Medicines Healthcare Products Regulatory Agency
National Patient Safety Alerts
Removal from service of Philips Health Systems V60 and V60 Plus ventilators
On 18 May 2023, we issued a National Patient Safety Alert to instruct that all Philips V60 and V60 Plus ventilators should be permanently removed from use in the UK healthcare system by no later than 30 September 2023. This is due to electrical issues with the devices that may, in rare instances, cause them to shut down unexpectedly.
V60 and V60 Plus devices are used in hospitals. Depending on the model, these ventilators can provide non-invasive and continuous positive airway pressure treatment to patients in critical-care, respiratory support units and high-dependency units.
The safety concern relates to several electrical faults in the devices. These faults can result in an unexpected shutdown leading to loss of ventilation in some instances without a warning alarm to alert users that the machine is shutting down. If unnoticed by healthcare professionals, ventilation failure can have severe consequences for patients including hypoxia, which can result in long-term cognitive impairment. There is also a risk of death if a patient is without ventilation for a sustained period.
If there is a risk of severe patient harm due to a lack of alternative ventilators, providers may continue to use affected ventilators until 30 September 2023, but only with appropriate risk mitigation measures in place see Risk assessment and additional patient monitoring requirements if temporary use of affected devices cannot be avoided. However, all V60 range ventilators must be removed from service with replacement devices in use by 30 September 2023.
This action follows a comprehensive scientific and technical review, and advice from the independent Interim Devices Working Group (IDWG), along with input from clinical experts and key partners across the healthcare system.
We are working closely with the Department of Health and Social Care, which will be able to provide information on arrangements to supply replacement ventilators to any hospitals where staff feel they are needed, to ensure capacity is maintained.
Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure
On 9 May 2023 we issued a National Patient Safety Alert to support the recall from patients of all unexpired Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens). This is due to an issue identified during testing where some auto-injectors failed to deliver the product or activated prematurely after they had been dropped (the 1-metre free-fall study).
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, all Emerade auto-injectors are being recalled in the UK.
Healthcare professionals are asked to:
- Stop supplying the impacted products immediately, quarantine remaining stock and return using their suppliers approved process.
- Identify patients who have been supplied with Emerade 500 micrograms and Emerade 300 micrograms auto-injectors and ensure that they are reviewed by their prescriber to determine whether their adrenaline auto-injector prescription is still appropriate and in line with existing guidance.
- Immediately inform patients and carers to request a new prescription to replace each Emerade 500 micrograms and Emerade 300 micrograms auto-injector with an adrenaline pen in an alternative brand. Epipen 300 micrograms or Jext 300 micrograms are appropriate alternatives to Emerade 500 micrograms. Dosing recommendations are available in the Summary of Product Characteristics (SmPC) and should be followed.
- Inform patients to return Emerade auto-injectors to any pharmacy after they have obtained a total of 2 equivalent-strength adrenaline pens in an alternative brand.
General Practitioners (GPs) and Pharmacy Teams are asked to send the linked letter Advice for patients who have been prescribed Emerade auto-injectors to all patients and carers who have been prescribed Emerade auto-injectors. For further information on safe and effective use of adrenaline auto-injectors please refer to the MHRAs Adrenaline Auto-Injectors (AAIs) safety campaign.
Letters
In April 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In April 2023, recalls and notifications for medicines were issued on:
Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04. Issued 20 April 2023. The importer and distributor of this product has informed the MHRA of reports that following tests, the microbial limit for Total Microbial Aerobic Count (TAMC) has been found to exceed the predefined limit of 200 CfU/g as per the product specification fixed according to Pharm. Eur. Monograph 5.1.4 (inhalation use). Therefore, these batches are being recalled as a precautionary measure. Spectrum Therapeutics UK is able to fully trace the onward distribution by their customers.
Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14. Issued 20 April 2023. Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating sugar free. The sugar free text was added to the carton in December 2008 in error. All batches supplied since December 2008 have contained a very small quantity of sugar originating from the flavouring. The contained sugars are dextrose and maltodextrin, which are both composed of glucose. However, for a small cohort of patients the product may not be suitable. There is no risk to product quality as a result of this issue, and the affected batches are not being recalled. Healthcare professionals are advised to inform patients about the error when dispensing subsequent batches or in discussion with patients who may have concerns related to sugar intake or glucose control, where appropriate.
Medical Device Safety Information
We recently published a Device Safety Information page on the following topics: