Implantable cardioverter defibrillators (ICDs) - disable all high voltage shock therapies before you remove ICD
(All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)
Central Alerting System (CAS) deadlines
Action underway: 20 October 2008, action complete: 23 March 2009
Device
Implantable cardioverter defibrillators – all manufacturers and models.
Problem
MHRA continues to receive reports of electric shocks sustained by mortuary personnel and medical practitioners during removal of ICDs after death. ICD removal is necessary prior to cremation, or when the ICD is needed for analysis/testing due to a suspected device malfunction.
Care during ICD removal
ICDs are normally implanted in the pectoral region, but older units may have been implanted in the abdominal cavity (usually in the rectus sheath). When an ICD is removed, the sensing pathway may be disturbed, particularly if the wire to the heart is cut. This may cause the ICD to detect noise from the cut lead and deliver an electric shock. The shock is normally delivered between the exposed electrode(s) on the heart lead, and the metal casing of the ICD. Any shock accidentally delivered to the personnel handling the device could be very uncomfortable, although it is unlikely be harmful.
ICDs contain a magnetic switch that is used during clinical programming. Placing a magnet over the implant site will inhibit shock therapy in nearly all ICD models, depending upon how the device is programmed. If attempting to inhibit shock therapy by magnet placement, care should be taken to ensure the magnet is kept very close to the ICD at all times, as separation may restore the potential for shock delivery. ICDs that are temporarily disabled and removed will therefore need to be packaged appropriately and labelled to prevent accidental shock to personnel.
ICD battery explosion
ICDs usually contain a lithium battery, which may explode if exposed to high temperatures (such as those used in the incineration of clinical waste). Ensure that ICDs are not disposed of by incineration.
Action
Before removal, identify the manufacturer and model name of the implant.
There are several options for this:
- consult the hospital or GP patient records or the patient’s device registration card (this may be held by a relative)
- consult the National Pacemaker and ICD Database (see details below)
- review an X-ray of the device in situ where the manufacturer’s radiopaque identification symbol can be observed (a list of X-ray ID marks is available from all ICD manufacturers and the MHRA)
- make a lateral incision across the implant location to reveal the ICD casing (the ICD is usually implanted with the manufacturer/device legend outermost) - when making an incision, take care to avoid the coiled heart lead, which may be located behind or adjacent to the ICD
Reprogramming or disabling the ICD
- once the ICD manufacturer/model details have been established, contact the patient’s follow-up centre (or contact the nearest cardiac centre) to obtain reprogramming support to permanently set the device to a non-shock delivery mode - this may require onward referral by the local cardiac centre to a specialist ICD follow-up centre and may take some time to arrange
- following ICD reprogramming, ensure that this action has been clearly recorded in the accompanying patient documentation
- if programming support cannot be made available then the device and leads should be removed intact - personnel involved should take care to insulate themselves by wearing appropriate rubber gloves and boots to avoid possible shocks
Disposal of the ICD
Do not dispose of the ICD by incineration.
If possible, advise the implanting hospital of patient death and the intention to remove/dispose of the ICD. The hospital may wish for the information stored in the device to be accessed for patient records or may require return of the ICD for full analysis and return to the manufacturer.
Where the ICD is subject to an adverse incident investigation
Prior to removal and reprogramming, carry out a full ICD interrogation using an appropriate programmer. Print hard copies of all device parameter settings and internal memory data areas and save all parameter settings electronically (eg ‘save to disk’).
Ensure that the complete system (including heart leads) is removed intact. Do not cut the heart leads.
Action by
Clinicians and mortuary personnel who remove ICDs post mortem.
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 liaison officers for onward distribution to all relevant staff including:
- Cardiac physiologists
- Cardiology directors
- Mortuary technicians
- Pathology directors
Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:
Healthcare Commission (CHAI) to:
Headquarters for onward distribution to:
- Hospitals in the independent sector
- Private medical practitioners
England
Enquiries to the MHRA should quote reference number 2008/005/001/291/008 and be addressed to:
Technical aspects
Miss Celina Cundy or Miss Sam Baxter
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3305 / 3242 Fax: 020 7084 3106 Email: celina.cundy@mhra.gsi.gov.uk or sam.baxter@mhra.gsi.gov.uk
Clinical aspects
Dr Christopher Brittain
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3126 Fax: 020 7084 3111 Email: christopher.brittain@mhra.gsi.gov.uk
National Pacemaker and ICD database
Mrs Morag Cunningham
PO Box 9205
Bridge of Weir
Strathclyde
PA11 3DZ
Tel/Fax: 01505 612829
Scotland
Enquiries for Scotland should be directed 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: iric@shs.csa.scot.nhs.uk
Change of address
Change of address or removal from address list for Healthcare Commission:
Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Tel: 020 7448 0842 Email: contacts@healthcarecommission.org.uk