Search the hub
Showing results for tags 'Medical device / equipment'.
Found 218 results
-
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 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 ArticleSurgeons' News is a magazine for surgical, dental and allied healthcare professionals. Published quarterly by the Royal College of Surgeons of Edinburgh, it features comment and opinion from leading professionals, plus reviews and reports on subjects relevant to all career levels. In an article in the June issue (page 18), Maryanne Mariyaselvam describes some of the latest solutions being developed to protect patients and clinicians from potential errors.
-
Content ArticleThe MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequences arising from inadequate supply of insulin, including diabetic ketoacidosis (DKA). Although the manufacturer Roche Diabetes Care (RDC) has implemented a number of risk minimisation strategies to reduce the incidence of these events, the impact of these is inconclusive and we are taking further action to protect patients. To protect patient safety, diabetes healthcare professionals should inform patients who use the Accu-Chek Insight of the risk of leakage. Clinical care decisions should be made to ensure patients are moved onto alternative pumps where possible.
-
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 ArticleThe Guidance for Human Factors Evaluations in the Procurement of Medical Devices, Equipment and Technology document provides comprehensive recommendations on how one may integrate human factors evaluations into procurement processes. While it is a relatively new aspect to consider in healthcare supply management, and may entail robust change management to implement, incorporating human factors evaluation in purchasing will enable best value and outcomes in health care.
-
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.
-
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.
-
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.
-
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.
-
Content ArticleAn overview of the industry study by MxD and IAAE between February and June 2021 funded by FDA Office of Counterterrorism and Emerging Threats. The aim of the study was to gain an initial baseline to deepen FDA’s understanding of the factors that impact a manufacturer’s decision to invest in and adopt digital technologies by illuminating both perceived and demonstrated barriers from technical, business, and regulatory perspectives, and related cybersecurity considerations.
-
Content ArticleThe International Electrotechnical Commission (IEC) is a worldwide organisation for standardisation comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardisation in the electrical and electronic fields. This part of IEC 62366 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
-
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.
-
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.
-
Content ArticlePeripherally inserted central catheters (PICCs) are medical devices often used for medium-to-long-term intravenous therapy, but they are often associated with morbid and potentially lethal complications. This multi-centre study in the journal Plos One aimed to identify barriers and facilitators to implementing evidence-based appropriateness criteria to improve PICC safety and patient outcomes in a pay-for-performance model. The authors found that structured quality improvement (QI) efforts led to sustained PICC appropriateness and improved patient safety. These interventions included a multidisciplinary vascular access committee, clear targets, local champions and support from an online education toolkit.
-
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. Tracey talks to us about the role of NHS Supply Chain in ensuring the products procured through the NHS Supply are of high quality and are safe for healthcare organisations to use. She also highlights the vital importance of complaints and the need for staff who don’t work in direct care delivery to recognise their role in patient safety. -
Content ArticleA safety alert from the US Patient Safety Authority and ECRI.
-
Content ArticleVideo recording technologies offer a powerful way to document what happens in clinical areas. Cameras, and to a lesser extent, microphones, can be found in a growing number of modern operating rooms in the USA, UK and other parts of the world. While they could be used to create a detailed record of what happens in and around the operating table, this is still rarely being done; the vast majority of operations are still only documented in written operation notes. In this paper, Bezemer et al. discuss using microanalysis of videos from the operating room.
-
Content ArticleOn 5 October 2022, the Safety for All campaign hosted a webinar on the prevention of sharps injuries and theatre safety. There were over fifty people in attendance and there was a lively discussion throughout in person and on the chat. The webinar featured five presentations which are summarised below.
-
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.
-
Content ArticleWhen something goes wrong in health and social care, the people affected and staff often say, "I don’t want this to happen to anyone else." These 'Learning from safety incidents' resources are designed to do just that. Each one briefly describes a critical issue - what happened, what the Care Quality Commission (CQC) and the provider have done about it, and the steps you can take to avoid it happening in your service.
-
Content ArticleThe purpose of the US Joint Commission's National Patient Safety Goals is to improve patient safety. The goals focus on problems in healthcare safety in the USA and how to solve them. They include identifying patients correctly, improving staff communication, use medicine safely, use alarms safely, prevent infection, identify patient safety risks and prevent mistakes in surgery.
-
Content ArticleSurgical instruments are essential for the delivery of modern healthcare. Their use is so widespread that they are easily taken for granted. The supplier base for instruments is diverse, including small, family owned businesses, and large multinational corporations. What they have in common are complex manufacturing processes, global supply chains, broad product ranges to suit varying clinical needs and product development with the capacity to innovate as required.
-
Content ArticleIn March 2020 Philips Health Systems released an FSN concerning V60 ventilators. This FSN concerned a hardware fault in the device, which can result in an unexpected shutdown. There are two ways in which this shutdown can occur: The first will sound a warning to alert the user that the machine is shutting down. This will let the user know they need to switch to an alternative source of ventilation. There is a risk that the patient will be unventilated while this second source of ventilation is prepared. The second failure mode will cause the device to shut down with no warning to the user. If a device fails in use and does not alarm, the patient will not be adequately ventilated and there is a potential risk of brain damage or death, depending on how long it takes clinicians to become aware of the situation and respond. There has been a significant delay of replacement parts arriving in the United Kingdom, resulting in an increased risk of this failure occurring. The MHRA has decided to update the guidance issued in the Medical Device Alert published in June. The MHRA will continue to work with the manufacturer to improve the delivery time for replacement components.
-
Content Article
NHS Resolution: Manual handling (19 October 2020)
Patient Safety Learning posted an article in Patient management
From 1 April 2009 to 31 March 2019, NHS Resolution was notifed of 4,733 claims relating to manual handling. NHS Resolution has produced a 'Did you know' guide on manual handling.
