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Showing results for tags 'Medical device / equipment'.
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Content ArticleAmong the results reported by the Scan4Safety demonstrator sites, were: the release of 140,000 hours of clinical time back to patient care non-recurrent inventory reductions of £9m recurrent inventory savings worth nearly £5m across the six trusts.
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News Article
Investigation launched into safety of maternity equipment used in NHS
Clive Flashman posted a news article in News
A national investigation has been launched into the equipment used by NHS staff to monitor babies heart rates during labour because of concerns they could be contributing to deaths and disabilities. The independent Healthcare Safety Investigation Branch (HSIB), which investigates systemic safety risks in the NHS, has opened an inquiry after reviewing hundreds of maternity incidents. It found equipment used to record cardiotocographic (CTG) traces were linked to 138 maternity investigations since 2018 with more than 238 separate findings referencing the use of CTG as a factor in the error. Read the full article here -
Content ArticleBetween April 2008 to March 2017, procedure data from the UK NHS confirmed that 100,516 patients had a mid-urethral tape procedure, while only 1195 patients had a non-tape SUI procedure. Although the 2013 national guideline from The National Institute for Health and Care Excellence (NICE) recommended that tape and non-tape SUI procedures be offered equally, 84 mesh tape procedures were performed for every 1 non-tape procedure over the 10-year period. Hundreds of patients recently engaged in litigation on the basis of lack of informed consent, particularly in offering alternatives to the mesh tape option. Little is known, however, about how patients choose among different treatment options for SUI and there are no validated patient decision aids (PDAs) in this context. PDAs have been shown to increase patient knowledge, clarity about their own values and accuracy of risk perceptions regarding various management options. Women considering SUI surgery require up-to-date information on all common and available surgical procedures as well as support in their decision-making, tailored to their values and needs. Agur et al. on behalf of the NHS Ayrshire & Arran Continence Multidisciplinary Team designed and developed a novel SUI surgery patient decision aid (SUI-PDA) to help women in making a choice of treatment based on their own individual values. This study reports the development and validation of SUI-PDA as well as the initial evaluation of its usefulness in clinical practice for women considering SUI surgery.
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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 -
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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 -
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Content ArticleSome aspects of COVID-19 presentation and treatment present special challenges for safely confirming nasogastric tube position. The dense ground-glass x-ray images can make x-ray interpretation more difficult, and the increasing use of proning manoeuvres in conscious patients increases the risk of regurgitation of gastric contents into the oesophagus and aspiration into the lungs which will render pH checks less reliable This aide-memoire is not designed to replace existing, established, NHSI compliant practice of NG confirmation. If a critical care provider is in the fortunate situation of having nursing and medical staff who have all completed local competency-based training in nasogastric tube placement confirmation aligned to local policy, they would be able to continue more complex local policies. Such policies might include specific advice indicating which critical care patients could have pH checks for initial placement confirmation, and which require x-tray confirmation, and how second-line checks should be used if first-line checks are inconclusive. However, staff returning to practice, or redeployed to critical care environments, including in Nightingale hospitals, will be helped by reminders of established safety steps in a form that can be used for all critical care patients, rather than requiring different processes for different patients.
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Content Article
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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 -
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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 Maternity
ECRI’s list of patient safety concerns for 2020: 1. Missed and delayed diagnoses—Diagnostic errors are very common. Missed and delayed diagnoses can result in patient suffering, adverse outcomes, and death. 2. Maternal health across the continuum—Approximately 700 women die from childbirth-related complications each year in the U.S. More than half of these deaths are preventable. 3. Early recognition of behavioural health needs—Stigmatisation, fear, and inadequate resources can lead to negative outcomes when working with behavioural health patients. 4. Responding to and learning from device problems—Incidents involving medical devices or equipment can occur in any setting where they might be found, including ageing services, physician and dental practices, and ambulatory surgery. 5. Device cleaning, disinfection, and sterilisation—Sterile processing failures can lead to surgical site infections, which have a 3% mortality rate and an associated annual cost of $3.3 billion. 6. Standardising safety across the system—Policies and education must align across care settings to ensure patient safety. 7. Patient matching in the EHR—Organisations should consistently use standard patient identifier conventions, attributes, and formats in all patient encounters. 8. Antimicrobial stewardship—Over prescribing of antibiotics throughout all care settings contributes to antimicrobial resistance. 9. Overrides of Automated Dispensing Cabinets (ADC)—Overrides to remove medications before pharmacist review and approval lead to dangerous and deadly consequences for patients. 10. Fragmentation across care settings—Communication breakdowns result in readmissions, missed diagnoses, medication errors, delayed treatment, duplicative testing and procedures, and dissatisfaction. -
Content ArticleThe anaesthetist has a primary responsibility to understand the function of the anaesthetic equipment and check it before use. Anaesthetists should not use equipment unless they have been trained in its use and are competent to do so. A self-inflating bag should be immediately available in any location where anaesthesia is given. A two-bag test should be performed after the breathing system, vaporisers and ventilator have been individually checked. A record should be kept with the anaesthetic machine that these checks have been carried out. The ‘first user’ check, after servicing, is especially important and should be recorded.
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Content Article
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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 -
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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 -
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