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02 Aug 2019

CLH Blog - MHRA Field Safety Updates For July 2019

CLH Blog - MHRA Field Safety Updates For July 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care 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 is vital that you act on it immediately.

 

Automated External Defibrilators - All Telefunken HR1 & FA1 - No Valid CE Certificate - Medical Device Alert MDA/2019/027

Description of the problem: Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

Action required:

  • Initiate a process for sourcing an alternative defibrillator as these devices do not meet regulatory requirements for safety and performance.
  • Complete a local risk assessment for the continued use of the affected devices until an alternative device is sourced.
  • Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Action by: All medical, nursing and technical staff involved in the use and maintenance of these devices.

FSN date: July 2019

 

Capillary Blood Specimen Collection - BD Microtainer Tubes - Field Safety Alert

Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes.

Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.

Action to be taken: 

Identify affected devices, distributed from July 2018 to April 2019 inclusive, as listed in the manufacturer's Field Safety Notice (FSN). NHS Supply Chain codes are provided on page 2 of this alert.

Follow actions recommended in the manufacturer's FSN.

Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

FSN date: July 26th 2019

 

Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18)

Pharmaswiss ńĆeska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

Brief description of the problem
Bausch & Lomb UK limited has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

Healthcare Professionals should contact all patients, and their carers, who have been supplied with an Emerade device to inform them of the potential defect and reinforce the advice to always carry two in-date adrenaline autoinjectors with them at all times.

FSN Date: 11 July 2019

 

Professional Use Monitor / Defibrilltor - LIFEPAK 15 - Field Safety Alert

Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy.

Description of the problem:

Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered. Specific serial numbers are affected (MDA/2019/010).

Action to be taken:

- Identify affected devices – see the manufacturer’s Field Safety Notice.
- Ensure alternative devices are available or request a loan device from Stryker. If no alternatives are available, perform a local risk assessment.
- Follow actions recommended in the manufacturer’s Field Safety Notice.
- Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

FSN date: July 2019

 

Notes:

MHRA launches consultation on how to best engage patients and the public:

- The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 12-week consultation on how to best engage and involve patients in the Agency’s work.

- The responses will help inform the MHRA’s future engagement with patients and the public. For more information, go to the MHRA website.

 

New consultation to include double yellow lines in care working parking scheme: 

- Currently, an exemption permit allows care workers and other health care staff to use on-street pay and display, limited waiting and residents parking for no charge if they are delivering essential services to residents in their own homes. However, this may soon change.    

- A Traffic Regulation Order, advertised on Thursday 1 August 2019, proposes to extend this exemption to include parking on single and double yellow lines – but only when alternative parking isn’t available.

- The proposed extension of the scheme recognises that in some communities parking can be limited and can add to the stress of an already demanding job.

 

As always, we’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroupLtd to let us know and don’t forget to use '#CommittedToCare' in your posts.

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