External pacemakers and temporary cardiac pacing leads - concerns that insecure systems still being used
(All ) concerns that some insecure adaptor systems are being used to connect temporary pacing leads to external pacemakers. (MDA/2007/042)
23 May 2007 at 15:30
Ref: MDA/2007/042
Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 27 June 2007, Deadline (action complete): 26 September 2007
Device
External pacemakers and temporary cardiac pacing leads.
Problem
Potential for loss of pacing due to accidental disconnection of temporary pacing leads and lead adaptors.
This alert supersedes Safety Notice SN2002(15) issued in May 2002, which outlined the risk to patients when inadequate connectors and adaptors were used to connect temporary cardiac pacing leads to external pacemakers.
Following a further report of patient asystole during temporary pacing, an MHRA investigation determined the cause to be insecure connections. Lead adaptors without a retention mechanism had been used to connect a pacing lead to an external pacemaker and the lead had become disconnected.
The MHRA is concerned that some insecure adaptor systems are still being used to connect temporary pacing leads to external pacemakers.Direct connection (ie without an adaptor) of a temporary cardiac pacing lead to external pacemaker or patient cable will reduce the potential for disconnection and will increase the compatibility of the electrical connection.Shrouded connectors were introduced following a non-UK incident in which an exposed connector pin was accidentally connected to a mains electrical supply. This resulted in amendments to the product safety standards governing external pacemakers and leads (IEC (60)601-1 and BS EN 60601-2-31). Subsequently external pacing leads have been supplied with shrouded connector pins.
Before purchasing a new external pacemaker, ensure that it is compatible with the types of temporary cardiac pacing leads that are used in your department.
Action
- Ensure that the connectors on temporary cardiac pacing leads and external pacemaker are compatible. Do not use lead adaptors.
- Under exceptional circumstances where the use of an adaptor is unavoidable, use only an adaptor that incorporates a retention mechanism, which prevents accidental disconnection.
- Note that the recommendations in this MDA supersede the advice given in Safety Notice SN2002(015) issued in May 2002.
Action by
Cardiologists, cardiothoracic surgeons, cardiac physiologists and biomedical engineering departments.
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:
SABS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- Anaesthesia, directors of
- Biomedical engineering staff
- Cardiologists
- Cardiothoracic surgeons
- Clinical governance leads
- Coronary care departments
- Coronary care nurses
- EBME departments
- Equipment stores
- Health and safety managers
- Intensive care medical staff
- Intensive care nursing staff (adult and paediatrics)
- Medical directors
- Nursing executive directors
- Paediatric intensive care units
- Purchasing managers
- Risk managers
- Supplies managers
- Theatre managers
Healthcare Commission (CHAI) to:Headquarters for onward distribution to:
- Hospitals in the independent sector
Contacts
Enquiries to the MHRA should quote reference number 2006/012/022/401/009 and be addressed to:
Technical aspects
Ms Samantha Baxter or Mr Peter Solesbury
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 3242 / 3215
Fax: 020 7084 3106
E-mail: sam.baxter@mhra.gov.uk & peter.solesbury@mhra.gov.uk
Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 3123
Fax: 020 7084 3111
E-mail: susanne.ludgate@mhra.gov.uk
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
E-mail: contacts@healthcarecommission.org.uk
How to report adverse incidents
Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible.
Further information about reporting incidents; online incident reporting facilities; and downloadable report forms are available from MHRA’s website (http://www.mhra.gov.uk).
Alternatively, further information and printed incident report forms are available from:
MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ
Telephone 020 7084 3080 or Fax 020 7084 3109 or e-mail: aic@mhra.gov.uk(An answerphone service operates outside normal officer hours)
Medical Device Alerts are available in full text on the MHRA website:http://www.mhra.gov.uk
Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf