Medical Device Alert: Devices used for endometrial ablation. All makes and models (MDA/2010/006)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/006 or SZT/001/001/449.

Technical aspects
Mrs Mel King
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3286
Fax: 020 7084 3209

Email: mel.king@mhra.gsi.gov.uk

Clinical aspects
Dr Susanne Ludgate
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3123
Fax: 020 7084 3111

Email: susanne.ludgate@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

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

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link)

This alert supersedes (in Scotland):

Safety Action Notice SAN(SC)98/12, Thermal devices used for endometrial ablation: risk of tissue damage, 30 March 1998.

Safety Action Notice SAN(SC)99/19, Devices used for endometrial ablation: risk of heat damage to tissue, 4 June 1999.

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

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

The MHRA continues to receive reports of uterine wall injury, wall perforation, or the creation of a false passage following use of endometrial ablation devices. In some cases resection of damaged tissue has been required.

The majority of complications occur due to either poor patient selection or endometrial ablation procedures being performed in difficult situations.

Patients with either a retroverted uterus or a fixed uterus (eg due to significant endometriosis or adhesions), or those that have had previous uterine surgery are at a higher risk.

Clinicians should confirm that there is no evidence of uterine perforation or false passage.

Clinicians are recommended to:

• employ hysteroscopy prior to the insertion of the ablation device to establish the condition of the uterus
• employ ultrasound to ensure correct uterine placement of the ablation device. If the device uses a balloon, this should remain inflated during the ultrasound scan.

This Medical Device Alert replaces SN9812 (issued March 1998) and SN1999(18) (issued April 1999).

The manufacturer’s instructions for use should be strictly adhered to and users should have full training for the specific equipment.

Clinicians are advised to consider carefully the use of thermal endometrial ablation in the following circumstances:

• previous uterine surgery
• a small (thin walled) uterus
• a history of recurrent pelvic infections (eg where fibrosis and bowel adhesions are more likely to be present)
• clinical history of patient indicates a contra-indication of the ablation device manufacturer’s instructions for use.

Additionally, concurrent use of diathermy (electrosurgery) during such procedures should not be undertaken due to the risk of the ablation device acting as a source of alternative site burns.

This notice should be brought to the attention of, and actioned by, all staff that need to know, including those listed in the distribution list.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Day surgery units
• Gynaecologists
• Medical directors
• Nursing executive directors
• Obstetrics and gynaecology departments
• Obstetrics and gynaecology directors
• Risk managers
• Theatre managers
• Theatre nurses
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Clinics
• Hospitals in the independent sector
• Independent treatment centres