MDSI2309 – BioIntegral Surgical Inc. No-React® cardiovascular bioprosthesis implantables: discontinuation of CE marking and manufacture

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MHRA has published the attached Device Safety Information (DSI) as a web page on the GOV.UK website. The information and advice applies across the UK and within Scotland it should be implemented by local authorities, health boards and contractors providing publicly funded health and social care services. 

The content of the DSI webpage has been transferred with minimal or no changes to the attached PDF document and assigned a Scottish reference. This enables it to be pushed to local safety alert governance systems where it can be logged and tracked to a conclusion. It also ensures the content is in a format that can be emailed or printed for anyone who cannot readily access the internet.

Healthcare professionals are a target group for MHRA’s DSI web pages. However, the subject matter may also be directly relevant to patients and for this reason MHRA may include actions which patients should take to protect themselves. Patients should access this information direct by checking or subscribing to the GOV.UK website. There is no requirement or expectation that equipment co-ordinators or healthcare professionals will extend this DSI cascade to include patients. However, they may make separate arrangements to do so if deemed necessary following a local assessment.

Onward cascade
As the nominated person for your organisation, you need to identify managers and staff in your organisation who need to know or be aware of this alert and cascade it onward to them. The cascade should include all contractors and private or independent service providers who provide affected care, staff, equipment, buildings or other services or facilities for the direct care of patients or service users.

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:

• Medical devices (e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator)
• In vitro diagnostic devices or IVDs (e.g. blood analyser, reagent, SARS-CoV-2 test kit)
• Estates and facilities (e.g. electrical installations, window restrictors, nurse call systems)
• Social care equipment (e.g. mobile wheeled commode, powered rise and recline chair)
• Personal protective equipment or PPE (e.g. visors, FFP3 respirators, aprons)

We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/  

Enquiries
If you have any enquiries in relation to this alert please email nss.iric@nhs.scot quoting the alert reference number in the message subject line, or call the IRIC Helpline 0131 275 7575. Alternatively, if you have received this message from someone in your own organisation, please direct all enquiries to them and they will liaise with IRIC as required.

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​Incident Reporting & Investigation Centre (IRIC) 

​Facilities Division

NHSScotland Assure

​NHS National Services Scotland 

​Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn

We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more about our services at www.nss.nhs.scot  

FAC406-276, 7D(vi), Rev 4

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