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The World Health Organization (WHO) has published a new edition of this guidance on health technology assessment (HTA) for medical devices. Health technology assessment (HTA) is described as ‘a well-recognised and methodologically robust evidence-based priority-setting process used to provide information on the safety, efficacy, quality, appropriateness, and cost-effectiveness of health technologies’. This document ‘is intended to provide guidance to policy-makers, particularly those in low- and middle-income countries that are currently developing HTA capacity.’ The document describes ‘general concepts of HTA and points to best-practice resources to enable low- and middle-income countries to make consistent, transparent and informed decision-making on the adoption and use of medical devices to ensure clinical needs are met whilst delivering value to patients, healthcare providers, and the broader health system.’

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents.

Healthcare at home has become an increasingly popular alternative to hospital-based treatment, offering patients the comfort and convenience of receiving care in familiar surroundings. However, while the home care model presents clear benefits, it also brings about unique challenges—especially when patients or their family members are tasked with operating complex medical devices. These devices, such as ventilators, haemodialysis machines, and infusion pumps, have traditionally been used in acute care settings, where healthcare professionals provide continuous oversight. With such devices increasingly being used in the home, the need for appropriate selection, management, and use of those technologies is becoming more critical. One of the most significant concerns associated with home healthcare is the potential for preventable harm due to improper use or malfunction of medical devices. As highlighted in ECRI’s annual Top 10 list of healthcare hazards, improper setup and management of these technologies, particularly by lay users, can result in delayed or inaccurate care, with serious consequences for patient health. This year, ECRI has expanded the discussion of this issue to explore in greater detail the risks associated with home use of complex medical devices.

Mrs Sheila Wexler lived with dementia and other significant comorbidities for a number of years. In the months prior to her death, she was thought to be entering the final phase of her life. In January 2024, Mrs Wexler developed an unstageable sacral pressure ulcer. The district nursing team ordered equipment from an external supplier (NRS Healthcare) which, among other things, would turn Mrs Wexler regularly to assist in the treatment of the pressure ulcer. There were delays in some of the equipment arriving and the turning equipment was not properly functioning. An engineer attended Mrs Wexler’s home, on behalf of NRS Healthcare, to repair the equipment, but used a pump that was not compatible with the turning system. As a result of these issues with the equipment, Mrs Wexler’s immobility was significantly increased for a period of days, which added to her underlying risks of developing a pulmonary embolism.  Mrs Wexler died at home on 17 February 2024. The immediate cause of her death was bilateral pulmonary embolism. A number of her comorbidities contributed to this. The increased immobility as a result of delayed and defective equipment being supplied also more than minimally contributed to her death.  For context, NRS Healthcare is a nationwide supplier of medical equipment for use in people’s own homes and it has contracts with numerous NHS bodies and others, to supply and maintain such equipment. In this specific case, NRS Healthcare was required to provide and install medical equipment (at the request of one of the district nursing teams that are part of Central and North West London NHS Foundation Trust). This equipment included, a lateral turning system (known as a TOTO), an air mattress, and side rails for a profiling bed. The principal need for the equipment was for assistance in treating a sacral pressure wound. It was confirmed in evidence, the order for the equipment from NRS Healthcare was placed correctly on 10 January 2024, on a next day delivery basis. Matters of concern NRS Healthcare related matters: The coroner heard evidence of a delay in delivering some of the required equipment, which in turn meant a delay in the patient being able to make use of the equipment. The delay meant that the patient’s family, carers, and the district nursing team underwent a period of time in which they were unable to provide the patient with the optimal care required in relation to the pressure ulcer. When the TOTO turning system arrived it was defective. An urgent repair/replace request was made to NRS Healthcare, which resulted in an engineer attending the patient’s home to replace the pump on 23 January 2024. However, despite advising that they had replaced pump with a like-for- like pump, it transpired that the replacement pump was a ’Tri-Pos Bariatric Alternating Air Cushion’ pump. This replacement pump had none of the settings that would allow the proper and effective use of the TOTO system. In this instance, the TOTO system was required to turn the patient from one side to the other every 60 minutes. I was told in evidence that equipment issues would have added to the patients ‘pain and distress’ and the fitting of the incorrect pump meant that the patient was not being turned every 60 minutes, as required. Again, this creates the risk that those caring for the patient were precluded from providing an optimal level of care. While the presence of a pressure ulcer, in itself, did not add to the underlying risk of the patient developing a pulmonary embolism, the delayed and defective equipment provided significantly increased the patient’s immobility in the weeks prior to her death. There was evidence that immobility is a major risk factor in the development of pulmonary emboli. The coroner heard evidence that issues with delays and defective equipment from NRS Healthcare persist to date. NRS Healthcare and NHS England related matters: The coroner heard evidence that since being awarded the contract to provide such equipment, there had been numerous and ongoing delays and ‘problems’ in the service provided by NRS Healthcare. The evidence was such that the repeated issues and concerns had actually been placed on the Trust/Integrated Care Board’s (ICBs) risk register. While I heard that there had been some improvement, I was told that the service provided was still ‘not great’. While this particular case is the first in which the coroner has formed the opinion that delayed and defective equipment has created a risk of future deaths, he has heard similar evidence of delayed and defective equipment issues relating to NRS Healthcare in other inquests concerning different NHS Trusts and ICBs. On that basis, the coroner is of the opinion, given NRS Healthcare’s operations are not confined to organisations within this coroner area, that the risks posed are likely to be more widespread and that action should be taken more widely.

This article by BD looks at the the risks related to irritants and vesicants when medications are administered to patients via vascular access (into their blood vessels through a cannula). It highlights the immediate risks of vein irritation, pain, discomfort and potential tissue damage during an infusion, as well as looking at the impact of damage to vascular endothelial cells caused by irritants and vesicants. It offers guidance on selecting the right vascular access device (VAD) and includes a Vascular Access Device Assessment Decision Tree, which is free to download.

This roadmap sets out the government’s ambition to transition away from all avoidable single-use medical technology (medtech) products towards a functioning circular system by 2045 that maximises reuse, remanufacture and recycling. Circularity in medtech means designing, procuring and processing medical products in a way that enables them to be reused, remanufactured or recycled, preserving their value for as long as possible. The benefits of a circular economy in the health sector are vast and increasingly well-understood, but are rarely put into practice and are difficult to scale. Unlocking these benefits across the UK medtech sector will bring many opportunities for innovation and growth, while improving patient care and value for money and supporting the transition to a net zero NHS. This document sets out a plan of 30 actions to deliver our 2045 vision, which will involve: driving positive behavioural change exploring new commercial incentives to provide circular medtech creating new standards to enable innovative products and services planning the decontamination and recycling infrastructure of the future establishing new collaborations to accelerate the emergence of transformative science.

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. Incident Before the incident, the person had been experiencing difficulties with mobility and had sometimes been confused and agitated. They had been provided with an adapted wheelchair with extended footplates for their own use, and staff helped them get around in it. However, staff mainly used a standard wheelchair for communal use within the care home. On several occasions, the person's foot had come away from the footplate when using a standard wheelchair, resulting in a risk of it getting trapped. On the day of the incident, while pushing the person down a slope in a standard wheelchair, the staff member noticed resistance and found the person's foot caught underneath. The staff member replaced the person's foot on the footplate and continued the journey. Afterwards, the person complained about pain in the affected leg and was taken to hospital for further assessment. The person was found to have significant, life-changing fractures to their leg and, at one stage, it was thought it may have to be amputated. The person spent 16 weeks in bed with their leg in a cast, before being discharged from hospital to a different service. Unfortunately, they did not make a full recovery and their physical health was permanently affected by the incident. The CQC's investigation found that, although the provider knew the risks associated with the use of a communal wheelchair, the care home failed to take adequate steps to assess and mitigate those risks. Recommendations To manage the risk of injuries to people from wheelchairs, health and social care providers need to: develop and implement adequate moving and handling plans develop and implement a risk assessment specific to a person's use of a wheelchair have adequate policies and procedures to support staff in managing these risks assess a person's mental capacity to decide about using a wheelchair, especially one not provided specifically for them provide staff with the training, skills and knowledge required to safely use a wheelchair seek the support of other professionals, such as occupational therapists, where required.

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. Actions required Update your organisation’s policies and procedures on procurement, provision, prescribing, servicing and maintenance of these devices in line with the MHRA’s updated guidance on the management and safe use of bed rails. Develop a plan for all applicable staff to have training relevant to their role within the next 12 months with regular updates. All training should be recorded. Review the medical device management system (inventory/database) for your organisation or third-party provider for devices within your organisation, including those which have been provided to a community setting (for example, the patient’s own home). Keep this system up to date. Implement maintenance and servicing schedules for the devices in the inventory/database, in line with the manufacturer’s instructions for use and/or service manual. Prioritise devices which have not had regular maintenance and servicing. If this is outsourced, compliance with the schedule should be monitored. Review patients who are children or adults with atypical anatomy as a priority. Ensure the equipment they have been provided with is compliant with BS EN 50637:2017 unless there is a reason for using a non-compliant bed. Record this on the risk assessment and put in place measures to reduce entrapment risks as far as possible. Review all patients who are currently provided with bed rails or bed grab handles to ensure there is a documented up-to-date risk assessment. Complete risk assessments for patients where this has not already been done and for each patient who is provided with bed rails or bed grab handles. Implement systems to update risk assessments where the equipment or the patient’s clinical condition has changed (for example, reduction/improvement in weight or mobility), and also at regular intervals.

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.

The extent to which postintensive care unit (ICU) clinics may improve patient safety for those discharged after receiving intensive care remains unclear. This observational cohort study from Karlick et al., conducted at an academic, tertiary care medical centre, used qualitative survey data analysed via conventional content analysis to describe patient safety threats encountered in the post-ICU clinic. For 83 included patients, safety threats were identified for 60 patients resulting in 96 separate safety threats. These were categorised into 7 themes: medication errors (27%); inadequate medical follow-up (25%); inadequate patient support (16%); high-risk behaviours (5%); medical complications (5%); equipment/supplies failures (4%); and other (18%). Of the 96 safety threats, 41% were preventable, 27% ameliorable, and 32% were neither preventable nor ameliorable. Nearly 3 out of 4 patients within a post-ICU clinic had an identifiable safety threat. Medication errors and delayed medical follow-up were the most common safety threats identified; most were either preventable or ameliorable.

Postpartum haemorrhage is a leading cause of maternal deaths. Now a new study points to a surprisingly simple and inexpensive solution. If the woman lies on a plastic sheet with a small transparent pouch at the other end to collect the blood, the medical team has an immediate sense of how much danger she's in and can take swift action. Read the full article, published by NPR, via the link below.