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Showing results for tags 'Medical device'.
Found 335 results
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Content Article
Nine specialist mesh centres have been set up by NHS England to offer removal surgery and other treatment to women suffering from complications and pain as a result of vaginal mesh surgery, but women are reporting that they are not operating effectively. In this opinion piece, Kath Sansom highlights ten problems with these specialist mesh centres, evidenced by the real experiences of women who are part of the Sling the Mesh campaign Facebook group. -
Content Article
Mesh Down Under
PatientSafetyLearning Team posted an article in Women's health
Across the world, people are suffering from life-altering and serious chronic pain conditions caused by surgical mesh complications.Mesh Down Under are a New Zealand based campaign group whose mission is to:raise awareness amongst New Zealanders about the complications that are not rare with the use of surgical mesh. provide information to enable anyone considering having surgical mesh surgery, particularly women having pelvic floor or bladder sling repairs, to be fully informed before consenting to this surgery.shout out to our health professionals and government bodies so that patient stories are no longer 'news to them' but an acknowledged public health issue that needs to be addressed.highlight the importance of reporting adverse events associated with medical devices.Follow the link below to find out more. -
Content ArticleAdvances in 3D printing, also called additive manufacturing, are capturing attention in the healthcare field because of their potential to improve treatment for certain medical conditions. A radiologist, for instance, might create an exact replica of a patient’s spine to help plan a surgery; a dentist could scan a broken tooth to make a crown that fits precisely into the patient’s mouth. In both instances, the doctors can use 3D printing to make products that specifically match a patient’s anatomy. The technology is not limited to planning surgeries or producing customised dental restorations such as crowns; 3D printing has enabled the production of customized prosthetic limbs, cranial implants, or orthopedic implants such as hips and knees. At the same time, its potential to change the manufacturing of medical products—particularly high-risk devices such as implants—could affect patient safety, creating new challenges for Food and Drug Administration (FDA) oversight. When 3D printing is used to manufacture a medical product at the point of care, oversight responsibility can become less clear. It is not yet apparent how the agency should adapt its regulatory requirements to ensure that these 3D-printed products are safe and effective for their intended use. The FDA does not directly regulate the practice of medicine, which is overseen primarily by state medical boards. Rather, the agency’s jurisdiction covers medical products. In some clinical scenarios where 3D printing might be used, such as the printing of an anatomical model that is used to plan surgery, or perhaps one day the printing of human tissue for transplantation, the distinction between product and practice is not always easy to discern. This issue brief explains how medical 3D printing is used in health care, how FDA regulates the products that are made, and what regulatory questions the agency faces.
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Content ArticleAt the First Do No Harm All Party Parliamentary Group (APPG) meeting on 26 January 2021 with the Minister for Patient Safety, Nadine Dorries MP, attendees asked a large number of questions, not all of which could be answered by the Minister due to time constraints. The unanswered questions were submitted to the Minister’s office at the Department for Health and Social Care for a written response. The Department has now provided answers.
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Content ArticleThe General Medical Council (GMC) has updated their ethical guidance on Good practice in prescribing and managing medicines and devices.
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Kate Pym, Managing Director of Pym's Consultancy, discusses the barriers involved in getting an innovative product into the NHS.- Posted
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Content ArticleA large proportion of the patient injuries or deaths attributable to medical device misuse can be eliminated and/or mitigated by adopting an effective human factors and ergonomics (HFE) approach. The implementation of a usability engineering process is now mandatory for medical devices manufacturers seeking to obtain the European Union’s CE Mark. In this article, Pelayo, Marcilly and Bellandi describe the European Union’s HFE regulation and highlight the challenges faced by (i) manufacturers implementing this regulation and (ii) regulatory bodies charged with assessing the compliance of usability files. In Europe, 95% of MD manufacturers are small- and medium-sized enterprises; compliance with the CE Mark regulations is a real challenge to their competitiveness. Levels of knowledge about HFE vary greatly from one regulatory organisation to another, which can sometimes lead to very different expectations. The authors also present the specific use-related risk management approach required by the HFE regulation. Lastly, they focus on the limitations of the HFE regulation for MDs and on future HFE challenges in further reducing and/or eliminating MD use errors. The main challenge is the need to go beyond technology design and the premarket assessment and to look at the postproduction stage; the coupling between an MD and a sociotechnical system can lead to consequences that were not predicted during the design process. This implies the need to consider the emerging properties of technologies in use by involving all the stakeholders.
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Content ArticleThis is a video recording of the All Party Parliamentary Group (APPG) for First Do No Harm meeting with Nadine Dorries MP, the Minister for Patient Safety, Suicide Prevention and Mental Health. The meeting took place on 26 January 2021 and is chaired by Baroness Cumberlege who is the Co-Chair of the APPG. The APPG was set up to raise awareness of and build 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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Content ArticleIn this written statement to Parliament, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, gives an update on the government’s response to the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review. Nadine Dorries concludes: "The report of the IMMDS Review powerfully demonstrates the importance of hearing the patient voice in patient safety matters. The actions outlined here demonstrate the government’s commitment to learning from this report, and will support vital work already underway to hear the voice of the patient as part of the NHS Patient Safety Strategy. We currently plan to respond further to the report of the IMMDS Review during 2021."
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Content ArticleNHS Resolution received 2,600 claims for needlestick injuries for incidents occurring between 2012 – 2022. Needlestick injuries can be costly to investigate and increase the risk blood-borne infections. Fortunately, the harm and cost of most needlestick injuries are largely avoidable. NHS Resolution has created two new resources to share the learning from these claims and help organisations identify how to prevent future injuries.
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Content ArticleThis Healthcare Safety Investigation Branch (HSIB) report charts the emerging patient safety risks that can come with the introduction of ‘smart’ infusion pump technology into hospitals. Smart infusion pumps are the latest generation of programmable devices that administer medication. They are seen as a way of improving safety as the smart functionality aims to prevent underdoses or overdoses – they are equipped with features such as alerts or alarms to help detect problems. The investigation was launched after one NHS Trust recorded three incidents where a smart infusion pump delivered an overdose of fentanyl, a powerful pain medication. The patients weren’t harmed as it was swiftly picked up, however it emphasised the new risks that come with introducing new technology and the potential for serious medication errors. The investigation focused on the barriers to implementing the technology effectively across the NHS, rather than on the technology itself.
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Content ArticleLaura Anne Jones MS (Member of the Senedd) tabled a formal written question concerning the implementation of the findings of the Cumberlege Review in Wales. This is the formal response from the Minister for Health and Social Services, Vaughan Gething MS.
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Content ArticleThis was a debate from the Scottish Parliament on the 8 September 2020 concerning the recommendations in the recently published First Do No Harm report by the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege (also known as the Cumberlege Review). The debate centred on a motion put forward by Jeane Freeman MSP, Cabinet Secretary for Health and Sport, which read as follows: That the Parliament welcomes the recommendations made by Baroness Cumberlege in her report on the independent medicines and medical devices safety review; acknowledges the Scottish Government's apology to women and families affected by Primodos, sodium valproate and transvaginal mesh; welcomes the Scottish Government’s commitment to establish a Patient Safety Commissioner, and notes the actions taken by the Scottish Government to offer improved services for women who have suffered complications as a result of transvaginal mesh.
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Content ArticleTo get the safest—and not just the cheapest—devices, the NHS needs to start taking ergonomics seriously, experts say. In March 2020, the UK government commissioned non-medical manufacturers, including Dyson and Renault, to produce ventilators for the excess number of patients expected to have respiratory failure as a result of COVID-19. Because the machines would be used by non-specialist clinicians during the pandemic, NHS England commissioned guidance1 on ergonomic (also known as human factors) design of the ventilators, aimed at achieving “optimum human safety and performance.” However, the commissioning of the ventilator guidance remains an exception rather than the rule. There are, however, signs that the NHS is starting to take human factors seriously—and COVID-19 is a driver.
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Content ArticleThe government-commissioned review, First Do No Harm, into why mesh implants and other treatments were allowed to harm hundreds of women said the failings were “caused and compounded by failings in the health system itself”. HSJ's Health Check podcast considers why it is being buried by government.
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Content ArticleOn Wednesday 8 July 2020 the Independent Medicines and Medical Devices Safety Review published its report First Do No Harm, examining how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices. Chaired by Baroness Julia Cumberlege, the review focused on looking at what happened in relation to three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. In this blog Patient Safety Learning consider the reports findings in more detail, highlighting the key patient safety themes running through this, which are also found in many other patient safety scandals in the last twenty years. It also looks at what needs to change to prevent these issues recurring and asks whether NHS leaders stick with the current ways of working, make a few improvements, or take this opportunity for transformational change.
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Content Article
Out-patient Parenteral Antibiotic Therapy (OPAT) is now a routine part of care in the UK following demonstration that it is safe and effective for patients and OPAT is now being actively promoted as part of the UK government’s stewardship initiatives. NHS North Tees and Hartlepool share their experience of redesigning their OPAT services. See the attachment below for details on the project. -
Content ArticleThis Review was announced in the House of Commons on 21 February 2018 by Jeremy Hunt, the then Secretary of State for Health and Social Care. Its purpose is to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future. The Review was asked to investigate what had happened in respect of two medications and one medical device: hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages; sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life- changing, complications; and to make recommendations for the future. The Review was prompted by patient-led campaigns that have run for years and, in the cases of valproate and Primodos over decades, drawing active support from their respective All-Party Parliamentary Groups and the media.
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Content Article
How to undertake intravenous infusion calculations
Patient Safety Learning posted an article in Nursing
As part of the Nursing Standard's 'How to' series, Jane Brindley, a senior lecturer in adult nursing, provides a step-wise, practical approach to undertaking intravenous (IV) infusion calculations. The article also explores the evidence base behind medication errors in relation to calculations. -
Content ArticleSoftware is playing an expanding role in modern medical devices, raising the question of how developers, regulators, medical professionals, and patients can be confident in the devices' reliability, safety, and security. Software- related errors in medical equipment have caused people's deaths in the past, so the issue is not simply theoretical. Device manufacturers need to provide safety assurance for complex software that is being developed in a competitive environment where price and time-to-market are critical factors. Further, security issues that previously were not a major concern now need to be anticipated and handled. In this interview, published by Electronic Design, Dr. Benjamin Brosgol, senior member of the technical staff at Adacore, talks about these issues.
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Content ArticleThe pharmacy contribution to antimicrobial stewardship document focuses on the pharmacist’s role as part of a multidisciplinary approach in tackling the challenges of inappropriate use of antibiotics. The recommendations in this policy have been produced in order to contribute to wider efforts in meeting the challenge set by the UK Government in 2016 of reducing inappropriate antibiotic prescribing by 50% by 2020.
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Content Article
Assistive technology: definitions, examples and safe use
Claire Cox posted an article in Equipment
The phrase ‘assistive technology’ is often used to describe products or systems that support and assist individuals with disabilities, restricted mobility or other impairments to perform functions that might otherwise be difficult or impossible. An assistive technology product can be classed either as a medical device, which needs a CE mark and is regulated by the applicable legislation, or it can be an ‘aid for daily living’. It depends on the claims made by the manufacturer. This guidance set out by the Medicines and Healthcare products Regulatory Agency (MHRA) helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living. -
Content ArticleRichard Greenwood is Trust Decontamination Lead & Head of Sterile Services at University Hospitals of Morecambe Bay (UHMB) NHS Foundation Trust. As with many NHS Trusts, UHMB were faced with problem of managing surgical instrument stocks, migration of the instruments from sets, and tracking and tracing single instruments through the decontamination process back to the patient. This case study shows how they solved this problem.
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Content ArticleIn intensive care units (ICU) and operating theatres, arterial lines are used to accurately measure a patient’s blood pressure and take numerous and repetitive blood samples. In order to prevent bacterial contamination and blood spillage from the arterial line, red arterial connectors, which are closed cap coverings, are placed on the sampling port of the arterial line. Doctors from The Queen Elizabeth Hospital NHS Foundation Trust, Kings Lynn have collaborated with Eastern Academic Health Science Network and the Patient Safety Collaborative on this patient safety solution.
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Content Article
Webinar: Using Human Factors in Hospital Technology Procurement
Claire Cox posted an article in Equipment design
Healthcare information technology procurement is critical for healthcare organisations, as procurement decisions on medical devices and IT infrastructure will impact safety, efficiency, staff and patient experiences. In this webinar, Svetlena Taneva, from Healthcare Human Factors, University Health Network, discusses using Human Factors in hospital technology.
