News

HEADLINES:

MDA/2018/022R - additional information has been added under 'Device details' in section 3 with sentences above each figure to help identify affected devices. Please note that the action dates have been updated to reflect this, so subscribers will receive a second email. CAS liaison officers please close off alert MDA/2018/022 as action not required - superseded by alert MDA/2018/022R. (Added 6 July 2018).


NHS/PSA/RE/2018/004: we have now updated the attachment to show 27 June. Subscribers will receive a second email, please be assured that the only change is to the date of the attachment.

NHS/PSA/RE/2018/004: please note that the alert attachment has the wrong date. It reads 27 April; it should read 27 June. We will be replacing the attachment shortly to display the correct date.

MDA/2018/016 - Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results. (Added 24 May 2018). This alert was issued with the incorrect telephone contact number for Roche, the manufacturer. The correct number is 01444 256 000.

CEM/CMO/2018/001 - VALPROATE CONTRAINDICATED IN WOMEN OF CHILDBEARING POTENTIAL UNLESS THERE IS A PREGNANCY PREVENTION PROGRAMME (Added 24 April 2018)

Due to a technical issue the email you received may contain code in the broadcast context. Please see the broadcast content below; this is displayed correctly on the web page.

Use of valproate medicines in pregnancy is associated with a 40% risk of persistent neurodevelopmental disorders and a 10% risk of physical birth defects. Despite repeated communications on this risk, it is estimated that 400 women in the UK took valproate medicines during pregnancy in 2016.

Following a review of the situation across the EU, valproate is now contraindicated in women of childbearing potential unless they meet the conditions of a Pregnancy Prevention Programme, which will include a risk acknowledgment form to be completed and signed by the specialist prescriber and the patient in a review at least once a year.

Please see the letter attached for actions required from the healthcare system.

For details on the new regulatory measures, see the MHRA website.

NEWS IN FULL

EFN/2017/26 - MDA/2017/036R - SYRINGE PUMPS - REQUIRED USER ACTIONS IN THE EVENT OF PL3 ALARM TO PREVENT RISK OF INTERRUPTED INFUSION. (Added 20 Dec 2017). This is a re-issue of MDA/2017/036 with an amendment to the 'action complete deadline. CAS liaison officers please close off alert MDA/2017/036 as action not required - superseded by alert MDA/2017/036R.

NEWS IN FULL

NHS/PSA/RE/2017/004 - Resources to support safe transition from the Luer connector to NRFit for intrathecal and epidural procedures, and delivery of regional blocks (Added 27 Nov 2017)

For clarity, the Dec 11th deadline identified in this Alert is the timescale in which organisations should have completed the four actions set out in the Alert i.e. (1) Bring this Alert to the attention of those holding leadership roles for the safe transition to NRFit™ connectors. (2) Review the resources signposted in this Alert and identify which of the three groups in the supporting information best reflects current use of neuraxial devices in your organisation. (3) Review current implementation plans for ISO-compliant devices or develop new implementation plans to reflect the advice provided in the resources. (4) Once you have agreed your implementation plan, ensure that all relevant clinical staff and staff involved in training, purchasing and distribution of neuraxial devices are aware of it and of any linked resources relevant to their practice.

As the Alert and associated resources stated, a full range of NRFit™ connectors is not expected to be available until April 2018 and links to product updates can be found at https://improvement.nhs.uk/resources/small-bore-connectors-safetyintroduction/ No national deadline by which organisations should have completed their transition to NRFit™ connectors has been set as this will depend on product availability and local circumstance.


EL (17)A/10 - Drug Alert Class 4: Kyowa Kirin, Bleo-Kyowa (Bleomycin), PL16508/0046. This alert was issued with the incorrect reference number. The correct reference number for the latest Bleomycin Drug Alert should be EL (17)A/11. We apologies for any inconvenience caused. Please continue to action the alert as normal.

EFN/2017/26 - The PDF attachments in this alert issued today were missing due to a technical glitch. CAS Liaison Officers: please close off the alert you received this morning, and action the second alert issued this afternoon. (Added 07/08/2017)

MDA/2017/020: Owing to a technical glitch you may have received three emails regarding this alert. When viewing this alert via the website you may also see a box indicating there is more than one version, please disregard this box, all versions are identical. CAS Liaison Officers: you do not need to record duplicate responses (Added 11/07/2017)




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