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Showing results for tags 'Medical device / equipment'.
Found 218 results
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Content ArticleNot knowing how to unfold or even sit in a wheelchair the right way can cause a catastrophic injury to patients, visitors, volunteers, and staff of a healthcare facility. Wheelchairs are one of the most common assistive devices used in healthcare facilities, from admission to discharge. They are often found at the entrance of a facility for use by both patients and visitors with mobility issues. Hospital volunteers, transport staff, and clinical staff use wheelchairs to take patients to different care areas to have tests performed. Many facilities require that patients be transported in a wheelchair upon discharge. However, not knowing the proper method of unfolding a wheelchair or where to place your hands when sitting down in the seat can cause injuries, specifically to fingers, ranging from lacerations to amputations.
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News Article
FBI spotlights cybersecurity risks of outdated medical devices
Patient Safety Learning posted a news article in News
On Tuesday, the FBI issued a report offering recommendations to address a number of cybersecurity vulnerabilities in active medical devices stemming from outdated software, as well as the lack of security features in older hardware. Once exploited, the vulnerabilities could impact healthcare facility operations, patient safety, data confidentiality and data integrity. If a cyberattacker takes control, they can direct devices to give inaccurate readings, administer drug overdoses or otherwise endanger patient health. The FBI noted in its briefing that a mid-year healthcare cybersecurity analysis found that equipment vulnerable to cyberattacks includes insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers, and intrathecal pain pumps. Routine challenges include the use of standardised configurations, specialised configurations – including a substantial number of managed devices on a network – and the inability to upgrade device security features, according to the FBI's announcement. The agency further adds that research has found an average of 6.2 vulnerabilities per medical device and that 40% of medical devices at the end-of-life stage offer little to no security patches or upgrades. Read full story Source: Healthcare IT News, 13 September 2022 -
News Article
NHS electric vehicles to help patients and the planet
Patient Safety Learning posted a news article in News
The NHS is trialling a fleet of electric vehicles to help relieve pressure on ambulance services while also helping the NHS cut its carbon footprint. The vehicles are part of a £2.1m investment as the NHS becomes the first health service in the world to commit to reaching net zero by 2040, said NHS England, with eight ambulance trusts trialling 21 zero-emission vehicles of various types. Six of these new green vehicles are "dedicated to mental health response in the community", NHS England said. It emphasised that it hoped this development will "cut emergency response times for people with mental health needs and help reduce demand on traditional double-crewed ambulances". The new dedicated mental health response vehicles differ in design from traditional ambulances by having fewer fluorescent markings and a much less clinical interior, to help put patients at ease. However, they still carry the equipment needed to respond to the most serious life-threatening emergencies. NHS England highlighted that the all-electric vehicles can be deployed as a rapid response vehicle when someone is experiencing a mental health crisis, "providing a safe space for healthcare workers to support patients with mental health needs". Claire Murdoch, national director for mental health, NHS England explained that the mental health response vehicles are an important addition to mental health care, and added: "we have a double win of being able to improve the experience of patients in crisis whilst also caring for the planet". Read full story Source: Medscape, 6 September 2022 -
Content ArticleEuropean Union Directive 2010/32/EU legally enforces a set of strategies aimed at preventing sharps injuries and determining the risk of bloodborne infections and psychological distress in healthcare workers. This article in the International Journal of Environmental Research and Public Health looks at the results of a national survey conducted in Italy in 2017 and repeated in 2021 to evaluate the progress of the Directive's implementation. The authors assessed the impact of the Covid-19 pandemic on implementation.
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Content ArticleThe UK is considered one of the safest health systems in the world, with dedicated teams of healthcare professionals delivering high standards of care. But with healthcare rates of avoidable harm stubbornly not reducing at the rate we all want, for the benefit of patients we need to strive to achieve more. This extends to how we source, supply and monitor the use of healthcare equipment and products. Procurement and supply chains can be complex and may involve many organisations, with patient safety concerns manifesting themselves in a range of diverse ways. Using value-based procurement (VBP) is one way we can achieve safer care.
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News Article
Family welcomes new guidance to prevent breathing tube deaths
Patient Safety Learning posted a news article in News
A grieving family has welcomed new guidance to try to prevent a common surgical procedure from going wrong and causing deaths. Oesophageal intubation occurs when a breathing tube is placed into the oesophagus, the tube leading to the stomach, instead of the trachea, the tube leading to the windpipe. It can lead to brain damage or death if not spotted promptly. Glenda Logsdail died at Milton Keynes University Hospital in 2020 after a breathing tube was accidentally inserted into her oesophagus. The 60-year-old radiographer was being prepared for an appendicitis operation when the error occurred. Her family welcomed the guidance, saying in a statement: “We miss her terribly but we know that she’d be happy that something good will come from her tragic death and that nobody else will go through what we’ve had to go through as a family." Oesophageal intubation can occur for a number of reasons including technical difficulties, clinician inexperience, movement of the tube or “distorted anatomy”. The mistake is relatively common but usually detected quickly with no resulting harm. The new guidance, published in the journal Anaesthesia, recommends that exhaled carbon dioxide monitoring and pulse oximetry – which measures oxygen levels in the blood – should be available and used for all procedures that require a breathing tube. Experts from the UK and Australia also recommended the use of a video-laryngoscope – an intubation device fitted with a video camera to improve the view – when a breathing tube is being inserted. Read full story Source: The Independent,18 August 2022 -
Content ArticleAcross multiple disciplines undertaking airway management globally, preventable episodes of unrecognised oesophageal intubation result in profound hypoxaemia, brain injury and death. These events occur in the hands of both inexperienced and experienced practitioners. Current evidence shows that unrecognised oesophageal intubation occurs sufficiently frequently to be a major concern and to merit a co-ordinated approach to address it. Harm from unrecognised oesophageal intubation is avoidable through reducing the rate of oesophageal intubation, combined with prompt detection and immediate action when it occurs. These guidelines provide recommendations for preventing unrecognised oesophageal intubation that are relevant to all airway practitioners independent of geography, clinical location, discipline or patient type.
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News ArticleAs the risk of cyberattacks on medical devices continues to mount, the Food and Drug Administration isn’t doing enough to ensure device makers include adequate security in their products, experts say. They charge that part of the problem is that the agency lacks the funds and the trained personnel to evaluate the cyber risk the devices carry and enforce the rules it does have on the books for approving devices. “I’ve spoken to device manufacturers, specifically product security people at device manufacturers, saying that they’ve been telling their organizations for the last year or two that they need to include cybersecurity as part of their submissions or else they’re going to get rejected,” said Mike Kijewski, CEO of medical device cybersecurity firm MedCrypt. “Yet for some of their recent submissions, they didn’t have a lot of cybersecurity documentation and they still got accepted by the FDA.” Cyberattacks remain a significant risk for healthcare companies. US patient safety group ECRI reported 173 medical device cybersecurity alerts in the past five years. The organisation warned that cybersecurity incidents don’t just disrupt business operations, but can “pose a real threat of physical harm.” For instance, ransomware attacks on hospitals can cause device outages that disrupt patient care, and at worst, put lives at risk. Read full story Source: MedTech Dive, 11 August 2022
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Content ArticleThe review, which has now concluded, advised the government on the health impact of potential ethnic and other biases in medical devices and made recommendations for more equitable solutions. The final report was published on 11 March 2024.
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News Article
‘Difficult discussions’ as NHS faces shortage of childbirth pain relief
Patient Safety Learning posted a news article in News
The NHS has been hit by a shortage of epidural kits to give mothers-to-be, a key form of pain relief during childbirth, as well as the drug that women are offered as an alternative. Supplies of epidural kits and the painkiller Remifentanil are now under such pressure that some hospitals cannot offer pregnant women their usual right to choose which one they want to reduce labour pains. Anaesthetists have told the Guardian that the simultaneous shortage of both forms of pain management has led to “difficult discussions” with women who had been told during their antenatal care that they would have that choice but were upset to learn that it was not available. The disruption to supplies of epidural kits is so acute that NHS Supply Chain (NHSSC), the health service body that ensures hospitals in England and Wales receive regular supplies of drugs and equipment, to ration deliveries to just one week’s worth of stock. Childbirth organisations voiced their concern and warned that the disruption to supplies meant some women in labour were already facing long delays before they received pain relief. “Offering a choice of options during birth is an integral element of good maternity care, and this includes pain relief. It is concerning that the shortage of epidural kits and Remifentanil could be denying many that right”, said Jo Corfield, the NCT’s head of communications and campaigns. “We don’t yet fully understand the impact this shortage is having but we have heard of long waiting times to receive pain relief and epidurals.” Read full story Source: The Guardian, 7 August 2022 -
Content ArticleThis is the first in a new series of ‘In Conversation with’ podcasts from the All Party Parliamentary Group (APPG) on First Do No Harm. In this episode Lord Philip Hunt discusses the key achievements of the Health and Care Act 2022 of relevance to the APPG’s work, and the areas still left to address. The APPG on First Do No Harm is a group of parliamentarians who are committed to raising awareness of and building support for the recommendations in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review, and to ensure the implementation of the recommendations by the UK Government and others.
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News ArticleNHS England patients with Type 1 diabetes will now be eligible for life-changing continuous glucose monitors after the health service secured a new cut-price deal. The wearable arm gadget sends information to a mobile app and allows diabetes patients to keep track of their glucose levels at all times without having to scan or take a finger prick test. Traditionally, continuous glucose monitors are more expensive than their flash monitor counterparts – which record glucose levels by scanning a sensor – but thanks to the NHS agreeing on a new cost-effective deal with manufacturers DEXCOM, they will now be available for NHS patients on prescription at a similar price. The monitor, called Dexcom ONE Real Time-Continuous Glucose Monitoring, uses a sensor no bigger than a bottle cap that attaches to the arm for up to 10 days and measures glucose levels from just under the skin. Patients will receive their starter pack – which will include information on the product and usage, a sensor and transmitter – from the hospital or GP surgery once prescribed, after which they can go to the pharmacy for their repeat prescription. Dr Partha Kar, national speciality advisor for diabetes and obesity said: “This is a huge step forward for Type 1 diabetes care and these monitors will be life-changing for anyone with the illness – giving them more choice to manage their condition in the most convenient way possible – as well as the best chance at living healthier lives, reducing their risk of hospitalisation and illnesses associated with diabetes, which in turn reduces pressure on wider NHS services. “The new deal also delivers on our commitment to get patients the latest cutting-edge medical technology at the best value for taxpayer money – saving the NHS millions over the coming years”. Read full story Source: NHS England, 2 August 2022 You may also be interested in: “I felt lucky to get out alive”: why we must improve hospital safety for people with diabetes Peer support makes a big difference to living with type 1 diabetes Improving safety for diabetic inpatients: 4 key steps - Interview with Dr Partha Kar
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News Article
NHS must learn to love smart IV pumps to avoid drug errors
Patient Safety Learning posted a news article in News
Hospitals must start using “smart” intravenous (IV) infusion technology to its full potential if they are to prevent dangerous drug errors, University of Manchester researchers have found. ‘Smart pumps’- which automatically calculate the dose and rate of different drugs before they are pumped into a vein - prevent potentially fatal errors by stopping the administration of the wrong rate. But according to the study published in BMJ Open Quality, though the technology probably saved the lives of 110 people in two Trusts over a year, it has largely failed to be adopted by hospitals. Though many IV pumps used in hospitals have a smart capability, most trusts do not utilise the functionality because they are difficult to configure and maintain. Smart pumps are usually configured by a pharmacist and checked by a consultant or senior nurse. Conventional pumps, however, are set by ward staff who calculate and input infusion rates themselves - increasing the risk of drug errors. The risks are illustrated by previous work from the Manchester team, who demonstrated that 1 in 10 IV drug administrations are associated with an error, and up to 1 in 10 of those were associated with harm. Read full story Source: University of Manchester, 1 August 2022 -
News Article
Over 47,000 stroke patients to ‘miss out on a miracle treatment’
Patient Safety Learning posted a news article in News
A new report by the Stroke Association released today warns that, if the thrombectomy rate stays at 2020/21 levels, 47,112 stroke patients in England would miss out on the game changing acute stroke treatment, mechanical thrombectomy, over the length of the newly revised NHS Long Term Plan. This year, NHS England missed its original target to make mechanical thrombectomy available to all patients for whom it would benefit – only delivering to 28% of all suitable patients by December 20212. The Stroke Association’s ‘Saving Brains’ report calls for a 24/7 thrombectomy service, which could cost up to £400 million. But treating all suitable strokes with thrombectomy would save the NHS £73 million per year. Stroke professionals quoted in the report cite insufficient bi-plane suites, containing radiology equipment, as a barrier to a 24/7 service. The Stroke Association is calling for: The Treasury to provide urgent funding for thrombectomy in the Autumn Budget 2022, for infrastructure, equipment, workforce training and support, targeting both thrombectomy centres and referring stroke units. Department of Health and Social Care to develop a sustainable workforce plan to fill the gaps in qualified staff. NHS England to address challenges in transfer to and between hospitals in its upcoming Urgent & Emergency Care Plan. Putting innovation - such as artificial intelligence (AI) imaging software and video triage in ambulances - into practice. Juliet Bouverie, Chief Executive of the Stroke Association said: “Thrombectomy is a miracle treatment that pulls patients back from near-death and alleviates the worst effects of stroke. It’s shocking that so many patients are missing out and being saddled with unnecessary disability. Plus, the lack of understanding from government, the NHS and local health leaders about the brain saving potential thrombectomy is putting lives at risk. There are hard-working clinicians across the stroke pathway facing an uphill struggle to provide this treatment and it’s time they got the support they need to make this happen. It really is simple. Thrombectomy saves brains, saves money and changes lives; now is the time for real action, so that nobody has to live with avoidable disability ever again." Read full story Source: The Stroke Association, 28 July 2022 -
Content ArticleThe Medicines and Healthcare product Regulatory Agency’s (MHRA) Annual Report and Accounts for 2021/22 has now been published. It provides an overview of MHRA's performance and the events that have had most impact on the Agency during the past year.
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Content ArticlePresentation from NHS Supply Chain at the Safer Healthcare & Biosafety Network meeting on safer sharps.
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Content Article
PRSB Diabetes standards (July 2022)
Patient-Safety-Learning posted an article in Diabetes
People with diabetes are increasingly using medical devices to help manage their condition, including devices for monitoring glucose and delivering insulin. However, healthcare professionals are finding that they cannot always access up to date information about a person with diabetes and the data from their medical devices. This makes it harder to provide the best advice and support. The Professional Record Standards Body (PRSB) was commissioned by NHS England and NHS Improvement to produce two standards for sharing diabetes information between people and professionals across all care settings, including self management data from digital apps and medical devices (for example, continuous glucose monitors). The Diabetes Information Record Standard which defines the information needed to support a person’s diabetes management. It includes information that could be recorded by health and care professionals or the person themselves that is relevant to the diabetes care of the person and should be shared between different care providers. The Diabetes Self-Management Standard which defines information that could be recorded by the person (or their carer) at home (either using digital apps or medical devices) and shared with health and care professionals. -
News Article
Breathing machines still not repaired after safety recall
Patient Safety Learning posted a news article in News
Two-thirds of defective breathing machines distributed by the health service have not been repaired or replaced in the 12 months since they were subject to a worldwide recall over safety concerns. Philips Respironics last year issued a field safety notice for a series of ventilation devices because the polyester-based foam used to dampen the noise of the machines can break down. The foam particles or potentially toxic chemicals may be inhaled or ingested by patients. Almost 8,000 of the affected machines have been contracted by the Health Safety Executive (HSE) for use in hospitals and private homes, including 6,394 continuous positive airway pressure (CPAP) devices, 1,348 bilevel positive airway pressure (BPAP) devices, and 147 mechanical ventilators. However, the HSE told The Times that only 2,723 devices had been repaired or replaced a year after the recall was announced. A spokesman did not respond when asked if the HSE was concerned about patient safety, given that more than 5,000 devices have not been attended to. Read full story (paywalled) Source: The Times, 8 July 2022 -
Content Article
Tracey Cammish, Patient safety, Clinical Intelligence and Partnership Lead, explains why patient safety is central to everything NHS Supply Chain does, and why clinical and end-user experience is so important. -
Content ArticleWhen critically ill premature infants require transfer by ambulance to another hospital, they frequently require mechanical ventilation. This observational study investigated acceleration during emergency transfers and looked at whether they result from changes in ambulance speed and direction, or from vibration due to road conditions. It aimed to assess how these forces impact on performance of neonatal ventilators and on patient-ventilator interactions. The authors found that infants are exposed to significant acceleration and vibration during emergency transport. Although these forces do not interfere with overall maintenance of ventilator parameters, they make the pressure-volume loops more irregular.
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News Article
UK to strengthen regulation of medical devices to protect patients
Patient Safety Learning posted a news article in News
New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published. Following the UK’s exit from the European Union (EU), the Medicines and Healthcare products Regulatory Agency (MHRA) has a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the UK. The package of reforms will apply to medical devices such as hearing aids, x-ray machines and insulin pumps; new technologies such as smartphone apps and Artificial Intelligence (AI); as well as certain cosmetic products like dermal fillers. The new measures include: Strengthening the MHRA’s powers to act to keep patients safe. Giving the public and patients greater assurance on both the performance and safety of the highest-risk medical devices, such as those which need to be implanted. Increasing the scope and extent of regulation to respond to public need. Enhancing systems that are already in place to better protect users of medical devices and certain cosmetic products, and providing greater assurance of their performance and safety. Addressing health disparities and mitigating identified inequities throughout medical devices development and use. Mitigating against inequities in medical devices, ensuring they function as intended for diverse populations. The government has launched a review into the potential equity issues in the design and use of medical devices to tackle health inequalities and will update in due course. Making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices. Ensuring the new regulatory framework encourages responsible innovation so that patients in the UK are better able to access the most advanced medical devices to meet their needs. Setting world-leading standards and building the new UKCA mark. Transforming a new stamp of certification, replacing the CE mark, into a trusted brand that signifies global safety, health and environment protection standards have been met for medical device products. This will in turn boost the MHRA’s global reputation and growing partnerships with other regulators. Health and Social Care Secretary Sajid Javid said: "Now we have left the EU, these new changes will allow innovation to thrive and ensure UK patients are among the first to benefit from technological breakthroughs." "We are now able to introduce some of the most robust safety measures in the world for medical devices to ensure patients are protected." Read press release Source: Gov.UK, 26 June 2022 -
News Article
Trust was sent ‘unfit’ ventilators at height of pandemic
Patient Safety Learning posted a news article in News
A trust was supplied with ventilators that were not ‘fit for NHS purposes’ by two suppliers at the height of the first Covid wave, HSJ has revealed. Guy’s and St Thomas’ Foundation Trust has now received a refund for both contracts, which were signed in March 2020 just as the pandemic began to hit the NHS. The service rushed to secure the equipment in response to fears that existing ventilator capacity would be inadequate to deal with the rising number of seriously ill Covid patients. At the time, the use of ventilators was the only effective therapy for the sickest Covid patients. Minutes published by the trust at its most recent board meeting revealed the issue. GSTT then told HSJ in a statement: “Two contracts for ventilators were in dispute. In one case, the trust has already received a refund. In the other, which involved equipment we do not assess as fit for NHS purposes, the trust was reimbursed by central funding.” The trust would not confirm the number of ventilators involved, the cost or the issue that meant they were not “fit for NHS purposes”. Read full story (paywalled) Source: HSJ, 23 June 2022 -
Content ArticleThis study in the journal Medical Devices: Evidence and Research aimed to assess health system experiences of implementing Unique Device Identifier (UDI) systems for medical devices. Although the US Food and Drug Administration (FDA formalised the Unique Device Identification System Rule in 2013, parallel regulatory requirement for US health systems to use UDIs is lacking. Through semi-structured interviews, the authors identified barriers to implementing UDI systems and strategies to overcome them.
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Content ArticleThe use of pelvic mesh was paused in the UK in 2018 after some patients developed complications and severe pain following the treatment. In this report for CNA, a Singapore-based news channel, Kath Sansom, founder of campaign group Sling The Mesh, talks about the severe pain and life-changing side effects she experienced after pelvic mesh surgery. The report highlights the risks associated with mesh removal surgery, the fact that women harmed by mesh have been dismissed and ignored by the healthcare system, and concerns that the number of patients who experience complications from pelvic mesh has been underestimated. It also outlines the need for stronger medical device regulation in the UK, and looks at issues with compensation and redress for patients harmed by mesh.
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Content ArticleThe variety of alarms from all types of medical devices has increased from 6 to 40 in the last three decades, with today’s most critically ill patients experiencing as many as 45 alarms per hour. Alarm fatigue has been identified as a critical safety issue for clinical staff that can lead to potentially dangerous delays or non-response to actionable alarms, resulting in serious patient injury and death. To date, most research on medical device alarms has focused on the nonactionable alarms of physiological monitoring devices. While there have been some reports in the literature related to drug library alerts during the infusion pump programming sequence, research related to the types and frequencies of actionable infusion pump alarms remains largely unexplored.
