DB 2005(03) Guidance on the Safe and Effective Use of Batteries and Chargers for Medical Devices

Executive summary
The MHRA continues to receive reports where users/carers have been injured as a result of batteries or chargers failing in use. The reports cover a variety of issues including:

• disastrous failures, where the battery overheats, leaks acid or explodes
• unexpected battery exhaustion during use
• inadequate battery and charger maintenance
• incorrect charging of rechargeable batteries
• use of replacement batteries that do not meet the required specification
• poor training of staff in battery usage, maintenance, charging or replacement requirements
• battery chargers and their leads and connectors overheating
• use of battery chargers that are incompatible with the batteries in the medical device.

This Device Bulletin has been prepared in consultation with a wide range of stakeholders to give general guidance to users, carers, health services, healthcare professionals, manufacturers and others involved in the provision, use and maintenance of medical devices and equipment with a battery.

The content identifies a wide variety of issues affecting batteries and chargers used with medical devices that generate risks to the safety of device users, healthcare staff and others. It gives guidance on reducing or removing the risks associated with battery related applications.

This document replaces Device Bulletin DB 9805, which is now withdrawn.

To order copies send an e-mail to: dh@prolog.uk.com or a fax to: 01623 724 524, quoting the title.