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04 Jul 2017

CLH Blog - MHRA Field Safety Updates For June

CLH Blog - MHRA Field Safety Updates For June

We've researched again, the many field safety alerts that have been filed over the last month (June 2017) and have put together a roundup of all the most relevant MHRA updates and recalls. These focus on updates for health care products and equipment that are relevant to UK care homes and other health facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it’s important to immediately act on it.

 

Joerns Important Update: Oxford® Dipper Service Life

As a result of extensive confidence and product endurance testing along with associated market feedback, Joerns Healthcare has revised its Expected Service Life statement for the Oxford Dipper pool-side lift.  Please ensure you read and understand the following information and preventative action in a concerted effort to minimise possible risk of injury to both patients and carers alike. 

Issue Date: 01/06/2017 - Technical Bulletin

Clarifiying Statement: 14/06/2017 - Re. Technical Bulletin 0409 (see above)

 

Medline International France: Surgical procedure kit - 8th June

Surgical devices, non-powered

Model: Surgical procedure kit

Medline International France has issued a Field Safety Notice for Medline Ophthalmic Sterile Procedure Trays containing Needles 25G Orange.  A potential safety issue has been identified on Ophthalmic Sterile Procedure Trays containing Needles 25G Orange following supplier change - may result in a risk of subconjunctival haemorrhage and / or perforation of the globe

MHRA reference: 2017/006/012/291/018

 

Boston Scientific: Extractor Pro RX-S Retrieval Balloon Catheter - Urgent Medical Device Recall

Surgical instruments, minimal access

Boston Scientific is implementing a voluntary Medical Device Removal on two lots of Extractor Pro RX-S Retrieval Balloon Catheters. The labeling on the affected devices incorrectly identifies the injection location as 'above' the balloon when it should be below the balloon and 'below' the balloon when it should be above the balloon.

MHRA reference: 2017/006/002/291/005

 

ResMed: Astral 100, Astral 100SC, Astral 150 - Lung ventilators

Model: 100, 100SC, 150

ResMed has received a small number of reports regarding the performance of the internal battery, where the false activation of a fuse leads to shut down of the internal battery.

Patient risk - When Astral ventilators are used with the internal battery as the sole power source, it is important to note that any performance issue with the internal battery could potentially lead to cessation of therapy.

Under these circumstances, ventilator dependent patients may be at risk of death or serious injury if no urgent action is taken to restore power or switch to back-up ventilation. It remains safe to continue using Astral ventilators, provided patients/carers follow precautions detailed in this FSN.

8th June 2017 - MHRA reference: 2017/006/006/291/017

 

Philips Healthcare: HeartStart MRx Defibrillator/Monitor - Medical Device Correction

Defective component may prevent delivery of shocks in AED mode

Infusion & transfusion, autologous

Model: M3535A, M3536A

These devices may fail over time, as repeated shocks continue to be delivered. Should the device fail, the device will no longer be able to deliver shocks in AED mode.

MHRA reference: 2017/006/013/291/005

 

BVM, Bag-Valve-Mask, Manual Resuscitation Systems - 16/06/2017 Field Safety Notice

Intersurgical has issued an urgent Field Safety Notice against a number of manual resuscitation systems and lot numbers due to the possibility that the valve may have become stuck during storage.

This could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment.

Intersurgical FSN Recall Ref 12

 

BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment

Resuscitators.  Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.

Action: Search for alternative devices to replace affected products and until alternative devices are available follow the guidelines in the Field Safety Notice

Once you have alternatives, quarantine the affected devices and contact Intersurgical.  To be underway by 28th June & actions complete by 19th July 2017.

Reference number: MDA/2017/017 or 2017/005/031/291/005

 

New COSHH (Control of Substances Hazardous to Health) and CLP (Classification, Labelling and Packaging) Regulations have come into force from 1 June 2017.  Please see link http://www.hse.gov.uk/coshh/detail/coshh-clp-reach.htm

Suppliers need to ensure that all products that are classed as hazardous are now labelled correctly with updated pictograms and are compliant with European Regulation (EC) No 1272/2008.

We have become aware that due to these regulation changes, certain supply routes have chosen to temporarily withdraw non-compliant lines from sale.  They will remain unavailable to order until they meet the regulations stated in EC 1272/2008.

*Due to the clinical nature of alternative products we do advise you to consult your own in-house clinical experts to ensure agreed suitability of alternatives before ordering.*

 

Please note this is a summary of alerts for information only, please browse the Medicines and Healthcare products Regulatory Agency (MHRA) website for more. If you receive a field safety notice (FSN) from a manufacturer you must always act on it and if you have a question about a particular FSN, please contact the manufacturer.

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