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Showing results for tags 'Medical device / equipment'.
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Content Article
The World Health Organization (WHO) has published a new edition of this guidance on health technology assessment (HTA) for medical devices. Health technology assessment (HTA) is described as ‘a well-recognised and methodologically robust evidence-based priority-setting process used to provide information on the safety, efficacy, quality, appropriateness, and cost-effectiveness of health technologies’. This document ‘is intended to provide guidance to policy-makers, particularly those in low- and middle-income countries that are currently developing HTA capacity.’ The document describes ‘general concepts of HTA and points to best-practice resources to enable low- and middle-income countries to make consistent, transparent and informed decision-making on the adoption and use of medical devices to ensure clinical needs are met whilst delivering value to patients, healthcare providers, and the broader health system.’- Posted
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- Medical device / equipment
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News Article
Thousands harmed and 87 dead after NHS equipment failures in England
Patient Safety Learning posted a news article in News
Almost 100 people have died and 4,000 have been harmed after equipment malfunctions in the NHS in the past three years, prompting calls for more government funding to upgrade broken and obsolete medical devices. A defibrillator advising paramedics not to administer a shock, an emergency alarm system on a neonatal ward failing, and the camera on an intubation device going dark were just three failures after which patients died. They are included in figures released for the first time by NHS England that show patients were harmed after 3,915 equipment malfunction incidents – with 87 being followed by a death – since 2022. Paul Whiteing, the chief executive of Action against Medical Accidents, said: “These are shocking statistics. Behind these numbers are real people who are needlessly harmed, the impact of which will be life-changing and traumatic. “The scale of the harm and loss of life that has resulted from basic equipment failures and malfunctions shows in stark relief the scale of the tragedy that has resulted from years of underfunding in the NHS.” The vast majority of incidents, which were logged by doctors and nurses when a device was broken, not fit for use or didn’t perform as expected, caused a low level of harm. That meant patients were unlikely to need further treatment beyond dressing changes or short courses of oral medicine. There were 522 moderate harm incidents, in which a patient’s independence could be limited for up to six months. Meanwhile, on top of the 87 deaths, 68 patients were severely harmed – meaning they could have received permanent damage from the incident, or had a reduced life expectancy. Read full story Source: The Guardian, 9 June 2025- Posted
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Content Article
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. -
News Article
Obsolete imaging equipment raises concerns in NI hospitals
Patient Safety Learning posted a news article in News
A report from the Northern Ireland Audit Office has found that 16% of imaging equipment used in healthcare settings is “effectively obsolete”. Comptroller and Auditor General Dorinnia Carville has raised concerns over the “substantial proportion of out-of-date equipment” and a growing gap between demand and capacity. Northern Ireland’s Department of Health said that while some of the equipment base “would ideally be replaced at a quicker rate”, it remains “safe and fit for purpose”. The report noted that around 90% of all hospital patients have images taken and interpreted. It said that increasing recognition of the benefits of imaging services has resulted in a “growing demand for them”. The report added: “Combined with changing patient demographics, and an absence of sustainable funding and resources, capacity has been unable to keep pace.” The report found that between 2018 and 2024, the health service delivered a total of 350,000 fewer scans (MRI, CT, and non-obstetric ultrasound scans) than what was required to meet demand. Similarly, waiting lists and waiting times for imaging services have risen in that period. The report said that timely replacement of imaging equipment is one of the “key components to service delivery and quality”. It said: “Currently 16% of all HSC imaging equipment is over 10 years old and is effectively obsolete. Older equipment can result in increased downtime and maintenance costs. It can also be potentially slower, reducing the number of patients which can be scanned, and may produce lower quality images meaning an increased risk of missed disease.” Read full story Source: Medscape, 31 March 2025- Posted
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- Screening
- Medical device / equipment
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News Article
NHS robots and scanners ‘must be used more intensively’
Patient Safety Learning posted a news article in News
Expensive scanners and surgical robots are underused and “lying fallow” at NHS hospitals, a report has said. Analysis shows a tenfold difference in how often NHS trusts use surgical robots — cutting-edge machines used for minimally invasive surgery that cost about £1.5 million each. There are also huge regional variations in the use of CT and MRI scanners, which help to diagnose illnesses including cancer and cost about £1 million each. Experts urged the NHS to ensure that each machine was used to the utmost to boost productivity and tackle hospital waiting lists of 7.4 million people. The report also warned that hospitals are failing to make full use of surgical robots, which can blitz through waiting lists by speeding up recovery times. In 2022 Buckinghamshire Healthcare Trust used its surgical robot less than once a week while other NHS hospitals used theirs nine times a week. Jonathan Eida, a researcher at the TPA, said: “Our analysis of high-value machines in the NHS further adds to the body of evidence that the health service is not in a healthy state. “It is absolutely absurd for such expensive equipment to lie fallow, particularly given the swollen waiting lists. If Labour wants to deliver the efficient and productive health service that taxpayers are paying for, maximising the use of these machines has to be a priority.” Read full story (paywalled) Source: The Times, 16 March 2025- Posted
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- Innovation
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News Article
Why popular blood sugar monitors could actually be harming your health
Patient Safety Learning posted a news article in News
Popular glucose monitors used to take regular blood sugar readings could be driving poor diets and food restrictions due to inaccurate measurements, according to a new study. Continuous Glucose Monitors (CGMs) take blood sugar readings every five minutes and were originally designed for people with diabetes to assess how their body responds to different foods. But they are growing in popularity and in recent years have increasingly been used by the health-conscious to track their diet and avoid glucose spikes. Carried out in healthy, non-diabetic volunteers, the research compared results from a CGM to the gold standard finger-prick test for blood sugar levels. Scientists found that the CGMs consistently reported higher levels than the finger-prick test. The monitors overestimated the time spent above the Diabetes UK’s recommended blood sugar level threshold by nearly 400 per cent, causing unnecessary concern for people whose blood sugar was actually well-controlled. Professor Javier Gonzalez, from the university’s department of health, warned people should stick with the finger-prick test if they are looking for accurate readings. “Continuous glucose monitors (CGMs) are fantastic tools for people with diabetes because even if a measurement isn’t perfectly accurate, it’s still better than not having a measurement at all,” he said. “However, for someone with good glucose control, they can be misleading based on their current performance." Read full story Source: The Independent, 26 February 2025- Posted
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Content Article
Healthcare at home has become an increasingly popular alternative to hospital-based treatment, offering patients the comfort and convenience of receiving care in familiar surroundings. However, while the home care model presents clear benefits, it also brings about unique challenges—especially when patients or their family members are tasked with operating complex medical devices. These devices, such as ventilators, haemodialysis machines, and infusion pumps, have traditionally been used in acute care settings, where healthcare professionals provide continuous oversight. With such devices increasingly being used in the home, the need for appropriate selection, management, and use of those technologies is becoming more critical. One of the most significant concerns associated with home healthcare is the potential for preventable harm due to improper use or malfunction of medical devices. As highlighted in ECRI’s annual Top 10 list of healthcare hazards, improper setup and management of these technologies, particularly by lay users, can result in delayed or inaccurate care, with serious consequences for patient health. This year, ECRI has expanded the discussion of this issue to explore in greater detail the risks associated with home use of complex medical devices.- Posted
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- Medical device / equipment
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News Article
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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News Article
Late delivery of equipment linked to patient’s death
Patient Safety Learning posted a news article in News
The late supply of defective equipment used by care staff to reduce harm from a pressure ulcer contributed to the death of a vulnerable patient, a coroner has concluded. Private provider NRS Healthcare supplies dozens of local authorities with equipment for patients in the community and contracts directly with NHS trusts providing community services. A prevention of future deaths notice issued by a coroner in north London last week said the court had heard evidence of “numerous and ongoing delays and ‘problems’ in the service provided by NRS Healthcare. While I heard that there had been some improvement, I was told that the service provided was still ‘not great’.” The inquest was into the death of Sheila Wexler, whom coroner Ian Potter found died of “natural causes, contributed to by increased immobility as a result of delayed and defective turning equipment being supplied for the treatment of a pressure ulcer”. Trust board papers presented to directors in January said: “There are known issues with NRS (pressure ulcer-relieving equipment company) for a number of equipment types since the contract implementation. Concerns were escalated to the integrated care board and the commissioners of this service. Although there [have] been some improvements it remains inconsistent.” The Whittington would not release its incident report or confirm how many people came to harm. It said: “Disclosing this incident report into the public domain could seek to damage our relations with the supplier in question, and possibly that with our other suppliers, which would not be in the public good.” Read full story (paywalled) Source: HSJ, 21 January 2025- Posted
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- Medical device / equipment
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Content Article
Mrs Sheila Wexler lived with dementia and other significant comorbidities for a number of years. In the months prior to her death, she was thought to be entering the final phase of her life. In January 2024, Mrs Wexler developed an unstageable sacral pressure ulcer. The district nursing team ordered equipment from an external supplier (NRS Healthcare) which, among other things, would turn Mrs Wexler regularly to assist in the treatment of the pressure ulcer. There were delays in some of the equipment arriving and the turning equipment was not properly functioning. An engineer attended Mrs Wexler’s home, on behalf of NRS Healthcare, to repair the equipment, but used a pump that was not compatible with the turning system. As a result of these issues with the equipment, Mrs Wexler’s immobility was significantly increased for a period of days, which added to her underlying risks of developing a pulmonary embolism. Mrs Wexler died at home on 17 February 2024. The immediate cause of her death was bilateral pulmonary embolism. A number of her comorbidities contributed to this. The increased immobility as a result of delayed and defective equipment being supplied also more than minimally contributed to her death. For context, NRS Healthcare is a nationwide supplier of medical equipment for use in people’s own homes and it has contracts with numerous NHS bodies and others, to supply and maintain such equipment. In this specific case, NRS Healthcare was required to provide and install medical equipment (at the request of one of the district nursing teams that are part of Central and North West London NHS Foundation Trust). This equipment included, a lateral turning system (known as a TOTO), an air mattress, and side rails for a profiling bed. The principal need for the equipment was for assistance in treating a sacral pressure wound. It was confirmed in evidence, the order for the equipment from NRS Healthcare was placed correctly on 10 January 2024, on a next day delivery basis. Matters of concern NRS Healthcare related matters: The coroner heard evidence of a delay in delivering some of the required equipment, which in turn meant a delay in the patient being able to make use of the equipment. The delay meant that the patient’s family, carers, and the district nursing team underwent a period of time in which they were unable to provide the patient with the optimal care required in relation to the pressure ulcer. When the TOTO turning system arrived it was defective. An urgent repair/replace request was made to NRS Healthcare, which resulted in an engineer attending the patient’s home to replace the pump on 23 January 2024. However, despite advising that they had replaced pump with a like-for- like pump, it transpired that the replacement pump was a ’Tri-Pos Bariatric Alternating Air Cushion’ pump. This replacement pump had none of the settings that would allow the proper and effective use of the TOTO system. In this instance, the TOTO system was required to turn the patient from one side to the other every 60 minutes. I was told in evidence that equipment issues would have added to the patients ‘pain and distress’ and the fitting of the incorrect pump meant that the patient was not being turned every 60 minutes, as required. Again, this creates the risk that those caring for the patient were precluded from providing an optimal level of care. While the presence of a pressure ulcer, in itself, did not add to the underlying risk of the patient developing a pulmonary embolism, the delayed and defective equipment provided significantly increased the patient’s immobility in the weeks prior to her death. There was evidence that immobility is a major risk factor in the development of pulmonary emboli. The coroner heard evidence that issues with delays and defective equipment from NRS Healthcare persist to date. NRS Healthcare and NHS England related matters: The coroner heard evidence that since being awarded the contract to provide such equipment, there had been numerous and ongoing delays and ‘problems’ in the service provided by NRS Healthcare. The evidence was such that the repeated issues and concerns had actually been placed on the Trust/Integrated Care Board’s (ICBs) risk register. While I heard that there had been some improvement, I was told that the service provided was still ‘not great’. While this particular case is the first in which the coroner has formed the opinion that delayed and defective equipment has created a risk of future deaths, he has heard similar evidence of delayed and defective equipment issues relating to NRS Healthcare in other inquests concerning different NHS Trusts and ICBs. On that basis, the coroner is of the opinion, given NRS Healthcare’s operations are not confined to organisations within this coroner area, that the risks posed are likely to be more widespread and that action should be taken more widely.- Posted
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News Article
The US Food and Drug Administration (FDA) has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labelling of these electronic medical devices. Pulse oximeters are small finger-clamp devices that estimate how much oxygen is being carried in the blood. Available both over the counter and by prescription, they grew in popularity during the Covid-19 pandemic. But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. One of the FDA's recommendations is to include “a diversely pigmented group of 150 or more healthy participants” in clinical studies of the devices, with at least 25% of participants falling within each skin color group on the system known as the Monk Skin Tone scale. Another is for manufacturers to “prominently display appropriate warnings” in the devices’ instructions, such as informing patients that “differences in skin pigmentation may cause differences in pulse oximeter sensor performance.” Read full article. Source: CNN, 6 January 2024.- Posted
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- Medical device / equipment
- Oxygen / gas / vapour
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Content Article
This article by BD looks at the the risks related to irritants and vesicants when medications are administered to patients via vascular access (into their blood vessels through a cannula). It highlights the immediate risks of vein irritation, pain, discomfort and potential tissue damage during an infusion, as well as looking at the impact of damage to vascular endothelial cells caused by irritants and vesicants. It offers guidance on selecting the right vascular access device (VAD) and includes a Vascular Access Device Assessment Decision Tree, which is free to download. -
Event
ECRI's Top 10 Health Technology Hazards for 2025 will identify the most significant and emerging risks in healthcare technology that require urgent attention this year. This influential annual report, now in its 18th year, has become a trusted resource for hospitals, health systems, ambulatory surgery centres and other care providers, as well as for medical device manufacturers and regulatory agencies. The report serves as a guide to help these organizations identify and address potential hazards that can impact both patient safety and staff well-being. Each year, ECRI evaluates and prioritizes risks across a wide range of healthcare technologies, offering actionable recommendations and specific calls to action for the industry to mitigate these dangers. The 2025 report covers 10 technology-related patient safety threats that warrant priority attention in today's rapidly evolving healthcare landscape. By identifying these risks early, ECRI helps healthcare providers and manufacturers take proactive steps to minimize harm, improve patient outcomes, and enhance the overall safety and reliability of healthcare systems. We invite you to join ECRI's Device Evaluation leaders as they examine the 10 hazards covered in our 2025 report. A panel of ECRI experts will describe the risks and offer insight into how each issue impacts both healthcare organizations and patients, and how all stakeholders can take effective action to reduce these risks. Learning Objectives This lab webcast will cover: The Challenges: Overview of the 10 technology safety topics selected for ECRI's 2025 report, along with discussion of the potential consequences for patient safety, clinician efficiency, and operational effectiveness. Practical Solutions: Step-by-step strategies and best practices for mitigating these risks, including recommendations for device selection and implementation, user training, and risk management practices that can help prevent harm. Industry Collaboration: Discussion of the current state of technology development and recommendations for how device manufacturers and other stakeholders can respond to these risks and improve the safety and reliability of these products. By participating in this webcast, you will gain a deeper understanding of the technology hazard landscape, learning how to identify and address the most pressing health technology hazards in your organization, and how collaboration across the healthcare ecosystem can drive meaningful change. Speakers Rob Schluth, Principal Project Officer I, Device Evaluation Francisco Rodriguez-Campos, Principal Project Officer I, Device Evaluation Priyanka Shah, Principal Project Officer I, Device Evaluation Kallie Smith, Vice President, Information Security Officer Karen Haberland, Senior Project Officer, Device Evaluation Jeremy Suggs, Senior Engineering Manager, Device Evaluation Brad Bonnette, Senior Project Officer, Device Evaluation Mukui Mutunga, Senior Project Officer, Device Evaluation Amanda Sivek, Principal Project Officer II, Device Safety Austin Hwang, Senior Project Officer, Device Safety Barbara Malanga, Director, Preventative Solutions and Device Safety Operations Patrice Hughes, Principal Project Officer I, Device Safety Register for the webcast -
News Article
The son of a man with motor neurone disease who died while waiting for a wheelchair from the NHS’ leading provider has accused them of "sincerely failing his dad". John Clarke, 67, was diagnosed with the disease in April. The NHS integrated care board in Stoke-on-Trent told him that AJM Healthcare would be providing his wheelchair and, following an assessment in May, he was told that it would be delivered in July. His family said they were then offered a different wheelchair, which was far too heavy, and instead resorted to buying him a second-hand wheelchair from eBay. Ben Clarke, John's son, told ITV News: "It’s not something anyone should have to face. "If you’re faced with a terminal illness and you’ve got limited time left, you don’t want to be fighting what you take to be the professionals from the off. Eight-year-old Summer Calvin is struggling at the hands of the same provider. She has a rare genetic condition which means she can’t walk or speak. It means that Summer is abnormally tall for her age and she grew out of her wheelchair in September 2022. But her family say the replacements being offered by AJM Healthcare haven’t been suitable. "We were told that they had a certain list of chairs that they could pick from, and they were only allowed to use those ones," Summer's mother Larissa Evans told ITV News. AJM Healthcare describes itself as the NHS’ leading provider of wheelchair services. The company supplies approximately 150,000 registered users, representing around 20% of all wheelchair service needs for NHS England. Yet over the past 12 months, the Parliamentary and Health Service Ombudsman (PHSO) has seen a sharp rise in complaints. Most relate to people not receiving new wheelchairs or the correct parts, and the waits range from a month to two years. Read full story Source: ITV News, 8 November 2024- Posted
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- Medical device / equipment
- Lack of resources
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News Article
‘I thought a vaginal mesh would help - instead it left me sobbing in agony’
Patient Safety Learning posted a news article in News
Women suffering complications from vaginal mesh implants, including after removal, are calling on the Government to overhaul the compensation process. Sharon Marchant, 61, from Bedfordshire, is one of thousands of women living with life-changing complications from a vaginal mesh implant. Vaginal mesh, which is made from the same material used to make drinks bottles, is an implant used to treat pelvic organ prolapse and stress urinary incontinence. For years it was viewed as the gold standard treatment for incontinence and prolapse in many women, but was later found to cause debilitating side effects including infection, pelvic and leg pain, difficulty urinating, pain during sex, and incontinence. Earlier this week it was revealed that propylene, the material used commonly used in vaginal mesh implants starts to degrade within 60 days of being implanted in the pelvis. Ms Marchant told i of the severe physical and mental pain she suffered due to her vaginal mesh implant. In 2014, she was recommended for a mesh implant after being diagnosed with stress-caused urinary incontinence. At the time, Ms Marchant did not know much about the vaginal mesh. “I hadn’t heard anything about it – good, bad or indifferent. “Having been a nurse in my younger years, I just thought, well, if they’re doing this, they must know what they’re doing,” she said. Within weeks she noticed something was wrong. “I could feel something that was uncomfortable. And so I had to do a self examination, and then I very quickly realised with the use of a mirror, there was a very large lump of blue mesh exposed.” She opted for a complete removal of the mesh and is relieved it is now gone. But as a result her stress incontinence worsened, requiring her to take new medication and does not feel comfortable enough to start a new relationship. “It’s just taken away a huge portion of my life,” she said. Some women are so desperate for the procedure they are travelling to the US and paying up to £30,000 for the procedure, i was told. Read full story Source: iNews, 26 October 2024- Posted
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- Womens health
- Medical device / equipment
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Content Article
This roadmap sets out the government’s ambition to transition away from all avoidable single-use medical technology (medtech) products towards a functioning circular system by 2045 that maximises reuse, remanufacture and recycling. Circularity in medtech means designing, procuring and processing medical products in a way that enables them to be reused, remanufactured or recycled, preserving their value for as long as possible. The benefits of a circular economy in the health sector are vast and increasingly well-understood, but are rarely put into practice and are difficult to scale. Unlocking these benefits across the UK medtech sector will bring many opportunities for innovation and growth, while improving patient care and value for money and supporting the transition to a net zero NHS. This document sets out a plan of 30 actions to deliver our 2045 vision, which will involve: driving positive behavioural change exploring new commercial incentives to provide circular medtech creating new standards to enable innovative products and services planning the decontamination and recycling infrastructure of the future establishing new collaborations to accelerate the emergence of transformative science.- Posted
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- Technology
- Medical device / equipment
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Event
Empower yourself to leverage adverse events as valuable lessons with this upcoming RAQA Deep Dives session. By analysing past adverse events (AEs) reported on similar products, you'll uncover crucial insights that help you better identify and mitigate potential risks in your own development process. Join expert speaker, Karolina Nożewska, a leading specialist in Quality Assurance and Regulatory Affairs for the medical device industry. With extensive expertise in ISO 13485, MDSAP, MDR, and FDA regulations, Karolina will provide you with comprehensive guidance to enhance compliance and empower you with essential industry insights. In this session, you'll dive deep into past AEs to gain insights for improving risk identification and mitigation strategies in your projects. You'll also learn how to transform these insights into actionable strategies for your current projects, with a special focus on refining your planning phase. Benefit from Karolina’s profound knowledge to strengthen your compliance practices and enhance your understanding of complex regulations. Finally, use lessons from past failures to refine your approach, leading to the development of safer and more effective medical devices. Register -
Event
Understanding the Mesh Scandal
Patient-Safety-Learning posted an event in Community Calendar
In this webinar, the patient campaigner Kath Sansom who will be talking to us about how the mesh scandal came about and the effect it has had on women, along with her amazing campaign work. She will be joined by two mesh injured women, Susan and Sharron, who will share their stories. Sign up for the webinar -
Event
An estimated 8% of injuries to healthcare workers in the hospital setting and 17% of worker injuries in the surgical setting are associated with scalpels. Scalpel-related injuries occur most commonly when blades are being attached to or removed from the scalpel handle. In addition to posing infection concerns, such incidents carry a high risk of causing structural damage to the hand, requiring extensive intervention and rehabilitation. Although the Occupational Safety and Health Administration mandates that employers "identify, evaluate, and implement" safer medical devices for healthcare workers, data indicates that such alternative devices are rarely used. In December, ECRI published evaluation findings for 11 scalpel blade removers—devices designed to facilitate safe blade removal and exchange in a variety of settings. Join experts from ECRI's Device Evaluation team as they discuss how this technology impacts patient safety and how to determine the best product for your needs. During this lab webcast, the following learning objectives will be discussed: The prevalence of scalpel-related injuries in healthcare Products available and ECRI's testing methodology Keys to successful implementation of the technology Register for the webcast- Posted
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- Medical device / equipment
- Surgery - General
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Content Article
This is one of a series of 'Learning from safety incidents' resources published by the Care Quality Commission (CQC). Each one briefly describes a critical issue—what happened, what the CQC and the provider have done about it, and the steps you can take to avoid it happening in your service. This edition is about ensuring the safety of people using wheelchairs in health and social care. The CQC recently prosecuted a care home provider for exposing someone using their service to a significant risk of avoidable harm, which resulted in a life-changing injury. Incident Before the incident, the person had been experiencing difficulties with mobility and had sometimes been confused and agitated. They had been provided with an adapted wheelchair with extended footplates for their own use, and staff helped them get around in it. However, staff mainly used a standard wheelchair for communal use within the care home. On several occasions, the person's foot had come away from the footplate when using a standard wheelchair, resulting in a risk of it getting trapped. On the day of the incident, while pushing the person down a slope in a standard wheelchair, the staff member noticed resistance and found the person's foot caught underneath. The staff member replaced the person's foot on the footplate and continued the journey. Afterwards, the person complained about pain in the affected leg and was taken to hospital for further assessment. The person was found to have significant, life-changing fractures to their leg and, at one stage, it was thought it may have to be amputated. The person spent 16 weeks in bed with their leg in a cast, before being discharged from hospital to a different service. Unfortunately, they did not make a full recovery and their physical health was permanently affected by the incident. The CQC's investigation found that, although the provider knew the risks associated with the use of a communal wheelchair, the care home failed to take adequate steps to assess and mitigate those risks. Recommendations To manage the risk of injuries to people from wheelchairs, health and social care providers need to: develop and implement adequate moving and handling plans develop and implement a risk assessment specific to a person's use of a wheelchair have adequate policies and procedures to support staff in managing these risks assess a person's mental capacity to decide about using a wheelchair, especially one not provided specifically for them provide staff with the training, skills and knowledge required to safely use a wheelchair seek the support of other professionals, such as occupational therapists, where required.- Posted
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- Disability
- Medical device / equipment
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Content Article
This alert is for action by all those responsible for the use, purchase, prescription and maintenance of medical beds, trolleys, bed rails, bed grab handles and lateral turning devices including all Acute and Community healthcare organisations, care homes, equipment providers, Occupational Therapists and early intervention teams. From 1 January 2018 to 31 December 2022, the MHRA received 18 reports of deaths related to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles, and 54 reports of serious injuries. The majority of these were due to entrapment or falls. Investigations into incidents involving falls often found the likely cause to be worn or broken parts, which should have been replaced during regular maintenance and servicing, but which were either not carried out or were carried out improperly. Actions required Update your organisation’s policies and procedures on procurement, provision, prescribing, servicing and maintenance of these devices in line with the MHRA’s updated guidance on the management and safe use of bed rails. Develop a plan for all applicable staff to have training relevant to their role within the next 12 months with regular updates. All training should be recorded. Review the medical device management system (inventory/database) for your organisation or third-party provider for devices within your organisation, including those which have been provided to a community setting (for example, the patient’s own home). Keep this system up to date. Implement maintenance and servicing schedules for the devices in the inventory/database, in line with the manufacturer’s instructions for use and/or service manual. Prioritise devices which have not had regular maintenance and servicing. If this is outsourced, compliance with the schedule should be monitored. Review patients who are children or adults with atypical anatomy as a priority. Ensure the equipment they have been provided with is compliant with BS EN 50637:2017 unless there is a reason for using a non-compliant bed. Record this on the risk assessment and put in place measures to reduce entrapment risks as far as possible. Review all patients who are currently provided with bed rails or bed grab handles to ensure there is a documented up-to-date risk assessment. Complete risk assessments for patients where this has not already been done and for each patient who is provided with bed rails or bed grab handles. Implement systems to update risk assessments where the equipment or the patient’s clinical condition has changed (for example, reduction/improvement in weight or mobility), and also at regular intervals.- Posted
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- Medical device / equipment
- Falls
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Content Article
The Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 aimed to: minimise burdens on public, independent and third sector employers and ensure businesses in UK are not placed at competitive disadvantage relative to EU counterparts offer good standards of protection to healthcare workers from risk of sharps injury at work see a fall in sharps injury numbers. This post implementation review (PIR) aimed to assess the success of these objectives. It found that: stakeholder consultation provided evidence of the increasing use of safer sharps across all healthcare sectors. evidence from RCN research and HSE inspections indicates that risks to healthcare workers from sharps injuries remains high. The policy conclusion from this evidence is that the Regulations are still required, and that the Regulations’ objectives cannot be met with a system that imposes less burden to business.- Posted
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- Staff safety
- Medical device / equipment
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Content Article
This blog from Matthew Bacon, CEO of TCC-CASEMIX Ltd, looks at why a multi-factorial dataset is needed to create holistic understanding of medical device performance and is the only effective means for determining the multi-factorial causes of failure. The Department of Health and Social Care has proudly announced that it has mandated the tracking of high-risk medical devices within NHS trusts – all in the name of avoidance of harm to patients. So, the Cumberlege report is now sorted! Advocates of patient safety need to be far more critical. I for one am astonished by the nativity of this simplistic strategy. A recent article in the New York Times suggesting that medical device makers have bankrolled a cottage industry of doctors and clinics that perform artery-clearing procedures that can lead to amputations is a great example of why I hold this opinion. The central point of failure here was not so much the failure of the medical devices (for example, stents, guidewires and catheters), but the procedural method associated with use. There will also be patient risk factors that are pertinent to the failure as well. The loss of a limb is the direct consequence of the surgical intervention. At TCC-CASEMIX Ltd we do not only identify each use of the device (Class IIb & Class III), but we also acquire a multi-factorial dataset to create holistic understanding of medical device performance. A few examples of the datasets that we consider are critical are: Patient risk factors (a few pointed out in the article New York Times article). We correlate these factors presented through the electronic patient record, with post-intervention outcomes following a procedural intervention tracking the use of the medical devices. This is how patient learning becomes part of the feedback loop to inform which devices, aligned to specific methods and outcomes, enable predictive safety. Procedural method. The best medical device used inappropriately (often with lack of evidence to inform the decision making by the health professional) can substantially increase the risk of harm to the patient. In many different interventions there are a variety of alternative procedures and associated medical devices available, each of which can be correlated to different patient complexities (risk factors). Human factors. Research shows that there can be repeated failures of the devices because of the incorrect/ inappropriate medical device selection. For example, for the less experienced healthcare professional, the choice of the correct size of stent, guidewire or catheter will be critical to the success of the outcome. Incompatibility between any of these devices can lead to an adverse event. Literature clearly identifies that the majority of device failures go unrecorded. This data acquisition platform records exactly what happens during a specific (atomic level) procedure associated with a specific devices or multiple devices used for it and is an effective means for determining the multi-factorial causes of failure. Routine data acquisition beyond simply identifying which device has been used with which patient is clearly insufficient. It will do nothing to improve patient safety.- Posted
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- Health and safety
- Medical device / equipment
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Content Article
The extent to which postintensive care unit (ICU) clinics may improve patient safety for those discharged after receiving intensive care remains unclear. This observational cohort study from Karlick et al., conducted at an academic, tertiary care medical centre, used qualitative survey data analysed via conventional content analysis to describe patient safety threats encountered in the post-ICU clinic. For 83 included patients, safety threats were identified for 60 patients resulting in 96 separate safety threats. These were categorised into 7 themes: medication errors (27%); inadequate medical follow-up (25%); inadequate patient support (16%); high-risk behaviours (5%); medical complications (5%); equipment/supplies failures (4%); and other (18%). Of the 96 safety threats, 41% were preventable, 27% ameliorable, and 32% were neither preventable nor ameliorable. Nearly 3 out of 4 patients within a post-ICU clinic had an identifiable safety threat. Medication errors and delayed medical follow-up were the most common safety threats identified; most were either preventable or ameliorable.- Posted
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- Patient safety incident
- Never event
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Content Article
Postpartum haemorrhage is a leading cause of maternal deaths. Now a new study points to a surprisingly simple and inexpensive solution. If the woman lies on a plastic sheet with a small transparent pouch at the other end to collect the blood, the medical team has an immediate sense of how much danger she's in and can take swift action. Read the full article, published by NPR, via the link below.