SN 2002(14) - Damage to battery terminal connectors in external pacemakers

MANUFACTURER/SUPPLIER
Various

PROBLEM
Intermittent operation and cessation of pacing output due to inadequate battery connections in external pacemakers.

For the attention of:

NHS Trusts (England) - Chief Executives
National Care Standards Commission - Headquarters

ACTION

1. Check the battery power level (using the internal battery/power indicator) prior to each use of external pacemakers.

2. When inserting or replacing batteries in external pacemakers ensure that:

a) the type of battery used and the frequency of the battery replacement are in accordance with the manufacturer's instructions

and

b) battery terminal connectors are:

• not misshapen or deformed
• secure and have an appropriate retention force
• free from corrosion or debris.

3. Ensure that any padding material provided by external pacemaker manufacturers (to reduce battery movement and enhance battery contact) is inserted in the battery compartment in accordance with the manufacturer's instructions.

4. Ensure that periodic checks of battery terminal connectors on external pacemakers are carried out by appropriately qualified personnel in accordance with the manufacturer's instructions.

5. Ensure that all external pacemakers with suspect battery terminal connectors are inspected and/or repaired in accordance with local procedures.

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

TRUSTS

• Liaison Officers (for onward distribution)
• Supplies Managers
• Medical Directors
• Cardiac/Coronary Care units
• Cardiologists
• Cardiac Surgeons
• Intensive Care Units
• Trauma/Accident & Emergency Units
• Surgical Units
• Theatre Managers
• Biomedical Engineering
• Catheter Laboratory Managers

NATIONAL CARE STANDARDS COMMISSION TO:

• Headquarters (for onward distribution)
• Hospitals in the Independent Sector

BACKGROUND
MDA has become aware of a number of incidents involving loosening of the battery terminal connectors of external pacemakers. While patient harm has not been reported, the potential exists for patient death or serious deterioration of health. The specific cause of loosening has not been determined, but may result from:

• weakening of the retention force of the battery connector over time, due to terminal deformation after repeated insertion and removal of batteries;
• attempts to insert incorrectly orientated batteries, causing deformation of battery terminals;
• replacement of batteries by inappropriate personnel;
• slight variations in battery terminal size or use of incorrect type of batteries;
• corrosion of the electrical connectors or the presence of debris.

Since the continued function of external pacemakers is critical to patient support, all battery terminal connectors should be checked for appropriate security and absence of corrosion or foreign material each time batteries are inserted. This is in accordance with Criterion 15 of the 2001-2002 Controls Assurance standard for medical equipment and devices, which requires Trusts to ensure that 'All medical devices/equipment are properly maintained and repaired'. This standard can be downloaded from the Department of Health's Risk Management website at http://tap.ccta.gov.uk/doh/rm5.nsf

ENQUIRIES
Enquiries to the MHRA should quote reference number 20011015.999-003

© Crown Copyright 2002