Equipment Management: Some Basic Principals of Equipment Management

Notice type: Advisory

Date: 15/12/2003

This notice has been written as a guide for those people who are responsible for purchasing, installation, commissioning, schedule maintenance and repair of medical devices in hospitals.  It is targeted particularly at:   

• Chief Executive Officers
• Clinical Engineering Personnel
• Medical Physics Personnel
• Purchasing Managers
• Risk Managers

• Responsibility for management of medical devices within an organisation should be clearly defined and clear lines of accountability throughout the organisation should be established  
• A comprehensive organisation-wide policy on the management of medical devices including purchasing (and acquisition) monitoring, control, and deployment should be in place
• All medical device, modifications and trials should be conducted in accordance with relevant legislation and guidance
• All professional users and end-users should have access to manufacturer's instructions and users sign statements to the effect that they have received instructions on the safe use of devices or equipment  
• Acceptance checks should be carried out on all newly delivered medical devices  
• All new devices should be subject to an 'acceptance procedure' before being put into use
• All medical devices and equipment should be properly stored when not in use
• Medical devices designated for single use are not to be reused.
• All necessary information required to properly manage the organisation's range of medical devices / equipment is recorded on a suitable system
• A tracking system allowing the identification of equipment and it location should be established
• All medical devices / equipment should be properly maintained and repaired
• The in-house maintenance department is subject to a process of governance
• All medical devices returned for servicing and repair should be properly decontaminated
• Medical devices / equipment should be replaced, decommissioned and disposed of in accordance with an agreed policy
• All adverse incidents involving medical devices should be reported in accordance with IMB guidance, Guidance Notes 7 and 13 respectively.
• A complete record of advice and recommendations issued by the Irish Medicines Board (IMB) Medical Devices Department should be maintained; notices should be distributed to the appropriate people in the organisation and recommendations contained in the notices are implemented
• Staff should be made aware of and, where necessary, trained in adverse incident reporting requirements for medical devices
• All professional users should be trained in the safe operation of medical devices
• All technical staff should be provided with appropriate training
• All end-users should be given appropriate training in the safe and effective use of medical devices