Letters and drug recalls sent to healthcare workers in April 2023


NATIONAL PATIENT SAFETY WARNINGS

End of service for Philips Health Systems V60 and V60 Plus ventilators

On 18 May 2023, we will issue a National Patient Safety Alert, directing all Philips V60 and V60 Plus ventilators to be permanently removed from use in the UK healthcare system by 30 September 2023 Did. This is due to an electrical problem with the equipment. In rare cases, it may shut down unexpectedly.

V60 and V60 Plus devices are used in hospitals. Depending on the model, these ventilators can provide non-invasive, continuous positive airway pressure therapy to patients in critical care wards, respiratory assistance wards, and highly dependent wards.

Safety concerns are related to some electrical faults in the device. These failures can lead to unexpected shutdowns and loss of ventilation. In some cases, no warning alarms are displayed to warn the user that the machine is shutting down. If unnoticed by medical professionals, ventilatory failure can have serious consequences in patients, such as hypoxia, leading to long-term cognitive impairment. There is also a risk of death if the patient is not ventilated for a long period of time.

If a patient is at risk of serious harm due to the lack of an alternative ventilator, healthcare providers should remove the affected ventilator by 2023, provided appropriate risk mitigation measures are in place. You can continue to use it until September 30th. See Risk Assessment and Additional Patient Monitoring Requirements for Temporary Use. A growing number of affected devices is inevitable. However, all V60 series ventilators must be retired by September 30, 2023 along with any replacements in use.

This action is based on a comprehensive scientific and technical review, advice from the independent Interim Device Working Group (IDWG), and input from clinical experts and key partners across the healthcare system.

We are working closely with the Department of Health and Human Services to provide information and ensure capacity for arrangements to supply replacement ventilators to hospitals staff deem necessary.

Emerade 500 microgram and Emerade 300 microgram auto-injectors recalled due to possible device failure

On May 9, 2023, the Company announced the National Patient Safety Commission to assist in the withdrawal of all unexpired Emerald 500 microgram and Emerald 300 microgram adrenaline autoinjectors (also known as pens) from patients. issued an alert. This is due to an issue identified during testing where some auto-injectors failed to deliver product or prematurely activated after a drop (1 meter free fall study).

It is unclear what impact this will have on auto-injectors in clinical use, but as a precautionary measure, all Emerald auto-injectors are being recalled in the UK as the problem cannot be identified before the auto-injectors are used. It has been.

Medical professionals are expected to:

  1. Immediately cease supply of affected products, quarantine remaining inventory, and return using supplier-approved processes.
  2. Patients who received Emerald 500 microgram and Emerald 300 microgram autoinjectors were identified and examined by prescribers to determine whether adrenaline autoinjector prescribing was still appropriate and in line with existing guidance. And confirm that it has.
  3. Immediately notify patients and caregivers to request new prescriptions to replace their Emerald 500 microgram and Emerald 300 microgram autoinjectors with alternative brand adrenaline pens. Epipen 300 micrograms or Jext 300 micrograms are good substitutes for Emerade 500 micrograms. Dosage recommendations are provided in the Summary of Product Characteristics (SmPC) and should be followed.
  4. Tell the patient to return the Emerald auto-injector to the pharmacy after obtaining a total of 2 alternative brand equivalent strength adrenaline pens.

General Practitioners (GPs) and pharmacy teams are asked to send a linked letter, Advice for Patients Prescribed with Emerald Autoinjectors, to all patients and caregivers who have been prescribed Emerard Autoinjectors. For more information on the safe and effective use of adrenaline autoinjectors, see MHRA’s Adrenaline Autoinjector (AAI) Safety Campaign.

letter

In April 2023, the following letter was sent or provided to relevant medical professionals.

Pharmaceutical recalls and notifications

In April 2023, the following drug recalls and notices were issued:

Company Led Drug Recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR(23)A/04. Published April 20, 2023. Importers and distributors of this product have been found to have a post-test microbial limit value for total microbial aerobic count (TAMC) that exceeds the pre-defined limit value of 200 CfU/g for each product. He notified the MHRA of the report. Specifications are fixed according to Pharm. EUR. Monograph 5.1.4 (inhalation use). These batches are therefore being recalled as a precautionary measure. Spectrum Therapeutics UK can fully track future distributions by their customers.

Class 4 Drug Deficiency Information: Sandoz Limited, Coamoxiclav 125/31.25mg/5ml, Oral Suspension Powder 250/62.5mg/5ml, EL (23)A/14. Published April 20, 2023. Sandoz Limited has informed MHRA that the products listed in this notice do not contain sugar, even though the box states “Sugar Free”. The “sugar free” text was mistakenly added to cartons in December 2008. All batches supplied after December 2008 contain very small amounts of sugar from flavorings. The carbohydrates contained are glucose and maltodextrin, both of which are composed of glucose. However, a minority of patients may not be suitable for this product. There is no risk to product quality due to this issue and affected batches will not be recalled. Health professionals are encouraged to inform patients of errors when dispensing subsequent batches or discussing concerns related to sugar intake or glycemic control with patients, as appropriate.

Medical Device Safety Information

We recently published device safety information pages on the following topics:

NuVasive Specialty Orthopedic (NSO) PRECICE Titanium System: UK Suspension Lift, DSI 2023/006

In 2021, all PRECICE Titanium System devices for orthopedic use were voluntarily suspended with additional testing for biosafety and under-18 use.

The MHRA has conducted a thorough evaluation of the technical and biological safety information provided by the manufacturer, NuVasive Specialized Orthopedics (NSO) and is pleased that a subset of the PRECICE Titanium devices can be used by adults in the UK. increase.

The PRECICE Titanium System Intramedullary Limb Lengthening (IMLL), Short, Unite and Freedom are now the right choice for surgical use. Medical professionals should follow the actions set forth in the manufacturer’s field safety notice. PRECICE devices should only be implanted according to the manufacturer’s instructions for use.

These devices have not been validated by NSO for use in children and adolescents and use of this device in these populations is considered “off label” use.

The CE marking of the PRECICE Biodur systems (Stryde and Plate) has not been restored and all PRECICE Biodur systems (Bone Transport, Stryde and Plate) remain withdrawn from the UK market.

Article Citation: Drug Safety Update Vol. 16, Issue 9: May 2023: 4.



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *