National Safety Flashes

This page has links to recent flashes on equipment faults, high risk procedures etc, as well as other safety organisations.

Please contact safety@rcem.ac.uk if you hear of additional topics that should be on this page.

See all RCEM issued safety newsflashes here or use the grey tab above.

Central Alerting System

The Central Alerting System (CAS) is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care.

Patient Safety Alerts

Links to NHS England, MHRA and Public Health England patient safety alerts can be found below:

2021

• Eliminating the risk of inadvertent connection to medical air via a flowmeter - 16 June 2021
• Updated Publication of Remdesivir guidance for patients hospitalised with Covid-19 (adults and children aged 12 years and older) - 14 June 2021
• Personal protective equipment and heat: risk of heat stress - 9 June 2021
• Urgent assessment/treatment following ingestion of 'super strong' magnets - 19 May 2021

   

• Medicine Supply Notification: Acetylcysteine 2g/10ml solution for injection - 25 March 2021

2020

• Steroid Emergency Card to support early recognition and treatment of adrenal crisis in adults - 13 Aug 2020
• Blood control safety cannula and needle thoracostomy for tension pneumothorax - 2 April 2020

2019

• National Patient Safety Alert: Depleted batteries in intraosseous injectors - 5 November 2019
• DNP (2,4 dinitrophenol) toxicity - 15 May 2019

2018

• Patient Safety Alert: Risk of death and severe harm from failure to obtain and continue flow from oxygen cylinders - 9th January 2018
• Plan for phased re-introduction of hepatitis B vaccine for lower priority groups - 9th March 2018

2017

• Hepatitis B: vaccine recommendations during supply constraints - 21 July 2017

MHRA Drug Safety Bulletin

• Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd due to precautionary risk of causing overdose - 16 June 2021
• Reporting illicit drug reactions (RIDR) - PHE and MHRA are running a one year pilot from Nov 2018-19 aiming to better understand the harms related to emerging illicit drugs. The pilot is based on the MHRA’s current Yellow Card pharmacovigilance system with the difference that it focuses exclusively on harms related to illicit drug use. Download the poster for your department here.
• Tetanus immunoglobin: recommendations on treatment and prophylaxis

• Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy
• Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
• Medicines taken during pregnancy: please report suspected adverse drug reactions, including in the baby or child, on a Yellow Card
• Intra-aortic balloon pump - 3rd October 2017
• IntelliVue patient monitors used with 12-lead ECG - 28th September 2017

• Adrenaline auto-injectors: updated advice after European review - 15 August 2017
• LMA mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray - 24 April 2017
• LMA® MAD Nasal™ intranasal mucosal atomization device – might not deliver a fully atomised plume of medication - 21 April 2017
• All Alaris GS,GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena GS, GH, CC, TIVA, PK, Syringe Pumps - risk of uncontrolled bolus of medicine - 12 April 2017
• Intravenous N-acetylcysteine (NAC) for paracetamol overdose: reminder of authorised dose regimen; possible need for continued treatment with NAC - 24 January 2017

Medical Device Alerts

All Medical Device Alerts (MDA) can be viewed on the MHRA website here. Selected MDAs sent by the MHRA for circulation to RCEM members are-- listed below:

2021

• Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port - 4 May 2021
• Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue - 20 April 2021
• Dexcom G6 Sensor: untested barrier methods to reduce skin reactions - 6 April 2021
• Medoject sterile hypodermic and blunt fill needles manufactured by Chirana T. Injecta – discontinue use - 29 March 2021

2019

• Arjo Minstrel passove floor lift (portable hoist) - risk of spreader bar detachment from lifts without a scale (MDA/2019/004)
• Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005)
• Ophthalmic implant Raindrop Near Vision Inlay - risk of corneal haze (MDA/2019/007)
• Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy (MDA/2019/008)
• Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy (MDA/2019/010)
• Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring (MDA/2019/011)
• Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps (MDA/2019/012)
• enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device (MDA/2019/015)
• enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer (MDA/2019/016)
• Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017)

2018

• Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags - potential breach in sterile barrier packaging (MDA/2018/34)
• CoaguChek Test Strips for Point of Care and Home use - risk of false high results (MDA/2018/033)
• Various trauma guide wires - risk of infection due to packaging failure (MDA/2018/032)
• SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018: risk of batteries overheating or igniting (MDA/2018/031)
• Flex connectors in Halyard Closed Suction Kits - risk of interruption of ventilation (MDA/2018/030)
• Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use (MDA/2018/025R)
• All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine(MDA/2018/024R)
• Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser (MDA/2018/023)
• SAM XT Extremity Tourniquet - Recall due to the risk of tourniquet failing in use (MDA/2018/022)
• Alaris Smartsite Add-On Bag Access device – removal and destruction of specific batches due to risk of disconnection or leakage (MDA/2018/021)
• Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs – recall of specific lots due to risk of under delivery of medication (MDA/2018/020)
• JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases (MDA/2018/019)
• Various Arrow Critical Care devices – recall due to incomplete packaging seals (MDA/2018/018)
• Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results (MDA/2018/16)
• Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated(MDA/2018/014)
• Medical device alert: cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements(MDA/2018/013)
• BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology (MDA/2018/012)
• All T34 ambulatory syringe pumps - risk of unintended pump shutdown and delay to treatment (MDA/2018/010)
• Bag valve mask (BVM) manual resuscitation system - risk of damage to lungs by delivery of excessive pressure (MDA/2018/009)
• Aquilon series of nebulisers - CE mark withdrawn and supply ceased(MDA/2018/008)
• Plum 360 infusion pumps - user actions required to prevent risk of interrupted or delay to treatment (MDA/2018/006)
• All Philips HeartStart MRx monitors/defibrillators - significant delay in the supply of batteries (MDA/2018/002)
• Pacemakers and CRT - overseeing of minute ventilation sensor signal leading to risk of syncope and pre-syncope (MDA/2018/001)

2017

• Syringe pumps - required user actions in the event of PL3 alarm to prevent risk of interrupted infusion (MDA/2017/027)
• Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 – risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy (MDA/2017/027)
• DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection (MDA/2017/022)
• Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask (MDA/2017/19)
• BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment (MDA/2017/017)
• Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff(MDA/2017/015)
• All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring (MDA/2017/14)
• All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy(MDA/2017/013)
• V60 ventilator – potential for unexpected shutdown (MDA/2017/012)
• BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy (MDA/2017/009)
• CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks (MDA/2017/004)
• Reflection® dead blow mallet (all batches) – risk of exposure to lead particles (MDA/2017/002)
• Oxylog 3000 and Oxylog 3000 plus ventilator – risk of failure (MDA/2017/001)