Search the hub
Showing results for tags 'Regulatory issue'.
Found 469 results
-
Content ArticleContinuing the 'Why investigate' series, in this blog, Martin Langham looks at collecting data, introduces the idea of measurement, and asks what published science is there for testing it ‘beyond reasonable doubt’.
-
Content ArticleHear from Amanda Hutchinson, Head of Policy for Regulatory Change and Lisa Annaly, Head of Analytic Content here at CQC, as they take you through the Care Quality Commission's (CQC) new regulatory approach. This video covers: CQC's assessment framework. CQC's assessment approach. What a 'year in the life' of a provider will look like under our new regulatory approach. Feedback from a recent engagement session CQC held with over 100 health and social care providers and professionals. Ways you can stay up to date with the changes CQC is making.
-
Content Article
Blog - When diabetes devices fail (8 December 2020)
Patient-Safety-Learning posted an article in Diabetes
In this article for US magazine Consumer Reports, Rachel Rabkin Peachman looks at the incidence and impact of malfunctions and design flaws in continuous blood glucose monitors, insulin pumps and other diabetes equipment. She highlights the case of Pamela, a 64-year-old with diabetes who died when her insulin pump unintentionally gave her a massive dose of insulin overnight. The numbers of adverse events and deaths reported to the FDA regarding diabetes devices is far greater than for any other type of medical device—between January 2019 and July 2020, almost 400 deaths and 66,000 injuries in the US were linked to commonly used diabetes devices. Reports are spread across the different device manufacturers and demonstrate the complexities of trying to determine the exact cause of each adverse event. The article also includes information on how people with diabetes can protect themselves from device malfunctions and errors. -
Content ArticleHertfordshire Partnership University NHS Foundation Trust's Quality Account has been designed to report on the quality of their services in line with regulations. The aim in this report is to describe in a balanced and accessible way of how the Trust provides high-quality clinical care to service users, the local population and commissioners.
-
Content ArticleFrom 28 June 2022, courts and tribunals will have new powers to allow reporters and other members of the public to observe hearings remotely. The purpose of this practice guidance is to help judicial office holders understand and apply the new law.
-
Content Article
Ministry of Justice Annual Report and Accounts 2020‑21
Patient Safety Learning posted an article in Legal matters
The Ministry of Justice and its agencies deliver prison, probation and youth custody services; administer criminal, civil and family courts and tribunals; and support victims, children, families and vulnerable adults. -
Content ArticleThe duty of candour is a general duty to be open and transparent with people receiving care from you. It applies to every health and social care provider that CQC regulates. The duty of candour requires registered providers and registered managers (known as ‘registered persons’) to act in an open and transparent way with people receiving care or treatment from them. The regulation also defines ‘notifiable safety incidents’ and specifies how registered persons must apply the duty of candour if these incidents occur. This document from the Care Quality Commission (CQC) gives the background to the duty of candour and explains the statutory and professional duties of candour.
-
Content ArticleThe purpose of these standards is to create and maintain the right environment, both organisational and physical, for the safe and effective practice of pharmacy. The standards apply to all pharmacies registered with the General Pharmaceutical Council.
-
Content ArticleOver the past few years, concerns have been raised about the level of funding and intervention regulators have received from the pharmaceutical industry. In this article for The BMJ, investigative journalist Maryanne Demasi examines whether regulators of medical devices and medications have enough independence from the companies they are meant to regulate. She asked six of the world's biggest regulators about their funding and transparency and found that industry money permeates the world's leading regulators. This casts doubt on their ability to provide effective regulation, especially in the wake of a string of drug and device scandals.
-
Content ArticleIn a 2021 survey conducted by the Federal Aviation Administration (FAA), 35% of engineers working for the aviation company Boeing said they couldn’t raise safety concerns without interference. As a result, US aviation regulators are opening a new review of Boeing. This article in the Irish Times outlines the issues faced by Boeing staff and the reasons for the FAA's concerns.
-
Content ArticleFollowing the UK's exit from the European Union, the government aims to improve how medical devices and diagnostic devices are regulated through a new framework. The MHRA held a consultation on the future regulation of medical devices in the UK in autumn 2021 and this report outlines the government's response to the consultation. The consultation received 891 responses and aimed to collect views on developing a future legislation for medical devices which delivers: improved patient and public safety greater transparency of regulatory decision making and medical device information close alignment with international best practice, and more flexible, responsive and proportionate regulation of medical devices.
-
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.
-
Content ArticleMesh complications are rare and in most cases relatively minor. However, in a small number of cases they can be serious. These include mesh erosion/extrusion (when the mesh pokes through the vaginal wall or cuts through internal tissue), vaginal scarring, fistula formation, painful sex, bladder infection or perforation (piercing), bowel and nerve trauma and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. Serious complications are rare, given the tens of thousands of women who have had the implants, but can be life-changing for some women. As a result of concerns raised by mesh-affected women, in April 2018 the then Secretary of State for Health and Social Care, Jeremy Hunt MP, announced a review into the use of vaginal mesh. The review was led by Baroness Julia Cumberlege and recommendations made in the report of the Independent Medicines and Medical Devices Safety (IMMDS) “First Do No Harm”. The Government published its response to the IMMDS Review in July 2021.
-
Content ArticleThere has been little evaluation of strategies to strengthen regulation in LMIC, a notable exception being the Kenya Patient Safety Impact Evaluation (KePSIE), a collaboration between the Kenyan Ministry of Health and the World Bank. KePSIE is one of the worlds largest trials on improving patient safety, testing at scale complementary approaches to protect patients and prevent disease outbreaks. KePSIE provides validated tools to measure patient safety and assess facility performance in resource-poor primary care settings across multiple domains; development of an inspection checklist in collaboration with the country and large-scale pilot of inspections using a professional cadre and globally relevant empirical evidence on the effectiveness of government inspections and consumer empowerment to ensure patient safety.
-
Content ArticleHealth systems in low and middle income countries (LMIC) are increasingly pluralistic, involving a wide mix of public, not-for-profit and for-profit providers. Regulation should be a key foundation of the Government's stewardship role of these heterogeneous facilities, but performance of this function is generally weak, with serious consequence for patient safety and quality of care. There has been little evaluation of strategies to strengthen regulation in LMIC, a notable exception being the Kenya Patient Safety Impact Evaluation (KePSIE), a collaboration between the Kenyan Ministry of Health and the World Bank. This randomised controlled trial is assessing the impact of a set of innovative regulatory interventions in public and private facilities in three Kenyan counties. These comprise the use of the Joint Health Inspections Checklist (JHIC), which synthesises the areas covered by all the regulatory Boards and Councils; increased inspection frequency; risk-based inspections where warnings, sanctions and time to re-inspection depend on inspection scores; and display of regulatory results outside facilities. The KePSIE trial will provide a rigorous quantitative assessment of these regulatory strategies. The results are expected to make an important contribution to the limited evidence base on regulation and regulatory reform. The findings will be of substantial benefit to those concerned with regulatory reform and the improvement of quality and safety more generally in Kenya and other LMIC settings.
-
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.
-
Content ArticleIn 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review made specific recommendations that the government provide justice and redress to thousands of women who have been harmed by surgical mesh implants. Surgical mesh, also known as transvaginal tape, is a medical device surgically implanted to support organs and tissue. It is primarily used to treat urinary incontinence in women, but is also used to treat hernias and to reinforce abdominal areas where women have had tissue removed to reconstruct their breasts after mastectomy. In this article for the Mail Online, John Naish highlights that two years after the IMMDS, none of its recommendations have been implemented properly and surgical mesh is still being used. He examines the case of Kelly Cook, a 37 year-old mother who has been left with constant pain, nerve issues and incontinence after mesh surgery in 2018. In spite of the impact the mesh is having on her life, she has been told she may not be seen at one of the new specialist mesh centres for two years due to the length of the waiting list. The article also highlights the fact that no financial redress has yet been offered to mesh victims, that women's pain is still not being seen as a serious issue, and that there is a concerning lack of research into the safety of mesh devices.
-
Content ArticleThis Healthcare Safety Investigation Branch (HSIB) investigation aims to improve patient safety in relation to the decontamination of surgical instruments. It focuses on the work of sterile services departments (SSDs) in hospitals, where reusable medical equipment is cleaned, disinfected and sterilised to make it safe before it is used again. The investigation looked at the regulatory framework which SSDs work within, and their use of assurance models, which provide evidence that a service is running according to the relevant policies and procedures. These mechanisms are designed to keep patients safe and enable NHS trusts to manage risk within their organisations. For its reference case, the investigation used the case of a 56 year-old woman who underwent surgery to remove a kidney stone in her right kidney. During the procedure, 'black stuff' came out of one of the instruments being used, which was later analysed and found to be dried blood. The surgeon stopped the surgery immediately and proceeded with an alternative procedure to remove the kidney stone, for which the patient had already consented. The patient was tested for blood-borne viruses as she had been exposed to another person's dried blood, but tests did not show any evidence that she had contracted any.
-
Content Article
This is part of our series of Patient Safety Spotlight interviews, where we talk to people working for patient safety about their role and what motivates them. Bill talks to us about how patient safety and transparency have been key priorities throughout his career as an Operating Department Practitioner (ODP) and then a leader in the NHS. He highlights the need for a longer-term approach to workforce planning and talks about how leaders can set a culture that engages with and prioritises patients. -
Content ArticleThe Queen’s Speech was debated on Tuesday 17 May 2022. Copied below is Baroness Julia Cumberlege's excerpts on fulfilling the recommendations of the Cumberlege Report for a redress scheme.
-
Content ArticlePEOPLE FIRST is a CQC resource to help system leaders and service providers.
-
Content ArticleThe Care Quality Commission provides answers to the following common myths.
-
Content ArticleMedication errors present a major public health burden and there is a need to optimise risk minimisation and prevention of medication errors through the existing regulatory framework. The European Medicines Agency (EMA) in collaboration with the EU regulatory network was mandated to develop regulatory guidance for medication errors, taking into account the recommendations of a stakeholder workshop held in London in 2013. This guidance is intended to support the implementation of the new legal provisions regarding the reporting, evaluation and prevention of medication errors and is intended mainly for the pharmaceutical industry and national competent authorities. Healthcare professionals (HCP) are expected to consult national clinical guidance on reducing the risk of medication errors.
-
Content ArticleMinutes from the General Pharmaceutical Council meeting held on 14 July 2022. To be confirmed 8 September 2022.
-
Content ArticlePerceptions of care work as low skilled continue to persist, despite the pandemic highlighting just how vital care workers are. In recent years there has been increased debate around the ‘professionalisation’ of this staff group, which generally refers to the creation of a statutory register of staff and their professional regulation. This new Nuffield Trust report reviews what the evidence shows about the professionalisation of care workers in other countries.
