adoption of eHealth innovations, arguing that national policy has intensified the digital divide. It states that the NHS Long Term Plan places great emphasis on the role of digital transformation in aiding communication and enabling people to access care quickly and easily, highlighting significant implications for effectiveness, efficiency and equity.
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News Article
Cardiac arrest: Thousands of defibrillators unknown to 999 service
Patient Safety Learning posted a news article in News
Tens of thousands of defibrillators across the UK risk being unusable because 999 call handlers do not know about them. When someone has a cardiac arrest, ambulance staff can only direct bystanders to the nearest defibrillator if it is on a central register. "That could be the difference between life and death," said Adam Fletcher, head of British Heart Foundation Cymru. A campaign to register defibrillators on The Circuit has now been launched. Survival rates are low in the more than 30,000 out-of-hospital cardiac arrests each year in the UK, according to the British Heart Foundation (BHF) - with fewer than one in 10 people surviving. BHF said early CPR and defibrillation could double the chances of surviving and it was often down to 999 call handlers being aware that a defibrillator was nearby. "If we don't know a defibrillator is there, we can't send somebody to get it, to potentially save somebody's life," said Carl Powell, the clinical support lead for cardiac care with the Welsh Ambulance Service. Read full story Source: BBC News, 22 October 2021 -
Content Article
WireSafe® is an innovative solution designed to prevent retained guidewires during central venous catheter (CVC) insertion. Retained guidewires are never events that require urgent removal if accidentally left in. They occur in about 1 in 300,000 procedures. We interviewed Maryanne, who developed the WireSafe®, on the innovation, the human factor considerations in designing it and the difficulties she faced getting a new product into the NHS. -
Content ArticleThis article looks at the issue of oxygen hoses becoming disconnected from transport ventilators when patients are moved between hospitals, which led to a patient death. Following the incident, the National Patient Safety team worked with national partners involved in transfer of patients to ensure a ‘tug test’ is incorporated into local practice.
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Content Article
NHS England: Variation in use of cardiac telemetry
Becky T posted an article in Medical devices (existing)
This article discusses the use of wireless heart monitoring in hospitals - telemetry - and the safety standards that need to be met. -
Content Article
Prevention of Future Deaths report – Mary Land
Mark Hughes posted an article in Coroner reports
Mary Land was a patient on an Acute Respiratory care unit 'surge' ward at Pinderfield Hospital, being treated for COVID pneumonia against a backdrop of comorbidities. On 5 February 2021 she was discovered in an unresponsive condition, with the tube connecting her facemask to a BIPAP ventilator detached at the connection point to the mask. In his report, the Coroner raised patient safety concerns relating to how the tubes of her Philips Respironics AF 541 mask became detached from the ventilator. -
Content Article
Prevention of Future Deaths report – Ann Geraghty
Patient Safety Learning posted an article in Coroner reports
Ann Geraghty was being treated for heart failure at Good Hope Hospital and subsequently died following a cardiac arrest. In their report, the Coroner raised patient safety concerns relating to two periods of ventricular standstill (this is a rare issue when the heart stops beating and stands perfectly still), which were missed due to a combination of policy, staffing, workplace and equipment issues. -
News ArticleAfter three Covid-19 patients died at the make-shift Nightingale Hospital in London following a breathing tube mix-up, NHS trusts in England could be issued tougher ventilation guidance. In each of the cases, filters which prevent the build-up of fluid were not attached to the machines, resulting in dangerous blockages, but it has not yet been determined if these incidents contributed to their deaths. Coroner Nadia Persaud has said the way the machines vary from model to model can be "confusing" and may lead to future deaths, also ruling that the classification and colour coding was "worthy of review, simplification, and standardisation". The original coroners report, carrying advice from an independent expert said "In my opinion, the non-standardised colour coding used by manufacturers of these filters, the number of different types of filters with different names, the variable optimal position of the filters, and whether a wet or a dry breathing system is being used, results in an extremely confusing situation. One of the leading manufacturers of these filters produces HMEs that are blue, which is the same colour as the non-HME filters supplied by another company. In my experience, few doctors and nurses working in ICU are knowledgeable about all these different filters and which ones should be used for any given breathing system." Inquests into the deaths are scheduled for October. Read full story. Source: The Daily Mail, 17 August 2021
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Content ArticleIn this article, published by the Harm & Evidence Research Collaborative, Sharon Hartles examines the UK Government’s response in relation to the implementation of the recommendations set out in the Independent Medicines and Medical Devices Safety Review, First Do No Harm report. She explores how the Government’s response has impacted on those harmed by the side effects of Primodos, Mesh and Sodium Valproate.
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Content ArticleKishorkumar Patel and Kofi Aning were both treated at the Nightingale Hospital in London in April 2021. In both cases there was a serious incident in which the wrong filter was found to have been used within the breathing systems of their intensive care ventilator.
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Content ArticleThe Government has recently published it's response to the recommendations set out in the First Do No Harm report of the Independent Medicines and Medical Devices Safety Review, chaired by Julia Cumberlege. One of the recommendations was for manufacturers to publish details of payments they make to teaching hospitals, research institutions, and individual clinicians, similar to the American Physician Sunshine Payment Act. The Government has said it is “exploring options to expand and reinforce current industry schemes, including making reporting mandatory through legislation.” In this editorial, Sonia McLeod looks at the gaps that exist in the UK's current system for disclosure and highlights some important considerations when setting up a new system or process if it is to be effective. Read the full article Related reading: A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Independent Report of the Patient Reference Group – response to the report of the Independent Medicines and Medical Devices Safety Review (21 July 2021) No such thing as a free lunch – why recording conflicts of interests must be mandatory
