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Showing results for tags 'Medical device / equipment'.
Found 224 results
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News Article
MHRA's response to the Cumberlege report
Patient Safety Learning posted a news article in News
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to the Independent Medicines and Medical Devices Safety Review. In its response, the MHRA said: “Today’s publication of the Independent Medicines and Medical Devices Safety Review is of profound importance for the MHRA, since the safety of the public is our first priority." "We therefore take this report and its findings extremely seriously. Throughout the Review’s work we have listened intently to the many distressing experiences of women and their families. We will now carefully study the findings and recommendations of the Report. We recognise that patient safety must be continually protected and that many of the major changes recommended by the Review cannot wait. We are therefore making changes without delay to ensure that we listen to patients and involve them in every aspect of our work. We are already taking steps to strengthen our collaboration with all bodies in the healthcare system and will strive to ensure that, working with these other bodies, the safety changes we advise are embedded without delay in clinical practice. We wholeheartedly commit to demonstrating to those patients and families who have shared their experiences during the Review, and anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. We are determined to put patients and the public at the heart of everything we do." Read full statement Source: GOV.UK, 8 July 2020 -
News ArticleFormer health secretary Jeremy Hunt has warned ministers not to let the Cumberlege review “gather dust on a shelf”. The chair of the Commons Health and Social Care Committee told The Independent it was vital action was taken to implement the recommendations. Mr Hunt, who made patient safety a key focus of his tenure as health secretary, backed the idea of an independent patient safety commissioner that would be outside the NHS and have powers to advocate for patient issues. Mr Hunt said: “This report should be a powerful wake-up call that our healthcare system is still too closed, defensive and focused on blame rather than learning lessons. It’s truly harrowing to hear of all the women and families who live with permanent anguish because of these medicines and devices, and it has clearly taken too long for their voices to be heard.” “The NHS is one of the safest health systems in the world, and we’re all rightly in awe of our frontline heroes. But in healthcare getting it right ‘most’ times isn’t good enough because the exceptions wreak lifelong devastation on families. So we must not allow this seminal report to gather dust on a shelf: lessons must be learnt once and for all.” Read full story Source: The Independent, 8 July 2020
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News Article
Lives ruined as damage viewed as 'women's problems'
Patient Safety Learning posted a news article in News
Many lives have been ruined because officials failed to hear the concerns of women given drugs and procedures that caused them or their babies considerable harm, says a review. More than 700 women and their families shared "harrowing" details about vaginal mesh, Primodos and an epilepsy drug called sodium valproate. Too often worries and complaints were dismissed as "women's problems". It says arrogant attitudes left women traumatised, intimidated and confused. June Wray, 73 and from Newcastle, experienced chronic pain after having a vaginal mesh procedure in 2009. "Sometimes the pain is so severe, I feel like I will pass out. But when I told GPs and surgeons, they didn't believe me. They just looked at me like I was mad." The chairwoman of the highly critical review, Baroness Julia Cumberlege, said the families affected deserved a fulsome apology from the government. She said: "I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself." Read full story Source: BBC News, 8 July 2020 -
News Article
DHSC tells care homes to destroy batch of COVID-19 tests over safety fears
Patient Safety Learning posted a news article in News
Care homes have been ordered to destroy a batch of faulty COVID-19 test kits after it was discovered that the swabs could break off while being used to gather samples from residents’ tonsils and noses. Care home managers were told on Sunday not to use the tests because they had “brittle stems at risk of snapping”. The kits were manufactured by Citotest, a company based in China, and were distributed by the government’s COVID-19 care home testing programme. It is tasked with providing tests for all staff and residents in care settings, not just people displaying symptoms. The affected batch should be destroyed or kept in a safe area clearly marked with warnings not to use them, officials said, adding that the problem emerged on Saturday and they were working as quickly as possible to resolve it. The Department of Health and Social Care (DHSC) said the batch could have contained tens of thousands of tests and that a complaint had been raised with the manufacturer, with whom discussions were ongoing. “We are aware of an issue with one batch of swab sticks which are being replaced where needed but this does not affect any tests, or the results of tests, previously taken,” a DHSC spokesperson said. “Testing is unaffected and people should still arrive for their booked tests.” Read full story Source: The Guardian, 15 June 2020 -
Content ArticleThis article, published in Drug Safety, Robust, argues that active cooperation and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.
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Content ArticleThis guide from the Clinical Human Factors Group is to help staff working in procurement or with medical devices and equipment, to use Human Factors to specify and select the best and safest products to use in healthcare. This is important because conformity with Regulations and Standards does not always guarantee safe outcomes when products are used in practice. This guide is particularly relevant to medical devices but can be used for other healthcare products.
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Content ArticleIf a nasogastric tube (NGT) has been misplaced into the respiratory tract and this is not detected before fluids, feed or medication are given, death or severe harm can be caused. The consequences are even more likely to be fatal for patients who are already critically ill. Most nasogastric ‘Never Events’ of feeding into the respiratory tract through a misplaced tube continue to arise from misinterpretation of x-rays by staff who had not been given training in the ‘four criteria’ technique and were unaware that relying on the position of the tube tip alone on a radiograph can be a fatal error. BAPEN has produced this easy reference guide.
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Content ArticleStress urinary incontinence (SUI) is the loss of urine when coughing, laughing, sneezing or exercising. It is a common and distressing condition, with negative impact on quality of life. If conservative treatment, e.g. pelvic floor muscle training, is not successful, the most successful surgical procedures are mid-urethral mesh tape, colposuspension, autologous fascial sling and urethral bulking agent injections.
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News Article
New face cover for cancer test patients to stop COVID-19 spread
Patient Safety Learning posted a news article in News
Surgeons have invented a new device to make it safer to diagnose some cancers during the coronavirus pandemic. Most nose and throat investigations have been cancelled due to increased risks of medics contracting COVID-19 via patients' coughs and sneezes. Two consultants have developed a device that clips over patients' masks and protects front-line workers. The West Midlands-based doctors want to raise £50,000 they say is enough to make devices for use across the NHS. Chris Coulson, a consultant ear, nose and throat surgeon at University Hospitals Birmingham NHS Foundation Trust, said procedures involving an endoscope to examine the nose or throat were known to put clinicians at a significantly increased risk of contracting coronavirus. "When clinicians carry out a nasendoscopy it can make patients cough, sneeze, and splutter - which risks spreading the virus to doctors, nurses and therapists," he said. His company endoscope-i Ltd, co-founded with Ajith George, a consultant head and neck surgeon at University Hospitals North Midlands, has now developed the SNAP. It clicks on to a conventional surgical mask, creating a hole through which the clinician can pass an endoscope directly into a patient's nose. A valve means, despite there being a hole, any coughs, sneezes or splutters are caught within the mask. Mr George said: "If we can raise the money needed to produce the devices, we can keep looking after patients and ensure that diagnosis and treatment is not delayed." Read full story Source: BBC News, 11 May 2020 -
Content ArticleSharps injuries are a well-known risk to workers in healthcare and for those who receive them they can cause anxiety and distress and may result in exposure to bloodborne viruses (BBVs) such as HIV or hepatitis B or C. This guide from NHS Employers has been developed to help individuals understand and manage the risks from sharps injuries
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Content ArticleThis is a specification of the minimally (and some preferred options) clinically acceptable ventilator to be used in UK hospitals during the current SARS-CoV2 outbreak. It sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.
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News ArticleNHS staff say they are being put at risk during the coronavirus outbreak because of a lack of protective gear. One doctor told the BBC that frontline healthcare workers felt like "cannon fodder" as they do not have access to equipment such as face masks. Health workers also expressed concerns that not enough of them were being tested for the virus. Prime Minister Boris Johnson said the UK had "stockpiles" of personal protective equipment (PPE). But Dr Samantha Batt-Rawden, from lobbying group the Doctors' Association, said she had heard from doctors who had not got access to PPE - or it had expired or run out. "All these doctors are worried that that's increasing their likelihood of contracting the virus and then ultimately spreading it to patients," she said. Read full story Source: BBC News, 18 March 2020
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Content Article
ECRI - Top 10 Patient Safety Concerns 2020
Claire Cox posted an article in International patient safety
ECRI Institute's Top 10 Patient Safety Concerns for 2020 features new topics, with an emphasis on concerns that have the biggest potential impact on patient health across all care settings. However, the number one topic on this year's list is one revisited from 2019: missed and delayed diagnoses. -
Content ArticleThis checklist, recommended by the Association of Anaesthetists, with accompanying guidance is written to ensure the correct functioning of draw-over anaesthetic equipment and is important to patient safety.
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Content ArticleA significant amount of professional time is wasted during a medical ward round retrieving patient notes from the ward trolley. If the efficiency of this non-clinical, non-functional interaction could be improved it would save time, maintain continuity and have financial implications. One identified constraint was the structure of the traditional ward trolley; a stationary filing tray with vertical sleeves. During ward round, time is spent returning and retrieving each patients notes from outside the patient bay and additional time may be wasted if the notes are misplaced or in use elsewhere. To resolve this, the ‘Vista 90’ trolley with horizontal, transparent trays, is portable and has an ergonomic writing surface was selected as a potential second generation replacement. An assessment of the impact of the Vista 90 trolley over the traditional trolley in the clinical setting was carried out on Erringham (medical) Ward, Worthing Hospital, West Sussex Hospital Trust, UK. This was by way of qualitative analysis performed by semi-structured interview of 12 doctors and other healthcare professionals who regularly interacted with the Vista 90 and traditional trolley in December 2012. The audit found that those interviewed preferred using the Vista 90 trolley over its predecessor as it improved the efficiency of the ward round and subsequent clinical work. It’s mobility allowed it to be easily transported with the ward round, reducing disruption during a consultation and between consecutives ones. The ergonomic writing surface was noted to improve legibility of documentation due to greater comfort and if placed appropriately, did not interfere with the doctor-patient interaction. The financial savings of this greater efficiency was found to be of significance and justify the cost of the Vista 90 within two weeks.
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News Article
Hernia mesh implants used 'with no clinical evidence'
Patient Safety Learning posted a news article in News
"Too many" types of hernia mesh implants are being used on NHS patients with little or no clinical evidence, the BBC has been told. New data shows more than 100 different types of mesh were purchased by NHS Trusts from 2012 to 2018 in England and Scotland, leading to fears over safety. The meshes can cut into tissue and nerves, leaving some people unable to walk, work or care for children. Currently, hernia mesh devices can be approved if they are similar to older products, which themselves may not have been required to undergo any rigorous testing or clinical trials in order to assess their safety or efficacy. In England, around 100,000 such operations are performed each year, the majority using mesh. Many go well. But the Victoria Derbyshire programme has heard from nearly 300 people who have experienced complications - including chronic pain, infections and organ perforations. International guidelines estimate one in 10 patients will experience "significant chronic pain" following a mesh repair. The director of devices at the Medicines and Healthcare products Regulatory Agency (MHRA), Graeme Tunbridge, told the BBC: "The benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis." Mr Tunbridge said he recognised the system "does need strengthening" and said new legislation on medical devices would take effect from May 2020. Read full story Source: BBC News, 15 January 2020 -
News Article
Urologists support New Zealand MOH report recommendations on surgical mesh
Patient Safety Learning posted a news article in News
The Urological Society of Australia and New Zealand (USANZ) supports recommendations in the Hearing and Responding to Stories of Survivors of Surgical Mesh report released by the New Zealand Ministry of Health in response to complications resulting from the use of surgical mesh in a range of operations, including for stress incontinence and pelvic organ prolapse. The Ministry of Health commissioned the review, in which New Zealand urologists participated alongside a wide range of consumer and other health groups, to provide a plan “to minimize future risk to consumers and support those harmed by it”. “The Urological Society acknowledges that complications from the use of mesh for treating stress urinary incontinence and pelvic organ prolapse has caused considerable physical and psychological harm in some patients, which we feel is unacceptable, said USANZ President, Dr Stephen Mark. "We also acknowledge and accept findings that there were deficiencies in technical and communication skills of some surgeons. We recognise the distress caused to these patients and want to be part of the solution in helping these people, as well as ensuring no patients are harmed in future." “Further research is necessary to achieve best practice outcomes and help us understand why, when, and in which patient complications may occur. For this reason, USANZ supports participation with Australia in a mesh registry. By collaborating with Australian researchers, we can be part of a substantial database that would underpin ongoing research in the interests of patient safety." Read full story Source: New Zealand Doctor, 13 January 2020 -
News Article
India: When a ‘never event’ hits a patient
Patient Safety Learning posted a news article in News
A young woman was left with a retained foreign object, after surgery in an India hospital. A checklist could have avoided her death. The response from the health officials was: “We have issued a show-cause notice to the staff seeking an explanation. We will initiate departmental action based on their replies and finding of our inquiry.” In the fields of healthcare quality and patient safety, such punitive measures of “naming and shaming” have not worked. T.S. Ravikumar, President, AIIMS Mangalagiri, Andhra Pradesh, moved back to India eight years ago with the key motive to improve accountability and safety in healthcare delivery. He believes that we have a long way to go in reducing “preventable harm” in hospitals and the health system in general. "We need to move away from fixing blame, to creating a 'blame-free culture' in healthcare, yet, with accountability. This requires both systems design for safe care and human factors engineering for slips and violations". "Providing safe care without harm is a 'team sport', and we need to work as teams and not in silos, with mutual respect and ability to speak up where we observe any deviation or non-compliance with rules, says Ravikumar. Basic quality tools and root-cause analysis for adverse events must become routine. Weekly mortality/morbidity conferences are routine in many countries, but not a routine learning tool in India. He proposes acceleration of the recent initiative of the DGHS of the Government of India to implement a National Patient Safety Framework, and set up an analytical “never events” or sentinel events reporting structure. Read full story Source: The Hindu, 12 January 2020 -
News Article
JAMA editorial blasts FDA's reporting of medical device problems
Patient Safety Learning posted a news article in News
The US Food and Drug Administration (FDA) needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an Editorial published in JAMA Internal Medicine. The editorial notes several instances where information on a medical device was withheld from the public or not reported fully. The current adverse events reporting system relies on device makers to voluntarily report adverse events, which the authors say does not place patient safety as a priority. The editorial specifically highlights a study involving Medtronic's Insync III model 8042 heart failure pacemaker, which the authors said caused a "high burden of serious adverse events (including death)." The authors said it took the FDA 19 months to recall the device after the first instance of the device failing was reported. The FDA also decided to classify the recall as Class II, which signifies a low probability of serious adverse events. "This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions," the authors wrote. Read full story Source: Becker's Hospital Review, 10 January 2020 -
Content ArticleAn ideal surveillance system for medical device safety would comprehensively collect data on adverse events across the life span of a device, discusses Salazar and Redberg in an Editorial in JAMA Internal Medicine. They suggest that the system should be integrated into electronic health records to allow seamless identification, tracking, and real-time reporting of device-associated adverse events. It would be able to take adverse events and detect substantial safety signals and underperforming devices. Such a system would also allow implementation of corrective actions quickly.
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News Article
Implementation of safety improvements for the placement of nasogastric tubes
Patient Safety Learning posted a news article in News
The Healthcare Safety Investigation Branch (HSIB) has launched an investigation looking at nasogastric tubes and how previously identified safety improvements for the placement of these tubes are put into practice. Nasogastric (NG) tubes are used to deliver fluid, food and medication to patients via a tube that passes through the nose and down into the stomach. There is a risk of serious harm and risk to life if NG tubes are incorrectly placed into the lungs, rather than the stomach, and feed is passed through them. HSIB has started this investigation after they were notified of a patient who inadvertently had a nasogastric tube inserted into his lung. Further information Source: HSIB, 7 January 2020 -
Content Article
NHS Resolution: Manual handling (19 October 2020)
Patient Safety Learning posted an article in Patient management
From 1 April 2009 to 31 March 2019, NHS Resolution was notifed of 4,733 claims relating to manual handling. NHS Resolution has produced a 'Did you know' guide on manual handling. -
Content ArticleThe hospital environment is both unique and unusual in that electrical equipment is directly applied to the human body. From this contact either capacitive or resistive coupling may lead to current flow and harm. Surgical diathermy, patient monitoring and imaging, although universal, are often misunderstood, and many clinicians are ignorant of their principles and hazards. Electrical equipment in hospital therefore has the potential to lead to serious injury or death. This article published in Anaesthesia and Intensive Care Medicine outlines the basic physics of electricity, in particular the principles behind diathermy, the hazards posed by it and by other devices and the various measures available to reduce the risk of these.
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News Article
Woman awarded £8m after doctors left sponge inside her during surgery
Patient Safety Learning posted a news article in News
A woman has been awarded $10.5 million (£8m) in damages after medical staff left a sponge inside her body. The sponge – which measured 18-by-18 inches and was left behind during surgery – was inside the woman's body for years before she realised. It had been left in her body after she underwent heart surgery at a Kentucky hospital in 2011. The bypass surgery is said to have gone wrong, leaving a mess – and as nurses rushed to deal with the problems, the sponge was left inside her body. It was not discovered for four years, until she had a CT scan in 2015. In the meantime, the sponge had moved around the woman's body, shifting around her intestines and causing pain as it did so. She had her leg amputated and was left with gastrointestinal issues after the sponge eroded into her intestine. The patient's lawyers said the case should be a reminder to hospitals to ensure that objects such as needles and other sharp objects, as well as sponges, are removed from patients after surgery. Read full story Source: The Independent, 1 January 2020 -
News Article
Safety fears for hundreds of ‘hidden’ children on ventilators
Patient Safety Learning posted a news article in News
Experts have warned hundreds of “hidden” children who rely on machines to help them breathe at home are at significant risk of harm due to staff shortages, poor equipment and a lack of training. The number of children who rely on long-term ventilation is rising but new research has shown the dangers they face with more than 220 safety incidents reported to the NHS between 2013 and 2017. In more than 40% of incidents the child came to harm, with two needing CPR after their hearts stopped. Other children had to have emergency treatment or were rushed back to hospital. Many parents reported concerns with the skills of staff looking after their children or reported paid carers falling asleep while caring for their child. Families reported having to cover multiple night shifts due to staff shortages, while also having to care for their child during the day. Other patient safety incidents including broken or faulty equipment or information on packaging that did not match the item or incorrect equipment being delivered. Consultant Emily Harrop, who led the study, said it was “easy for the plight of individual complex children to slip down the agenda”. She warned: “This is a very hidden group of very vulnerable children who are at risk without investment in staffing, access to training and good communication." Read full story Source: The Independent, 18 December 2019
