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Found 217 results
  1. Content Article
    In February 2023, the Department of Health and Social Care (DHSC) published the government’s Medical Technology Strategy. This set out how, over the next 5 to 10 years, the DHSC will ensure the health and social care system can reliably access safe, effective and innovative technologies. These technologies will enable the delivery of high-quality care, outstanding patient safety and excellent health outcomes, while making the best use of taxpayer money.  One year into delivery of the medtech strategy, the DHSC present an update on their achievements towards establishing an innovation pathway, to realise our vision of right product, right price, right place. 
  2. Content Article
    More health systems and hospitals are looking to expand options to care for patients at home, but a new report points to some obstacles that threaten the safety of patients. ECRI, a nonprofit organisation focused on patient safety, released its annual list of the 10 leading healthcare technology hazards Wednesday. Safety challenges involving medical devices at home topped the 2024 list of technology trouble spots. ECRI also cites other challenges, including poor instruction in cleaning medical devices, sterile drug compounding, the insufficient governance of artificial intelligence in healthcare, and cybersecurity. But the concerns over the use of medical devices at home rose above all others. Marcus Schabacker, MD, president and CEO of ECRI, talked with Chief Healthcare Executive® about the potential hazards in patients using medical devices and tools at home.
  3. News Article
    Minority ethnic people, women and people from deprived communities are at risk of poorer healthcare because of biases within medical tools and devices, a report has revealed. Among other findings, the Equity in Medical Devices: Independent Review has raised concerns over devices that use artificial intelligence (AI), as well as those that measure oxygen levels. The team behind the review said urgent action was needed. Prof Frank Kee, the director of the centre for public health at Queen’s University Belfast and a co-author of the review, said: “We’d like an equity lens on the entire lifecycle of medical devices, from the initial testing, to recruitment of patients either in hospital or in the community, into the early phase studies and the implementation in the field after they are licensed,.” The government-commissioned review was set up by Sajid Javid in 2022 when he was health secretary after concerns were raised over the accuracy of pulse oximeter readings in Black and minority ethnic people. The widely used devices were thrown into the spotlight due to their importance in healthcare during the Covid pandemic, where low oxygen levels were an important sign of serious illness. The report has confirmed concerns pulse oximeters overestimate the amount of oxygen in the blood of people with dark skin, noting that while there was no evidence of this affecting care in the NHS, harm has been found in the US with such biases leading to delayed diagnosis and treatment, as well as worse organ function and death, in Black patients. The team members stress they are not calling for the devices to be avoided. Instead the review puts forward a number of measures to improve the use of pulse oximeters in people of different skin tones, including the need to look at changes in readings rather than single readings, while it also provides advice on how to develop and test new devices to ensure they work well for patients of all ethnicities. Read full story Source: The Guardian, 11 March 2024
  4. 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
  5. Content Article
    A core responsibility of the NHS is to maintain the highest standards of safety and effectiveness of medical devices available for all patients in its care. Evidence has emerged, however, about the potential for racial and ethnic bias in the design and use of some medical devices commonly used in the NHS, and that some ethnic groups may receive sub-optimal treatment as a result. In response to these concerns, the UK Government commissioned this independent review on equity in medical devices. In its final report, the Review sets out the need for immediate action to tackle the impact of ethnic biases in the use of medical devices. Its findings and recommendations have also been published in a short animation. The Government’s response to the Review's 18 recommendations has also been published alongside its final report.
  6. Content Article
    Female urologists report higher rates of work-related physical discomfort compared to male urologists. This study in the American Journal of Surgery compared ergonomics during simulated ureteroscopy—the most common surgery for kidney stones—between male and female urologists. The authors found that across all conditions, women required greater muscle activation in multiple muscle groups and had greater NASA Task Load Index (NASA-TLX) scores compared to men. These results suggest there may be gender differences in ergonomics during ureteroscopy based on muscle activation and subjective workload. There is therefore potential for personalising surgical workspaces and equipment.
  7. Content Article
    Postoperative surgical site infection is a serious problem. Coverage of sterile goods may be important to protect the goods from bacterial air contamination while awaiting surgery. This study from Wistrand and colleagues, evaluated the effectiveness of this practice in a systematic review covering five databases using search terms related to bacterial contamination in the operating room and on surgical instruments. No negative effects regarding bacterial contamination were found and the authors conclude that protection with a sterile cover decreases bacterial air contamination of sterile goods while waiting for surgery to start.
  8. Content Article
    Connections are critical junctures and points of access along intravenous (IV) lines. Microorganisms may colonise these connections, potentially leading to catheter-related bloodstream infections (CRBSIs). For patients, CRBSIs are a significant cause of morbidity and death, and for healthcare facilities these infectious complications lead to unnecessary costs. Safe connections may help reduce the risk of needlestick injuries for healthcare professionals (HCPs) and the occurrence of CRBSIs for patients. In this webinar recording, Nancy Trick, Registered Nurse and Adjunct Instructor at Perdue Global University in West Lafayette, USA, discusses CRBSIs and presents solutions to help prevent them. After watching this webinar, you should be able to: describe open versus closed infusion systems in VAM. briefly discuss the clinical risks of open infusion systems. discuss clinical practice change. consider how evidence-based standards of practice recommend using closed IV access/needleless connectors.
  9. Content Article
    Left-handedness was historically considered a disability and a social stigma, and teachers would make efforts to suppress it in their students. Little data are available on the impact of left-handedness on surgical training and this report aimed to review available data on this subject. The review revealed 19 studies on the subject of left-handedness and surgical training. Key findings include: Left-handedness produced anxiety in residents and their trainers. There was a lack of mentoring on laterality. Surgical instruments, both conventional and laparoscopic, are not adapted to left-handed use and require ambilaterality training from the resident. There is significant pressure to change hand laterality during training. Left-handedness might present an advantage in operations involving situs inversus or left lower limb operations.
  10. Content Article
    In 2017-18, the Department of Health & Social Care (DHSC) implemented a new operating model and delivery body for NHS procurement known as NHS Supply Chain (to replace the previous, fully outsourced model which was also called NHS Supply Chain). The new body was responsible for procuring products, warehousing, and delivering goods on behalf of the NHS. NHS Supply Chain (Supply Chain) estimates that the NHS collectively spends approximately £8 billion annually on buying medical equipment and consumables, from gloves and paper to stents and prosthetic hips.
  11. Content Article
    Increasing diversity amongst surgeons results in a wide range of sizes and strengths. There are many types of biases affecting women surgeons. This study evaluates what challenges women surgeons may have with surgical equipment. Key findings include: 89% of women surgeons report difficulty with surgical instruments due to size. 71% of women surgeons report difficulty with surgical instruments due to grip strength. The study highlights a potential source of gender bias which could be addressed to improve equity for women surgeons.
  12. Content Article
    This investigation explores the patient safety risk of unintended retention of surgical swabs after surgery. Surgical swabs are sterile pieces of gauze which are used to absorb bodily fluids, such as blood, during a surgical procedure. The investigation will: explore the factors associated with unintentional retained surgical swab events identify alternative safety controls to reduce the likelihood of foreign objects being unintentionally retained. The interim report analyses the findings of 31 NHS trust serious incident reports.
  13. Content Article
    Ambulatory infusion pumps are small, battery powered devices that allow patients to carry out day-to-day activities while receiving medication. They are used for many healthcare needs, including symptom relief during palliative care, and in different settings including hospitals, hospices and patients’ homes. Despite having audio and visual warning alarms to notify when medication is not being delivered as it should be, there is a risk that alarms can go unnoticed, particularly by healthcare staff in inpatient settings. The patient case in the Health Services Safety Investigations Body (HSSIB) investigation report is Stephen, a 45-year-old cancer patient on palliative care in hospital, who did not receive his pain relief medication for six hours. Over the course of six hours, there were eight warnings.
  14. News Article
    Weight management is a sensitive topic. Nevertheless, the measurement is often used as a marker to inform medical decisions or for someone's personal interest. But for many wheelchair users, accessing scales has proved near impossible. "The last time I was weighed was about 22 years ago, " Lizzie tells the BBC podcast, Access All. "I think I was about 15." As a result, now aged 37, Lizzie has been through three successful pregnancies, all without knowing how her body was adapting or how her baby was growing. Based in Devon, she has a degenerative muscle-related impairment and uses a wheelchair. This makes weighing herself on traditional bathroom scales, which require you to stand still and independently on a small platform, a challenge. There is equipment out there to help wheelchair users, like Lizzie. Chair scales enable someone to sit on a seat which records their weight and there are similar bed and hoist versions too. There are also wheel-on scales which are very large and involve subtracting the weight of the chair afterwards. But none of these seem widely available. Dr Georgie Budd, who is based in Merthyr Tydfil, says this worries her. A wheelchair user herself she appreciates how difficult it can be for people to access scales. "There's a lot of things that we use weight for in health - anaesthetics and drug dosing - and just to keep an eye on it as well for someone's general health. During pregnancy for example, if someone was losing weight I, as a GP, would actually be really quite concerned," she says. Neither NHS England nor the government have guidance for doctors nor advice on what equipment to use and no figures are kept on how many hospitals have access to such equipment and where they are. The National Institute for Health and Care Excellence (NICE) previously considered the issue in 2014 and requested more research be carried out. But so far nothing has been started. Read full story Source: BBC News, 13 October 2023
  15. 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.
  16. 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.
  17. 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.
  18. News Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system following concerns raised about cracked cartridges and insulin leaks. Patients are being asked to check the pre-filled glass insulin cartridge for cracks prior to use. The cartridge should not be used if it has been dropped even if no cracks are visible. Closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges. The device, which releases the insulin your body needs through the day and night, comprises a pump, tube, battery and a pre-filled glass insulin cartridge. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. However, leakages also occurred in cases where no cracks in the cartridge were visible. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis (a serious complication of diabetes when the body produces high levels of blood acids called ketones). Health care professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. Key patient recommendations are: Check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin (a strong antiseptic chemical smell) this could also indicate a leakage. Do not use the cartridge if cracks or leakage are seen or if the cartridge was dropped. Follow the instructions of your Accu-Chek Insight user manual for replacing a cartridge and for cleaning the cartridge compartment in the insulin pump. During the day and before going to sleep please carefully check that your insulin pump is delivering insulin and there are no leakages. Never change treatment delivery methods without first consulting a relevant healthcare professional. Failure of insulin delivery due to leakage may not result in an alert notification from the insulin pump and cracks and leakages may not always be visible. You should check blood glucose levels multiple times throughout your day whilst using pumps. Tell your healthcare professional immediately if you suspect a problem with your insulin delivery. Read full story Source: Gov.UK, 26 May 2022
  19. News Article
    The NHS has become 'dangerously over-reliant' on China for vital medicines and supplies, a report has warned. One in six medical items used in UK hospitals — including needles, bandages and oxygen — are shipped from the communist state. Thinktank Civitas found that overall NHS dependency on Chinese supply chains has trebled since 2019, with the UK now sending £6.2billion a year to Beijing for medical gear. Security experts are now calling for an 'NHS Security Act' to wean Britain off Chinese medical items and start manufacturing more domestically. Civitas looked at 228 medical items on the Government's disaster relief list — which include drugs, tests, medical devices and personal protective equipment (PPE). The team found that 17% came from China in 2020, up from 6% before the pandemic. The report found up to a third of tests and diagnostic equipment and 30% of PPE used in the health service now come from China. Almost all paper masks used by medics in hospitals come from China (90%), more than half of all gloves (54%) and almost 80% of bandages. And 42% of emergency trolleys and wheelchairs are Chinese-made. Robert Clark, head of defence and security at Civitas, said: 'Things like gloves, monitors, wheelchairs and bandages all largely come from China rather than the UK. We are dangerously over-reliant on China." "Let's not be naïve about China. This is an urgent issue for health bosses with the risk that future geo-political spats could lead to the Chinese switching off critical medical supplies destined for the NHS." Read full story Source: Mail Online,17 May 2022
  20. News Article
    A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women, but reduced the amount by $42 million to $302 million. Johnson & Johnson had appealed in 2020 after Superior Court Judge Eddie Sturgeon assessed the $344 million in penalties against Johnson & Johnson subsidiary Ethicon. Sturgeon found after a non-jury trial that the company made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures for nearly two decades. The instructions for use in all of the company’s pelvic mesh implant packages "falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences," Presiding Justice Judith McConnell of the appeals court said in a 3-0 ruling upholding the $302 million in penalties. The products, also called transvaginal mesh, are synthetic and surgically implanted through the vagina of women whose pelvic organs have sagged or who suffered from stress urinary incontinence when they cough, sneeze or lift heavy objects. Many women have sued the New Jersey-based company alleging that the mesh caused severe pain, bleeding, infections, discomfort during intercourse and the need for removal surgery. Read full story Source: Fox News, 12 April 2022
  21. News Article
    Two thousand ventilators being used in UK hospitals are at risk of suddenly shutting down due to electrical faults that have led to a global safety alert. Hospitals have been ordered to source replacement ventilators after Philips Respironics said its breathing support devices could suddenly stop working, in some cases without activating a warning alarm. The Medicines and Healthcare products Regulatory Agency (MHRA) said the problem related to “a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation”. It said there had been five reported cases of shutdowns in the UK so far, none of which involved patient harm. Globally, there have been 389 reports of failures, including one where the patient died and four where they were seriously injured. In six of the total cases, the warning alarm didn’t sound. Philips Respironics is one of several manufacturers that increased production of ventilators during the pandemic. The MHRA brought in a fast approval process for ventilators and other medical devices in response to Covid-19. The MHRA said the root cause of the problem was not yet known and remained under investigation, but that Philips Respironics currently had “no permanent solution” to correct it. Helen Hughes, chief executive of Patient Safety Learning, said there was a “significant patient safety concern” that some Philips devices could remain in use until replacements were sourced. Read full story Source: The Guardian, 9 April 2022 National Patient Safety Alert: Philips Health SystemsV60, V60 Plus and V680 ventilators – potential unexpected shutdown leading to complete loss of ventilation
  22. News Article
    Medical devices are one major weak point in health care cybersecurity, and both the US Congress and the Food and Drug Administration took steps towards closing that gap this week —Congress with a proposed bill and the FDA with new draft guidelines for device makers on how they should build devices that are less likely to be hacked. Devices like infusion pumps or imaging machines that are connected to the internet can be targets for hacks. Those attacks can siphon off patient data or put their safety directly at risk. Experts consistently find that devices in use today have vulnerabilities that could be exploited by hackers. The new document is still just a draft, and device makers won’t start using it until it’s finalised after another round of feedback. But it includes a few significant changes from the last go-around — including an emphasis on the whole lifecycle of a device and a recommendation that manufacturers include a Software Bill of Materials (SBOM) with all new products that gives users information on the various elements that make up a device. An SBOM makes it easier for users to keep tabs on their devices. If there’s a bug or vulnerability found in a bit of software, for example, a hospital could easily check if their infusion pumps use that specific software. The FDA also put out legislative proposals around medical device cybersecurity, asking asking Congress for more explicit power to make requirements. “The intent is to enable devices to be that much more resilient to withstand the potential for cyber exploits or intrusion,” Schwartz says. Manufacturers should be able to update or patch software problems without hurting the devices’ function, she says. Read full story Source: The Verge, 8 April 2022
  23. News Article
    A patient was left traumatised when his body caught on fire halfway through surgery - leaving his insides scorched. Mark, 52, went to hospital for a routine abscess removal - but woke up to the news that a freak accident in theatre had sparked an horrific blaze. A diathermy machine, used to stop bleeding, caused a swab to catch fire - before flames burnt their way through his exposed flesh, Mark explained. It took over a year for Mark - not his real name - to recover from his dreadful injuries - and the emotional scarring it caused. Between 2008 and 2018, 37 cases were acknowledged by NHS trusts across Britain. But from 2009 to 2019, it has paid out nearly £14 million in compensation settlements and legal fees. Fires such as these are often fuelled by leaking oxygen - and are caused by faulty machinery or sparking equipment. Campaigners are concerned that UK hospitals are lagging behind other countries in recording surgical fires and introducing protocols to reduce both their frequency and severity. Theatre scrub nurse Kathy Nabbie has spent the past five years trying to make colleagues more aware of the threat of surgical fires. In 2017 - after hearing how a woman in Oregon, USA, had suffered severe burns when her face was set alight in surgery - she made a simple safety checklist. Her Fire Risk Assessment tool allowed colleagues to check for the presence of elements that together might cause a fire to break out. But senior staff failed to implement the initiative and - when a surgical fire actually took place three months later - Kathy learned that her laminated checklist had simply been put in a drawer. “I couldn’t believe it,” she said. “After that they did start using it, but why on earth should it have taken an actual fire to persuade them?” Read full story Source: The Sun, 7 April 2022 Further reading What can we do to improve safety in the theatre? Reflections from theatre nurse Kathy Nabbie How I raised awareness of fires in the operating theatre - Kathy Nabbie
  24. News Article
    The national supply chain agency will bring management of significant areas of NHS spend in-house on a permanent basis in a major overhaul of its operating model, HSJ has been told. NHS Supply Chain’s current operating model, which has existed since 2018, has outsourced day-to-day management of the procurement of most of the goods and services bought by trusts as part of the “category towers” structure. Under this structure, 11 category towers each cover a different spend area with a service provider to manage the available products and services. But, in an exclusive interview, NHSSC chief Andrew New said the 11 categories would be reduced to eight. Three of the new categories — personal protective equipment, “medical capital” (which combines large capital diagnostics equipment with smaller scale diagnostics, pathology and point of care testing categories) and “medical clinically complex” surgical products and services — would be managed in-house. The new model will come into effect in 2023-24 following a procurement process to find new suppliers for the revamped category structure, which starts on 11 April 2022 with the publication of the contract notice. Read full story (paywalled) Source: HSJ, 4 April 2022
  25. News Article
    Amazon, eBay and Wish have stopped stocking some monitors that let people keep track of their blood oxygen levels after an investigation found they were not fit to be sold. The online marketplaces removed a number of pulse oxygen testing devices known as oximeters from sale after being alerted to flaws identified by the consumer organisation Which? Pulse oximeters have boomed in popularity as a result of Covid, with millions of people keeping one at home so they can quickly assess if their blood oxygen level has fallen worryingly low – a condition known as “silent hypoxia” – which is a common side-effect of the disease. Some of the devices were not legally fit to be sold in the UK, did not carry the CE quality Kitemark or wrongly claimed that they had been approved by the NHS. The Department of Health and Social Care (DHSC) said it would look into the unauthorised use of the health service’s iconic blue and white branding on the devices. It made clear that “the NHS does not approve or endorse any medical devices, including oximeters”. “The department strictly controls the NHS identity and takes unauthorised use or adaptation of the NHS logo and the letters ‘NHS’ very seriously”, a DHSC spokesperson said. Which? said that 11 of the cheap pulse oximeters it bought from those websites failed to comply with UK and European Union law when it examined them closely. “It is very concerning that our investigation found these medical devices for sale without the required safety markings or brazenly claiming to be approved by the NHS, and the biggest online marketplaces were not picking up on these red flags”, said Natalie Hitchens, the consumer group’s head of home products and services. Read full story Source: The Guardian, 26 March 2022
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