In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products – precautionary measure

Manufactured by CooperSurgical: specific batches of products were manufactured with increased histamine levels in the gentamicin sulphate.

Action

  1. Identify affected devices in your inventory (listed in the appendix) and return these to CooperSurgical for a replacement.
  2. Ensure all relevant healthcare professionals are aware.
  3. If after reviewing this notice you have further technical questions or concerns please contact your sales representative at CooperSurgical.
  4. If after reviewing this notice you have further clinical questions or concerns please contact your Human Fertilisation and Embryology Authority (HFEA) Inspector, or the Association of Clinical Embryologists (ACE).
  5. If any adverse events occur relating to these products, please report this to MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Action by

  • Clinical embryologists
  • IVF Clinics
  • HFEA licenced centres

Deadlines for actions

Actions underway: 05 February 2018

Actions complete: 19 February 2018

Problem / background

MHRA was made aware by the supplier of gentamicin sulphate API, used in the manufacture of IVF media and associated products, that some batches contained higher than expected levels of histamine due to a change in supplier. It should be noted that histamine is an impurity normally found in gentamicin in low levels because of the manufacturing process.

MHRA and the Human Fertilisation & Embryology Authority (HFEA) have worked together to determine whether any risk may have occurred while using affected products in IVF procedures. This included getting advice from experts at the Association of Clinical Embryologists (ACE) and an expert in immunology. The risks, if any, from the increased histamine levels could not be determined from the available scientific literature, therefore this MDA has been published to ensure users are aware of the issue, so they can contact the manufacturer, HFEA, or ACE if they have any concerns.

Affected products (all batches) were manufactured from 07/11/2016 to 30/10/2017.

Products still within their expiry date were distributed from 07/04/2017 to 18/10/2017.

Device details

Please refer to pages 5-10 in the MDA for details on the batches affected and additional unique item identification information.

Manufacturer contacts

For all products:

Andrew Millward
CooperSurgical UK
Hamilton House
Mabledon Place
London WC1H 9BB
Tel: 07496 719651

Email: customerservice.uk@origio.com or aMillward@origio.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland)

CAS and NICAS liaison officers for onward distribution to all relevant staff including:

  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Medical directors
  • Obstetricians
  • Obstetrics and gynaecology departments
  • Obstetrics and gynaecology directors
  • Obstetrics departments
  • Obstetrics nurses
  • Purchasing managers
  • Supplies managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Clinics
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2018/003 or 2017/010/030/451/001.

Technical aspects

Mojisola Ajeneye, MHRA
Tel: 020 3080 7271

Mojisola.ajeneye@mhra.gov.uk

Association of Clinical Embryologists (ACE)

ace@profileproductions.co.uk

Clinical aspects

Devices Clinical Team, MHRA
Tel: 020 3080 7274

DCT@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NICAS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products – precautionary measure MDA/2018/003

Published 22 January 2018