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The Royal College of Emergency Medicine have issued a safety alert on children's toys containing water beads. Doctors are warning these gifts could pose a danger to children and vulnerable adults if swallowed.

This National Patient Safety Alert, issued by the NHS England National Patient Safety Team and endorsed by the Royal College of Obstetricians & Gynaecologists, Royal College of Midwives and Royal College of Anaesthetists, instructs all relevant NHS funded maternity care providers to cease pre-preparing oxytocin infusions at ward level in all clinical areas. All actions should be completed by 31 March 2025. Midwives need to complete several tasks immediately and simultaneously following birth to ensure the safety of both the mother and baby. To support this, postpartum oxytocin infusions have been prepared in advance of being required. If a pre-prepared oxytocin infusion is unintentionally given before the baby is born, for example if it is confused with standard fluids or the intrapartum and postpartum infusions are confused, the woman’s contractions will increase in frequency and strength. This can lower the baby’s oxygen levels and alter their heart rate, increasing the risk of placental abruption (where the placenta prematurely separates from the uterus and deprives the baby of oxygen). A review of the National Reporting and Learning Systems over a 5 year period identified 25 incidents. Actions required: Review and update local clinical procedures (or equivalent documents) to ensure: Oxytocin infusions for any indication are not pre-prepared at ward level in any clinical area (including delivery suites and theatres). Post-partum haemorrhage (PPH) kits/ trolleys are immediately available in all clinical areas/theatres where it may be required. Where a woman is identified to be at high risk of PPH: (a) the PPH kit/trolley should be brought into the labour/delivery room/theatre during the second stage of labour, (b) the postpartum oxytocin infusion should be prepared at the time of birth and not before, (c) a second midwife should be available to support the administration of the postpartum oxytocin infusion. Roles and responsibilities of staff groups in the labour setting, including theatres, are clearly defined in terms of prescribing, preparation, administration and disposal of oxytocin infusions. Including: intrapartum oxytocin infusions, postpartum oxytocin infusions and unused, pre-prepared oxytocin. infusions.

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 number of cyberattacks and information system breaches in healthcare has grown steadily, escalating from isolated incidents to widespread targeted and malicious attacks. In 2022, 707 data breeches occurred in the US, exposing more than 51.9 million patient records, according to data from the Department of Health and Human Services (DHHS).  To help healthcare organisations address this growing patient safety concern, The Joint Commission has issued this Sentinel Event Alert that focuses on risks associated with cyberattacks and provides recommendations on how healthcare organizations can prepare to deliver safe patient care in the event of a cyberattack. 

Potential serious risks to patient safety have been identified with the use of Magentus Software Limited’s Euroking maternity information system. These concern specific data fields: certain new patient information, recorded during a patient contact, can overwrite ('back copy') information previously recorded in the patient’s pregnancy record. certain pregnancy-level data (information relevant only to a specific pregnancy event) can be saved at a patient level (where information relevant throughout a person's life is recorded), causing new information to overwrite (‘back copy’) previously recorded data across an entire patient record. certain recorded pregnancy-level data can pre-populate into new pregnancy records (‘forward copy’), which can mean clinicians will see incorrect patient information, and attempts to correct this can result in the issue described at (ii) above. Actions Organisations using Euroking: 1. must consider if Euroking meets their maternity service’s needs and ensure that their local configuration is safe. To do this they will need to work with their supplier to make changes to their existing system, and this will need to be overseen by their clinical safety officer. 2. must review and ensure that each data field within the system does not copy forward or backward. 3. if procurement of a new system is deemed necessary, organisations must ensure that all clinical information is appropriately backed-up, accessible for any future requirement and, when Euroking becomes a legacy system, must comply with action Organisations with legacy Euroking contracts: 4. must implement a process to ensure users who access any legacy Euroking records will be alerted to the issues identified in this alert. Organisations currently using another maternity information system/EPR: 5. must reassess the clinical safety of their maternity EPR with a suitably qualified clinical safety officer and, as a minimum, must ensure that the issues listed under ‘Additional information’ relating to the back and forward copying of information do not occur. 6. must assess that their current maternity EPR complies with the core maternity capabilities in the Maternity Digital Capabilities Framework.

The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations. This alert is for action by: Integrated Care Boards (in England), Health Boards (in Scotland), Health Boards (in Wales), and Health and Social Care Trusts (in Northern Ireland). Due to the known significant risk of serious harm to a baby after exposure to valproate in pregnancy, these measures aim to ensure valproate is only used if other treatments are ineffective or not tolerated, and that any use of valproate in women of childbearing potential who cannot be treated with other medicines is in accordance with the Pregnancy Prevention Programme (PPP). Given these and other risks of valproate, these measures also aim to reduce initiation of valproate to only in patients for whom no other therapeutic options are suitable. A. Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. B. At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes Advise leaders that current safety measures for valproate continue to apply, including the valproate PPP for any girls and women of childbearing potential. Advise leaders in general practice and pharmacy that teams should continue to prescribe and dispense valproate but also discuss the current warnings and upcoming measures relating to valproate with their patients and consider together how it affects the patient’s individual circumstances. New educational materials should be integrated into local guidance to ensure patients are able to make an informed choice. Actions required 1. Designate a new or existing group to co-ordinate the implementation of the new regulatory measures in providers, with oversight from a senior quality group. This group should include (but is not restricted to): a. An appointed chair with delegated responsibility for the actions in this alert. b. Representation from clinical leads in all the specialities named above and any other relevant departments. c. A mechanism by which the group can involve and be informed by patients with lived experience. 2. The group should be tasked with, and document, progress towards: a. Updating all local guidance and protocols relating to prescribing of valproate to reflect the new regulatory position, including definitions of the roles and responsibilities of clinicians and provider organisations, and the recording of compliance with the risk forms b. Commissioning work if necessary to understand the needs of the affected population, including those people most at risk of health inequalities. c. Reviewing the results of local audit(s) of compliance with the existing PPP measures for girls and women of childbearing potential prescribed valproate. d. Commissioning/determining the local pathways of care for women of childbearing potential and girls in relation to the prescribing and review of valproate. e. Planning for and identification of clinical resource to meet the identified needs of the population and implement the new regulatory measures. Based upon the findings of the above, the group should produce an Action and Improvement Plan by the alert deadline that is communicated with all relevant staff to ensure smooth implementation of the new regulatory measures and to allow for continuous improvement in care of patients who are considering or being prescribed valproate, including ongoing improvement, monitoring and audit.

There are supply disruptions affecting various strengths of the following medications which are licensed for the treatment of attention deficit hyperactivity disorder (ADHD): methylphenidate (Equasym® XL) capsules, methylphenidate (Xaggitin XL® , Concerta XL® , Xenidate XL® ) prolonged-release tablets, lisdexamfetamine (Elvanse® ) capsules, and guanfacine (Intuniv® ) prolonged-release tablets. This is a safety critical and complex National Patient Safety Alert. Implementation should be co-ordinated by an executive lead (or equivalent role in organisations without executive boards) and supported by clinical leaders in pharmacy, community pharmacy, GP practices, mental health services and those working in the health and justice sector. Prescribers should: 1. not initiate new patients on products affected by this shortage until the supply issues resolve. Healthcare professionals in primary care (and secondary care if appropriate) should: 2. identify all patients currently prescribed these products, and 3. make early contact with patients to establish how much supply they have remaining. Where patients have insufficient supplies to last until the re-supply date, contact: 4. community pharmacies, hospital pharmacy departments, or other dispensing pharmacy services, to establish availability of supply; and 5. patient’s specialist team for advice on management options if the product cannot be sourced. Specialist teams should: 6. support primary care teams seeking advice for patients currently prescribed the affected products, 7. provide individualised management plans, where required; and 8. recommend alternatives in line with NICE guidance, where appropriate.

Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely. Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled. Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.

A joint National Patient Safety Alert issued by the NHS England and NHS Improvement National Patient Safety Team and Royal College of Emergency Medicine, on the need for urgent assessment/treatment following ingestion of ‘super strong’ magnets.

Dr Helen Simpson, Lisa Shepherd and Dr Steve Kell summarise the guidance and implementation of the steroid emergency card in primary care. Adrenal insufficiency (AI) is an uncommon but potentially life-threatening condition, where patients are unable to produce enough of the glucocorticoid, cortisol. Every practice will have patients with a known diagnosis of AI, such as those with Addison’s disease, congenital adrenal hyperplasia or hypothalamo-pituitary diseases. Patients who take oral, inhaled, injected or topical steroids for other medical conditions may develop adrenal insufficiency and become steroid dependent. Over a two-year period in England between July 2018 and July 2020, four deaths and four intensive care admissions were attributed to steroid omission, according to the NHS Improvement national reporting and learning system. To prevent such incidents, the Society for Endocrinology, Royal College of Physicians, and NHS England’s patient safety team has developed an NHS steroid emergency card (SEC). This is a patient-held prompt that can be given to healthcare professionals when in crisis, or when undergoing a procedure to ensure steroid treatment is given appropriately and promptly. These cards should also be flagged up by hospital electronic systems and by patients in remote consultations. A patient safety alert was issued alongside this, which requires general practice to take action by 13 May 2021. This includes assessing patients who are prescribed steroids and ensuring that all eligible patients are issued with an SEC.

The purpose of wearing a type II fluid resistant surgical mask (FRSM) during surgical and invasive procedures is to minimise the transmission of pathogens in the nose, mouth and throat of staff to patients. They also protect staff from splash or spray of blood/body fluids onto their respiratory mucosa (nose and mouth). A wide range of FFP3 respirators have been used as protection by staff across healthcare settings during the COVID-19 pandemic, including FFP3 respirators with and without exhalation valves. The exhalation valves do not filter exhaled breath, even when of a ‘shrouded’ type. Current infection control guidance states that: “Valved respirators should not be worn by a healthcare worker/operator when sterility directly over the surgical field is required, eg in theatres/surgical settings or when undertaking a sterile procedure”. Powered hoods (also known as powered air purifying respirators or PAPRs) have been provided as respiratory protective equipment (RPE) for staff unable to achieve a tight fit with an FFP3 respirator(s). The air exiting PAPR hoods is not filtered. Incident reports received since March 2020 identified five incidents describing dripping of condensation from the exhalation valve of an FFP3 respirator, potentially compromising the sterile field; one cerebral abscess involving an oral bacterium linked to the use of a valved FFP3 respirator during brain surgery; and three cases of endocarditis linked to PAPR use during cardiac surgery. These incident reports and feedback from services suggest that the risks of valved respirators and PAPRs for surgical and invasive procedures is not well recognised, and that their use may have become routine in some theatre environments.

A National Patient Safety Alert has been issued on the elimination of bottles of liquefied phenol 80%. The alert has been issued by the NHS England and NHS Improvement National Patient Safety Team, British Orthopaedic Society, The Association of Coloproctology Great Britain and Ireland, and Royal College of Podiatry. Following incidents where bottles of liquefied phenol 80% were either confused with other medication or caused burns when spilt, this alert asks providers to eliminate its use and to follow professional guidance to use safer alternatives. Phenol, a caustic compound used for its antimicrobial, anaesthetic, and antipruritic properties, is highly toxic and corrosive. Liquefied phenol 80% can cause burns, severe tissue injury and is rapidly and well absorbed causing systemic toxicity. It is most commonly used in podiatry and orthopaedic foot surgery for destroying the nail matrix. Actions to be completed as soon as possible and no later than 25 Feb 2022: Identify where liquefied phenol 80% is used and update procedures/guidelines to substitute use for a safer, suitable alternative. Ensure clinical areas have stock of agreed safer alternatives and then remove bottles of liquefied phenol 80% from clinical areas, and update stock lists. Amend electronic prescribing systems to ensure liquefied phenol 80% cannot be prescribed. Amend current purchasing systems, and introduce ongoing controls on purchasing, to ensure liquefied phenol 80% cannot be purchased inadvertently via the pharmacy department or any alternative purchasing route.

In 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. Actions required Primary actions to be completed by 7 October 2020: Identify and locate affected devices in your organisation. Identify alternative ventilators available on site. If no suitable alternative available, and capacity is an issue currently or expected imminently, follow protocol for resource shortage escalation set out by your local governance. Train all relevant staff on alternative ventilators and ensure training records are up to date. When actions 1–4 are complete, remove affected V60s from use and quarantine until repaired by the manufacturer. Place the alternative devices into service in place of the affected V60s. You may continue to use affected V60s if there is a risk of severe patient harm due to lack of ventilator availability. A thorough risk assessment must be completed, and additional monitoring must be used. A backup form of ventilation must be available at all times. Secondary action to be completed by 23 December 2020: 8. Review procurement and stock policies to ensure you are not reliant on one manufacturer or model of ventilator.

A National Patient Safety Alert has been issued on the risk of foreign body aspiration during intubation, advanced airway management or ventilation. Foreign body aspiration can occur if loose items are unintentionally introduced into the airway during intubation, ventilation or advanced airway management. This can lead to partial or complete airway blockage or obstruction, and if the cause is not suspected, can be fatal. The most common types of foreign bodies identified in incident reports were transparent backing plastic from electrocardiogram (ECG) electrodes and plastic caps of unclear origin. The alert asks providers to reduce this risk by purchasing safer alternative equipment without loose and transparent parts. Providers are also asked to develop or amend local protocols to ensure pre-prepared intubation and advanced airway management devices are covered or protected until use; and that the ends of reusable breathing system hoses are closed between patient cases.

A joint National Patient Safety Alert has been issued by NHS Improvement and NHS England national patient safety team, Royal College of General Practitioners, Royal College of Physicians and Society for Endocrinology, regarding the introduction of a new Steroid Emergency Card to support the early recognition and treatment of adrenal crisis in adults.

Sodium nitrite has one licensed indication: as an antidote to cyanide poisoning. The Royal College of Emergency Medicine (RCEM) and National Poisons Information Service (NPIS) guideline recommends that it should be “immediately available in the emergency department”. Sodium nitrite can cause significant side effects and is categorised as ‘highly toxic’. Historically, sodium nitrite 30mg/ml has been an unlicensed product supplied in ampoules by ‘Specials’ manufacturers. However a licensed product, supplied as a vial, has been available since 2016. The National Reporting and Learning System (NRLS) identified two incidents where unlicensed sodium nitrite was inadvertently administered to premature babies instead of sodium bicarbonate 4.2%: one very premature baby died soon after this incident occurred and the other died after a period of neonatal intensive care. Hospitals have been given until 6 November to physically check all wards for the wrong drug and to destroy any unlicensed sodium nitrite supplies. This alert is an action for all acute trusts (children and adult).

This report from the Action against Medical Accidents (AvMA), authored by Dr David Cousins, reveals serious delays in NHS trusts implementing patient safety alerts, which are one of the main ways in which the NHS seeks to prevent known patient safety risks harming or killing patients. The report identifies serious problems with the system of issuing patient safety alerts and monitoring compliance with them. Compliance with alerts issued under the now abolished National Patient Safety Agency and NHS England are no longer monitored – even though patient safety incidents continue to be reported to the NHS National Reporting and Learning System.  The report recommends a number of urgent actions to address these risks to patients.

Typically issued in response to a new or under-recognised patient safety issue with the potential to cause death or severe harm. NHS Improvement aim to issue warning alerts as soon as possible after becoming aware of an issue and identifying that healthcare providers could take constructive action to reduce the risk of harm. Warning alerts ask healthcare providers to agree and coordinate an action plan, rather than to simply distribute the alert to frontline staff.

Babies and young children (under five years) can suffer serious injury if they ingest coin/button batteries or poke them into their nostrils or ears. While the larger lithium batteries have the greatest potential to cause harm, including death, the smaller zinc–air batteries, used in hearing aids, cochlear implants, bone-anchored hearing aids (BAHA) and similar equipment, still present a significant risk. This National Patient Safety Alert requires all organisations supplying NHS-funded hearing aids to ensure those issued to babies and children under five years of age have secure battery compartments. Where hearing aids are issued to older children and adults, organisations are required to consider the need for a secure battery compartment for anyone living with young children and babies, or with a person with additional risk factors, such as those with a significant learning disability, dementia or other cognitive or sensory impairment.