Equipment Management: Some Basic Principals of Equipment Management

Notice type: Advisory

Date: 15/12/2003


Product name or type:
Equipment Management: Some Basic Principals of Equipment Management


Manufacturer Or Supplier:

Target Audience:

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

Problem Or Issue:
Poor equipment management in organisations that use medical devices can either lead to or result in undesirable effects e.g. adverse incidents or near incidents or delayed implementation of corrective actions.

Background Information Or Related Documents:
Equipment management is a very important topic encompassing many areas including the choice of the device, purchase, commissioning, training, storage, repair and service and replacement of the medical device. To ensure effective management of equipment in a healthcare setting a well-structured coordinated multidisciplinary approach is required.  The aim of this safety notice is to highlight the importance of good equipment management and introduce some of the principal areas involved.

Equipment Management: Some Basic Principals of Equipment Management Document

Actions To Be Taken:
  • 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

Further Information:
All adverse incidents relating to a medical device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:    +353-1-6764971 
Fax:              +353-1-6767836 

SN2003(09): Equipment Management: Some Basic Principals of Equipment Management

« Back